eplerenone

Generic Name: eplerenone (ep LER e none)

Brand Names: Inspra

What is eplerenone?

Eplerenone blocks the actions of the hormone aldosterone in the body. Aldosterone is important for the regulation of blood pressure.

Eplerenone is used to treat congestive heart failure after a heart attack. Eplerenone is also used to treat high blood pressure (hypertension).

Eplerenone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about eplerenone?

You may not be able to take this medication if you have severe kidney disease, high potassium levels in your blood, or type 2 diabetes with protein in your urine.

You also may not be able to take eplerenone if you are also taking ketoconazole (Nizoral), itraconazole (Sporanox), nefazodone, clarithromycin (Biaxin), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or troleandomycin (Tao).

Before taking eplerenone, tell your doctor if you have kidney or liver disease, high cholesterol, or high triglycerides.

Do not use salt substitutes or potassium supplements while taking eplerenone, unless your doctor has told you to. To be sure this medication is helping your condition and is not causing harmful effects, your blood pressure will need to be checked on a regular basis. Your potassium levels will also need to be checked with frequent blood tests. Visit your doctor regularly. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What should I discuss with my healthcare provider before taking eplerenone?

You may not be able to take this medication if you are allergic to eplerenone, or if you have:

• 
  

  high potassium levels in your blood (hyperkalemia);

  
  


• severe kidney disease;


• 
  

  type 2 diabetes with protein in your urine; or

  
  


• 
  

  if you are also taking ketoconazole (Nizoral), itraconazole (Sporanox), nefazodone, clarithromycin (Biaxin), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or troleandomycin (Tao).

  
  

To make sure you can safely take eplerenone, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease;

  
  


• 
  

  liver disease; or

  
  


• 
  

  high cholesterol or triglycerides;

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether eplerenone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take eplerenone?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Eplerenone may be taken with or without food.

To be sure this medication is helping your condition and is not causing harmful effects, your blood pressure will need to be checked on a regular basis. Your potassium levels will also need to be checked with frequent blood tests. Visit your doctor regularly. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture and heat.

See also: Eplerenone dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow heart rate, weak pulse, muscle weakness, dizziness, or feeling like you might pass out.

What should I avoid while taking eplerenone?

Do not use salt substitutes or potassium supplements while taking eplerenone, unless your doctor has told you to.

This drug side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

  
  

Less serious side effects may include:

• 
  

  diarrhea, stomach pain;

  
  


• 
  

  cough;

  
  


• 
  

  dizziness;

  
  


• 
  

  tired feeling;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  vaginal bleeding; or

  
  


• 
  

  breast swelling or tenderness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Eplerenone Dosing Information

Usual Adult Dose for Congestive Heart Failure:

Congestive heart failure post-myocardial infarction:
Initial dosage: 25 mg orally once daily. Dosage should titrated to the target dose of 50 mg once daily preferably within 4 weeks.

Usual Adult Dose for Hypertension:

50 mg orally once daily. Patients with an inadequate blood pressure response should be increased to 50 mg twice a day.

What other drugs will affect eplerenone?

Many drugs can interact with eplerenone. Below is just a partial list. Tell your doctor if you are using:

• 
  

  lithium (Lithobid, Eskalith, others);

  
  


• 
  

  other blood pressure medications such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), or valsartan (Diovan);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);

  
  


• 
  

  an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

  
  


• 
  

  HIV/AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir, Kaletra);

  
  


• 
  

  an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with eplerenone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More eplerenone resources

• Eplerenone Side Effects (in more detail)
• Eplerenone Dosage
• Eplerenone Use in Pregnancy & Breastfeeding
• Drug Images
• Eplerenone Drug Interactions
• Eplerenone Support Group
• 0 Reviews for Eplerenone - Add your own review/rating

• eplerenone Advanced Consumer (Micromedex) - Includes Dosage Information


• Eplerenone Prescribing Information (FDA)


• Eplerenone Professional Patient Advice (Wolters Kluwer)


• Eplerenone Monograph (AHFS DI)


• Eplerenone MedFacts Consumer Leaflet (Wolters Kluwer)


• Inspra Prescribing Information (FDA)

Compare eplerenone with other medications

• Heart Failure
• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about eplerenone.

See also: eplerenone side effects (in more detail)

Wart-Off Treatment

Generic Name: salicylic acid topical (SAL i SIL ik AS id TOP ik al)

Brand Names: Compound W, DermalZone, Dermarest Psoriasis Skin Treatment, Dr Scholl's Callus Removers, Dr Scholl's Clear Away Wart Remover, Dr Scholl's Corn Removers, Duofilm, Freezone Corn Remover, Hydrisalic, Keralyt, Mediplast, Oxy Face Scrub, Propa P.H., Salac, Salex, Scalpicin Scalp Relief, Sebucare, Stri-Dex, Wart-Off Treatment

What is Wart-Off Treatment (salicylic acid topical)?

Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin.

Salicylic acid topical is used in the treatment of acne, dandruff, corns, and warts.

Salicylic acid topical may also be used for purposes other than those listed here.

What is the most important information I should know about Wart-Off Treatment (salicylic acid topical)?

Avoid the eyes, mouth, lips, inside the nose, genitals, and anal areas when applying salicylic acid topical. Do not use the wart remover on moles or birthmarks, or warts with hair growing from them, red edges, or unusual color. Also, do not use salicylic acid topical on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. If medication is applied to any of these areas, wash with water.

What should I discuss with my healthcare provider before using Wart-Off Treatment (salicylic acid topical)?

Avoid the eyes, mouth, lips, inside the nose, genitals, and anal areas when applying salicylic acid topical. Do not use the wart remover on moles or birthmarks, or warts with hair growing from them, red edges, or unusual color. Also, do not use salicylic acid topical on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. If medication is applied to any of these areas, wash with water.

Before using salicylic topical, talk to your doctor if you

• have kidney disease;


• have liver disease;


• 
  

  have diabetes;

  
  


• 
  

  have poor circulation; or

  
  


• 
  

  are treating a child.

