Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
candesartan cilexetil, Quantity: 8 mg
Sandoz Pty Ltd
Candesartan cilexetil
Tablet
Excipient Ingredients: lactose monohydrate; carrageenan; maize starch; povidone; iron oxide red; croscarmellose sodium; titanium dioxide; magnesium stearate
Oral
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 less than or equal to 40percent) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Visual Identification: Pink, mottled, round, biconvex tablet, debossed with 8 on one side and scored on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-01-05
CANDESARTAN SANDOZ ® 1 CANDESARTAN SANDOZ ® _CANDESARTAN CILEXETIL TABLETS _ _Candesartan cilexetil (kan-de-SAR-tan sil-EX-etil) _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Candesartan 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 risks of you taking this medicine 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 THE MEDICINE. You may need to read it again. WHAT CANDESARTAN SANDOZ IS USED FOR Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists (or blocker). This medicine is used to treat: • high blood pressure, also called hypertension. • heart failure. It is used in combination with other medicines to treat your condition. It contains the active ingredient candesartan cilexetil. WHEN TAKING THIS MEDICINE FOR HYPERTENSION, IT WORKS BY : Lowering blood pressure by dilating (expanding) small blood vessels from the heart, letting the blood be pumped around the body more easily. All people have blood pressure. This pressure helps to push blood all around your body. Your blood pressure changes during the day, depending on how busy you are or how you are feeling. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. Regular blood pressure checks are the only way of knowing that you have hypertension. There are usually no symptoms of hypertension and you may feel fine. If hypertension is not treated, serious health problems such as stroke or heart attack and heart or kidney failure may occur. WHEN TAKING THIS MEDICINE FOR HEART FAILURE, IT WORKS BY: Widening the blood vessels, so that the heart does not have to pump as hard to move the blood around the body. This also me Soma hati kamili
190415-candesartan-sandoz-pi Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION CANDESARTAN SANDOZ ® (CANDESARTAN CILEXETIL) TABLETS 1 NAME OF THE MEDICINE Candesartan cilexetil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Candesartan Sandoz 4 mg tablet contains 4 mg candesartan cilexetil. Each Candesartan Sandoz 8 mg tablet contains 8 mg candesartan cilexetil. Each Candesartan Sandoz 16 mg tablet contains 16 mg candesartan cilexetil. Each Candesartan Sandoz 32 mg tablet contains 32 mg candesartan cilexetil. _Excipient with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Candesartan Sandoz 4 mg tablets are white, round biconvex tablets, debossed with 4 on one side and scored on the other. Candesartan Sandoz 8 mg tablets are pink, mottled, round biconvex tablets, debossed with 8 on one side and scored on the other. Candesartan Sandoz 16 mg tablets are pink, mottled, round biconvex tablets, debossed with 16 on one side and scored on the other. Candesartan Sandoz 32 mg tablets are pink, mottled, round biconvex tablets, debossed with 32 on one side and scored on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • Treatment of hypertension. • Treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add on therapy to angiotensin converting enzyme (ACE) inhibitors or when ACE inhibitors are not tolerated. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Candesartan Sandoz should be taken once daily with or without food. _Hypertension _ The recommended maintenance dose of Candesartan Sandoz is 8 or 16 mg once daily. The maximal antihypertensive effect is attained within four 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 Soma hati kamili