Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
VALSARTAN, HYDROCHLOROTHIAZIDE
Novartis Pharmaceuticals UK Ltd
C09DA03
VALSARTAN, HYDROCHLOROTHIAZIDE
160/12.5 mg/mg
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2003-11-04
Live Text: Yes / No / Both Production Site: Torre WO: 1387650 CTM: Gargiulo, Nicola Comp. Description: LFT_CO-DIOVAN_FCT IE Printing Colours: Black Comp. No. New: 1222613 IE TA Comp. No. Old: 1222037 IE TA Format/Dimension: 148 x 630 mm Tech. Drawing No.: 5666/O Technical Colours: Cutting Min. Font Size Text: 9 pt Font Type: News Gothic Version No.: 2 Date: 13 Jun 2015 J.N.: 252441 Braille: N/A ! PLEASE TURN OVERPRINTING ON ! 1 of 2 1222613 IE TA PACKAGE LEAFLET: INFORMATION FOR THE USER CO‑DIOVAN 80 MG/12.5 MG FILM‑COATED TABLETS CO‑DIOVAN 160 MG/12.5 MG FILM‑COATED TABLETS CO‑DIOVAN 160 MG/25 MG FILM‑COATED TABLETS CO‑DIOVAN 320 MG/12.5 MG FILM‑COATED TABLETS CO‑DIOVAN 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 Co‑Diovan is and what it is used for 2. What you need to know before you take Co‑Diovan 3. How to take Co‑Diovan 4. Possible side effects 5. How to store Co‑Diovan 6. Contents of the pack and other information 1. WHAT CO‑DIOVAN IS AND WHAT IT IS USED FOR Co‑Diovan 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 Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-Diovan 160 mg/12.5 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Dark red, ovaloid tablet imprinted with HHH on one side and CG on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Co-Diovan 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 Co-Diovan 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 Co-Diovan should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Co-Diovan 320 mg/25 mg. The antihypertensive effect is substantially present within 2 weeks. In most patients, maximal effects are observed within 4 weeks. However, in some patients 4 - 8 weeks treatment may be required. This should be taken into account during dose titration. _Method of administration_ Co-Diovan can be taken with or without food and should be administered with water. _Special populations_ _Patients with Renal impairment_ No dose adjustment is required for patients with mild to moderate r Przeczytaj cały dokument