  
  

You may not be able to use salicylic acid topical, or you may require a dosage adjustment or special monitoring during treatment.

It is not known whether salicylic acid topical will be harmful to an unborn baby. Do not use salicylic acid topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. Salicylic acid topical may pass into breast milk and affect a nursing baby. Do not use salicylic acid topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Wart-Off Treatment (salicylic acid topical)?

Use salicylic acid topical exactly as directed by your healthcare provider or as directed on the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Gently clean and dry the affected area. For the treatment of warts and calluses, gentle removal of loose skin with a soft brush, wash cloth, or emery board may be recommended before application of the medication.

Shake the lotion gently before application.

Apply a thin film of the medication to the affected area(s) as directed.

Use the soap and shampoo as directed on the package.

Apply the salicylic acid topical adhesive pads as directed on the package.

It is important to use salicylic acid topical regularly to get the most benefit. Do not stop using the medication if you do not see results immediately. Use the medication for the full amount of time directed.

Talk to your doctor if you experience excessive burning, dryness, or irritation of the skin, or changes in the color of the skin.

Store salicylic acid topical at room temperature away from moisture and heat. Some forms of salicylic acid topical may be flammable, keep away from heat and flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose.

Do not apply a double dose of the medication.

What happens if I overdose?

An overdose of salicylic acid topical is unlikely to occur. If you do suspect an overdose, or if the medication has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using Wart-Off Treatment (salicylic acid topical)?

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.

Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.

Wart-Off Treatment (salicylic acid topical) side effects

Serious side effects are not likely to occur with the use of salicylic acid topical. If you do experience any of the following rare serious side effects, stop using salicylic acid topical and seek emergency medical attention or contact your doctor:

• 
  

  an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives); or

  
  


• 
  

  severe skin irritation.

  
  

Other, less serious side effects are more likely to occur. Continue to use salicylic acid topical and talk to your doctor if you experience skin burning; stinging; itching; dryness; redness; peeling; or irritation.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Wart-Off Treatment (salicylic acid topical)?

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.

Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.

Drugs other than those listed here may also interact with salicylic acid topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Wart-Off Treatment resources

• Wart-Off Treatment Use in Pregnancy & Breastfeeding
• Wart-Off Treatment Drug Interactions
• Wart-Off Treatment Support Group
• 0 Reviews for Wart-Off Treatment - Add your own review/rating

• Akurza Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Duofilm Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Duoplant Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Durasal Prescribing Information (FDA)


• Freezone Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrisalic Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Ionil Plus Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Keralyt Prescribing Information (FDA)


• Keralyt Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Keralyt Scalp Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Salacyn Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Salex Prescribing Information (FDA)


• Salex Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Salkera Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Salvax Prescribing Information (FDA)


• Virasal Prescribing Information (FDA)


• Virasal Film-Forming Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Wart-Off Treatment with other medications

• Acne
• Warts

Where can I get more information?

• Your pharmacist has additional information about salicylic acid topical written for health professionals that you may read.

Leustatin

Pronunciation: KLAD-ri-been
Generic Name: Cladribine
Brand Name: Leustatin

Leustatin may decrease bone marrow function and decrease your ability to fight infection. At high doses, Leustatin may cause serious nervous system problems (eg, paralysis) and kidney problems. Notify your doctor immediately if you develop signs of infection, kidney problems, or nervous system problems, such as change in amount of urine; persistent sore throat or fever; or tingling or numbness in the hands and feet.

Leustatin is used for:

Treating hairy cell leukemia.

Leustatin is a cytotoxic agent. It works by stopping the replication and repair of the tumor cells.

Do NOT use Leustatin if:

• you are allergic to any ingredient in Leustatin

Contact your doctor or health care provider right away if this applies to you.

Before using Leustatin:

Some medical conditions may interact with Leustatin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have bone marrow problems, or liver or kidney problems

Some MEDICINES MAY INTERACT with Leustatin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that may weaken your immune system (eg, cyclosporine) because the risk of side effects may be increased. Check with your doctor or pharmacist if you are unsure if any of your other medicines may weaken your immune system

This may not be a complete list of all interactions that may occur. Ask your health care provider if Leustatin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Leustatin:

Use Leustatin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Leustatin is usually given as an injection at your doctor's office, hospital, or clinic. Leustatin must be properly diluted prior to use. If you will be using Leustatin at home, a health care provider will teach you how to use it. Be sure you understand how to use Leustatin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Leustatin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• If Leustatin accidentally spills on your skin, wash it off right away with soap and water. Clean any areas (counters, tables) where Leustatin may have spilled or sprayed.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Leustatin, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Leustatin.

Important safety information:

• Leustatin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Leustatin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Leustatin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Leustatin may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Talk with your doctor before you receive any vaccine while you are taking Leustatin.


• Tell your doctor or dentist that you take Leustatin before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including complete blood cell counts, may be performed while you use Leustatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Leustatin with caution in the ELDERLY; they may be more sensitive to its effects.


• Leustatin has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.


• Leustatin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Leustatin may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Leustatin while you are pregnant. It is not known if Leustatin is found in breast milk. Do not breast-feed while taking Leustatin.

Possible side effects of Leustatin:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; decreased appetite; diarrhea; dizziness; headache; mild tiredness or weakness; muscle or joint pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or side pain; black, tarry stools; blood in the urine; chest pain or tightness; cough; fever, chills, or sore throat; irregular heartbeat; irritation or pain at the injection site; numbness, tingling, or burning of the hands or feet; painful or difficult urination; persistent loss of appetite, unusual feeling of fullness, or unusual weight loss; severe or persistent vomiting; severe tiredness or weakness; shortness of breath; swelling (eg, of the hands or feet); unusual bleeding or bruising; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Leustatin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include change in amount of urine; paralysis (with high doses); tingling or numbness in the arms or legs.

