Држава: Јужноафричка Република
Језик: Енглески
Извор: South African Health Products Regulatory Authority (SAHPRA)
Pharmacare Limited û Woodmead
See ingredients
TABLET
EACH TABLET CONTAINS ENALAPRIL MALEATE 20,0 mg
Registered
2002-03-06
_ZA_PHARMCOMB_2401_00 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 17 _ 1.3.2 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S3 PHARMAPRESS 10 MG TABLETS ENALAPRIL MALEATE CONTAINS SUGAR: LACTOSE MONOHYDRATE 66,435 MG PHARMAPRESS 20 MG TABLETS ENALAPRIL MALEATE CONTAINS SUGAR: LACTOSE MONOHYDRATE 133,246 MG READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PHARMAPRESS • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse, or other healthcare provider. • PHARMAPRESS has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What PHARMAPRESS is and what it is used for 2. What you need to know before you take PHARMAPRESS 3. How to take PHARMAPRESS 4. Possible side effects 5. How to store PHARMAPRESS 6. Contents of the pack and other information _ZA_PHARMCOMB_2401_00 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 17 _ 1. WHAT PHARMAPRESS IS AND WHAT IT IS USED FOR PHARMAPRESS belongs to a group of medicines called Angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by causing blood vessels to relax, lowering blood pressure, and increasing the supply of blood and oxygen to the heart. PHARMAPRESS is used in adults to: • treat high blood pressure (hypertension) including renovascular hypertension (caused by high blood pressure due to narrowing of the arteries that carry blood to the kidneys). • the treatment of heart failure (weakening of the heart function), usually combined with other medicines used for high blood pressure (diuretics) and medicine used to treat heart rhythm problems (digoxin). • the treatment of a form of heart failure with no symptoms (asymptomatic left ventricular dysfunction). PHARMAPRESS decreases the rate of development of heart failure with symptoms and decreases the incidence of hospitalisation for heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHARMAPRESS DO NO Прочитајте комплетан документ
_ _ _ZA_PHARMCOMB_2401_00 _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 27 _ 1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS S3 1. NAME OF THE MEDICINE PHARMAPRESS 10 MG tablets PHARMAPRESS 20 MG tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of PHARMAPRESS 10 mg contains 10 mg of enalapril maleate. Contains sugar: Lactose monohydrate 66,435 mg Each tablet of PHARMAPRESS 20 mg contains 20 mg of enalapril maleate. Contains sugar: Lactose monohydrate 133,246 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablets PHARMAPRESS 10 mg is a round, pink tablet with bevelled edges, bisected on one side. PHARMAPRESS 20 mg is a round, peach tablet with bevelled edges, bisected on one side. 4. CLINICAL PARTICULARS _ _ _ZA_PHARMCOMB_2401_00 _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 27 _ 4.1 THERAPEUTIC INDICATIONS PHARMAPRESS is indicated in: • HYPERTENSION - All grades of essential hypertension; - renovascular hypertension. • HEART FAILURE PHARMAPRESS is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and when appropriate, digoxin. In these patients, PHARMAPRESS improves symptoms, increases survival and decreases the frequency of hospitalisation. • ASYMPTOMATIC LEFT VENTRICULAR DYSFUNCTION In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤ 35 %), PHARMAPRESS decreases the rate of development of overt heart failure and decreases the incidence of hospitalisation for heart failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults _ _ _ ESSENTIAL HYPERTENSION The initial dose is 10 mg to 20 mg depending on the degree of hypertension and is given once daily. In mild hypertension the recommended initial dose is 10 mg daily. For other degrees of hypertension, the initial dose is 20 mg daily. The usual maintenance dose is one 20 mg tablet taken once daily. The dosage should be adjusted according to the needs of the patient. _ _ _ZA_PHARMCOMB_2401_00 _ Прочитајте комплетан документ