Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
GLIPIZIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
A10BB07
TABLETS
GLIPIZIDE 5 MG
PER OS
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
GLIPIZIDE
GLIPIZIDE
Is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with diabetes mellitus type II
2015-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS‘ REGULATIONS )PREPARATIONS( - 1986 This medicine is dispensed with a doctor’s prescription only GLUCO-RITE 5 MG TABLETS EACH TABLET CONTAINS 5 MG GLIPIZIDE Inactive ingredients and allergens in the medicine: see section 2 ‘IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF GLUCO-RITE’ and section 6 in the leaflet. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. Keep this leaflet, you may want to read it again. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Gluco-Rite is used for control of hyperglycemia )high blood sugar levels( and the accompanying symptoms in patients with type 2 diabetes in addition to a change in diet. THERAPEUTIC GROUP: Medicine to lower blood sugar level from the sulphonylurea group. 2. BEFORE USING THE MEDICINE DO NOT USE GLUCO-RITE IF: • You are hypersensitive )allergic( to the active ingredient glipizide, to another similar antidiabetic drug or to any of the other ingredients this medicine contains )see section 6(. • You have juvenile diabetes )type 1 diabetes which probably began in your childhood and is an insulin-dependent diabetes(. • Ketone bodies or sugar have appeared in your urine )you may suffer from diabetic ketoacidosis(. • You suffer from episodes of unconsciousness )you may suffer from diabetic coma(. • You suffer from problems with the kidneys or liver. • You are pregnant, planning to become pregnant or breastfeeding. • You are currently taking miconazole to treat fungal infections. ! SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE BEFORE STARTING TREATMENT WITH GLUCO-RITE, TELL THE DOCTOR IF: • You have been told that you have a problem with the adrenal gland or the pituitary gland. • You Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gluco-Rite 5mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Glipizide 5 mg Excipient with known effect: Each tablet contains 153 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White tablets, convex, scored with a break line on one side and with 'A' on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Gluco-Rite is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with diabetes mellitus type II. 4.2 Posology and method of administration PosologyAs for any hypoglycaemic agent, dosage must be adapted for each individual case. Short term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet. In general, glipizide should be given shortly before a meal to achieve the greatest reduction in post-prandial hyperglycaemia. Initial Dose The recommended starting dose is 5 mg, given before breakfast or the midday meal. Mild diabetics, geriatric patients or those with liver disease may be started on 2.5 mg. 2 Titration Dosage adjustments should ordinarily be in increments of 2.5 to 5 mg, as determined by blood glucose response. At least several days should elapse between titration steps. The maximum recommended single dose is 15 mg. If this is not sufficient, splitting the daily dosage may prove effective. Doses above 15 mg should ordinarily be divided. Maintenance Some patients may be effectively controlled on a once-a-day regimen. Total daily dosage above 15 mg should ordinarily be divided. The maximum recommended daily dosage is 20 mg_._ Paediatric population Safety and effectiveness in children have not been established. Use in Elderly and High Risk Patients In elderly, debilitated and malnourished patients or patients with an impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglyca Прочитайте повний документ