Proper storage of Leustatin:

Leustatin is usually handled and stored by a health care provider. If you are using Leustatin at home, store Leustatin as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Leustatin, please talk with your doctor, pharmacist, or other health care provider.


• Leustatin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Leustatin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Leustatin resources

• Leustatin Side Effects (in more detail)
• Leustatin Use in Pregnancy & Breastfeeding
• Leustatin Drug Interactions
• Leustatin Support Group
• 0 Reviews for Leustatin - Add your own review/rating

• Leustatin Prescribing Information (FDA)


• Leustatin Advanced Consumer (Micromedex) - Includes Dosage Information


• Leustatin Concise Consumer Information (Cerner Multum)


• Leustatin Monograph (AHFS DI)


• Cladribine Prescribing Information (FDA)


• Cladribine Professional Patient Advice (Wolters Kluwer)

Compare Leustatin with other medications

• Hairy Cell Leukemia

ella

Generic Name: ulipristal (UE li PRIS tal)

Brand Names: ella

What is ulipristal?

Ulipristal is an emergency contraceptive. It works by stopping or delaying the release of an egg from an ovary. Ulipristal may also make it harder for a fertilized egg to attach to the uterus.

Ulipristal is used to prevent pregnancy after having sex without using a condom or other effective birth control method. Ulipristal is also used to prevent pregnancy after a regular form of birth control has failed.

Ulipristal is not to be used as a regular form of daily, weekly, or monthly birth control.

Ulipristal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ulipristal?

Ulipristal can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

Ulipristal is not to be used as a regular form of daily, weekly, or monthly birth control, and SHOULD NOT BE USED TO TERMINATE AN EXISTING PREGNANCY.

You should not use ulipristal if you are allergic to it, or if you have already confirmed that you are pregnant.

Before you take ulipristal, tell your doctor if you have a history of ectopic (tubal) pregnancy, or if your last menstrual period was less than 4 weeks ago. Also tell your doctor about all other medicines you use.

Call your doctor if your next menstrual period is more than 1 week late. You will need a pregnancy test to make sure you are not pregnant. Do not take a second course of ulipristal. Call your doctor at once if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using ulipristal.

What should I discuss with my healthcare provider before taking ulipristal?

You should not use ulipristal if you are allergic to it, or if you have already confirmed that you are pregnant.

Do not use ulipristal if you have not yet started having menstrual periods, or if you are past menopause.

To make sure you can safely take ulipristal, tell your doctor if you have any of these other conditions:

• 
  

  a history of ectopic (tubal) pregnancy; or

  
  


• 
  

  if your last menstrual period was more than 4 weeks ago.

  
  

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use emergency contraception if you are already pregnant or think you might be pregnant. Ulipristal IS NOT FOR USE IN TERMINATING AN EXISTING PREGNANCY. It is not known whether ulipristal passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using ulipristal.

How should I take ulipristal?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Ulipristal is usually given as soon as possible after unprotected sex or failed birth control method. Follow your doctor's dosing instructions very carefully. Ulipristal can be taken any time during your menstrual cycle, but you must use the medicine within 5 days (120 hours) after unprotected sex.

You may take ulipristal with or without food.

If you vomit within 3 hours after taking ulipristal, your medication may not be as effective. Call your doctor to discuss the need for taking another ulipristal tablet. Call your doctor if your next menstrual period is more than 1 week late. You will need a pregnancy test to make sure you are not pregnant. Do not take a second course of ulipristal.

Start or continue a barrier form of birth control (such as a condom or diaphragm with spermicide) as soon as possible after using ulipristal.

Ulipristal can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy for a short time after you take ulipristal.

Store at room temperature away from moisture and heat.

See also: Ella dosage (in more detail)

What happens if I miss a dose?

Since ulipristal is used only once when needed, it does not have a daily dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ulipristal?

Ulipristal will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Ulipristal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using ulipristal.

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness, tired feeling;

  
  


• 
  

  nausea, stomach pain; or

  
  


• 
  

  menstrual pain.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ulipristal?

Tell your doctor about all other medicines you use, especially:

• 
  

  bosentan (Tracleer);

  
  


• 
  

  griseofulvin (Fulvicin);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

  
  


• 
  

  antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

  
  

This list is not complete and other drugs may interact with ulipristal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More ella resources

• Ella Side Effects (in more detail)
• Ella Dosage
• Ella Use in Pregnancy & Breastfeeding
• Ella Drug Interactions
• Ella Support Group
• 1 Review for Ella - Add your own review/rating

• ella Monograph (AHFS DI)


• ella Consumer Overview


• ella MedFacts Consumer Leaflet (Wolters Kluwer)


• Ella Prescribing Information (FDA)


• Ella Advanced Consumer (Micromedex) - Includes Dosage Information

Compare ella with other medications

• Birth Control
• Emergency Contraception

Where can I get more information?

• Your pharmacist can provide more information about ulipristal.

See also: ella side effects (in more detail)

Sebomin MR

1. Name Of The Medicinal Product

Sebomin 100mg MR Capsules.

2. Qualitative And Quantitative Composition

Each capsule contains 100mg anhydrous minocycline (as the hydrochloride).

For excipients, see 6.1

3. Pharmaceutical Form

Prolonged-release capsule, hard.

Orange, opaque, hard gelatin capsules (size 2) printed “C” and “MR” in white.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of acne.

4.2 Posology And Method Of Administration

Dosage:

Adults: One 100mg capsule every 24 hours.

Children over 12 years: One 100mg capsule every 24 hours.

Children under 12 years: Sebomin MR is not recommended.

Elderly: No special dosing requirements.

Treatment of acne should be continued for a minimum of 6 weeks. If there is no satisfactory response to Sebomin MR after six months, the treatment should be discontinued and other therapies considered. If Sebomin MR is to be continued for longer than six months, patients should be monitored at least three monthly thereafter for signs and symptoms of hepatitis or SLE (see Special warnings and precautions for use).

