Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
C09CA02
EPROSARTAN 600 mg
FILM-COATED TABLET
EPROSARTAN 600 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2007-05-16
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER TEVETEN 400 MG AND TEVETEN 600 MG, FILM-COATED TABLETS Eprosartan 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 Teveten and what it is used for 2. What you need to know before you take Teveten 3. How to take Teveten 4. Possible side effects 5. How to store Teveten 6. Contents of the pack and other information 1. WHAT TEVETEN IS AND WHAT IT IS USED FOR Teveten is used: • to treat high blood pressure. Teveten contains the active ingredient eprosartan. • EPROSARTAN belongs to a group of medicines called ‘angiotensin II receptor antagonists’. It blocks the action of a substance in your body called ‘angiotensin II’. This substance causes your blood vessels to narrow. This makes it more difficult for the blood to flow through the vessels and so your blood pressure increases. By blocking this substance, the vessels relax and your blood pressure decreases. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVETEN DO NOT TAKE TEVETEN IF: • you are allergic (hypersensitive) to eprosartan or any of the other ingredients in Teveten (listed in Section 6) • you have SEVERE liver disease • you have SEVERE problems with the blood flow in your kidneys • you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren • you are more than 3 months pregnant (it is also better to avoid Teveten in early pregnancy – see pregnancy section. Do not take Teveten if any of the above apply Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TEVETEN 600 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains eprosartan mesylate equivalent to 600 mg eprosartan. Excipient with known effect: Each film-coated tablet contains 43.3 mg lactose (as lactose monohydrate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Teveten Mono 600 mg is a capsule-shaped, white, film-coated tablet marked “5046” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eprosartan is indicated for the treatment of essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is 600 mg eprosartan once daily. Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment. Eprosartan may be used alone or in combination with other anti-hypertensives (see sections 4.3, 4.4, 4.5 and 5.1). In particular, addition of a thiazide-type diuretic such as hydrochlorothiazide or a calcium channel blocker such as sustained release nifedipine has been shown to have an additive effect with eprosartan. Eprosartan may be taken with or without food. Duration of treatment is not limited. _Geriatric patients _ No dose adjustment is required in the elderly. _Dosage in Hepatically Impaired Patients _ There is limited experience in patients with hepatic insufficiency (see section 4.3). _Dosage in Renally Impaired Patients _ In patients with moderate or severe renal impairment (creatinine clearance <60 ml/min), the daily dose should not exceed 600 mg. _Paediatric patients _ Teveten is not recommended for use in children and adolescents due to lack of data on safety and efficacy. 4.3 CONTRAINDICATIONS • Known hypersensitivity to eprosartan or to any of the excipients. • Severe hepatic impairment. • Second and third trimester of pregnancy (see sections 4.4 and 4.6). • Hemodynamically significant bilateral renovascular disease or severe stenosis of a solitary functioning k Lesen Sie das vollständige Dokument