Pays: Malte
Langue: anglais
Source: Medicines Authority
VALSARTAN
Jubilant Pharmaceuticals nv Axxes Business Park, Guldensporenpark 22 – Block C, 9820 Merelbeke, Belgium
C09CA03
VALSARTAN 80 mg
FILM-COATED TABLET
VALSARTAN 80 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2019-02-26
PACKAGE LEAFLET: INFORMATION FOR THE USER VALSARTAN JUBILANT 40 MG FILM-COATED TABLETS VALSARTAN JUBILANT 80 MG FILM-COATED TABLETS VALSARTAN JUBILANT 160 MG FILM-COATED TABLETS 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 Jubilant is and what it is used for 2. What you need to know before you take Valsartan Jubilant 3. How to take Valsartan Jubilant 4. Possible side effects 5. How to store Valsartan Jubilant 6. Contents of the pack and other information 1. WHAT VALSARTAN JUBILANT IS AND WHAT IT IS USED FOR Valsartan Jubilant belongs to a class of medicines known as angiotensin II receptor antagonist, 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 Jubilant works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Valsartan Jubilant 40 mg film-coated tablets 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 ( Lire le document complet
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Valsartan Jubilant 40 mg film-coated tablets Valsartan Jubilant 80 mg film-coated tablets Valsartan Jubilant 160 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Valsartan Jubilant 40 mg film-coated tablets Each tablet contains 40 mg valsartan. Excipient with known effect: Lactose anhydrous. Each tablet contains 51,3 mg lactose anhydrous. Valsartan Jubilant 80 mg film-coated tablets Each tablet contains 80 mg valsartan. Excipient with known effect: Lactose anhydrous. Each tablet contains 102,5 mg lactose anhydrous. Valsartan Jubilant 160 mg film-coated tablets Each tablet contains 160 mg valsartan. Excipient with known effect: Lactose anhydrous. Each tablet contains 205,0 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Valsartan Jubilant 40 mg film-coated tablets Yellow coloured, round, biconvex, film-coated tablets of 7.1 ± 0.2 mm diameter, debossed with “J” on one side and “40” on the other side of the tablet. Valsartan Jubilant 80 mg film-coated tablets Peach coloured, round, biconvex film-coated tablets of 8.7 ± 0.2 mm diameter, scored on one side and debossed with “80” on scored side and “J” on the other side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Valsartan Jubilant 160 mg film-coated tablets Yellow coloured, oval shaped, biconvex, film-coated tablets of 17.4 ± 0.2 mm length and of 6.9 ± 0.2 mm width, scored on one side and debossed with “160” on scored side and “J” on the other side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Page 2 of 20 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Valsartan Jubilant 40 mg film-coated tablets _ Hypertension Treatment of hypertension in children and adolescents 6 to 18 years of age. Recent myocardial infarction Treatment of clinically stable Lire le document complet