Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Amlodipine besilate; Valsartan; Hydrochlorothiazide
Rowex Ltd
C09DX; C09DX01
Amlodipine besilate; Valsartan; Hydrochlorothiazide
10/160/25 milligram(s)
Film-coated tablet
Angiotensin II antagonists, other combinations; valsartan, amlodipine and hydrochlorothiazide
Not marketed
2019-08-19
PACKAGE LEAFLET: INFORMATION FOR THE USER AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE ROWEX 5 MG/160 MG/25 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE ROWEX 10 MG/160 MG/25 MG FILM-COATED TABLETS AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE ROWEX 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 Rowex is and what it is used for 2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide Rowex 3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Rowex 4. Possible side effects 5. How to store Amlodipine/Valsartan/Hydrochlorothiazide Rowex 6. Contents of the pack and other information 1. WHAT AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE ROWEX IS AND WHAT IT IS USED FOR Amlodipine/Valsartan/Hydrochlorothiazide Rowex 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 and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. • Hydrochlorothiazide belongs Läs hela dokumentet
Health Products Regulatory Authority 07 September 2022 CRN00D0TX Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlodipine/Valsartan/Hydrochlorothiazide Rowex 10 mg/160 mg/25 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan and 25 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed "NVR" on one side and "VHL" on the other side. Length: approx. 15 mm Width: approx. 5.9 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 Rowex is one tablet per day, to be taken preferably in the morning. Before switching to Amlodipine/Valsartan/Hydrochlorothiazide Rowex patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Amlodipine/Valsartan/Hydrochlorothiazide Rowex 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 Rowex is 10 mg/320 mg/25 mg. _Special populations_ _Renal impairment_ Due to the hydrochlorothiazide component, Amlodipine/Valsartan/Hydrochlorothiazide Rowex 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 m 2 ) (see sections 4.3, 4.4 and 5.2). No adjustment of the initial dose is required for patients with mild to moderate renal im Läs hela dokumentet