Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENALAPRIL MALEATE
RANBAXY (MALAYSIA) SDN. BHD.
ENALAPRIL MALEATE
30 Tablet Tablets; 100Tablet Tablets
RANBAXY (MALAYSIA) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ INVORIL TABLET Enalapril Maleate (5mg, 10mg and 20mg) Page | 1 WHAT IS IN THIS LEAFLET 1. What INVORIL TABLET is used for 2. How INVORIL TABLET works 3. Before you use INVORIL TABLET 4. How to use INVORIL TABLET 5. While you are using INVORIL TABLET 6. Side effects 7. Storage and Disposal of INVORIL TABLET 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What INVORIL TABLET is used for INVORIL TABLET contain the active ingredient enalapril maleate. It is used: • to treat high blood pressure (hypertension) • to treat heart failure (weakening of heart function). It can lower the need to go to hospital and can help some patients live longer • to prevent the signs of heart failure. The signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet. • to reduce the incidence of heart attack and reduce hospitalisation for unstable angina pectoris (a feeling of tightness, pressure or heaviness in the chest) Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet. Ask your doctor if you want more information. This medicine is available only with a doctor’s prescription. HOW INVORIL TABLET WORKS INVORIL TABLET (enalapril) belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. One of the ways INVORIL TABLET helps to lower blood pressure and treat heart failure is that it widens your blood vessels, which reduces pressure in the vessels, making it easier for your heart to pump blood around your body. This helps increase the supply of oxygen to your heart, so that when you place extra demands on your heart, such as during exercise, your heart may cope better and you may not get breathless as easily. BEFORE YOU USE INVORIL TABLET - _When you must not use it_ Do not take INVORIL TABLET: • If you are allergic to enalapril, or any of the ingredients of the tablets Lue koko asiakirja
_For the use of a Registered Medical Practitioner only _ PRESCRIBING INFORMATION INVORIL TABLETS (Enalapril Maleate Tablets 5 mg/ 10 mg/ 20 mg) COMPOSITION INVORIL TABLETS 5 MG Each tablet contains Enalapril Maleate USP 5 mg. INVORIL TABLETS 10 MG Each tablet contains Enalapril Maleate USP 10 mg INVORIL TABLETS 20 MG Each tablet contains Enalapril Maleate USP 20 mg EXCIPIENTS: Colloidal Anhydrous Silica, Croscarmellose Sodium, Zinc Stearate, Purified Talc, Microcrystaline Cellulose, Lactose, Maleic acid, Sunset Yellow Lake, Ferric Oxide (Yellow) PRODUCT DESCRIPTION INVORIL TABLETS 5 MG White, barrel shaped uncoated tablets embossed with '5' on one side and scored on other side. INVORIL TABLETS 10 MG Peach, barrel shaped uncoated tablets embossed with '10' on one side and scored on other side. INVORIL TABLETS 20 MG Light yellow, barrel shaped uncoated tablets embossed with '20' on one side and scored on other side DESCRIPTION INVORIL TABLETS contain enalapril maleate. Enalapril maleate is chemically described as (S)-1- [_N_-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (_Z_)-2-butenedioate salt (1:1). Its empirical formula is C 20 H 28 N 2 O 5 •C 4 H 4 O 4 , and its structural formula is: STRUCTURAL FORMULA ENALAPRIL MALEATE PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES PHARMACODYNAMICS Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. Although the latter decrease is small, it results in small increases of serum potassium. In h Lue koko asiakirja