Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Lisinopril Dihydrate
AS Grindeks
C09AA03
Lisinopril Dihydrate
Tablet
lisinopril
Not marketed
2023-05-19
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LISINOPRIL GRINDEKS 5 MG TABLETS LISINOPRIL GRINDEKS 10 MG TABLETS LISINOPRIL GRINDEKS 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 Lisinopril Grindeks is and what it is used for 2. What you need to know before you take Lisinopril Grindeks 3. How to take Lisinopril Grindeks 4. Possible side effects 5. How to store Lisinopril Grindeks 6. Contents of the pack and other information 1. WHAT LISINOPRIL GRINDEKS IS AND WHAT IT IS USED FOR Lisinopril Grindeks contains a medicine called lisinopril. This belongs to a group of medicines called ACE inhibitors. Lisinopril Grindeks can be used for the following conditions: • To treat high blood pressure (hypertension) in adults, adolescents and children aged 6 years and older. • To treat heart failure in adults. • If you have recently had a heart attack (myocardial infarction) in adults. • To treat kidney problems caused by Type 2 diabetes in adults with high blood pressure. Lisinopril Grindeks works by making your blood vessels widen. This helps to 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 LISINOPRIL GRINDEKS _ _ DO NOT TAKE LISINOPRIL GRINDEKS • 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 caus Baca dokumen lengkap
Health Products Regulatory Authority 22 May 2023 CRN00CQ6Z Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lisinopril Grindeks 20 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg lisinopril (as dihydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round plain uncoated tablets with bevelled edges and score line on one side. Dimensions of tablet: diameter 10 mm. 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 in adults, adolescents and children aged 6 years and older. HEART FAILURE Treatment of symptomatic heart failure in adults. ACUTE MYOCARDIAL INFARCTION Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction in adults. RENAL COMPLICATIONS OF DIABETES MELLITUS Treatment of renal disease in hypertensive adult patients with Type 2 diabetes mellitus and incipient nephropathy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose should be individualised according to patient profile and blood pressure response (see section 4.4). Posology HYPERTENSION Lisinopril 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 us Baca dokumen lengkap