Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
candesartan cilexetil, Quantity: 32 mg; hydrochlorothiazide, Quantity: 25 mg
Arrotex Pharmaceuticals Pty Ltd
Candesartan cilexetil,Hydrochlorothiazide
Tablet, uncoated
Excipient Ingredients: carmellose calcium; lactose monohydrate; macrogol 8000; magnesium stearate; hyprolose; maize starch; iron oxide red
Oral
30 tablets
(S4) Prescription Only Medicine
The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.
Visual Identification: Light pink oval biconvex uncoated mottled tablets debossed with 'L3' & '04' on either side of break line on one side & break line on one other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-03-27
CANDESAN COMBI – Consumer Medicine Information Page 1 of 5 Candesan Combi _(16mg/12.5mg, 32mg/12.5mg & 32mg/25mg tablets) _ _contains the active ingredients candesartan cilexetil and hydrochlorothiazide _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CANDESAN COMBI. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking CANDESAN COMBI against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT CANDESAN COMBI IS USED FOR CANDESAN COMBI is used to treat high blood pressure, also called hypertension. CANDESAN COMBI contains two medicines, candesartan cilexetil and hydrochlorothiazide. In combination, they lower your blood pressure more than using either one on its own. Candesartan cilexetil belongs to a group of medicines known as angiotensin-II receptor antagonists. It works by relaxing the blood vessels. Hydrochlorothiazide is type of medicine called a diuretic. It works by reducing the amount of excess fluid in the body. Your doctor will have explained why you are being treated with Candesartan/hydrochlorothiazide tablets and told you what dose to take. Your doctor may have prescribed CANDESAN COMBI for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CANDESAN COMBI HAS BEEN PRESCRIBED FOR YOU. CANDESAN COMBI is available only with a doctor's prescription. There is no evidence that CANDESAN COMBI is addictive BEFORE YOU TAKE CANDESAN COMBI _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE CANDESAN COMBI IF YOU ARE ALLERGIC TO: • medicines containing candesartan cilexetil or hydrochlorothiazide • other angiotensin II receptor antagonists (or blocker) • any sulphur drugs (sulphonamides) such as some antibiotics or some medicines read_full_document
1 AUSTRALIAN PRODUCT INFORMATION – CANDESAN COMBI (CANDESARTAN CILEXETIL & HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Candesartan cilexetil & hydrochlorothiazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CANDESAN COMBI tablets come in three strengths and contain 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide, 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide or 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide. EXCIPIENTS WITH KNOWN EFFECT Sugars as lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM _CANDESAN COMBI 16/12.5_ Candesartan cilexetil 16 mg and hydrochlorothiazide 12.5 mg uncoated tablet; Light pink, oval biconvex uncoated tablet with ‘L3’ & ‘02’ on either side of break line on one side and a break line on the other side _CANDESAN COMBI 32/12.5_ Candesartan cilexetil 32 mg and hydrochlorothiazide 12.5 mg uncoated tablet; Light yellow, oval biconvex uncoated tablet with ‘L3’ & ‘04’ on either side of break line on one side and a break line on the other side. _CANDESAN COMBI 32/25_ Candesartan cilexetil 32 mg and hydrochlorothiazide 25 mg uncoated tablet; Light pink, oval biconvex uncoated tablet with ‘L3’ & ‘04’ on either side of break line on one side and a break line on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of hypertension. Treatment should not be initiated with this fixed dose combination. 2 4.2 D OSE AND METHOD OF ADMINISTRATION The dose of candesartan with hydrochlorothiazide combination tablets must be determined by careful titration of the dose of each of the individual components. The recommended dose is 1 tablet once daily. The tablets may be taken with or without food. The tablets should not be divided. CANDESAN COMBI 16/12.5 may be administered in patients whose blood pressure is not optimally controlled with hydrochlorothiazide alone or candesartan cilexetil 16 mg monotherapy. CANDESAN COMBI 32/12.5 or 32/25 read_full_document