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Unipine Xl

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TEXT FOR NON-MARKETED PACKS PIL FOR

UNIPINE XL (NIFEDIPINE) 28’s

What you should know about Unipine XL

(nifedipine)

Please read this leaflet carefully before you start taking your medicine.

This leaflet does not contain the complete information about your medicine.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

About your medicine

•    Unipine XL (nifedipine) tablets contain 30mg of nifedipine as the active ingredient and is a sustained release preparation. This means that the active ingredient is released slowly into your body so as to act over a 24 hour period.

•    Your tablets also contain povidone, ammoniomethacrylate copolymer, lactose, hydrogenated castor oil, talc and colours (E110, E171, E120, E132).

•    The tablets are presented in a blister strip containing 14 tablets, two strips per pack.

•    Nifedipine belongs to a group of drugs called calcium antagonists. These are used to treat high blood pressure in adults.

Marketing Authorisation Holder

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.

Manufacturer

Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary, Ireland.

Unipine XL is used for the treatment of high blood pressure.

Before taking your medicine

If the answer to any of these questions is yes, tell your doctor or pharmacist before taking Unipine XL.

•    Do you have any problems with your heart?

•    Have you previously had a heart attack?

•    Do you suffer from liver disease?

•    Are you taking any other medication on a regular basis especially ones containing cimetidine (for ulcers/heartburn), beta-blockers or other medicine for high blood pressure, the anti-arrhythmic drugs (which are used to treat problems with irregular heartbeats) such as quinidine, phenytoin (which may also be used to treat epilepsy), digoxin (which may also be used in heart failure) or theophylline, which is used to treat asthma or rifampicin (an antibiotic)?

•    Diabetic patients may need to adjust the dosage of insulin or other medication, when using Unipine XL. Discuss this with your doctor.

Do not take this medicine:

•    If you are pregnant, or may become pregnant

•    If you are breast-feeding your baby

•    At the same time as grapefruit juice, or near the time of eating grapefruit. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine.

•    Do not use Unipine XL to treat a heart attack, or within one month of a heart attack.

•    Do not take Unipine XL to treat an angina attack when it occurs

•    Do not take this medicine if you have ever had an allergic reaction after taking other nifedipine preparations or similar drugs (dihydropyridines)

TEXT FOR NON-MARKETED PACKS PIL FOR

UNIPINE XL (NIFEDIPINE) 28’s

•    Unipine XL should not be given to children

•    If you are suffering from a severe form of high blood pressure, Unipine XL may not be suitable for you. Your doctor will decide which treatment is best for you.

Taking your medicine

•    It is important to take your medicine as directed by your doctor.

•    The recommended dose of Unipine XL is one (30mg) tablet, once daily preferably in the morning. If necessary, your doctor may prescribe two tablets daily.

•    Always take your tablet at the same time, preferably every morning

•    Swallow your tablet whole with little water. Do not chew. Tablets should not be taken with or immediately after food.

•    If you are elderly, your doctor may prescribe a lower dose. Take the tablets as prescribed by your doctor.

•    In the event of an accidental overdose contact your nearest hospital casualty department or tell your doctor immediately.

•    If you forget to take a tablet, take another as soon as you remember. Then go on as before.

After taking your medicine

•    This medicine might cause some side-effects. Most of these (for example headache, dizziness, flushing and fluid retention) are nothing to worry about and tend to disappear as treatment continues. Other common side-effects include feeling sick, feeling sleepy and increased frequency of urination.

•    If you experience any chest (ischaemia) tell your doctor before you take any more of this medicine. Your doctor may stop your treatment with this medicine.

•    If you have any of the following, tell your doctor: rash, jaundice, swelling of your gums, tingling sensations.

•    As with similar medicines, anginal pain may very rarely occur at the start of the treatment with nifedipine.

•    There have been reports of heart attacks during treatment with nifedipine medicines. However, it is not possible to determine if these were as a result of the medicine or if they would have occurred anyway.

•    If you notice any side-effects, consult your doctor.

Storing your medicine

   Keep out of reach and sight of children

•    Do not use your tablets after the expiry date indicated on the pack

•    Keep your tablets below 25°C in a dry place, protected from light in their original container

•    If your doctor decides to stop treatment, return any left over tablets to the pharmacist. Only keep them if your doctor tells you to.

Remember:

This medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them

even if their symptoms are the same as yours.

This leaflet was last revised: June 2014

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