Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
repaglinide
Novo Nordisk A/S
A10BX02
repaglinide
Drugs used in diabetes
Diabetes Mellitus, Type 2
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Revision: 16
Authorised
1998-08-16
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER NOVONORM 0.5 MG TABLETS NOVONORM 1 MG TABLETS NOVONORM 2 MG TABLETS Repaglinide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NovoNorm is and what it is used for 2. What you need to know before you take NovoNorm 3. How to take NovoNorm 4. Possible side effects 5. How to store NovoNorm 6. Contents of the pack and other information 1. WHAT NOVONORM IS AND WHAT IT IS USED FOR NovoNorm is an _oral antidiabetic medicine containing repaglinide_ which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose). TYPE 2 DIABETES is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces. NovoNorm is used to control type 2 diabetes in adults as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar. NovoNorm can also be given with metformin, another medicine for diabetes. NovoNorm has been shown to lower the blood sugar, which helps to prevent complications from your diabetes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOVONORM DO NOT TAKE NOVONORM • If you are ALLERGIC to repaglinide or any of the other ingredients in this medicine (listed in section 6). • If you have TYPE 1 DIABETES . • If the acid level in your blood is raised (DIABETIC KETOACIDOSIS). • If you have a SEVERE LIV Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NovoNorm 0.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg of repaglinide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Repaglinide tablets are white, round and convex and engraved with Novo Nordisk logo (Apis bull). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient. Glycosylated haemoglobin levels are also of value in monitoring the patient’s response to therapy. Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood glucose-lowering response after an initial period of effectiveness (i.e. secondary failure). Short-term administration of repaglinide may be sufficient during periods of transient loss of control in type 2 diabetic patients usually controlled well on diet. Initial dose The dosage should be determined by the physician, according to the patient’s requirements. The recommended starting dose is 0.5 mg. One to two weeks should elapse between titration steps (as determined by blood glucose response). If patients are transferred from an Aqra d-dokument sħiħ