Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Propranolol hydrochloride 160mg
Viatris Limited
Propranolol hydrochloride 160 mg
160 mg
Modified release capsule
Active: Propranolol hydrochloride 160mg Excipient: Gelatin Maize starch Purified talc Shellac Sucrose
Blister pack, 30 capsules
Prescription
Prescription
Cosma SpA
CARDINOL LA indicated for the following: · Management of angina pectoris. · Control of hypertension. · Long term prophylaxis after recovery from acute myocardial infarction.
Package - Contents - Shelf Life: Blister pack, - 30 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with white PP wadded (Cello LDPE & Alcoflex foil) tampertel closure - 100 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with white PP tamper evident cap and LDPE wad - 100 capsules - 24 months from date of manufacture stored at or below 25°C
1984-02-22
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION CARDINOL LA _PROPRANOLOL HYDROCHLORIDE, MODIFIED RELEASE CAPSULES 160MG_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CARDINOL LA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine 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 CARDINOL LA IS USED FOR CARDINOL LA capsules contain the active ingredient propranolol hydrochloride, which belongs to a group of medicines called beta- blockers. These medicines work by changing the body's response to some nerve impulses, especially in the heart. CARDINOL LA is used to lower blood pressure, help in the prevention of chest pain (angina) and for the long-term prevention of future heart attacks. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribe it for another reason. There is no evidence that CARDINOL LA is addictive. This medicine is available only with a doctor’s prescription. CARDINOL LA is not recommended for use in children. BEFORE YOU TAKE CARDINOL LA _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE CARDINOL LA IF YOU HAVE AN ALLERGY TO: propranolol any of the ingredients listed at the end of this leaflet any other similar medicines such as beta-blockers Symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE CARDINOL LA IF YOU HAVE: asthma or severe breathing problems heart problems such as, heart failure, low blood pressure, problems with your circulation, Prinzmetal’s angina or a slow heart beat low blood sug Přečtěte si celý dokument
Page 1 of 9 NEW ZEALAND DATA SHEET CARDINOL LA 1. PRODUCT NAME CARDINOL LA, 160mg, modified release capsule. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release capsule contains 160mg of propranolol hydrochloride BP. Excipient with known effect: Sugars For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM CARDINOL LA is presented as size 1 gelatin capsules with a clear colourless body and opaque, green cap containing cream and white pellets. CARDINOL LA capsules contain spheroids of the beta-blocker propranolol hydrochloride which have a sustained release coating to provide long action. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ CARDINOL LA is indicated for the following: 1. Control of hypertension. 2 Management of angina pectoris. 3. Long term prophylaxis after recovery from acute myocardial infarction. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ ADULTS _HYPERTENSION_ The starting dose is one capsule daily, taken either morning or evening. An adequate response is seen in most patients at this dosage. If necessary, it can be increased to two capsules and a further reduction in blood pressure can be attained if a diuretic or other antihypertensive agent is given in addition to CARDINOL LA. _ANGINA_ An adequate response is usually obtained with one capsule daily either morning or evening, dependant on patient convenience. Page 2 of 9 _POST MYOCARDIAL INFARCTION_ Treatment should start between days 5 and 21 after myocardial infarction with one 40 mg propranolol tablet four times a day for 2 or 3 days. In order to achieve maximum compliance, the total daily dosage of 160 mg propranolol may thereafter be given as a single CARDINOL LA capsule. Compliance is extremely important as beta- blockade may have to be continued indefinitely. _SPECIAL POPULATIONS_ ELDERLY Evidence concerning the relation between blood level and age is conflicting. With regard to the elderly, the optimum dose should be individually determined according to clinical response. CHILDREN CARDINOL LA is not Přečtěte si celý dokument