Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
EPROSARTAN MESYLATE
McDermott Laboratories Ltd t/a Gerard Laboratories
EPROSARTAN MESYLATE
600 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER EPROSARTAN MYLAN 300 MG EPROSARTAN MYLAN 400 MG EPROSARTAN MYLAN 600 MG FILM-COATED TABLETS (eprosartan) 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 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. IN THIS LEAFLET: 1. What Eprosartan Mylan is and what it is used for 2. Before you take Eprosartan Mylan 3. How to take Eprosartan Mylan 4. Possible side effects 5. How to store Eprosartan Mylan 6. Further information. 1. WHAT EPROSARTAN MYLAN IS AND WHAT IT IS USED FOR Eprosartan Mylan belongs to a family of medicines known as angiotensin II antagonists Angiotensin II is produced in your body and causes blood vessels to become narrower. This makes the blood flow through the vessels more difficult and the blood pressure increases. Eprosartan blocks this action so that the blood vessels relax and the blood pressure is lowered. Eprosartan is used to treat high blood pressure (hypertension). 2. BEFORE YOU TAKE EPROSARTAN MYLAN DO NOT TAKE EPROSARTAN MYLAN IF: • you are allergic (hypersensitive) to eprosartan or any of the other ingredients in Eprosartan tablets • you are more than 3 months pregnant. (It is also better to avoid Eprosartan in early pregnancy – see pregnancy section.) • you have severe liver problems • you have damaged blood flow to the kidneys or serious constrictions in a single Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eprosartan Mylan 600mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 735.80 mg of eprosartan mesylate equivalent to 600 mg of eprosartan. Excipient(s): 42.788 mg of lactose monohydrate per 600 mg tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet A white to off-white, film coated, capsule shaped, biconvex, bevelled edge tablet imprinted with ‘M EN3’ in black ink on one side of the tablet and blank on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eprosartan Mylan is indicated for the treatment of essential hypertension. Eprosartan Mylan is indicated in adults. 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. 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 could 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 impairment (see section 4.3). _Dosage in renally impaired patients_: As clinical experience is limited in patients with creatinine clearance <60 ml/min a daily dose of 600 mg should not be exceeded. _Paediatric population_ Eprosartan is not recommended for use in children or adolescents due to lack of data on safety an Přečtěte si celý dokument