Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
EPROSARTAN MESYLATE
BGP Products Ltd
C09CA02
EPROSARTAN MESYLATE
600 Milligram
Film Coated Tablet
Oral use
Blister packs: 14, 28, 56, 98, 250
Product subject to prescription which may be renewed (B)
Mylan Laboratories SAS
Angiotensin-II antagonists, plain C
Angiotensin II antagonists, plain
Eprosartan is indicated for the treatment of essential hypertension
Authorised
2015-03-27
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. Do not pass it on to others. It may harm them, even if their symptoms 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. IN THIS LEAFLET: 1. What Teveten is 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 The full name of your medicine is either Teveten 400 mg or Teveten 600 mg film-coated tablets. In this leaflet the shorter name Teveten is used and applies to both of these different strength tablets. 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. BEFORE YOU TAKE TEVETEN DO NOT TAKE TEVETEN IF: you are allergic (hypersensitive) to eprosartan or any of the other ingredients in Teveten (listed Läs hela dokumentet
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. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Film-coated tablet Capsule-shaped, white, film-coated tablet marked “5046” on one side and no inscription on the other 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Läs hela dokumentet