البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
NIFEDIPINE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
C01CA05
NIFEDIPINE 10 mg
FILM-COATED TABLET
NIFEDIPINE 10 mg
POM
CARDIAC THERAPY
Authorised
2016-05-06
mt-pl-nifelat-10mg-fc-tabs-a5 _ _ _ _ Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NIFELAT 10 MG FILM-COATED TABLETS NIFEDIPINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nifelat is and what it is used for 2. What you need to know before you take Nifelat 3. How to take Nifelat 4. Possible side effects 5. How to store Nifelat 6. Contents of the pack and other information 1. WHAT NIFELAT IS AND WHAT IT IS USED FOR Nifelat contains the active substance nifedipine. One cause of high blood pressure is when the resistance in the blood vessels is too high. Nifelat is a calcium channel blocker (an agent that inhibits the influx of calcium into certain cells). Treatment with Nifelat reduces the tension in the muscle cells of the blood vessels. Hereby more blood (and thus more oxygen) is delivered and the blood vessels dilate. The most common type of angina occurs when the heart muscle receives too little oxygen. In case of angina, Nifelat dilates blood vessels, the heart does not have to work as hard to pump out the blood and thus less oxygen is needed. Raynaud’s disease is due to local vasoconstriction including fingers, which turn bluish, white, pulseless, cold, insensitive and clumsy. Nifelat counteracts this type of vasoconstriction. Nifelat is used to treat high blood pressure, stable angina, and Raynaud's disease (vasoconstriction in the fingers). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIFELAT DO NOT TAKE NIFELAT • if you are allergic to nifedipine or any of the other in اقرأ الوثيقة كاملة
mt-spc-nifelat-10mg-fc-tabs-v03-r00-a1f Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL PRODUCT Nifelat 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg nifedipine. Excipient(s) with known effect This product contains 60,9 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow, round, scored, film-coated tablets with Remedica’s logo on one side. The tablet can be divided into equal doses using a pill cutter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stable angina pectoris. Hypertension. Short-term treatment of Raynaud disease, primary as well as secondary. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose is adjusted individually. The tablets are swallowed whole with liquid, independently of meals. The tablets must not be split or crushed. Grapefruit juice should be avoided in conjunction with ingestion of the tablets (see 4.5 Interactions). The recommended dosing interval for Nifelat is approximately 12 hours but no less than 4 hours. _Angina pectoris:_ The appropriate starting dose is 10 mg twice daily. Normal dosage is 1-2 tablets (10-20 mg) twice daily. _Hypertension:_ The appropriate starting dose and usual maintenance dose is 10 mg twice daily. The dose may be increased gradually up to 40 mg twice daily. If a satisfactory therapeutic mt-spc-nifelat-10mg-fc-tabs-v03-r00-a1f Page 2 of 14 response has not been achieved after about 4-6 weeks with the initial dose, a dose increase or addition of another blood pressure lowering agent is recommended. _Raynaud disease:_ Given mainly to patients with bothersome symptoms when they are expected to be exposed to triggers. The usual dose is 10-20 mg twice daily. Experimentally, the dose may be increased to 40 mg twice daily. _Special patient groups _ _ _ _Paediatric population _ The efficacy and safety of nifedipine in children below 18 years of age has not been established. The information currently available اقرأ الوثيقة كاملة