Riik: Rootsi
keel: rootsi
Allikas: Läkemedelsverket (Medical Products Agency)
hydroklortiazid; valsartan
Novartis Sverige AB
C09DA03
hydrochlorothiazide; valsartan
320 mg/12,5 mg
Filmdragerad tablett
valsartan 320 mg Aktiv substans; hydroklortiazid 12,5 mg Aktiv substans
Apotek
Receptbelagt
Valsartan och diuretika
Förpacknings: Blister, 280 x 1 tabletter (endos); Blister, 56 x 1 tabletter (endos); Blister, 98 x 1 tabletter (endos); Blister, 7 tabletter; Blister, 28 tabletter (kalenderförpackning); Blister, 280 tabletter; Blister, 56 tabletter; Blister, 98 tabletter (kalenderförpackning)
Avregistrerad
2007-04-13
PACKAGE LEAFLET: INFORMATION FOR THE USER VALSARTAN/HYDROKLORTIAZID NOVARTIS 80 MG/12.5 MG FILM-COATED TABLETS VALSARTAN/HYDROKLORTIAZID NOVARTIS 160 MG/12.5 MG FILM-COATED TABLETS VALSARTAN/HYDROKLORTIAZID NOVARTIS 160 MG/25 MG FILM-COATED TABLETS VALSARTAN/HYDROKLORTIAZID NOVARTIS 320 MG/12.5 MG FILM-COATED TABLETS VALSARTAN/HYDROKLORTIAZID NOVARTIS 320 MG/25 MG FILM-COATED TABLETS Valsartan/hydrochlorothiazide 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/Hydroklortiazid Novartis is and what it is used for 2. What you need to know before you take Valsartan/Hydroklortiazid Novartis 3. How to take Valsartan/Hydroklortiazid Novartis 4. Possible side effects 5. How to store Valsartan/Hydroklortiazid Novartis 6. Contents of the pack and other information 1. WHAT VALSARTAN/HYDROKLORTIAZID NOVARTIS IS AND WHAT IT IS USED FOR Valsartan/Hydroklortiazid Novartis film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension). VALSARTAN 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. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. HYDROCHLOROTHIAZIDE belongs to a group of medicines called thiazide diuretic Lugege kogu dokumenti
Produktinformationen för Valsartan/Hydroklortiazid Novartis, 320 mg/12,5 mg, filmdragerad tablett, MTnr 23645, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Valsartan/Hydroklortiazid Novartis 320 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, ovaloid shaped, beveled edge tablet, imprinted with NVR on one side and HIL on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Valsartan/Hydroklortiazid Novartis fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ The recommended dose of Valsartan/Hydroklortiazid Novartis 320 mg/ 12.5 mg is one film-coated tablet once daily. Dose titration with the individual components is recommended. In each case, up- titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events. When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed. The clinical response to Lugege kogu dokumenti