Administration:

The capsules should be swallowed whole with plenty of fluid, while sitting or standing in order to reduce the risk of oesophageal irritation and ulceration. They should not be taken with food as this affects the absorption of minocycline.

4.3 Contraindications

• Known hypersensitivity to tetracyclines

• Pregnancy

• Lactation

• Children under the age of 12 years

• Complete renal failure.

4.4 Special Warnings And Precautions For Use

Minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with alcohol and other hepatotoxic drugs. It is recommended that alcohol consumption should remain within the Government's recommended limits.

Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) and also exacerbation of pre-existing SLE have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, or suffer exacerbation of pre-existing SLE, minocycline should be discontinued.

Clinical studies have shown that in patients with renal impairment there is no significant drug accumulation when they are treated with minocycline in the recommended doses. However, reduction of dosage and monitoring of renal function may be required in cases of severe renal insufficiency.

Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. Minocycline should be discontinued if there are signs/symptoms of overgrowth of resistant organisms, e.g. enteritis, glossitis, stomatitis, vaginitis, pruritus ani or staphylococcal enteritis.

Patients taking oral contraceptives should be warned that there is a possibility of contraceptive failure if diarrhoea or breakthrough bleeding occurs.

Minocycline may cause hyperpigmentation at various body sites. Hyperpigmentation may be present regardless of dose or duration of treatment but develops more commonly during long term treatment. Patients should be advised to report any unusual pigmentation without delay and minocycline should be discontinued.

If a photosensitivity reaction occurs, patients should be warned to avoid direct exposure to natural or artificial light and to discontinue therapy at the first sign of skin discomfort.

The capsule shell contains sunset yellow (E110), which can cause allergic - type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

Use in children:

The use of tetracyclines during tooth development in children under the age of 12 years may cause permanent discolouration. Enamel hypoplasia has also been reported.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Minocycline should not be used with penicillins. Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary.

Absorption of minocycline is impaired by the concomitant administration of antacids, iron, calcium, magnesium, aluminium and zinc salts. It is recommended that any indigestion remedies, vitamins, or other supplements containing these salts are taken at least 3 hours before or after a dose of minocycline. The capsules should not be taken with food as this affects the absorption of minocycline.

4.6 Pregnancy And Lactation

Pregnancy:

Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

Minocycline therefore, should not be used in pregnancy unless considered essential.

The use of drugs of the tetracycline class during tooth development (last half of pregnancy) may cause permanent discolouration of the teeth (yellow-grey-brown). This adverse reaction has been observed following repeated short term courses however it is more common during long term use of the drug. Enamel hypoplasia has also been reported.

Lactation:

Tetracyclines have been found in the milk of lactating women who are taking a drug in this class. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has been reported.

4.7 Effects On Ability To Drive And Use Machines

Minocycline has been associated with headache, light-headedness, dizziness and vertigo and rarely impaired hearing. Patients should be warned about the possible hazards of driving or operating machinery during treatment.

4.8 Undesirable Effects

Common

As with other tetracyclines, gastrointestinal disturbances including nausea, anorexia, vomiting and diarrhoea may occur. Dermatological reactions such as erythema multiforme, erythema nodosum, Stevens Johnson syndrome, exfoliative dermatitis, hair loss and photosensitivity have been reported, as well as maculopapular and erythematous rashes. Hypersensitivity reactions can include urticaria, fever, arthralgia, myalgia, arthritis, pulmonary infiltration, wheezing, angioneurotic oedema, anaphylaxis and anaphylactoid purpura.

Cases of systemic lupus erythematosus (SLE) and also exacerbation of pre-existing SLE have been reported (see also Special warnings and precautions for use).

In common with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported. If evidence of raised intracranial pressure develops, treatment should cease.

Blood haemolytic anaemia, thrombocytopenia, neutropenia and eosinophilia have been reported with tetracyclines.

As with other tetracyclines, transient increases in liver function test values have been reported. Some hepatic reactions have an auto-immune basis, and may occur after several months of minocycline treatment (see Posology and method of administration). When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discolouration of thyroid tissue.

Uncommon

There have been isolated incidences of pancreatitis.

Hyperpigmentation of skin, nails or discolouration of teeth and buccal mucosa have been reported occasionally. These are generally reversible on cessation of therapy.

There are isolated cases of discolouration of conjunctiva, lacrimal secretions, breast secretions and perspiration.

Rare

Hepatitis and acute liver failure have been reported.

Fixed drug eruptions have been observed.

Pericarditis, myocarditis, vasculitis and renal failure including interstitial nephritis have been reported.

Bone discolouration has been observed.

(See also Pregnancy and Lactation).

4.9 Overdose

No specific antidote. Gastric lavage plus appropriate supportive treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotheraputic group: Tetracycline, ATC code: J01A A08

Sebomin MR contain the active ingredient minocycline as minocycline hydrochloride, a semi-synthetic derivative of tetracycline.

Minocycline has a long serum half-life and can be administered at 12 hour intervals, the modified release form can be given once daily.

Minocycline interferes with the third stage of bacterial protein synthesis. After amino acids are activated and attached to t-RNA (transfer RNA), the resulting amino acyl-t-RNA migrates to the bacterial ribosome for synthesis of proteins. Minocycline binds to the 30s subunit on the ribosome and inhibits binding of the aminoacyl-t-RNA molecules.

There is also evidence that minocycline may cause alterations in the cytoplasmic membrane, thereby allowing leakage of nucleotides and other compounds from the cell. This would explain the rapid inhibition of DNA replication that ensues when cells are exposed to concentrations of minocycline greater than that needed to inhibit protein synthesis.

In higher concentration, minocycline inhibits mammalian protein synthesis and may aggravate pre-existing renal functional impairment. The drug may interfere with parenteral nutrition in post operative patients by inhibiting utilization of amino acids for protein synthesis.

Minocycline is reported to be active against both Gram negative and Gram positive organisms.

