Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
LISINOPRIL
McDermott Laboratories Ltd t/a Gerard Laboratories
C09AA03
LISINOPRIL
5mg Milligram
Tablets
Product subject to prescription which may be renewed (B)
lisinopril
Marketed
2001-02-08
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZESGER 5 MG, 10 MG AND 20 MG TABLETS lisinopril 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 Zesger is and what it is used for 2. What you need to know before you take Zesger 3. How to take Zesger 4. Possible side effects 5. How to store Zesger 6. Contents of the pack and other information 1. WHAT ZESGER IS AND WHAT IT IS USED FOR Zesger contains lisinopril, which belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. ACE inhibitors reduce blood pressure and widen blood vessels, this allows the blood to flow more easily and reduces the effort needed to pump blood around the body. Lisinopril is used to treat high blood pressure (hypertension), heart failure, and along with other medicine, may be given following a heart attack. Lisinopril can also be given to treat kidney problems in diabetic patients with high blood pressure (hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZESGER DO NOT TAKE ZESGER: • if you are allergic to lisinopril, any other angiotensin converting enzyme (ACE) inhibitor e.g. captopril, enalapril, ramipril or any of the other ingredients of this medicine (listed in section 6). • if you have previously been treated with an ACE inhibitor and have suffered an allergic reaction. Signs may include swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema). • if you or a family member have a history of angioedema. • if y Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zesger 5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains lisinopril dihydrate equivalent to 5 mg anhydrous lisinopril. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 5 mg tablets are white or almost white, round, bevelled edge tablets, debossed with 5 on one side and a breakline on the other. The tablet can be divided 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 Zesger tablets 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 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Aqra d-dokument sħiħ