Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
candesartan cilexetil, Quantity: 8 mg
Arrotex Pharmaceuticals Pty Ltd
Candesartan cilexetil
Tablet, uncoated
Excipient Ingredients: macrogol 8000; lactose monohydrate; carmellose calcium; magnesium stearate; maize starch; hyprolose; iron oxide red
Oral
7, 28, 30 tablets
(S4) Prescription Only Medicine
Treatment of hypertension.,Treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction <=40percent) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Visual Identification: Light pink, round, biconvex uncoated mottled tablets debossed with 292 on one side and break line on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-07-02
APO-CANDESARTAN TABLETS 1 APO-CANDESARTAN TABLETS _Candesartan cilexetil _ _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. 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. You can also download the most up to date leaflet from www.apotex.com.au. 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. It contains the active ingredient candesartan cilexetil. It is used to treat: • high blood pressure, also called hypertension. • heart failure - increase survival, reduce hospitalisation and improve symptoms. It is used in combination with other medicines to treat your condition. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. _HOW IT WORKS _ Candesartan is a type of medicine called an angiotensin II receptor inhibitor (or antagonist). HYPERTENSION: All people have blood pressure. This pressure helps to push blood all around your body. Your blood pressure changes during the day, d Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION- APO-CANDESARTAN TABLETS (CANDESARTAN) 1 NAME OF THE MEDICINE Candesartan cilexetil 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each candesartan tablet contains candesartan cilexetil as the active ingredient. In addition, each candesartan tablet contains the following inactive ingredients: lactose, carmellose calcium, maize starch, macrogol 8000, hydroxypropylcellulose, magnesium stearate and Pigment Blend PB-24880 Pink (ARTG 108327) which contains iron oxide red and lactose. The tablets are gluten free. 4 MG TABLETS Light pink, mottled, round biconvex uncoated tablet with ‘291’ on one side and a scoreline on the other side. 8 MG TABLETS Light pink, mottled, round biconvex uncoated tablet with ‘292’ on one side and a scoreline on the other side. 16 MG TABLETS Light pink, mottled, round biconvex uncoated tablet with ‘L293’ on one side and a scoreline on the other side. 32 MG TABLETS Light pink, mottled, round biconvex uncoated tablet with ‘L294’ on one side and a scoreline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO- Candesartan is indicated for the treatment of: • Hypertension. • Patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated. 2 4.2 DOSE AND METHOD OF ADMINISTRATION APO- Candesartan should be taken once daily with or without food. HYPERTENSION The recommended maintenance dose of candesartan is 8 mg or 16 mg once daily. The maximal antihypertensive effect is attained within 4 weeks following initiation of treatment. For those patients who start on 8 mg and require further blood pressure reduction, a dose increase to 16 mg is recommended. An initial dose of 16 mg is also well tolerated. Some patients may receive an additional benefit by increasing the dose to 32 mg once daily. In patients with less than optimal blood pressure reduction on candesartan, combi Прочитајте комплетан документ