Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil
Rowex Ltd
C09CA; C09CA08
Olmesartan medoxomil
20 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; olmesartan medoxomil
Marketed
2016-04-15
PACKAGE LEAFLET: INFORMATION FOR THE USER OLMESARTAN ROWEX 10MG FILM-COATED TABLETS OLMESARTAN ROWEX 20MG FILM-COATED TABLETS OLMESARTAN ROWEX 40MG FILM-COATED TABLETS Olmesartan medoxomil 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 Rowex is and what it is used for 2. What you need to know before you take Olmesartan Rowex 3. How to take Olmesartan Rowex 4. Possible side effects 5. How to store Olmesartan Rowex 6. Contents of the pack and other information 1. WHAT OLMESARTAN ROWEX IS AND WHAT IT IS USED FOR Olmesartan Rowex belongs to a group of medicines called angiotensin II receptor antagonists. They lower blood pressure by relaxing the blood vessels. Olmesartan Rowex is used for the treatment of high blood pressure (also known as ‘hypertension’) in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain and eyes. In some cases this may lead to a heart attack, heart or kidney failure, stroke or blindness. Usually high blood pressure has no symptoms. It is important to have your blood pressure checked to prevent damage occurring. High blood pressure can be controlled with medicines such as Olmesartan Rowex tablets. Your doctor has probably also recommended that you make some changes in your lifestyle to help lower your blood pressure (for example losing weight, giving up smoking, reducing the amount of alcohol you drink and reducing the amount of salt in your diet). Your doct Przeczytaj cały dokument
Health Products Regulatory Authority 13 February 2024 CRN00CTVD Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan Rowex 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg olmesartan medoxomil. Excipient with known effect Contains 111.05 mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet White, round, biconvex film-coated tablet with inscription ’20’ on one side. Dimension: 8.5 mm – 8.8 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Treatment of hypertension in children and adolescents from 6 to less than 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults The recommended starting dose of olmesartan medoxomil is 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, olmesartan medoxomil dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added. The antihypertensive effect of olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. This should be borne in mind when considering changing the dose regimen for any patient. Elderly (65 years or over) No adjustment of dosage is generally required in elderly people (see below for dose recommendations in patients with renal impairment). If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored. Renal impairment The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20 – 60 mL/min) is 20 mg olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group. The use of olmesartan medoxomil in patients with severe renal i Przeczytaj cały dokument