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
Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
medinfo_uk@merck.com
This leaflet was last approved in April 2010
denotes registered trademark of Merck Sharp & Dohme Corp., a subsidiary
© Merck Sharp & Dohme Limited 2010. All rights reserved.
PIL.FSP.10.UK.3286-IA-IG003-015
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