Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Irbesartan
SYNERRV SDN BHD
Irbesartan
28 Tablets
Macleods Pharmaceuticals Ltd
_Consumer Medication Information Leaflet (RiMUP) _ IRBEMAC 150MG TABLET (IRBESARTAN) IRBEMAC 300MG TABLET (IRBESARTAN) Irbesartan 150mg and 300 mg Tablet 1 WHAT IS IN THIS LEAFLET 1. What Irbemac is used for 2. How Irbemac works 3. Before you use Irbemac 4. How to use Irbemac 5. While you are using it 6. Side effects 7. Storage and Disposal of Irbemac 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IRBEMAC IS USED FOR Irbemac is used to treat high blood pressure and to protect the kidney in patients with high blood pressure, type 2 diabetes and impaired kidney function. HOW IRBEMAC WORKS Irbemac belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increased in blood pressure. Irbemac prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbemac slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. BEFORE YOU USE IRBEMAC - _When you must not use it _ Do not take Irbemac if: • You are allergic to Irbesartan or any ingredients of Irbemac • You are pregnant more than 3 months • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren (anti- hypertensive medicine) _Pregnancy and lactation _ It is not recommended to take Irbemac during the first trimester and do not take Irbemac during the second and third trimester. Do not take Irbemac if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start use it _ Talk to your doctor before taking irbesartan and if any of the following apply to you: • if you get excessive vomiting or diarrhoea • if you suffer from kidney problems • if you suffer from heart problems • if you receive irbesartan for diabetic kidney disea Belgenin tamamını okuyun
_ _ IRBEMAC 300MG TABLET (Irbesartan Tablets 300 mg) MACLEODS PHARMACEUTICALS LTD. For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory IRBEMAC 150MG TABLET (IRBESARTAN) IRBEMAC 300MG TABLET (IRBESARTAN) COMPOSITION: IRBEMAC 150MG TABLET Each tablet contains Irbesartan Ph.Eur 150mg IRBEMAC 300MG TABLET Each tablet contains Irbesartan Ph.Eur 300mg LIST OF EXCIPIENTS: Carboxymethylcellulose Calcium Colloidal silicon dioxide (Aerosil 200) Povidone (PVP K29/32) Sodium Starch Glycolate Type A (Glycolys) Talc Magnesium stearate Opadry II white 32F58900 DOSAGE FORM : Film coated tablet DESCRIPTION: IRBEMAC 150MG TABLET : White to off white oval film coated tablets debossed with “ML 95” on one side and plain on other side. IRBEMAC 300MG TABLET : White to off white oval film coated tablets debossed with “ML 96” on one side and plain on other side. PHARMACOLOGICAL CLASSIFICATION Angiotensin II Receptor Antagonist _ _ IRBEMAC 300MG TABLET (Irbesartan Tablets 300 mg) MACLEODS PHARMACEUTICALS LTD. PHARMACOLOGICAL ACTION: PHARMACOKINETICS Absorption After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%. Concomitant food intake does not significantly influence the bioavailability of irbesartan. Distribution Plasma protein binding is approximately 96%, with negligible binding to cellular blood components. The volume of distribution is 53 - 93 litres. Biotransformation Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan. Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation. The major circulating metabolite is irbesartan glucuronide (approximately 6%). In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect. Linearity/non-linearity Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose r Belgenin tamamını okuyun