Friday, 28 September 2012

Alupent Syrup






Alupent Syrup


(orciprenaline sulphate)




Read all of this leaflet carefully before you start taking this medicine.


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



In this leaflet:


  • 1. What ALUPENT Syrup is and what it is used for

  • 2. Before you take ALUPENT Syrup

  • 3. How to take ALUPENT Syrup

  • 4. Possible side effects

  • 5. How to store ALUPENT Syrup

  • 6. Further information




What Alupent Syrup Is And What It Is Used For


ALUPENT Syrup contains a medicine called orciprenaline. This belongs to a group of medicines called bronchodilators.


ALUPENT Syrup is used for something called ‘reversible airways obstruction’. This is where there is a narrowing of the airways of the lungs. Reversible airways obstruction is common in asthma and chronic obstructive pulmonary disease (COPD).


ALUPENT Syrup works to help people breathe more easily by relaxing the muscles and opening up the airways in their lungs.




Before You Take Alupent Syrup



Do not take ALUPENT Syrup if:


  • You are allergic (hypersensitive) to orciprenaline or any of the other ingredients of ALUPENT Syrup (listed in Section 6 below)

  • You have a heart problem called ‘hypertrophic obstructive cardiomyopathy’. This is where the wall between the two sides of the heart gets bigger and blocks the blood flow

  • You have a very fast heart beat (called ‘tachyarrhythmia’)

  • You are pregnant, likely to get pregnant or are breast-feeding

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.




Take special care with ALUPENT Syrup


Check with your doctor or pharmacist before taking your medicine if:


  • You have recently had a heart attack or have any other heart or circulation problems

  • You have an over-active thyroid gland

  • You have diabetes

  • You have ever had something called ‘pheochromocytoma’. This is a rare tumour that is not malignant. The chemicals the tumour produces may make the effects of the medicine stronger.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking ALUPENT Syrup.




Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because ALUPENT Syrup can affect the way some other medicines work. Also some other medicines can affect the way ALUPENT Syrup works.


In particular tell your doctor or pharmacist if you are taking any of the following medicines:


  • Other medicines for breathing problems such as theophylline

  • Medicines for high blood pressure such as beta-blockers and diuretics (water pills)

  • Medicines for depression such as ‘monoamine oxidase inhibitors’ (MAOIs) for example phenelzine or ‘tricyclic antidepressants’ for example amitriptyline

  • Medicines called ‘anti-cholinergics’. These are often in products for colicky pain.



Operations


Some gases used in operations (anaesthetic gases) may affect how your medicine works. If you are about to have surgery, make sure you mention that you are taking ALUPENT Syrup to the doctor, dentist or anaesthetist.




Pregnancy and breast-feeding


Do not take ALUPENT Syrup if you are pregnant, likely to get pregnant or if you are breast-feeding.




Important information about some of the ingredients of ALUPENT Syrup


ALUPENT Syrup contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These can cause allergic reactions in some people that could occur some time after taking the medicine.


ALUPENT Syrup also contains sodium metabisulphite which can cause allergic type reactions (including severe reactions and breathing problems) in some people, especially those with a history of asthma or allergies.


Each 300 ml bottle of syrup also contains 84 g of sorbitol. When taken according to the dosage recommendations, each 5 ml dose supplies up to 1.4 g of sorbitol which has a calorific value of 3.64Kcal. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The sorbitol in the product may have a mild laxative effect. If in doubt ask your doctor or pharmacist.





How To Take Alupent Syrup


Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.



Taking this medicine


  • Use a 5 ml plastic spoon to take the syrup. They are available from your pharmacist

  • ALUPENT Syrup should only be taken by mouth



How much to take



Children under 1 year


  • The usual starting dose is half a 5 ml spoonful (2.5 ml) three times a day

  • This may be increased up to one 5 ml spoonful three times a day by your doctor

  • The most your doctor will prescribe to be taken in a day is three 5 ml spoonfuls


Children between 1 and 3 years


  • The usual starting dose is half a 5 ml spoonful (2.5 ml) four times a day

  • This may be increased up to one 5 ml spoonful four times a day by your doctor

  • The most your doctor will prescribe to be taken in a day is four 5 ml spoonfuls


Children between 3 and 12 years


  • The usual starting dose is one 5 ml spoonful four times a day

  • This may be increased to two 5 ml spoonfuls three times a day by your doctor

  • The most your doctor will prescribe to be taken in a day is six 5 ml spoonfuls


Adults


  • The usual dose is two 5 ml spoonfuls four times a day

  • The most your doctor will prescribe to be taken in a day is eight 5 ml spoonfuls



If you take more ALUPENT Syrup than you should


If you take more of this medicine than you should, see your doctor or go to a hospital straight away. Take the medicine container with you even if there is no ALUPENT Syrup left.




If you forget to take ALUPENT Syrup


  • If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose

  • Do not take a double dose to make up for a forgotten dose



If you think this medicine is not working well enough


If your medicine does not seem to be working for you, talk to your doctor as soon as possible.


Do not take extra ALUPENT Syrup unless your doctor tells you to.





Alupent Syrup Side Effects


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


The following side effects may happen with this medicine:



Allergic reactions


If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. The signs may include:


  • swelling of the mouth and face

  • sudden breathing difficulties

  • your blood pressure being lower than it normally is



Other side effects


  • Feeling shaky, nervous or moody

  • Feeling sick (nausea), being sick (vomiting) or having an upset stomach

  • Feeling weak, dizzy, sweating or having a headache

  • Muscle cramps or pain

  • A faster or uneven heartbeat or a change in blood pressure

  • Tightness of the chest

  • Chest pain (due to heart problems such as angina). Tell your doctor or pharmacist if this occurs but do not stop taking this medicine unless told to do so.

  • Mild skin reactions or allergic reactions


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


If very high doses of ALUPENT are taken, it may cause unusually low levels of potassium in the blood (hypokalemia).




How To Store Alupent Syrup


Keep out of the sight and reach of children.


Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.


The bottle containing ALUPENT Syrup should be stored in the outer carton and not above 25°C.


Keep the bottle tightly closed.


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 ALUPENT Syrup contains


  • Each 5 ml of your medicine contains 10 mg of the active substance orciprenaline sulphate

  • The other ingredients are sodium metabisulphite, disodium edetate dihydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, hydroxyethylcellulose, saccharin, sorbitol solution, woodruff aroma, sodium hydroxide and purified water



What ALUPENT Syrup looks like and content of the pack


ALUPENT Syrup is 300 ml of syrup in a bottle.


This bottle comes in a carton.




Marketing Authorisation Holder and Manufacturer


The Marketing Authorisation for ALUPENT Syrup is held by:



Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom



And the syrup is manufactured by:



Istituto de Angeli S.r.l.

Localitá Prulli di Sotto n.103/C

50066 Reggello (FI)

Italy




This leaflet was revised in February 2009.


© Boehringer Ingelheim Limited 2009


437123/GB/6


20081216





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