Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
hydrochlorothiazide, Quantity: 12.5 mg; candesartan cilexetil, Quantity: 32 mg
Amneal Pharma Australia Pty Ltd
Candesartan cilexetil,Hydrochlorothiazide
Tablet, uncoated
Excipient Ingredients: magnesium stearate; maize starch; macrogol 8000; lactose monohydrate; carmellose calcium; hyprolose; iron oxide yellow
Oral
30 tablets
(S4) Prescription Only Medicine
The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.
Visual Identification: Light yellow, 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: Bottle; Container Material: HDPE; Container Life Time: 6 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2012-12-05
_Candesartan HCTZ AN tablets – Consumer Medicine Information _ _ _ _Doc ID: 45.AN.M.1.0 _ _ _ _ _ _Page 1 _ CANDESARTAN HCTZ AN TABLETS _Candesartan cilexetil and hydrochlorothiazide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CANDESARTAN HCTZ AN. 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 CANDESARTAN HCTZ AN 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 CANDESARTAN HCTZ AN IS USED FOR CANDESARTAN HCTZ AN is used to treat high blood pressure, also called hypertension. CANDESARTAN HCTZ AN 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 a diuretic. It works by reducing the amount of 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 CANDESARTAN HCTZ AN for another reason. Ask your doctor if you have any questions about why CANDESARTAN HCTZ AN has been prescribed for you. CANDESARTAN HCTZ AN is available only with a doctor's prescription. BEFORE YOU TAKE CANDESARTAN HCTZ AN _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE CANDESARTAN HCTZ AN IF YOU ARE ALLERGIC TO: medicines containing candesartan cilexetil other angiotensin II receptor antagonists any sulphur drugs (sulphonamides) such as some antibiotics or some medicines to treat diabetes any of the ingredients listed at the end of this leaflet. Symptoms of an Baca dokumen lengkap
_Candesartan HCTZ AN tablets Product Information _ _ _ _Scentia Pharmaceuticals Pty Ltd _ Doc ID: 45.AN.P.1.1 Page 1 CANDESARTAN HCTZ AN 16/12.5, 32/12.5 & 32/25 _ _ _(CANDESARTAN CILEXETIL 16 MG & HYDROCHLOROTHIAZIDE 12.5 MG TABLETS _ _CANDESARTAN CILEXETIL 32 MG & HYDROCHLOROTHIAZIDE 12.5 MG TABLETS _ _CANDESARTAN CILEXETIL 32 MG & HYDROCHLOROTHIAZIDE 25 MG TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE The name of the medicine is candersartan cilexetil and hydrochlorothiazide. CANDESARTAN CILEXETIL CHEMICAL NAME: (1_RS_)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl 2- ethoxy-1-[[2′-(1_H_-tetrazol-5- yl)biphenyl-4-yl]methyl]-1_H_-benzimidazole-7-carboxylate MOLECULAR FORMULA: C 33 H 34 N 6 O 6 MOLECULAR WEIGHT: 611 CAS REGISTRY NUMBER: _[145040-37-5] _ HYDROCHLOROTHIAZIDE CHEMICAL NAME: 6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide MOLECULAR FORMULA: C 7 H 8 ClN 3 O 4 S 2 MOLECULAR WEIGHT: 297.7 CAS REGISTRY NUMBER: _[58-93-5] _ DESCRIPTION Candesartan cilexetil is a white or almost white powder and is practically insoluble in water, freely soluble in methylene chloride and slightly soluble in anhydrous ethanol. Three polymorphic forms have been identified; crystal form I, crystal form II and an amorphous form. Crystalline form I is used in Candesartan HCTZ AN 16/12.5, 32/12.5 & 32/25. _Candesartan HCTZ AN tablets Product Information _ _ _ _Scentia Pharmaceuticals Pty Ltd _ Doc ID: 45.AN.P.1.1 Page 2 Hydrochlorothiazide is a white, crystalline powder. It is very slightly soluble in water, soluble in acetone, sparingly soluble in ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides. Candesartan HCTZ AN 16/12.5, 32/12.5 & 32/25 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 and 25 mg of hydrochlorothiazide. The tablets also contain lactose, carmellose calcium, maize starch, macrogol 8000, hydroxypropylcell Baca dokumen lengkap