Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Eprosartan mesilate
Creo Pharma Ltd
C09CA02
Eprosartan mesilate
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5060222600674
PACKAGE LEAFLET: INFORMATION FOR THE USER Eprosartan 300mg Film-coated Tablets Eprosartan 400mg Film-coated Tablets Eprosartan 600mg Film-coated Tablets eprosartan mesilate 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 EPROSARTAN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPROSARTAN 3. HOW TO TAKE EPROSARTAN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE EPROSARTAN 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT EPROSARTAN IS AND WHAT IT IS USED FOR Eprosartan 300mg, 400mg and 600mg film-coated tablets 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 EPROSARTAN 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 Eprosartan 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 Eprosartan on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your b Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eprosartan 400 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 490.56 mg eprosartan mesilate equivalent to 400 mg eprosartan. Excipient(s) with known effect: 28 mg lactose monohydrate per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Peach coloured, oval shaped, biconvex film-coated tablets. Tablets are approximately 18 x 7 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 400 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. Secon Прочитать полный документ