দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
VALSARTAN
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
C09CA03
VALSARTAN 80 mg
HARD CAPSULE
VALSARTAN 80 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2013-08-08
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER VALSARTAN 40 MG CAPSULES, HARD VALSARTAN 80 MG CAPSULES, HARD VALSARTAN 160 MG CAPSULES, HARD Valsartan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet See section 4. WHAT IS IN THIS LEAFLET 1. What Valsartan is and what it is used for 2. What you need to know before you take Valsartan 3. How to take Valsartan 4. Possible side effects 5. How to store Valsartan 6. Contents of the pack and other information 1. WHAT VALSARTAN IS AND WHAT IT IS USED FOR Valsartan capsules belong to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsartan capsules work by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Valsartan 40 mg capsules CAN BE USED FOR THREE DIFFERENT CONDITIONS: TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO 18 YEARS OF AGE. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders. TO TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK (myocardial infarction). “Recent” here means between 12 hours and 10 days. Valsartan can be used t সম্পূর্ণ নথি পড়ুন
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Valsartan 40 mg capsules, hard Valsartan 80 mg capsules, hard Valsartan 160 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg of valsartan. Each hard capsule contains 80 mg of valsartan. Each hard capsule contains 160mg of valsartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard _Valsartan 40 mg Capsules: _ Opaque light grey cap/Opaque light grey body, size '4' hard gelatin capsules imprinted in black ink with ‘I’ on cap and '70' on body, filled with white to off white granular powder. _Valsartan 80 mg Capsules: _ Opaque light grey cap / Flesh opaque body, size '3' hard gelatin capsules imprinted in black ink with ‘I’ on cap and '71' on body, filled with white to off white granular powder. _Valsartan 160 mg Capsules: _ Opaque dark grey cap/Flesh opaque body, size '1' hard gelatin capsules imprinted in white ink with ‘I’ on cap and '72' on body with black ink, filled with white to off white granular powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension (only 40 mg) Treatment of hypertension in children and adolescents 6 to less than 18 years of age. Hypertension (only 80 mg and 160 mg) Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to less than 18 years of age. Recent myocardial infarction Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours – 10 days) myocardial infarction (see sections 4.4 and 5.1). Page 2 of 20 Heart failure Treatment of adult patients with symptomatic heart failure when Angiotensin Converting enzyme (ACE) inhibitors are not tolerated or in beta-blocker intolerant patients as add-on therapy to ACE- inhibitors when mineralocorticoid receptor antagonists cannot be used (see Sections 4.2, 4.4, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posol সম্পূর্ণ নথি পড়ুন