Country: Malta
Tungumál: enska
Heimild: Medicines Authority
NIFEDIPINE
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
C08CA05
NIFEDIPINE 20 mg
MODIFIED-RELEASE TABLET
NIFEDIPINE 20 mg
POM
CALCIUM CHANNEL BLOCKERS
Withdrawn
2006-11-23
PMR 85987860 (H3/01-C/MU-0201710565) Pantone: Black, Orange 021 85987860 PACKAGE LEAFLET: INFORMATION FOR THE USER 0 ADALAT ® RETARD 20 MG Modified-release 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 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 ADALAT RETARD IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADALAT RETARD 3 HOW TO TAKE ADALAT RETARD 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ADALAT RETARD 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT ADALAT RETARD IS AND WHAT IT IS USED FOR Adalat retard contains nifedipine, which belongs to a group of medicines called_ calcium antagonists._ ADALAT RETARD IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA (_chest pain_). For high blood pressure: Adalat retard works by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart. For angina: Adalat retard works by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADALAT RETARD DO NOT TAKE ADALAT RETARD: • IF YOU HAVE HAD A HEART ATTACK within the last month. • IF YOU GET A SUDDEN ANGINA ATTACK. Adalat retard will not help relieve symptoms of angina quickly. • IF YOU HAVE UNSTABLE ANGINA. • IF YOU ARE ALLERGIC to nifedipine, any other similar medicines (known as_ dihydropyridines_) o Lestu allt skjalið
V023_0 1 1.3.1 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Adalat retard 20 mg modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 20 mg nifedipine. Excipient with known effect: Lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablets. Grey-pink, round, modified-release tablets marked with 1U on one side and a Bayer cross on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis of chronic stable angina pectoris and the treatment of hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose of Adalat retard is 10 mg every 12 hours swallowed with water with subsequent titration of dosage according to response. Adalat retard tablets permit titration of the initial dosage, which may be adjusted to 40 mg every 12 hours, to a maximum daily dose of 80 mg. Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (see section 4.5). _Duration of treatment_ _ _ Treatment may be continued indefinitely. _Additional information on special populations_ _ _ _Paediatric population_ The safety and efficacy of Adalat retard in children below 18 years of age has not been established. Currently available data for the use of nifedipine in hypertension are described in section 5.1 _Older people (>65 years)_ The pharmacokinetics of Adalat retard are altered in the older people so that lower maintenance doses of nifedipine may be required _Patients with hepatic impairment_ Nifedipine is metabolised primarily by the liver and therefore patients with mild, moderate or severe liver dysfunction should be carefully monitored and a dose reduction may be necessary. The pharmacokinetics of nifedipine has not been investigated in patients with severe hepatic impairment (see section 4.4 and 5.2). V023_0 2 1.3.1 2 _Patients with renal impairment_ Lestu allt skjalið