Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
B & S Healthcare
NIFEDIPINE
20 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET - INFORMATION FOR THE USER ADALAT ® LA 20MG PROLONGED-RELEASE TABLETS (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. The name of your medicine is Adalat LA 20mg Prolonged- release Tablets but it will be referred to as Adalat LA throughout this leaflet. IN THIS LEAFLET 1. What Adalat LA is 2. Before you take Adalat LA 3. How you take Adalat LA 4. Possible side effects 5. How to store Adalat LA 6. Further information 1. WHAT ADALAT LA IS Adalat LA contains nifedipine, which belongs to a group of medicines called _calcium antagonists._ ADALAT LA IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA _(chest pain). _ For high blood pressure: Adalat LA 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 LA 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. BEFORE YOU TAKE ADALAT LA DO NOT TAKE ADALAT LA: • IF YOU HAVE HAD A HEART ATTACK within the last month. • IF YOU GET A SUDDEN ANGINA ATTACK. Adalat LA will not help relieve symptoms of angina quickly. • IF YOU HAVE UNSTABLE ANG Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 20mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release Film-coated tablet contains 20 mg nifedipine. Excipients: Sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release, film-coated tablet. _Product imported from UK:_ Pink, circular biconvex tablets marked 'Adalat 20' with black ink on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of mild to moderate hypertension. For the management of chronic stable angina pectoris either as monotherapy or in combination with a beta-blocker. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION ORAL USE As far as possible the treatment must be tailored to the needs of the individual. Depending on the clinical picture in each case, the basic dose must be introduced gradually. Unless otherwise prescribed, the following dosage guidelines apply for adults: • For CORONARY HEART DISEASE: CHRONIC STABLE ANGINA PECTORIS (angina of effort) 1 Adalat LA 20 mg tablet once daily (1 x 20 mg/day) • For HYPERTENSION: 1 Adalat LA 20 mg tablet once daily (1 x 20 mg/day) In general therapy should be initiated with 30 mg once daily. Where registered a starting dose of 20 mg once daily may be considered when medically indicated. Interim doses i.e. 40 mg, 50 mg etc. can be applied by combinations of i.e. 20 mg + 20 mg or 20 mg + 30 mg tablets. Depending on the severity of the disease and the patient's response the dose can be increased in stages up to 90 mg once daily. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/09/2013_ _CRN 2129159_ _page number: 1_ Co-admi Lestu allt skjalið