Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil; Hydrochlorothiazide
KRKA, d.d., Novo mesto
C09DA; C09DA06
Candesartan cilexetil; Hydrochlorothiazide
32 mg/12.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics; candesartan and diuretics
Not marketed
2011-08-12
PACKAGE LEAFLET: INFORMATION FOR THE USER CANDESARTAN HYDROCHLOROTHIAZIDE KRKA 8 MG/12.5 MG TABLETS CANDESARTAN HYDROCHLOROTHIAZIDE KRKA 16 MG/12.5 MG TABLETS CANDESARTAN HYDROCHLOROTHIAZIDE KRKA 32 MG/12.5 MG TABLETS CANDESARTAN HYDROCHLOROTHIAZIDE KRKA 32 MG/25 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 Krka is and what it is used for 2. What you need to know before you take Candesartan Hydrochlorothiazide Krka 3. How to take Candesartan Hydrochlorothiazide Krka 4. Possible side effects 5. How to store Candesartan Hydrochlorothiazide Krka 6. Contents of the pack and other information 1. WHAT CANDESARTAN HYDROCHLOROTHIAZIDE KRKA IS AND WHAT IT IS USED FOR The name of your medicine is Candesartan Hydrochlorothiazide Krka. 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 lower your blood pressure. Your doctor may prescribe Candesartan Hydrochlorothiazide Krka if your blood pressure has not been p read_full_document
Health Products Regulatory Authority 16 January 2024 CRN00DPGQ Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan Hydrochlorothiazide Krka 32mg/12.5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 32 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Excipient with known effect: Lactose 142.79 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Candesartan Hydrochlorothiazide Krka 32 mg/12.5 mg tablets are yellowish white, biconvex, oval, with a score on one side. 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 Candesartan Hydrochlorothiazide Krka 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 in hypertension The recommended dose of Candesartan Hydrochlorothiazide Krka 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 Hydrochlorothiazide Krka may be considered. Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy. Candesartan Hydrochlorothiazide Krka may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Candesartan Hydrochlorothiazide Krka at lower doses. Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment. _ _ Special populations _Elderly_ No dose adjustment is necessary in elderly patients. _Intravascular volume depletion_ Dose titration of candesartan cilexetil is recommended in patients at risk for hypotension such as patients with possible volume depletion (an init read_full_document