Country: United Kingdom
Language: English
Source: myHealthbox
valsartan
Milpharm Limited
C09AA03
valsartan
80mg
Capsule, hard
Oral use
28, 30 and 500 capsules, hard
POM - Prescription Only Medicine
APL Swift Services (Malta) Limited
Angiotensin II Antagonists, plain
Hypertension Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 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 Heart failure Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used
Authorised
2015-09-14
VALSARTAN 40 MG CAPSULES, HARD VALSARTAN 80 MG CAPSULES, HARD VALSARTAN 160 MG CAPSULES, HARD Valsartan PACKAGE LEAFLET: INFORMATION FOR THE USER 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. 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 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. • TO TREAT SYMPTOMATIC HEART FA Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valsartan 80 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 80 mg of valsartan. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard 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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 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). Heart failure Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Hypertension The recommended starting dose of Valsartan is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg. Valsartan may also be administered with other antihypertensive agents. The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients. Recent myocardial infarction In clinically stable patients, therapy may be initiated as early as 12 hours after a Read the complete document