Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
hydrochlorothiazide, Quantity: 12.5 mg; candesartan cilexetil, Quantity: 16 mg
Arrotex Pharmaceuticals Pty Ltd
Candesartan cilexetil,Hydrochlorothiazide
Tablet, uncoated
Excipient Ingredients: carmellose calcium; magnesium stearate; lactose monohydrate; macrogol 8000; hyprolose; maize starch; iron oxide red
Oral
30 tablets, 7
(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' & '02' 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
2013-07-16
APO-CANDESARTAN HCTZ TABLETS 1 APO-CANDESARTAN HCTZ TABLETS _Contains the active ingredient candesartan cilexetil and hydrochlorothiazide _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about candesartan cilexetil and hydrochlorothiazide (HCTZ). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. Ask your doctor or pharmacist: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. 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. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Candesartan HCTZ tablets. It contains the active ingredients candesartan cilexetil and hydrochlorothiazide. It is used to treat: • high blood pressure, also called hypertension. Ask your doctor if you have any questions about why this medicine has been prescribed for you. They may differ from the information contained in this leaflet. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ Candesartan cilexetil is a type of medicine called an angiotensin II receptor inhibitor (or antagonist). 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 wil Leggi il documento completo
1 AUSTRALIAN PRODUCT INFORMATION APO- CANDESARTAN HCTZ (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Candesartan cilexetil and hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg or 32 mg candesartan cilexetil and 12.5 mg or 25 mg hydrochlorothiazide as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Sugars as lactose monohydrate. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM CANDESARTAN HCTZ 16/12.5 TABLETS Light pink, oval shape, biconvex, uncoated, mottled tablets debossed with ‘L3’ and ’02’ on either side of breakline on one side and break line on other side CANDESARTAN HCTZ 32/12.5 MG TABLET 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 CANDESARTAN HCTZ 32/25 MG TABLET 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 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Candesartan HCTZ is indicated for the treatment of hypertension. Treatment should not be initiated with these fixed dose combinations. 4.2 DOSE AND METHOD OF ADMINISTRATION APO- candesartan HCTZ are intended for oral administration. DOSAGE The dose of Candesartan HCTZ must be determined by careful titration of the dose of each of the individual components. The recommended dose is 1 tablet once daily. Candesartan HCTZ may be taken with or without food. The tablets should not be divided. Candesartan HCTZ 16/12.5 may be administered in patients whose blood pressure is not optimally controlled with hydrochlorothiazide alone or candesartan 16 mg monotherapy. 2 Candesartan HCTZ 32/12.5 or 32/25 may be administered in patients whose blood pressure is not optimally controlled with hydrochlorothiazide alone or candesartan 32 mg monotherapy, or at a lower dose of Candesartan HCTZ. Dose titration of candesartan cilexetil is recomm Leggi il documento completo