Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
hydrochlorothiazide, Quantity: 12.5 mg; candesartan cilexetil, Quantity: 16 mg
Alphapharm Pty Ltd
Candesartan cilexetil,Hydrochlorothiazide
Tablet, uncoated
Excipient Ingredients: hyprolose; iron oxide yellow; maize starch; iron oxide red; glyceryl monostearate; carmellose calcium; lactose monohydrate; magnesium stearate
Oral
30, 7, 28
(S4) Prescription Only Medicine
The treatment of hypertension. Treatment should not be initiated with this fixed dose combination.
Visual Identification: Peach coloured, mottled, round, biconvex tablet debossed with "M" on one side and "CH2" on the other.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2013-02-20
ADESAN HCT _Candesartan cilexetil / hydrochlorothiazide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers to some common questions people ask about ADESAN HCT. It does not contain all the information that is known about ADESAN HCT. 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 ADESAN HCT 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 THIS MEDICINE. You may need to read it again. WHAT ADESAN HCT IS USED FOR ADESAN HCT is used to treat high blood pressure. Candesartan cilexetil is a type of medicine called an angiotensin II receptor antagonist (or blocker). It mainly works by causing relaxation of blood vessels. Hydrochlorothiazide is a type of medicine called a diuretic. It works by reducing the amount of excess fluid in the body. Using these two medicines together will lower your blood pressure more than using either one on its own. Your doctor will have explained why you are being treated with ADESAN HCT and told you what dose to take. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR CAREFULLY. They may differ from the information contained in this leaflet. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. There is no evidence that ADESAN HCT is addictive. BEFORE TAKING ADESAN HCT _WHEN YOU MUST NOT TAKE IT_ DO NOT USE ADESAN HCT IF YOU HAVE AN ALLERGY TO: • any medicine containing candesartan cilexetil, or hydrochlorothiazide • any of the ingredients listed at the end of this leaflet • any medicine containing an angiotensin II receptor antagonist (or blocker) • any sulphur drugs (sulphonamides) such as some antibiotics or some medicines to treat diabetes Some of the symptoms of an allergic reaction may include • shortness of breath • wheezing or difficulty breathing • swelling of the face, lip Lire le document complet
AUSTRALIAN PRODUCT INFORMATION ADESAN HCT _Candesartan cilexetil/Hydrochlorothiazide tablet_ _ _ 1 NAME OF THE MEDICINE Candesartan cilexetil and hydrochlorothiazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredients in ADESAN HCT are candesartan cilexetil and hydrochlorothiazide. Candesartan is an angiotensin II receptor antagonist. Hydrochlorothiazide is a sulfonamide derived drug. Each tablet contains the following active ingredients: Adesan HCT 16/12.5 mg Tablet: : 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide Adesan HCT 32/12.5 mg Tablet: : 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide Adesan HCT 32/25 mg Tablet: : 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide Excipients with known effect: Sugars (as lactose). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 16/12.5 mg Tablet: : Peach coloured, mottled, round, biconvex tablet debossed with “M” on one side and “CH2” on the other. 32/12.5 mg Tablet: : Yellow coloured, mottled, round, biconvex tablets debossed with “CH” above the break line and “3” below the break line on one side of the tablet and “M” on the other side. 32/25 mg Tablet: : Peach coloured, mottled, round, biconvex tablets debossed with “CH” above the break line and “4” below the break line on one side of the tablet and “M” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations. 4.2 DOSE AND METHOD OF ADMINISTRATION The dose of ADESAN HCT must be determined by careful titration of the dose of each of the individual components. Adesan HCT – PRODUCT INFORMATION 2 The recommended dose of ADESAN HCT is 1 tablet once daily, ADESAN HCT may be taken with or without food. ADESAN HCT tablets should not be divided. ADESAN HCT 16/12.5 may be administered in patients whose blood pressure is not optimally controlled with hydrochlorothiazide alone or Lire le document complet