Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLIMEPIRIDE; METFORMIN HYDROCHLORIDE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
GLIMEPIRIDE; METFORMIN HYDROCHLORIDE
10Tablet Tablets
TORRENT PHARMACEUTICALS LTD.
GLIMET TABLETS _ _ Glimepiride / Metformin Hydrochloride (1mg / 500mg , 2mg / 1000mg) _ _ _ _ 1 _ _ _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is GLIMET used for 2. How GLIMET works 3. Before you use GLIMET 4. How to use GLIMET 5. While you are using it 6. Side effects 7. Storage and Disposal of GLIMET 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT GLIMET IS USED FOR GLIMET is used as an adjunct to diet and exercise in non-insulin dependent diabetes mellitus (NIDDM) (Type 2) patients who are unable to achieve sufficient sugar control with monotherapy of Metformin or Glimepiride alone or who are already treated with the combination of Metformin and Glimepiride as separate tablets. HOW GLIMET WORKS GLIMET contains medicines called Glimepiride and Metformin hydrochloride. Glimepiride is an oral glucose-lowering drug of the sulphonylureas class, which acts by increasing the release of insulin from the pancreatic beta cells. This results in opening of calcium channels & increase in intracellular calcium. Thus insulin level in increased. Metformin, a biguanides class, reduces the output of glucose from the liver and thus reduces the requirement of insulin at the level of liver. Thus, sulphonylureas and biguanides have additive action. Moreover, Metformin and Glimepiride are often co prescribed in clinical practice, and have proven to be efficacious in achieving the target glycemic control and also in preventing the multiple metabolic defects, which are often present in diabetic subjects. BEFORE YOU USE GLIMET - _When you must not use it _ Do not take GLIMET if: • You are allergic (hypersensitive) to: - Glimepiride. - Other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide). - Sulfonamides (medicines for bacterial infections such as sulfamethoxazole). - Metformin. - Any of the other ingredients. • An allergic reaction can include a rash, itching or shortness of breath. • You have insulin dependent Прочитајте комплетан документ
mortality. So the blood glucose level must be closely monitored during pregnancy in order to avoid the teratogenic risk. The use of insulin is required under such circumstances. Patients who consider pregnancy should inform their physician. There are no adequate data from the use of glimepiride in pregnant women. Animal studies have shown reproductive toxicity which likely was related to the pharmacologic action (hypoglycaemia) of glimepiride. The excretion in human milk is unknown; however, Glimepiride is excreted in rat milk. As other sulfonylureas are excreted in human milk and because there is a risk of hypoglycaemia in nursing infants, it is advised to discontinue breastfeeding during treatment with Glimet. PEDIATRIC USE There are no adequate studies for safety and effectiveness of Glimepiride in pediatric population. _METFORMIN:_ LACTIC ACIDOSIS: Metformin is not generally recommended for patients with IDDM. But if this drug is planned to be given, it is always as an adjunct to insulin therapy in patients who are not at risk of ketoacidosis. Impaired renal function predisposes to lactic acidosis. A normal creatinine clearance is essential for treatment with Metformin. Serum creatinine should be monitored regularly during Metformin therapy. Lactic acidosis, which may be caused by Metformin, is of the Type B and is not associated with reduced tissue perfusion and hypoxia. Theoretically, diabetics may be predisposed to Type B lactic acidosis since insulin deficiency is associated with low levels of pyruvate dehydrogenase in the muscle, which may increase lactate production. Diabetics also tend to overproduce lactate during exercise. In spite of this predisposition Type B lactic acidosis is rare with Metformin until renal impairment is present. Even though Metformin is not associated with Type A lactic acidosis it should be given with caution to patients with risk factors for hypoxia such as sepsis, dehydration, congestive heart failure, seizures or alcoholism. Lactic acidosis in patients with malignancy is tho Прочитајте комплетан документ