Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
KRKA, d.d., Novo mesto
C09DX03
Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
40/10/25 milligram(s)
Film-coated tablet
olmesartan medoxomil, amlodipine and hydrochlorothiazide
Not marketed
2020-10-23
PACKAGE LEAFLET: INFORMATION FOR THE USER OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 20 MG/5 MG/12.5 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 40 MG/5 MG/12.5 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 40 MG/5 MG/25 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 40 MG/10 MG/12.5 MG FILM- COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA 40 MG/10 MG/25 MG FILM-COATED TABLETS olmesartan medoxomil/amlodipine/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 Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka is and what it is used for 2. What you need to know before you take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 3. How to take Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 4. Possible side effects 5. How to store Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 6. Contents of the pack and other information 1. WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE KRKA IS AND WHAT IT IS USED FOR Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide. All three substances help to control high blood pressure. - Olmesartan medoxomil belongs to a group of medicines called “angiotensin-II receptor antagonists”, which lowers blood pressure by relaxing the blood vessels. - Amlod Đọc toàn bộ tài liệu
Health Products Regulatory Authority 20 December 2023 CRN00DP2Q Page 1 of 25 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 40 mg/10 mg/25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide. Excipient(s) with known effect: Each film-coated tablet contains 14.54 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Pale greyish-violet to pale grey-violet, biconvex, capsule-shaped, film-coated tablets, scored on both sides of the tablet. The tablet can be divided into equal doses. Tablet dimensions: 15 mm ± 1 mm x 8 mm ± 1 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. _ADD-ON THERAPY_ Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka is indicated in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. _SUBSTITUTION THERAPY_ Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults_ The recommended dose of Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka is 1 tablet per day. _ _ _ADD-ON THERAPY_ Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 40 mg/10 mg/25 mg may be administered in patients whose blood pressure is not adequately controlled on Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka 40 mg/10 mg/12.5 mg Đọc toàn bộ tài liệu