5.2 Pharmacokinetic Properties

Absorption

Oral bioavailability for minocycline has been reported to be 90%.

One report has demonstrated that food did not significantly affect the absorption of minocycline following 50 mg oral doses. However, another study reported that minocycline absorption was decreased by 77%, 27% and 13% when given with iron, milk and food.

Distribution

Total protein binding of minocycline has been reported to be in the order of 76%.

Other sites of distribution of minocycline include the following:

AQUEOUS HUMOR

Minocycline administered orally with a loading dose of 200 mg followed by 2 doses of 100 mg 12 hours apart produce adequate drug concentration in the aqueous humor of noninflamed eyes. The plasma to aqueous humor ratio was approximately 2:1.

CEREBROSPINAL FLUID

Minocycline has been reported to cross the blood/brain barrier to a higher degree than doxycycline. However, passage of either drug has been shown to be significantly decreased in patients with uninflamed meninges.

GINGIVAL FLUID

The mean gingival crevicular fluid drug concentration of 8.03 +/- 1.64 mcg/ml was reported after 7 days of oral minocycline 200 mg in patients with moderate to severe periodontal disease. Mean serum concentration was 2.58 +/- 0.32 mcg/ml.

JOINT FLUID CONCENTRATIONS

Following 200 mg oral doses of minocycline, joint fluid levels 3 to 12 hours following the dose were 0.43 to 0.88 mcg/ml.

SALIVA/TEARS

Minocycline achieved significant levels in saliva and tears sufficient to inhibit most strains of meningococci. Following oral doses of 100 mg every 12 hours for 5 days, the concentration of drug in saliva and tear equalled or was greater than the average MIC for meningococci for up to 12 hours after the dose. Two hours following an oral dose, concentrations of minocycline in saliva and tears were at 0.3 mcg/mL and 0.4 mcg/mL, respectively.

SINUS SECRETIONS

Following a dose of 100 mg twice daily for 4 days in patients with sinusitis a sinus level of 1.06 mcg/5 mL was found. The mean minocycline serum level was 3.16 mcg/ml, giving a sinus secretion to serum level ratio of 0.34:1.

Metabolism

An inactive metabolite, 9-hydroxyminocycline has been isolated.

Elimination

Minocycline has a very low renal clearance as compared to other tetracyclines. However, urinary concentrations approximating 10 times that of serum are attained for the first 4 to 6 hours following an oral dose.

Minocycline is excreted 19% in the faeces, this level is much lower than most other tetracyclines.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

glycerol monostearate 40-55,

microcrystalline cellulose 101 (E460(i)),

povidone K-30 (E1201),

purified talc (E553b).

Capsule shell

gelatin,

purified water,

titanium dioxide (E171),

sunset yellow (E110),

quinoline yellow (E104).

Printing ink

shellac (E904),

ethyl alcohol,

isopropyl alcohol,

propylene glycol,

butyl alcohol,

povidone (E1201),

sodium hydroxide,

titanium dioxide (E171).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 30°C.

Polypropylene container - store in the original container,

PVC/aluminium blister pack - keep container in the outer carton.

6.5 Nature And Contents Of Container

PVC/aluminium blister pack in outer cardboard container

28, 30, 56, 60, 84, 90

Polypropylene container with polyethylene cap

100, 112, 120, 200, 250, 500

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

Barnstaple

North Devon

EX32 8NS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00142/0526

9. Date Of First Authorisation/Renewal Of The Authorisation

20 June 2003

Renewed – 19.03.09

10. Date Of Revision Of The Text

19.03.09

Tamiflu

Generic Name: oseltamivir (Oral route)

oh-sel-TAM-i-vir FOS-fate

Commonly used brand name(s)

In the U.S.

• Tamiflu

Available Dosage Forms:

• Powder for Suspension


• Capsule

Therapeutic Class: Antiviral

Pharmacologic Class: Oseltamivir

Uses For Tamiflu

Oseltamivir belongs to the family of medicines called antivirals, which are used to treat infections caused by viruses. Oseltamivir is used in the treatment of the infection caused by the flu virus (influenza A and influenza B). Oseltamivir may also be used to prevent and treat swine influenza A.

Oseltamivir may reduce flu symptoms (weakness, headache, fever, cough, runny or stuffy nose, and sore throat) by 1 day. Oseltamivir is also used to prevent influenza infection if you have come into close contact with someone who has the flu.

If you receive the flu vaccine every year, continue to do so. Oseltamivir is not a substitute for your yearly flu shot.

This medicine is available only with your doctor's prescription.

Before Using Tamiflu

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Oseltamivir is not indicated to treat and prevent flu in children younger than 1 year of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oseltamivir in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or


• Illnesses caused by viruses other than influenza Type A or B or


• Liver disease, severe or


• Lung disease or


• Serious medical problems that may need admission to a hospital or


• Weakened immune system—Safety of this medicine for people with these conditions is not established.

• Hereditary fructose intolerance—Use with caution. The oral suspension contains sorbitol, which can make this condition worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Tamiflu

Talk to your doctor about the possibility of getting a flu shot if you or your child have not had one yet. This medicine comes with a patient information leaflet. Read this information carefully and talk to your doctor if you have any questions.

For patients taking oseltamivir for the treatment of flu: This medicine works best if taken within 2 days of having flu symptoms (weakness, headache, fever, cough, runny or stuffy nose, and sore throat). This medicine should be taken for 5 days. Continue taking this medicine for the full time of treatment even if you begin to feel better after a few days. This will help clear up your infection completely. If you stop taking this medicine too soon, your symptoms may return.

For patients taking oseltamivir for the prevention of flu after an exposure: The medicine should be taken within 2 days of being exposed to the flu. This medicine should be taken for at least 10 days.

You may take this medicine with meals or on an empty stomach. Taking oseltamivir with food may lessen the possibility of stomach upset.

The oral liquid form of this medicine is available in two dosage strengths (concentrations). Check with your doctor if you have any questions about the dosing instructions, how to measure a dose using the new dosing dispenser (in mL), or about which concentration of Tamiflu® for oral suspension you have.

