Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Candesartan cilexetil 16mg;
Viatris Limited
Candesartan cilexetil 16 mg
16 mg
Tablet
Active: Candesartan cilexetil 16mg Excipient: Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate Mannitol
Blister pack, cold form, OPA/Al/PVC, hard tempered Al foil, 30 tablets
Prescription
Prescription
Zhejiang Huahai Pharmaceutical Co Ltd
Hypertension
Package - Contents - Shelf Life: Blister pack, cold form, OPA/Al/PVC, hard tempered Al foil - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, cold form, OPA/Al/PVC, hard tempered Al foil - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE, white, with opaque screw, absorbent cotton and desiccant - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE, white, with opaque screw, absorbent cotton and desiccant - 90 tablets - 24 months from date of manufacture stored at or below 25°C
2010-05-27
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION CANDESTAR _CANDESARTAN CILEXETIL _ _4 MG, 8 MG, 16 MG AND 32 MG TABLETS _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Candestar. This leaflet answers some common questions about Candestar. 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 will have weighed the risks of you taking Candestar 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 CANDESTAR IS TAKEN FOR Candestar contains the active ingredient candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor blockers, or ARBs. Candestar is taken to treat: high blood pressure (hypertension) heart failure patients with reduced heart muscle function Candestar works by blocking the effects of the hormone, angiotensin II. This causes relaxation or widening of the blood vessels which results in a lowering of the blood pressure. It also helps with heart failure by widening the blood vessels, so that the heart does not have to pump as hard to move the blood around the body. This also means that when you place extra demands on your heart, such as during exercise, the heart may cope better so you may not get short of breath as easily. 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. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE CANDESTAR _WHEN YOU MUST NOT TAKE IT:_ DO NOT TAKE CANDESTAR IF YOU HAVE AN ALLERGY TO: any medicine containing candesartan 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 o Preberite celoten dokument
Page 1 of 12 NEW ZEALAND DATA SHEET CANDESTAR 1. PRODUCT NAME Candestar, 4 mg, 8 mg, 16 mg and 32 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil. Excipients with known effect: Contains sugars as lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Candestar 4 mg: White to off white, round, biconvex tablet debossed with “M” over “C1” on one side, and plain with a break line on the other side. Candestar 8 mg: White to off white, round, biconvex tablet debossed with “M” over “C5” on one side, and plain with a break line on the other side. Candestar 16 mg: White to off white, round, biconvex tablet debossed with “M” over “C6” on one side, and plain with a break line on the other side. Candestar 32 mg: White to off white, round, biconvex tablet debossed with “M” over “C7” on one side, and plain with a break line on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Hypertension Treatment of patients with heart failure and left ventricular systolic dysfunction. Treatment with candesartan cilexetil reduces mortality, reduces hospitalisation due to heart failure, and improves symptoms. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSAGE IN HYPERTENSION The recommended initial and maintenance dose of Candestar is 8 mg once daily. The dose may be increased to 16 mg once daily. In patients who require further blood pressure reduction, the dose may be increased to 32 mg once daily. Therapy should be adjusted according to blood pressure response. The maximal antihypertensive effect is attained within 4 weeks after initiation of treatment. Page 2 of 12 In patients with less than optimal blood pressure reduction on Candestar, combination with a thiazide diuretic is recommended. USE IN THE ELDERLY No initial dosage adjustment is necessary for elderly patients. USE IN IMPAIRED RENAL FUNCTION No initial dosage adjustment Preberite celoten dokument