País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Lisinopril Dihydrate
Accord Healthcare Ireland Ltd.
C09AA; C09AA03
Lisinopril Dihydrate
5 milligram(s)
Tablet
ACE inhibitors, plain; lisinopril
Marketed
2009-01-23
PACKAGE LEAFLET: INFORMATION FOR THE USER LESTACE 5 MG, 10 MG AND 20 MG TABLETS Lisinopril 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 Lestace Tablets are and what they are used for 2. What you need to know before you take Lestace Tablets 3. How to take Lestace Tablets 4. Possible side effects 5. How to store Lestace Tablets 6. Contents of the pack and other information 1. WHAT LESTACE TABLETS IS AND WHAT IT IS USED FOR Lestace Tablets belong to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). It acts by widening the blood vessels, which helps reduce your blood pressure and makes it easier for the heart to pump blood to all parts of your body. Lestace Tablets are used for the treatment of: - High blood pressure (hypertension) - Symptomatic heart failure, a condition where the heart does not pump the blood through your body as well as it should. - Heart attack (acute myocardial infarction) that may lead to a weakening of your heart. - Kidney problems related to Type II diabetes in people with high blood pressure. Lestace is recommended in children and adolescents (6 to 16 years old) only for the treatment of high blood pressure (hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LESTACE TABLETS DO NOT TAKE LESTACE TABLETS - if you are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6) or any other medicine in the same group of drugs as Lestace Tablets (ACE inhibitors) - if you have previously been treated Leer el documento completo
Health Products Regulatory Authority 24 October 2022 CRN00CTHF Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lestace 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg, of lisinopril as lisinopril dihydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 5 mg tablets are white, round and flat with a diameter of 8 mm, and scored on both sides. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of hypertension. Heart failure Treatment of symptomatic heart failure. Acute myocardial infarction Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction. Renal complications of diabetes mellitus Treatment of renal disease in hypertensive patients with Type 2 diabetes mellitus and incipient nephropathy (see section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lestace should be administered orally in a single daily dose. As with all other medication taken once daily, Lestace should be taken at approximately the same time each day. The absorption of Lestace tablets is not affected by food. The dose should be individualised according to patient profile and blood pressure response (see section 4.4). Hypertension Lestace may be used as monotherapy or in combination with other classes of antihypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1). _Starting dose_ In patients with hypertension the usual recommended starting dose is 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 2.5-5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. A lower starting dose is required in the presence of renal Leer el documento completo