Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
LISINOPRIL
McDermott Laboratories Ltd t/a Gerard Laboratories
LISINOPRIL
2.5mg Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER ZESGER 2.5 MG, 5 MG, 10 MG AND 20 MG TABLETS (lisinopril) 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 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 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 Zesger is and what it is used for 2. Before you take Zesger 3. How to take Zesger 4. Possible side effects 5. How to store Zesger 6. Further information 1. WHAT ZESGER IS AND WHAT IT IS USED FOR Zesger 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. Zesger Tablets are used to treat high blood pressure (hypertension), heart failure, and along with other medicine, may be given following a heart attack. Zesger can also be given to diabetic patients, to help treat conditions related to their diabetes such as hypertension and kidney problems. 2. BEFORE YOU TAKE ZESGER DO NOT TAKE ZESGER IF • you are allergic (hypersensitive) to Lisinopril or any of the other ingredients of this medicine. • you are allergic (hypersensitive) to any other ACE inhibitor eg. Captopril, Enalapril, Ramipril. • you, or a family member, have previously been treated with an ACE inhibitor and have suffered an allergic reaction. Symptoms may include swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema). • you are more than 3 months pregnant. (It is also better to avoid Zesger in ear Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zesger 2.5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains lisinopril dihydrate equivalent to 2.5 mg anhydrous lisinopril. For a 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 breakline on the other. 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, Pharmacodynamic properties)._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lisinopril tablets should be administered orally in a single daily dose. As with all other medication taken once daily, lisinopril should be taken at approximately the same time each day. The absorption of lisinopril is not affected by food. The dose should be individualised according to patient profile and blood pressure response (see section 4.4). Hypertension Lisinopril tablets may be used as monotherapy or in combination with other classes of antihypertensive therapy. Use in Hypertensive Paediatric Patients aged 6- 16 years The recommended initial dose is 2.5mg once daily in patients 20 to <50kg, and 5mg once daily in patients 50kg. The dosage should be individually adjusted to a maximum of 20mg daily in patients weighing 20 to <50 kg, and 40mg in patients 50 kg. Doses above 0.61mg/kg (or in excess of 40mg) have not Baca dokumen lengkapnya