For patients taking the oral liquid:

• This medicine is to be taken only by mouth. Shake it well before using. Use the specially marked dosing dispenser that comes with the medicine to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid. If the measuring device is lost or damaged, contact your pharmacist or doctor to find out the appropriate dose.


• Do not use the medicine after the expiration date on the label. The medicine may not work properly after that date. If you have any questions about this, check with your pharmacist.

If the oral liquid is not available, you may open the capsules and mix the contents in a bowl with sweetened liquids such as regular or sugar-free chocolate syrup, corn syrup, caramel topping, or light brown sugar (dissolved in water). Ask your doctor or pharmacist if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or suspension):
  
  • For treatment of the flu:
    
    • Adults and teenagers—75 milligrams (mg) or 12.5 milliliters (mL) two times a day (one in the morning and one in the evening) for 5 days.
    
    
    • Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor. It is usually between 30 to 75 mg or 5 to 12.5 mL two times a day for 5 days.
    
    
    • Children younger than 1 year of age—Use is not recommended.
    
    
  
  
  • For prevention of the flu:
    
    • Adults and teenagers—75 milligrams (mg) or 12.5 milliliters (mL) once a day for at least 10 days.
    
    
    • Children 1 year of age or older—Dose is based on body weight and must be determined by your doctor. It is usually between 30 to 75 mg or 5 to 12.5 mL once a day for 10 days.
    
    
    • Children younger than 1 year of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use it, take it as soon as you can, except if it is less than 2 hours before your next dose. Take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules at room temperature, away from heat, moisture, and direct light.

Store the oral liquid in the refrigerator and use it within 17 days after it has been mixed. Do not freeze. You may also store it at room temperature for up to 10 days. Throw away any mixed medicine that has not been used within this time.

Precautions While Using Tamiflu

It is very important that your doctor check your or your child's progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects.

This medicine is not a substitute for an annual flu shot. It also will not keep you or your child from getting a bacterial infection that starts with flu-like symptoms.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you or your child are using this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you or your child are using this medicine.

Oseltamivir may cause some people, especially children and teenagers, to be agitated, irritable, or display other abnormal behaviors, which may result in injury. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Make sure your doctor knows if you or your child plan to get the live nasal mist flu vaccine before you start using this medicine. You should not receive the vaccine within two weeks before or 48 hours after using this medicine.

If your or your child's symptoms do not improve after you or your child finish taking the medicine, or if they become worse, check with your doctor.

Tamiflu Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Phlegm-producing cough


• wheezing

Rare

• Abdominal or stomach cramps or tenderness


• arm, back, or jaw pain


• bloating


• chest pain or discomfort


• chest tightness or heaviness


• diarrhea, watery and severe, which may also be bloody


• drooling


• facial swelling


• fast or irregular heartbeat


• fever


• hoarseness


• humerus fracture (broken forearm)


• increased thirst


• pain


• shortness of breath


• tender glands of the jaw and throat


• unusual tiredness or weakness


• unusual weight loss

Incidence not known

• Blistering, peeling, or loosening of the skin


• chills


• convulsions (seizures)


• dark urine


• difficulty with swallowing


• fainting


• fast, slow, or irregular heartbeat


• general tiredness and weakness


• hives or welts


• itching


• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue


• joint or muscle pain


• light-colored stools


• loss of bladder control


• loss of consciousness


• muscle spasm or jerking of all extremities


• red skin


• red skin lesions, often with a purple center


• red, irritated eyes


• shortness of breath


• skin rash


• skin rash or itching over the entire body


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• sudden loss of consciousness


• sweating


• swelling of the face or tongue


• upper right abdominal or stomach pain


• weakness


• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• nausea


• vomiting

Less common

• Abdominal or stomach pain


• bloody nose or unexplained nosebleeds (occurs mainly in children)


• burning, dry, or itching eyes (mainly in children)


• cough


• dizziness


• ear disorder (occurs mainly in children)


• excessive tearing of the eyes (mainly in children)


• headache


• redness, pain, or swelling of the eye or eyelid (mainly in children)


• trouble with sleeping

Rare

• Pale skin


• sneezing


• troubled breathing


• troubled breathing with exertion


• unusual bleeding or bruising

Incidence not known

• Blistering, crusting, irritation, itching, or reddening of the skin


• blurred vision


• cracked, dry, or scaly skin


• dry mouth


• flushed, dry skin


• fruit-like breath odor


• increased hunger


• increased urination


• mood or mental changes


• skin rash that is encrusted, scaly, and oozing


• stomachache


• unexplained weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tamiflu side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tamiflu resources

• Tamiflu Side Effects (in more detail)
• Tamiflu Use in Pregnancy & Breastfeeding
• Drug Images
• Tamiflu Drug Interactions
• Tamiflu Support Group
• 20 Reviews for Tamiflu - Add your own review/rating

• Tamiflu Prescribing Information (FDA)


• Tamiflu Monograph (AHFS DI)


• Tamiflu MedFacts Consumer Leaflet (Wolters Kluwer)


• Tamiflu Consumer Overview

Compare Tamiflu with other medications

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• Influenza Prophylaxis
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FOSAVANCE Tablets

FOSAVANCE 70 mg/2800 IU tablets

Alendronic acid as alendronate sodium trihydrate/colecalciferol

Read all of this leaflet carefully before you start taking this medicine, even if this is a repeat prescription.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


• It is particularly important to understand the information in section 3. HOW TO TAKE FOSAVANCE, before taking this medicine.

In this leaflet:

• 1. What FOSAVANCE is and what it is used for


• 2. Before you take FOSAVANCE


• 3. How to take FOSAVANCE


• 4. Possible side effects


• 5 How to store FOSAVANCE


• 6. Further information

What Fosavance Is And What It Is Used For

What is FOSAVANCE?

