מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
Bayer Limited
C08CA05
NIFEDIPINE
5 Milligram
Capsules, Soft
Product subject to prescription which may be renewed (B)
nifedipine
Not Marketed
1982-02-26
PACKAGE LEAFLET - INFORMATION FOR THE USER ADALAT® 5MG soft capsules NIFEDIPINE _ _ 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 more 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1 WHAT ADALAT CAPSULES ARE 2 BEFORE YOU TAKE ADALAT CAPSULES 3 HOW YOU TAKE ADALAT CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ADALAT CAPSULES 6 FURTHER INFORMATION _ _ 1 WHAT ADALAT CAPSULES ARE 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 _ _SYNDROME _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 syndrome: Adalat capsules work by relaxing and expanding the blood vessels in the fingers and toes. This helps ensure a good blood supply. _ _ 2 BEFORE YOU TAKE ADALAT CAPSULES DO NOT TAKE ADALAT CAPSULES: • IF YOU HAVE HAD A HEART ATTACK within the last month. • קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat 5 mg soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg nifedipine. Excipients: Sunset yellow (E110) 0.13 mg per capsule For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft. Orange, gelatin ovoid capsules containing a yellow viscous liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of chronic stable angina pectoris, the treatment of Raynaud’s syndrome and essential hypertension. For patients suffering from essential hypertension or chronic stable angina pectoris, and treated with fast release forms of nifedipine (Adalat 5 mg and 10 mg capsules), a dose dependent increase in the risk of cardiovascular complications (e.g., myocardial infarction) and mortality may occur. Due to this, Adalat 5 mg and 10 mg 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 METHOD OF ADMINISTRATION ORAL USE DOSAGE REGIMEN As far as possible the treatment must be tailored to the needs of the individual according to the severity of the disease and the patient's response. Depending on the clinical picture in each case, the basic dose must be introduced gradually. Dose titration is recommended for hypertensives with severe cerebrovascular disease and for patients, who because of low body weight or multiple therapies with other antihypertensive drugs, are likely to have an excessive reaction to nifedipine. In addition, patients in whom side effects in response to the nifedipine treatment make a finer dose adjustment desirable should be individually stabilized with Adalat 5 mg capsule. Unless otherwise prescribed, the following dosage guidelines are recommended for adults: IN CORONARY HEART DISEASE: H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ קרא את המסמך השלם