Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Nifedipine
Bayer Limited
C08CA; C08CA05
Nifedipine
30 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; nifedipine
Marketed
1994-04-11
20083 PACKAGE LEAFLET - INFORMATION FOR THE USER ADALAT® LA 30 MG PROLONGED 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 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 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 LA IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADALAT LA 3 HOW TO TAKE ADALAT LA 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ADALAT LA 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT ADALAT LA IS AND WHAT IT IS USED FOR 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 WHAT YOU NEED TO KNOW_ _ 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 ANGINA. • IF YOU ARE ALLERGIC to nifedipine, to any other similar medicines (known as _dihydropyridines) _ or any of the other ingredients of this medicine (listed in section 6). IF YOU ARE TAKING RIFAMPICIN, an ant Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 04 November 2020 CRN009Z6W Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 30 mg Prolonged-Release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 30 mg nifedipine. Excipients with known effect Each tablet contains 9.4 mg sodium. Please see section 4.4 for further information. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet. Pink, circular convex tablets with Adalat 30 marked on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of all grades of 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 POSOLOGY 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 are recommended for adults: For CORONARY HEART DISEASE: CHRONICSTABLE ANGINA PECTORIS(angina of effort)1 Adalat LA 30 mg tablet once daily (1 x 30 mg/day) For HYPERTENSION:1 Adalat LA 30 mg tablet once daily (1 x 30 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. 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 "Interaction with other medicinal products other forms of interaction")_. _ _ _ _ _Duration of Treatment_ The attending doctor will determine the duration of use. Health Products Regulatory Author Διαβάστε το πλήρες έγγραφο