국가: 몰타
언어: 영어
출처: Medicines Authority
NIFEDIPINE
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
C08CA05
NIFEDIPINE 10 mg
SOFT CAPSULE
NIFEDIPINE 10 mg
POM
CALCIUM CHANNEL BLOCKERS
Withdrawn
2006-11-23
PMR 86015161 (AB/00-C/MU-201711970) Pantone: Black, Orange 021 PACKAGE LEAFLET: INFORMATION FOR THE USER 0 ADALAT ® 10 MG Soft capsules 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 CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADALAT CAPSULES 3 HOW TO TAKE ADALAT CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ADALAT CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT ADALAT CAPSULES ARE AND WHAT THEY ARE USED FOR Adalat capsules contain nifedipine, which belongs to a group of medicines called_ calcium antagonists._ ADALAT CAPSULES ARE USED TO TREAT HIGH BLOOD PRESSURE, ANGINA_ (chest_ _pain)_ OR A CONDITION CALLED_ RAYNAUD’S PHENOMENON_ which causes discolouration (often whitening) of the fingers and toes. For high blood pressure: Adalat capsules work 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 capsules work 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. Adalat capsules can increase the risk of serious heart problems in patients with high blood pressure or angina. Because of this, Adalat capsules are only used in these patients if no other treatments are appropriate. For Raynaud’s phenomenon: Adalat capsules 전체 문서 읽기
v024_0 Page 1 of 13 1.3.1 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Adalat 10 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 10 mg nifedipine. Excipient with known effect: Yellow orange S (E110) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, soft. Orange, softgel capsule (6 minims, oblong) containing a yellow viscous fluid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis of chronic stable angina pectoris, the treatment of Raynaud's phenomenon and essential hypertension. For patients suffering from essential hypertension or chronic stable angina pectoris, and treated with fast release forms of nifedipine (Adalat capsules), a dose dependent increase in the risk of cardiovascular complications (e.g., myocardial infarction) and mortality may occur. Due to this, Adalat capsules should only be used for treatment of patients with essential hypertension or chronic stable angina pectoris if no other treatment is appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ _ _ The maximum total daily dose is 60 mg. The recommended starting dose is 5 mg every eight hours with subsequent titration of dose according to response permitting an increase to a maximum of 20 mg every eight hours. 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_ v024_0 Page 2 of 13 1.3.1 2 Treatment may be continued indefinitely. _Additional information for special populations _ _Paediatric population_ The safety and efficacy of Adalat capsules 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 capsules are altered in the older people so that lower maintenance doses of nifedipine may be required. _Patients with 전체 문서 읽기