Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
ZENTIVA SOUTH AFRICA (PTY) LTD
See ingredients
TABLET
EACH TABLET CONTAINS GLIMEPIRIDE 1,0 mg
Canceled
2004-09-10
Page 1 of 6 PATIENT INFORMATION LEAFLET Read all of this leaflet carefully before you start taking AMARYL tablets. Keep this leaflet. You may need to read it again. If you have any questions, ask your doctor or pharmacist. AMARYL 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. SCHEDULING STATUS: S3 PROPRIETARY NAME AND DOSAGE FORM: AMARYL 1 (tablets) AMARYL 2 (tablets) AMARYL 3 (tablets) AMARYL 4 (tablets) WHAT AMARYL CONTAINS: The active ingredient in your AMARYL tablets is glimepiride. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose, polyvidone 25 000 and sodium starch glycolate. In addition the tablets contain colouring agents. The 1 mg tablets contain red ferric oxide; the 2 mg and 3 mg tablets contain yellow ferric oxide; and the 2 mg and 4 mg contain indigo carmine aluminium lake. Page 2 of 6 WHAT AMARYL IS USED FOR: Amaryl is one of a group of medicines called oral hypoglycaemics, which are used for the treatment of diabetes in patients whose blood sugar levels are not adequately controlled by diet and exercise alone. Diabetes is a disease where the body does not produce enough insulin to control the level of blood sugar. Oral hypoglycaemics help control blood sugar levels. BEFORE TAKING AMARYL: DO NOT TAKE AMARYL IF: you are allergic to glimepiride, other medicines used to treat high blood sugar levels or any of the ingredients listed above. you are pregnant or breastfeeding. you have liver problems. you have Type 1 insulin-dependant diabetes mellitus. TAKE SPECIAL CARE WITH AMARYL: Stressful situations (e.g. trauma, surgery and febrile infections) may affect blood sugar levels and your medication may need to be adjusted. Amaryl must be used with caution in patients with kidney problems and G6PD- deficiency. If your blood sugar level is not lowered (hyperglycaemia) sufficiently with Amaryl, you may experience increased ur Read the complete document
Page 1 of 16 SCHEDULING STATUS: S3 PROPRIETARY NAME AND DOSAGE FORM: AMARYL 1 (tablets) AMARYL 2 (tablets) AMARYL 3 (tablets) AMARYL 4 (tablets) COMPOSITION: Per tablet: Glimepiride 1 mg Glimepiride 2 mg Glimepiride 3 mg Glimepiride 4 mg Excipients: Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose, polyvidone 25 000 and sodium starch glycolate. In addition the tablets contain colouring agents. The 1 mg tablets contain red ferric oxide; the 2 mg and 3 mg tablets contain yellow ferric oxide; and the 2 mg and 4 mg tablets contain indigo carmine aluminium lake. PHARMACOLOGICAL CLASSIFICATION: A 21.2 Oral hypoglycaemics PHARMACOLOGICAL ACTION: Page 2 of 16 Glimepiride is a sulphonylurea. Glimepiride decreases blood glucose concentrations mainly by stimulating insulin release from pancreatic beta cells. This effect is based predominantly on an improved responsiveness of the pancreatic beta cells to the physiological glucose stimulus. Glimepiride also has extra pancreatic (insulin-sensitising and insulin-mimetic) effects. The effect of glimepiride is dose-dependent over the dose range of 1 to 6 mg. The physiological response to acute physical exercise, i.e. reduction of insulin secretion, is still present with glimepiride. There was no significant difference in effect regardless of whether glimepiride was given 30 minutes or immediately before a meal. The absolute bioavailability of glimepiride is complete. Food intake has no relevant influence on absorption. Maximum serum concentrations are reached approximately 2,5 hours after oral intake and there is a linear relationship between dose and both maximum concentrations and area under the time/concentration curve. Glimepiride has a high protein binding (> 99 %). Mean dominant serum half-life, which is of relevance for the serum concentrations under multiple-dose conditions, is about 5 to 8 hours. After single-dose radiolabelled glimepiride, 58 % of the radioactivity was recovered in the urine, and 35 % in the faeces. No unchanged substanc Read the complete document