Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Eprosartan mesilate
Alliance Healthcare (Distribution) Ltd
C09CA02
Eprosartan mesilate
600mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502
TEVETEN 600MG TABLETS / EPROSARTAN 600MG TABLETS (eprosartan mesilate) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE * 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your medicine is called Teveten 600mg Tablets / Eprosartan 600mg Tablets, but will be referred to as Teveten throughout this Leaflet. IN THIS LEAFLET: What Teveten is and what it is used for Before you take Teveten How to take Teveten Possible side effects How to store Teveten Further information WHAT TEVETEN IS AND WHAT IT IS USED FOR WHAT TEVETEN IS USED FOR Teveten contains a medicine called eprosartan mesilate. This belongs to a group of medicines called ‘angiotensin II receptor antagonists’. This medicine is used to treat high blood pressure, also called hypertension. The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body. You may not feel unwell, but, if high blood pressure is not treated, it can lead to heart disease and stroke. HOW TEVETEN WORKS * Angiotensin II is a chemical found in the body which makes your blood vessels contract. This makes it more difficult for blood to pass through them * This causes your blood pressure to rise * Teveten works by preventing the chemical, angiotensin II, from causing your blood vessels to contract. This has the effect of lowering your blood pressure. You may be given Teveten on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your blood pressure more than one on its own. BEFORE YOU TAKE TEVETEN DO NOT TAKE TEVETEN IF: * You are allergic (hype Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eprosartan 600 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 735.84 mg eprosartan mesilate equivalent to 600 mg eprosartan. Excipient(s) with known effect: 43 mg lactose monohydrate per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, capsule shaped, biconvex film-coated tablets. Tablets are approximately 20 x 9 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eprosartan is indicated in adults for the treatment of essential hypertension._ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. Duration of treatment is not limited. _Older people_ No dose adjustment is required in older people. _Patients with Hepatic impairment _ There is limited experience in patients with hepatic insufficiency _(see section 4.3, _ _Contraindications)_. _ _ _Patients with Renal impairment _ In patients with moderate or severe renal impairment (creatinine clearance <60 ml/min), the daily dose should not exceed 600 mg. _Paediatric population _ Eprosartan 600 mg Film-coated Tablets is not recommended for use in children and adolescents. The safety and efficacy of eprosartan in children and adolescents under 18 years have not been established. No data are available. Method of administration Oral use. Eprosartan may be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe hepatic impairment. Second a Прочитать полный документ