国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LISINOPRIL
DKSH MALAYSIA SDN BHD
LISINOPRIL
30 Tablets; 50 Tablets; 100Tablet Tablets
STELLAPHARM J.V. Co., LTD. - BRANCH 1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LISINOPRIL STADA® 10MG TABLET Lisinopril 10.89mg (equivalent to 10mg lisinopril) 1 WHAT IS IN THIS LEAFLET 1. What Lisinopril STADA® 10 mg is used for 2. How Lisinopril STADA® 10 mg works 3. Before you take Lisinopril STADA® 10 mg 4. How to take Lisinopril STADA® 10 mg 5. While you are using Lisinopril STADA® 10 mg 6. Side effects 7. Storage and Disposal of Lisinopril STADA® 10 mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LISINOPRIL STADA® 10 MG IS USED FOR • Treatment of high blood pressure (arterial hypertension) • Treatment of symptomatic heart failure (cardiac insufficiency) • Acute heart attack (acute myocardial Infarction) – of patients with a stable cardiocirculatory situation (haemodynamically stable patients with a systolic blood pressure above 100mmHg, serum-creatinine below 177μmol/l (2.0mg/dl) and proteinuria less than 500mg/24hours. Lisinopril should be administered additionally to the usual standard heart attack treatment, preferably together with nitrates. HOW LISINOPRIL STADA® 10 MG WORKS • Lisinopril STADA® 10 mg is an angiotensin-converting enzyme inhibitor (ACE inhibitor) for the treatment of high blood pressure. BEFORE YOU TAKE LISINOPRIL STADA® 10 MG _When you must not take it _ • If you are allergic (hypersensitive) to lisinopril or any of the other ingredients of Lisinopril STADA® 10 mg or to another angiotensin converting enzyme (ACE) inhibitor • if you have had a tissue swelling (angioneurotic edema) related to previous treatment with an ACE inhibitor • if you are suffering from an inherited or idiopathic (without identifiable cause) angioedema (serious allergic reaction which causes swelling of the face or throat) • In the second and third trimester of pregnancy. _Before you start to take it _ • Always take Lisinopril STADA® 10 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. • It is recomm 阅读完整的文件
Ver03 USE IN PREGNANCY – When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to developing foetus. When pregnancy is detected this drug should be discontinued as soon as possible. STADAPHARM GMBH, Stadastr, 2-18, 61118 Bad Vilbel, Germany LISINOPRIL STADA ® 10 MG COMPOSITION Active ingredient: Each tablet contains 10.89mg Lisinopril dihydrate, equivalent to 10mg Lisinopril. Excipients: Mannitol, maize starch, calcium hydrogen phosphate dihydrate, pregelatinized starch, colloidal anhydrous silica, magnesium stearate PHARMACOLOGICAL PROPERTIES Lisinopril is an inhibitor of the angiotensin-converting enzyme. The angiotensin converting enzyme (ACE) is a peptidyl dipeptidase, which catalyses the conversion of angiotensin I into the vasoconstricting peptide, angiotensin II. Inhibition of ACE results in a lower concentration of plasma angiotensin II, which causes an increase of the plasma renin activity (caused by the elimination of the negative feedback of angiotensin II on the reninsecretion) and reduced aldosterone secretion. ACE is identical with kininase II. That is why lisinopril can block bradykinin, a strong vasodepressive peptide. Although it is still not clear, which part this plays in the therapeutic effect of lisinopril. Although the blood pressure reducing mechanism of lisinopril supposedly works primarily by suppression of the renin-angiotensin-aldosterone system, which plays an essential role in the blood pressure regulation, lisinopril has an antihypertensive effect also in patients with a low plasma renin level. PHARMACOKINETICS In clinical trials the maximum plasma concentration was achieved within about 7 hours of oral administration. Patients with an acute myocardial infarction showed a tendency towards a slightly longer time to peak plasma concentration. With repeated doses lisinopril proved to have an effective half-life of 12.6 hours. The major part of the active agent is eliminated during the early phase, in lower concentrations a prolo 阅读完整的文件