Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIOGLITAZONE HYDROCHLORIDE
SYNERRV SDN BHD
PIOGLITAZONE HYDROCHLORIDE
28 Tablets
IND-SWIFT LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 GLIT 15 (PIOGLITAZONE TABLETS 15MG) GLIT 30 (PIOGLITAZONE TABLETS 30MG) Pioglitazone hydrochloride (15mg, 30mg) WHAT IS IN THIS LEAFLET 1. What GLIT is used for 2. How GLIT works 3. Before you use GLIT 4. How to use GLIT 5. While you are using it 6. Side effects 7. Storage and Disposal of GLIT 8. Product Description 9. Manufacturer and Product registration Holder 10. Date of revision 11. Serial number WHAT GLIT IS USED FOR • GLIT is used as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients whom are inadequately controlled by diet and exercise and where metformin cannot be tolerated. • GLIT is used for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or sulfonylurea. HOW GLIT WORKS GLIT is a thiazolidonedione antidiabetic agent that depends on the presence of insulin for its mechanism of action. It acts primarily by decreasing insulin resistance. It decreases insulin resistance in the body, resulting in increased insulin- dependent glucose disposal and decreased liver glucose output. BEFORE YOU USE GLIT - _When you must not use it _ Do not use GLIT if you are: a) Hypersensitive to pioglitazone or to any of the excipients of the tablet listed at the end of this leaflet. b) Having heart failure or history of heart failure (all stages). c) A patient of reduced liver function. d) Pregnant or breastfeeding. e) A type 1 diabetes patient. f) A bladder cancer patient or have a history of bladder cancer. g) Having blood in your urine. - _Before you start to use it _ • You must undergo blood tests for liver function prior to the start of therapy, and periodically thereafter per clinical judgment of the health care professional. • Talk to your doctor if you are pregnant. - _Taking other medicines _ • GLIT can be co-administered with: a) Oral contraceptives b) Fexofenadine HCI c) Glipizide d) Digoxin e) W Baca dokumen lengkapnya
GLIT 15 / GLIT 30 Pioglitazone Tablets 15mg & 30mg COMPOSITION: GLIT 15 (Pioglitazone Tablets 15mg) Each uncoated tablet contains Pioglitazone Hydrochloride equivalent to Pioglitazone 15mg Excipients q.s. GLIT 30 (Pioglitazone Tablets 30mg) Each uncoated tablet contains Pioglitazone Hydrochloride equivalent to Pioglitazone 30mg Excipients q.s. PRESENTATION: GLIT 15 (Pioglitazone Tablets 15mg) - White to off white, round, biconvex, uncoated tablets embossed "15" on one side and plain on other side. GLIT 30 (Pioglitazone Tablets 30mg) - White to off white, round, flat, beveled edged, uncoated tablets embossed "30" on one side and plain on the other side. CLINICAL PHARMACOLOGY PHARMACODYNAMICS: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03. Pioglitazone effects may be mediated by a reduction of insulin resistance. Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals. Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance. Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus. The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations. Pioglitazone was associated with significant weight gain. Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass. Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity. Reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed with small, but not clinically significant increases in LDL-cholesterol levels. Pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HD Baca dokumen lengkapnya