Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
candesartan cilexetil, Quantity: 16 mg; hydrochlorothiazide, Quantity: 12.5 mg
Sandoz Pty Ltd
Candesartan cilexetil,Hydrochlorothiazide
Tablet
Excipient Ingredients: magnesium stearate; carrageenan; lactose monohydrate; maize starch; iron oxide red; croscarmellose sodium; povidone; iron oxide yellow
Oral
30
(S4) Prescription Only Medicine
The treatment of hypertension. Treatment should not be initiated with this fixed dose combination.
Visual Identification: apricot, mottled, oval biconvex tablets, scored on both sides; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2011-01-05
CANDESARTAN/ HCT SANDOZ ® 1 CANDESARTAN/ HCT SANDOZ ® _Candesartan cilexetil and hydrochlorothiazide tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Candesartan/HCT Sandoz. 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 has weighed the risk of you taking Candesartan/HCT Sandoz against the benefits it is expected to 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 CANDESARTAN/HCT SANDOZ IS USED FOR This medicine is used to treat high blood pressure. It contains the active ingredients candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil belongs to a group of medicines called angiotensin II - receptor antagonists (or blocker). It works by causing relaxation of blood vessels. Hydrochlorothiazide belongs to a group of medicines called diuretics. 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR CAREFULLY Your doctor may have prescribed it for another reason. They may differ from the information contained in this leaflet. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE CANDESARTAN/HCT SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • candesartan cilexetil and hydrochlorothiazide, the active ingredients, or to any of the other ingredients listed at the end of this leaflet under Product Description • any other similar medicines (such as Irbesartan), angiotensin II receptor antagonist • any sulphur drugs (sulphonamides) such as some anti Olvassa el a teljes dokumentumot
210826-Candesartan.HCT-pi Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION CANDESARTAN/HCT SANDOZ ® TABLETS (CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE) 1 NAME OF THE MEDICINE Candesartan cilexetil/ Hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Candesartan/HCT Sandoz 16 mg/12.5 mg contains candesartan cilexetil 16 mg and hydrochlorothiazide 12.5 mg. Candesartan/HCT Sandoz 32 mg/12.5 mg contains candesartan cilexetil 32 mg and hydrochlorothiazide 12.5 mg. Candesartan/HCT Sandoz 32 mg/25 mg contains candesartan cilexetil 32 mg and hydrochlorothiazide 25 mg. Candesartan cilexetil is a white to off white powder and is practically insoluble in water. Excipients with known effect: Sugars as Lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Candesartan/HCT Sandoz 16 mg/12.5 mg tablets are apricot, mottled, oval biconvex tablets, scored on both sides. Candesartan/HCT Sandoz 32 mg/12.5 mg tablets are light brown, mottled, oblong, biconvex tablets, debossed with 32 on one side and with score line on both sides. Candesartan/HCT Sandoz 32 mg/25 mg tablets are reddish brown, mottled, oblong, biconvex tablets, debossed with H 32 on one side and with score line on both sides. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS The treatment of hypertension. Treatment should not be initiated with this fixed dose combination. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The dose of Candesartan/HCT Sandoz must be determined by careful titration of the dose of each of the individual components. METHOD OF ADMINISTRATION The recommended dose of Candesartan/HCT Sandoz is one tablet once daily, taken with or without food. Candesartan/HCT Sandoz tablets should not be divided. 210826-Candesartan.HCT-pi Page 2 of 20 Candesartan/HCT Sandoz 16 mg/12.5 mg may be administered in patients whose blood pressure is not optimally controlled with hydrochlorothiazide alone or with candesartan 16 mg monotherapy. Candesartan/HCT Sandoz 32 mg/12.5 mg or 32 mg/25 mg may be administered in pat Olvassa el a teljes dokumentumot