País: Malta
Idioma: inglés
Fuente: Medicines Authority
OLMESARTAN MEDOXOMIL
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C09CA08
OLMESARTAN MEDOXOMIL 20 mg
FILM-COATED TABLET
OLMESARTAN MEDOXOMIL 20 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2013-09-17
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER VIVACTRA 5 MG FILM-COATED TABLETS VIVACTRA 10 MG FILM-COATED TABLETS VIVACTRA 20 MG FILM-COATED TABLETS VIVACTRA 40 MG 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 Vivactra is and what it is used for 2. What you need to know before you take Vivactra 3. How to take Vivactra 4. Possible side effects 5. How to store Vivactra 6. Contents of the pack and other information 1. WHAT VIVACTRA IS AND WHAT IT IS USED FOR Vivactra belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels. Vivactra 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 Vivactra 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 doctor may also have urged you to Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vivactra 5 mg film-coated tablet Vivactra 10 mg film-coated tablet Vivactra 20 mg film-coated tablet Vivactra 40 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olmesartan medoxomil Each 5 mg tablet contains 5 mg of olmesartan medoxomil Each 10 mg tablet contains 10 mg of olmesartan medoxomil Each 20 mg tablet contains 20 mg of olmesartan medoxomil Each 40 mg tablet contains 40 mg of olmesartan medoxomil Excipients with known effect: Each 5 mg tablet contains 37.365 mg of lactose monohydrate Each 10 mg tablet contains 75.53 mg of lactose monohydrate Each 20 mg tablet contains 151.06 mg of lactose monohydrate Each 40 mg tablet contains 302.12 mg of lactose monohydrate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. Vivactra 5 mg film-coated tablets are white, round, biconvex and 5.5 mm in diameter, with OL debossed on one side and 5 on the other side. Vivactra 10 mg film-coated tablets are white, round, biconvex and 6.5 mm in diameter, with OL 10 debossed on one side. Vivactra 20 mg film-coated tablets are white, round, biconvex and 8.5 mm in diameter, with OL 20 debossed on one side. Vivactra 40 mg film-coated tablets are white, oval, biconvex and 15x7 mm in diameter, with OL 40 debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults _ Treatment of essential hypertension. _Paediatric population _ 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 antihyper Leer el documento completo