Country: Malta
Language: English
Source: Medicines Authority
LISINOPRIL DIHYDRATE
Atnahs Pharma Netherlands B.V. Copenhagen Towers Ørestads Boulevard 108, 5.tv DK-2300 København S , Denmark
C09AA03
LISINOPRIL DIHYDRATE 20 mg
TABLET
LISINOPRIL DIHYDRATE 20 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2006-03-29
Page 1 of 12 Package leaflet: Information for the patient ZESTRIL 5 MG TABLETS ZESTRIL 10 MG TABLETS ZESTRIL 20 MG TABLETS lisinopril Page 2 of 12 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS Page 3 of 12 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 reac Read the complete document
Summary of Product Characteristics Page 1 of 21 1. NAME OF THE MEDICINAL PRODUCT Zestril, 20 mg, tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains lisinopril dihydrate equivalent to 20 mg anhydrous lisinopril. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Round, brownish-red, uncoated, biconvex tablet with “♥ 20” on one side and plain on the other side. Diameter 8 mm. 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 Summary of Product Characteristics Page 2 of 21 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 the presence of renal impairment (see Tabl Read the complete document