Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Eprosartan mesilate
Viatris UK Healthcare Ltd
C09CA02
Eprosartan mesilate
600mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5012781062158
PACKAGE LEAFLET: INFORMATION FOR THE USER TEVETEN ® 600MG TABLETS (eprosartan mesilate) 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. The name of your medicine is Teveten 600mg tablets but will be referred to as Teveten throughout this leaflet. Please note that this leaflet also contains information about other strength Teveten 300mg tablets. IN THIS LEAFLET: 1. WHAT TEVETEN IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE TEVETEN 3. HOW TO TAKE TEVETEN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TEVETEN 6. FURTHER INFORMATION 1. 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 pres Read the complete document
OBJECT 1 TEVETEN 600MG FILM-COATED TABLETS Summary of Product Characteristics Updated 11-Apr-2018 | Mylan Products Limited 1. Name of the medicinal product Teveten 600mg film-coated tablets 2. Qualitative and quantitative composition Eprosartan mesilate equivalent to 600mg eprosartan free base. For excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablets. Capsule-shaped, biconvex, white film-coated tablet with the inscription '5046'. 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. 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 Hypersensitivity to the active substance or to any of the excipients. Second and third trimester of pregnancy (see sections 4.4 and 4.6). Severe hepatic impairment. Haemodynamically significant bilateral renovascular disease or severe stenosis of a solitary functioning kidney The concomitant use of Teveten with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal Read the complete document