Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Hydrochlorothiazide
Accord Healthcare Ireland Ltd.
C09DA; C09DA08
Olmesartan medoxomil; Hydrochlorothiazide
40 mg/25 milligram(s)
Film-coated tablet
Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics
Not marketed
2017-08-18
NL/H/3765/001-004/IA/013, version 01, 10/2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 40 MG/12.5 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 40 MG/25 MG FILM-COATED TABLETS Olmesartan Medoxomil/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/Hydrochlorothiazide tablets are and what they are used for 2. What you need to know before you take Olmesartan Medoxomil/Hydrochlorothiazide tablets 3. How to take Olmesartan Medoxomil/Hydrochlorothiazide tablets 4. Possible side effects 5. How to store Olmesartan Medoxomil/Hydrochlorothiazide tablets 6. Contents of the pack and other information 1. WHAT OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR Olmesartan Medoxomil/Hydrochlorothiazide tablets contains two active substances, olmesartan medoxomil and hydrochlorothiazide, that are used to treat high blood pressure (hypertension): • Olmesartan medoxomil is one of a group of medicines called angiotensin II-receptor antagonists. It lowers blood pressure by relaxing the blood vessels. • Hydrochlorothiazide is one of a group of medicines called thiazide diuretics (“water tablets”). It lowers blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. You will only be given Olmesartan Medoxomil/Hydrochlorothiazide tablets if olmesartan medoxomil alone has not adequately controlled your blood pressure. When given to Baca dokumen lengkap
Health Products Regulatory Authority 16 August 2022 CRN00CV39 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan Medoxomil/Hydrochlorothiazide 40 mg/25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg olmesartan medoxomil and 25 mg hydrochlorothiazide. Excipients- with known effect: Each 40 mg olmesartan medoxomil and 25 mg hydrochlorothiazide film-coated tablet contains 221 mg of lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Pinkish, oval film-coated tablets; debossed with “OH3” on one side and plain on other side. Approximate dimensions: Length 15.3 mm, width 7.1 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/25 mg fixed dose combinations are indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil 40 mg alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The recommended dose of Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/25 mg is 1 tablet per day. Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil 40 mg alone. Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg /25 mg may be administered in patients whose blood pressure is not adequately controlled on Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg fixed dose combination. For convenience, patients receiving olmesartan medoxomil and hydrochlorothiazide from separate tablets may be switched to Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg and 40 mg/25 mg tablets containing the same component doses. Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg and 40 mg/25 mg can be taken with or without food. _Older people (age 65 years or over)_ In older people the same dosage of Baca dokumen lengkap