Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
nifedipine
Bayer Australia Ltd
Registered
Adalat® CMI vX1.0 1 ADALAT ® (ADD·A·LAT) _nifedipine _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Adalat tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet is for Adalat tablets. It work by opening up blood vessels in the body to lower blood pressure and improve the supply of blood and oxygen to the heart. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. It may affect your developing baby if you take it during pregnancy. DO NOT BREAST-FEED IF YOU ARE TAKING THIS MEDICINE. The active ingredient in Adalat passes into breast milk and there is a possibility that your baby may be affected. DO NOT TAKE THIS MEDICINE AFTER is different from the leaflet for THE EXPIRY DATE PRINTED ON THE another form of Adalat known as Adalat Oros. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Adalat against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ADALAT IS USED FOR Adalat tablets are used either to treat high blood pressure or to manage a type of angina (chest pain), known as chronic stable angina. ADALAT TABLETS ARE NOT USED FOR THE RELIEF OF A SUDDEN ATTACK OF ANGINA OR TO MANAGE UNSTABLE ANGINA . Adalat tablets contain the active substance nifedipine which belongs to a group of medicines called calcium channel blockers. They BEFORE YOU TAKE ADALAT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ADALAT IF YOU HAVE AN ALLERGY TO: • nifedipine, the active ingredient in Adalat • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, t Lees het volledige document
ADALAT® PI VX1.0, CCDS23 1 AUSTRALIAN PRODUCT INFORMATION ADALAT 10, ADALAT 20 (NIFEDIPINE) TABLETS 1 NAME OF THE MEDICINE Nifedipine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ADALAT tablets are round, pink-grey, film-coated tablets containing micronised nifedipine 10 mg or 20 mg. EXCIPIENTS WITH KNOWN EFFECT: Contains lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM ADALAT tablets are film-coated tablets. ADALAT 10: Pink-grey biconvex lacquered tablets, one side marked A10, each containing 10 mg nifedipine. ADALAT 20: Pink-grey biconvex lacquered tablets, one side marked 1U, the reverse side with the Bayer cross, each containing 20 mg nifedipine. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ADALAT 10 and 20 are indicated for: i. the management of chronic stable angina pectoris and vasospastic angina pectoris (Prinzmetal’s angina, variant angina) due to coronary heart disease. ii. the treatment of hypertension. 4.2 D OSE AND METHOD OF ADMINISTRATION Dosage should be individualised depending on severity of disease, patient's tolerance and responsiveness to Adalat (nifedipine) 10 or 20 and to concurrent antihypertensive medications (see Section 4.5 Interaction with Other Medicines and other forms of interactions). Depending on the clinical picture in each case, the basic dose must be introduced gradually. The recommended initial dose is 10-20 mg twice daily swallowed with a little fluid, with or without food. The tablets must not be chewed or broken up. Grapefruit juice is to be avoided. The usual adult dose is 20 mg twice daily. If required, the dose may be increased up to 40 mg twice daily. The maximum daily dose of 80 mg should not be exceeded. The recommended dose interval is about 12 hours. Due to its pronounced anti-ischaemic and antihypertensive action, Adalat should be discontinued gradually, particularly when high doses are used. ADALAT® PI VX1.0, CCDS23 2 Adalat 10 tablets permit dosage titration. Dose titration is particular Lees het volledige document