Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Amlodipine; Valsartan; Hydrochlorothiazide
KRKA, d.d., Novo mesto
C09DX01
Amlodipine; Valsartan; Hydrochlorothiazide
10/160/25 milligram(s)
Film-coated tablet
valsartan, amlodipine and hydrochlorothiazide
Not marketed
2020-10-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 5 MG/160 MG/12.5 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 5 MG/160 MG/25 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 10 MG/160 MG/12.5 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 10 MG/160 MG/25 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 10 MG/320 MG/25 MG FILM-COATED TABLETS amlodipine/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 Amlodipine/Valsartan/Hydrochlorothiazide Krka is and what it is used for 2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide Krka 3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Krka 4. Possible side effects 5. How to store Amlodipine/Valsartan/Hydrochlorothiazide Krka 6. Contents of the pack and other information 1. WHAT AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE KRKA IS AND WHAT IT IS USED FOR Amlodipine/Valsartan/Hydrochlorothiazide Krka tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help to control high blood pressure. - Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall, which stops the blood vessels from tightening. - Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is produced by the body Les hele dokumentet
Health Products Regulatory Authority 22 November 2022 CRN00D899 Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlodipine/Valsartan/Hydrochlorothiazide Krka 10 mg/160 mg/25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 160 mg valsartan and 25 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Brown yellow, oval, biconvex, film-coated tablets,engraved with mark K4 on one side of the tablet, dimensions approximately 13 x 8 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ The recommended dose of Amlodipine/Valsartan/Hydrochlorothiazide Krka is one tablet per day, to be taken preferably in the morning. Before switching to Amlodipine/Valsartan/Hydrochlorothiazide Krka patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Amlodipine/Valsartan/Hydrochlorothiazide Krka should be based on the doses of the individual components of the combination at the time of switching. The maximum recommended dose of Amlodipine/Valsartan/Hydrochlorothiazide Krka is 10 mg/320 mg/25 mg. Special populations _Renal impairment _ Due to the hydrochlorothiazide component, Amlodipine/Valsartan/Hydrochlorothiazide Krka is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2). No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and Les hele dokumentet