البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
valsartan
Apotex Pty Ltd
Valsartan
Registered
APO-VALSARTAN _Contains the active ingredient valsartan_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Valsartan. It contains the active ingredient valsartan. This medicine belongs to a group of medicines called angiotensin II receptor antagonists (AIIRAs). It is used to treat: HYPERTENSION This medicine is used to control high blood pressure, also called hypertension. Everyone has blood pressure. This pressure helps get your blood around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension when your blood pressure stays higher than is needed, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have it is to have your blood pressure checked regularly. High blood pressure increases the workload of the heart and blood vessels. If it continues for a long time, it can damage the blood vessels in the brain, heart and kidneys. This can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure reduces the chance of these disorders happening. HEART FAILURE This medicine is used to treat heart failure. Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack and does not m اقرأ الوثيقة كاملة
1 AUSTRALIAN PRODUCT INFORMATION APO-VALSARTAN (VALSARTAN) TABLETS 1 NAME OF THE MEDICINE Valsartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40, 80, 160 or 320 mg of valsartan as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM VALSARTAN 40 MG TABLETS Yellow, modified, capsule shaped, film-coated tablets, engraved ‘APO’ on one side and ‘VA’ scored ‘40’ on the other side. VALSARTAN 80 MG TABLETS Pale red, round, biconvex, film-coated tablets, engraved ‘APO’ on one side and ‘VA’ over ‘80’ on the other side. VALSARTAN 160 MG TABLETS Yellow, modified, capsule shaped, film-coated tablets, engraved ‘APO’ on one side and ‘VA160’ on the other side. VALSARTAN 320 MG TABLETS Dark grey-violet, oval shaped, film-coated tablets, engraved ‘APO’ on one side and ‘VA320’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of hypertension • Treatment of heart failure (NYHA class II-IV) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ACE inhibitors. • To improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE DOSAGE IN ADULTS ONLY Hypertension The recommended dose of valsartan is 80 mg once daily, irrespective of race, age or gender. The maximum antihypertensive effect is seen after 4 weeks. In patients whose blood pressure 2 is not adequately controlled, the daily dose may be increased to 160 mg. If additional blood pressure reduction is required, a diuretic may be added or the dose can be increased further to a maximum of 320 mg. Valsartan may also be administered with other antihypertensive agents. Heart failure The recommended starting dose of valsartan is 40 mg twice daily. Titration u اقرأ الوثيقة كاملة