FOSAVANCE is a tablet containing the two active substances, alendronate sodium trihydrate and colecalciferol known as vitamin D₃.

What is alendronate?

Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

What is vitamin D?

Vitamin D is an essential nutrient, required for calcium absorption and healthy bones. The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin. As we get older our skin makes less vitamin D. Too little vitamin D may lead to bone loss and osteoporosis. Severe vitamin D deficiency may cause muscle weakness which can lead to falls and a greater risk of fractures.

What is FOSAVANCE used for?

Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of vitamin D insufficiency. FOSAVANCE reduces the risk of spine and hip fractures.

FOSAVANCE is a once weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to begin treatment. FOSAVANCE not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.

As well as your treatment with FOSAVANCE, your doctor may suggest you make changes to your lifestyle to help your condition, such as:

Stopping smoking: Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.

Exercise: Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.

Eating a balanced diet: Your doctor can advise you about your diet or whether you should take any dietary supplements.

Before You Take Fosavance

Do not take FOSAVANCE

• (1) if you are allergic (hypersensitive) to alendronate sodium trihydrate, colecalciferol or any of the other ingredients,


• (2) if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing,


• (3) if you cannot stand or sit upright for at least 30 minutes,


• (4) if your doctor has told you that you have low blood calcium.

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Take special care with FOSAVANCE

It is important to tell your doctor before taking FOSAVANCE

• if you suffer from kidney problems,


• if you have any allergies,


• if you have any swallowing or digestive problems,


• if your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),


• if you have low blood calcium levels,


• if you have cancer,


• if you are undergoing chemotherapy or radiotherapy,


• if you are taking steroids,


• if you don’t receive routine dental care,


• if you have gum disease,


• if you have a planned dental extraction.

Irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking FOSAVANCE. These side effects may worsen if patients continue to take FOSAVANCE after developing these symptoms.

Children and adolescents

FOSAVANCE should not be given to children and adolescents.

Taking other medicines

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAVANCE if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAVANCE.

It is likely that certain medicines or food additives may prevent the vitamin D in FOSAVANCE from getting into your body, including artificial fat substitutes, mineral oils, orlistat and the cholesterol-lowering medicines, cholestyramine and colestipol. Medicines for fits (seizures) may decrease the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking FOSAVANCE with food and drink

It is likely that food and beverages (including mineral water) will make FOSAVANCE less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAVANCE.

Pregnancy and breast-feeding

FOSAVANCE is only intended for use in postmenopausal women. You should not take FOSAVANCE if you are or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

There have been side effects reported with FOSAVANCE that may affect your ability to drive or operate machinery. Individual responses to FOSAVANCE may vary. (See POSSIBLE EFFECTS.)

Important information about some of the ingredients of FOSAVANCE

FOSAVANCE contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Fosavance

Take one FOSAVANCE tablet once a week.

Follow these instructions carefully to make sure you will benefit from FOSAVANCE.

• 1) Choose the day of the week that best fits your schedule. Every week, take one FOSAVANCE tablet on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the FOSAVANCE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).

• 2) After getting up for the day and before taking any food, drink, or other medicine, swallow your FOSAVANCE tablet whole with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.).
  
  
  • Do not take with mineral water (still or sparkling).
  • Do not take with coffee or tea.
  • Do not take with juice or milk.

Do not crush or chew the tablet or allow it to dissolve in your mouth.

• 3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.


• 4) Do not take FOSAVANCE at bedtime or before getting up for the day.


• 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.


• 6) After swallowing your FOSAVANCE tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. FOSAVANCE is effective only if taken when your stomach is empty.

If you take more FOSAVANCE than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

If you forget to take FOSAVANCE

If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

If you stop taking FOSAVANCE

It is important that you continue taking FOSAVANCE for as long as your doctor prescribes the medicine. FOSAVANCE can treat your osteoporosis only if you continue to take the tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

FOSAVANCE Tablets Side Effects

Like all medicines, FOSAVANCE can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

Common (occurring in at least 1 of 100 patients and less than 1 of 10 patients treated).

Uncommon (occurring in at least 1 of 1000 patients and less than 1 of 100 patients treated).

Rare (occurring in at least 1 of 10,000 patients and less than 1 of 1000 patients treated).

Very rare (occurring in less than 1 of 10,000 patients treated).

Common:

• heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing,


• bone, muscle and/or joint pain,


• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,


• headache.

Uncommon:

• nausea; vomiting,


• irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach,


• black or tar-like stools,


• rash; itching; redness of the skin.

Rare:

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing,


• symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,


• stomach or peptic ulcers (sometimes severe or with bleeding),


• narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach),


• blurred vision, pain or redness in the eye,


• rash made worse by sunlight,


• severe bone, muscle and/or joint pain,


• mouth ulcers when the tablets have been chewed or sucked,


• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment.

Very rare:

• severe skin reactions.

During post-marketing experience the following side effects have been reported (frequency not known):

• dizziness,


• changed sense of taste,


• joint swelling,


• tiredness,


• hair loss,


• jaw problems associated with delayed healing and infection, often following tooth extraction,


• swelling in the hands or legs,


• fracture of the thigh bone in patients on long-term treatment with FOSAVANCE. Thigh pain, weakness or discomfort may be an early indication of a possible fracture of the thigh bone.

Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

It will help if you make a note of what you experienced, when it started and how long it lasted.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Fosavance

Keep out of the reach and sight of children.

Do not use FOSAVANCE after the expiry date which is stated on the carton and the wallet after EXP. The expiry date refers to the last day of that month.

Store in the original blister in order to protect from moisture and light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What FOSAVANCE contains

The active substances are alendronate sodium trihydrate and colecalciferol (vitamin D₃). Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) colecalciferol (vitamin D₃).

The other ingredients are microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572) butyl hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).

What FOSAVANCE looks like and contents of the pack

FOSAVANCE 70 mg/2800 IU tablets are available as capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710’on the other.

