País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
Actavis Group PTC ehf
C09DA06
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
8/12.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2012-04-20
PACKAGE LEAFLET: INFORMATION FOR THE USER CANDESARTAN HYDROCHLOROTHIAZIDE ACTAVIS 8 MG/12.5 MG TABLETS candesartan cilexetil/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 Candesartan Hydrochlorothiazide Actavis is and what it is used for 2. What you need to know before you take Candesartan Hydrochlorothiazide Actavis 3. How to take Candesartan Hydrochlorothiazide Actavis 4. Possible side effects 5. How to store Candesartan Hydrochlorothiazide Actavis 6. Contents of the pack and other information 1. WHAT CANDESARTAN HYDROCHLOROTHIAZIDE ACTAVIS IS AND WHAT IT IS USED FOR The name of your medicine is Candesartan Hydrochlorothiazide Actavis tablets. It is used for treating high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to lower your blood pressure. - Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes your blood vessels relax and widen. This helps to lower your blood pressure. - Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine. This helps to Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan Hydrochlorothiazide Actavis 8 mg/12.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One Candesartan Hydrochlorothiazide Actavis 8 mg/12.5 mg tablet contains 8 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Excipients with known effect: Each tablet contains 117.30 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Candesartan Hydrochlorotiazide Actavis 8 mg/12.5 mg Tablets are white, round, biconvex tablets with a score line on one side and an embossing CH8 on the same side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Candesartan Hydrochlorothiazide Actavis is indicated for the: - Treatment of essential hypertension in adult patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Candesartan Hydrochlorotiazide Actavis is one tablet once daily. Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended. When clinically appropriate a direct change from monotherapy to Candesartan Hydrochlorotiazide Actavis may be considered. Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy. Candesartan Hydrochlorotiazide Actavis may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Candesartan Hydrochlorotiazide Actavis at lower doses (see sections 4.3, 4.4, 4.5 and 5.1). Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment. Special populations _Elderl Leia o documento completo