Country: Malta
Language: English
Source: Medicines Authority
OLMESARTAN MEDOXOMIL
Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece
C09CA08
OLMESARTAN MEDOXOMIL 40 mg
FILM-COATED TABLET
OLMESARTAN MEDOXOMIL 40 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2019-08-07
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLMESARTAN/ VOCATE 10 MG, 20MG AND 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/ VOCATE is and what it is used for 2. What you need to know before you take OLMESARTAN/ VOCATE 3. How to take OLMESARTAN/ VOCATE 4. Possible side effects 5. How to store OLMESARTAN/ VOCATE 6. Contents of the pack and other information 1. WHAT OLMESARTAN/ VOCATE IS AND WHAT IT IS USED FOR OLMESARTAN/ VOCATE belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels. The tablets are 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/ VOCATE. 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 doctor may also have urged you to take regula Read the complete document
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT OLMESARTAN/ VOCATE 10 mg film-coated tablets OLMESARTAN/ VOCATE 20 mg film-coated tablets OLMESARTAN/ VOCATE 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olmesartan medoxomil Each film-coated tablet contains 10 mg olmesartan medoxomil Each film-coated tablet contains 20 mg olmesartan medoxomil Each film-coated tablet contains 40 mg olmesartan medoxomil Excipient with known effect: OLMESARTAN/ VOCATE 10 mg film-coated tablets: each film-coated tablet contains 75.41 mg lactose monohydrate OLMESARTAN/ VOCATE 20 mg film-coated tablets: each film-coated tablet contains 150.82 mg lactose monohydrate OLMESARTAN/ VOCATE 40 mg film-coated tablets: each film-coated tablet contains 301.65mg lactose monohydrate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. OLMESARTAN/ VOCATE 10 mg are white to off-white, round film-coated tablets, debossed with 476 on one side and plain on the other side with a characteristic odour, approx. 6.3 mm in diameter. OLMESARTAN/ VOCATE 20 mg are white to off-white, round film-coated tablets, debossed with 437 on one side and plain on the other side with a characteristic odour, approx. 8.6 mm in diameter. OLMESARTAN/ VOCATE 40 mg are white to off-white, oval-shaped film-coated tablets debossed with 438 on one side and plain on the other side with a characteristic odour, approx.15.3 mm in length and 7.2 mm in breadth. 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. _ _ Page 2 of 15 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 redu Read the complete document