Land: Sverige
Språk: svensk
Kilde: Läkemedelsverket (Medical Products Agency)
valsartan
Orifarm AB
C09CA03
valsartan
160 mg
Filmdragerad tablett
valsartan 160 mg Aktiv substans
Receptbelagt
Valsartan
Avregistrerad
2007-05-21
PACKAGE LEAFLET: INFORMATION FOR THE USER DIOVAN 40 MG FILM-COATED TABLETS DIOVAN 80 MG FILM-COATED TABLETS DIOVAN 160 MG FILM-COATED TABLETS DIOVAN 320 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 Diovan is and what it is used for 2. What you need to know before you take Diovan 3. How to take Diovan 4. Possible side effects 5. How to store Diovan 6. Contents of the pack and other information 1. WHAT DIOVAN IS AND WHAT IT IS USED FOR Diovan contains the active substance: valsartan and belongs 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. Diovan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Diovan 40 mg film-coated tablets CAN BE USED FOR THREE DIFFERENT CONDITIONS: • TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO LESS THAN 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” her Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Diovan 40 mg film-coated tablets Diovan 80 mg film-coated tablets Diovan 160 mg film-coated tablets Diovan 320 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg of valsartan. Each film-coated tablet contains 80 mg of valsartan. Each film-coated tablet contains 160 mg of valsartan. Each film-coated tablet contains 320 mg of valsartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. 40 mg: Yellow, ovaloid film-coated tablet with bevelled edges, slightly convex, scored on one side with debossing “D” on one side of the score and “O” on the other side of the score and NVR on the reverse side of the tablet. The tablet can be divided into equal doses. 80 mg: Pale red, round film-coated tablet with bevelled edges, scored on one side with debossing “D” on one side of the score and “V” on the other side of the score and “NVR” on the reverse side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 160 mg: Grey-orange, ovaloid film-coated tablet, slightly convex, scored on one side with debossing “DX” on one side of the score and “DX” on the other side of the score and “NVR” on the reverse side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 320 mg: Dark grey-violet, ovaloid film-coated tablet with bevelled edges, slightly convex, scored on one side with debossing “DC” on one side of the score and “DC” on the other side of the score and “NVR” on the reverse side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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, 160 mg and Les hele dokumentet