Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nifedipine
Sigma Pharmaceuticals Plc
C08CA05
Nifedipine
60mg
Modified-release tablet
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 02060200
_325 LEAFLET Adalat LA 20180731 _ PACKAGE LEAFLET: INFORMATION FOR USER ADALAT ® LA 60 TABLETS (nifedipine) Your medicine is known as Adalat LA 60 Tablets but will be referred to as Adalat LA throughout the following leaflet. 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 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, any other similar medicines (known as _dihy Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 60 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 60 mg nifedipine. Each tablet contains a 10% overage of nifedipine to deliver the label claim. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet. Pink, round, convex tablet with a laser hole on one side and marked with Adalat 60. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the treatment of all grades of hypertension. For the prophylaxis of chronic stable angina pectoris either as monotherapy or in combination with a beta-blocker. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ In mild to moderate hypertension, the recommended initial dose is one 20 mg tablet once-daily. In severe hypertension, the recommended initial dose is one 30 mg tablet once-daily. If necessary, the dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily. For the prophylaxis of angina pectoris, the recommended initial dose is one 30 mg tablet once-daily. The dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily. Patients in whom hypertension or anginal symptoms are controlled on Adalat capsules or Adalat retard may be safely switched to Adalat LA. Prophylactic anti- anginal efficacy is maintained when patients are switched from other calcium antagonists such as diltiazem or verapamil to Adalat LA. Patients switched from other calcium antagonists should initiate therapy at the recommended initial dose of 30 mg Adalat LA once-daily. Subsequent titration to a higher dose may be initiated as warranted clinically. 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 _ _ Lue koko asiakirja