Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Lisinopril
Gedeon Richter Plc
C09AA; C09AA03
Lisinopril
2.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; lisinopril
Marketed
2002-02-08
PACKAGE LEAFLET: INFORMATION FOR THE USER LISOPRESS TABLETS 2.5 MG, 5 MG, 10 MG AND 20 MG lisinopril (as dihydrate) 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 Lisopress is and what it is used for 2. What you need to know before you take Lisopress 3. How to take Lisopress 4. Possible side effects 5. How to store Lisopress 6. Contents of the pack and other information 1. WHAT LISOPRESS IS AND WHAT IT IS USED FOR Lisopress tablet contains an active substance called lisinopril. This belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Lisopress tablet can be used for the following conditions: - to treat high blood pressure (hypertension). - to treat heart failure. - if you have recently had a heart attack (myocardial infarction). - to treat kidney problems caused by Type II diabetes in people with high blood pressure. Lisopress tablet works by making your blood vessels widen. This helps lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISOPRESS DO NOT TAKE LISOPRESS • if you are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6). • if you have ever had an allergic reaction to another ACE inhibitor medicine. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue or throat. It may also have made it difficult to swallow or breathe (angioedema). • if a member of your fa Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 31 August 2020 CRN009TJJ Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lisopress 2.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 2.5 mg lisinopril as 2.72 mg lisinopril dihydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 2.5 mg tablets are white, round, debossed with 2.5 on one side and a break line on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 The dose should be individualised according to patient profile and blood pressure response (see section 4.4). _Hypertension_ Lisopress 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 impairment (see Table 1 below). _Maintenance dose_ The usual effective maintenance dosage is 20 mg administered in a single daily dose. In general if the Olvassa el a teljes dokumentumot