The tablets are supplied in wallets with sealed aluminium blisters in cartons in the following pack sizes

• 2 tablets (1 wallet containing 2 tablets in aluminium blisters)


• 4 tablets (1 wallet containing 4 tablets in aluminium blisters)


• 6 tablets (3 wallets each containing 2 tablets in aluminium blisters).


• 12 tablets (3 wallets each containing 4 tablets in aluminium blisters).


• 40 tablets (10 wallets each containing 4 tablets in aluminium blisters).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

United Kingdom

Manufacturer

Merck Sharp & Dohme BV.

Waarderweg 39

2031 BN

Haarlem

Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom

Merck Sharp and Dohme Limited

Tel:+44 (0) 1992 467272

medinfo_uk@merck.com

This leaflet was last approved in April 2010

denotes registered trademark of Merck Sharp & Dohme Corp., a subsidiary

Merck & Co., Inc.

Whitehouse Station

NJ

USA

© Merck Sharp & Dohme Limited 2010. All rights reserved.

PIL.FSP.10.UK.3286-IA-IG003-015

Kao-Tin Bismuth Subsalicylate Formula

Generic Name: bismuth subsalicylate (BIZ muth sub sa LISS i late)

Brand Names: Bismarex, Bismatrol, Bismatrol Maximum Strength, Kao-Tin Bismuth Subsalicylate Formula, Kaopectate, Maalox Total Stomach Relief, Peptic Relief, Pepto-Bismol, Pepto-Bismol Maximum Strength, Pink Bismuth

What is Kao-Tin Bismuth Subsalicylate Formula (bismuth subsalicylate)?

Bismuth subsalicylate is an antacid and anti-diarrhea medication.

Bismuth subsalicylate is used to treat diarrhea, nausea, heartburn, indigestion, and upset stomach.

Bismuth subsalicylate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Kao-Tin Bismuth Subsalicylate Formula (bismuth subsalicylate)?

This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye's syndrome in children. You should not use bismuth subsalicylate if you have a stomach ulcer, a recent history of stomach or intestinal bleeding, or if you are allergic to salicylates such as aspirin, Doan's Extra Strength, Salflex, Tricosal, and others.

Do not take more than 8 doses in one day (24 hours).

Bismuth subsalicylate can cause you to have a black or darkened tongue. This is a harmless side effect.

This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken bismuth subsalicylate.

What should I discuss with my health care provider before taking Kao-Tin Bismuth Subsalicylate Formula (bismuth subsalicylate)?

This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Subsalicylate can cause a serious and sometimes fatal condition called Reye's syndrome in children. You should not use bismuth subsalicylate if you are allergic to it, or if you have:

• 
  

  a stomach ulcer;

  
  


• 
  

  a recent history of stomach or intestinal bleeding; or

  
  


• 
  

  if you are allergic to salicylates such as aspirin, Doan's Extra Strength, Salflex, Tricosal, and others.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  fever;

  
  


• 
  

  mucus in your stools;

  
  


• 
  

  diabetes;

  
  


• 
  

  arthritis; or

  
  


• 
  

  gout.

  
  

Do not take bismuth subsalicylate without medical advice if you are pregnant. Bismuth subsalicylate can pass into breast milk and may harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

How should I take Kao-Tin Bismuth Subsalicylate Formula (bismuth subsalicylate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take more than 8 doses in one day (24 hours). Shake the liquid medicine well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable tablet must be chewed before you swallow it.

Bismuth subsalicylate can cause you to have a black or darkened tongue. This is a harmless side effect.

This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken bismuth subsalicylate.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since bismuth subsalicylate is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. Do not take more than 8 doses in one day (24 hours).

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include increased thirst, anxiety, muscle spasm, ringing in your ears, dizziness, confusion, severe headache, problems with speech or vision, severe stomach pain, or worsening diarrhea or vomiting.

What should I avoid while taking Kao-Tin Bismuth Subsalicylate Formula (bismuth subsalicylate)?

Ask your doctor or pharmacist before taking other antacids or diarrhea medications together with bismuth subsalicylate.

Kao-Tin Bismuth Subsalicylate Formula (bismuth subsalicylate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

• 
  

  hearing loss or ringing in your ears;

  
  


• 
  

  diarrhea lasting longer than 2 days; or

  
  


• 
  

  worsened stomach symptoms.

  
  

Less serious side effects include:

• 
  

  constipation;

  
  


• 
  

  dark colored stools; or

  
  


• 
  

  black or darkened tongue.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Kao-Tin Bismuth Subsalicylate Formula (bismuth subsalicylate)?

Ask a doctor or pharmacist if it is safe for you to use bismuth subsalicylate if you are also using any of the following drugs:

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  insulin or oral diabetes medications;

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  an antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

  
  


• 
  

  medication used to prevent blood clots, such as alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase); or

  
  


• 
  

  other salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

  
  

This list is not complete and other drugs may interact with bismuth subsalicylate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Kao-Tin Bismuth Subsalicylate Formula resources

• Kao-Tin Bismuth Subsalicylate Formula Side Effects (in more detail)
• Kao-Tin Bismuth Subsalicylate Formula Use in Pregnancy & Breastfeeding
• Kao-Tin Bismuth Subsalicylate Formula Drug Interactions
• 0 Reviews for Kao-Tin Bismuth Subsalicylate Formula - Add your own review/rating

• Bismuth Subsalicylate Professional Patient Advice (Wolters Kluwer)


• Bismuth Subsalicylate MedFacts Consumer Leaflet (Wolters Kluwer)


• Bismatrol Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Bismatrol Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Kao-Tin Bismuth Subsalicylate Formula with other medications

• Diarrhea
• Diarrhea, Chronic
• Helicobacter Pylori Infection
• Indigestion
• Lymphocytic Colitis

Where can I get more information?

• Your pharmacist can provide more information about bismuth subsalicylate.

See also: Kao-Tin Bismuth Subsalicylate Formula side effects (in more detail)