מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Lisinopril
Atnahs Pharma Netherlands B.V.
C09AA; C09AA03
Lisinopril
5 milligram(s)
Tablet
ACE inhibitors, plain; lisinopril
Marketed
1989-05-10
Page 1 of 9 Package leaflet: Information for the patient ZESTRIL 5 MG TABLETS ZESTRIL 10 MG TABLETS ZESTRIL 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 Zestril is and what it is used for 2. What you need to know before you take Zestril 3. How to take Zestril 4. Possible side effects 5. How to store Zestril 6. Contents of the pack and other information 1. WHAT ZESTRIL IS AND WHAT IT IS USED FOR Zestril contains a medicine called lisinopril. This belongs to a group of medicines called ACE inhibitors. Zestril 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. Zestril 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 ZESTRIL DO NOT TAKE ZESTRIL: • 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 you have taken or are currently taking sacubitril/valsartan, a medicine use קרא את המסמך השלם
Health Products Regulatory Authority 28 July 2022 CRN00CSTX Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zestril 5mg 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 Round, pink, uncoated, biconvex tablets with “♥ 5” on one side and bisected on the other side. Diameter 6mm. 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 Zestril should be administered orally in a single daily dose. As with all other medication taken once daily, Zestril should be taken at approximately the same time each day. The absorption of Zestril tablets is not affected by food. The dose should be individualised according to patient profile and blood pressure response (see section 4.4). HYPERTENSION Zestril 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 t קרא את המסמך השלם