Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
nateglinide
Novartis Europharm Ltd.
A10BX03
nateglinide
Drugs used in diabetes
Diabetes Mellitus, Type 2
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Revision: 5
Withdrawn
2001-04-03
Medicinal product no longer authorised 36 B. PACKAGE LEAFLET Medicinal product no longer authorised 37 PACKAGE LEAFLET: INFORMATION FOR THE USER TRAZEC 60 MGFILM-COATED TABLETS TRAZEC 120 MG FILM-COATED TABLETS TRAZEC 180 MG FILM-COATED TABLETS Nateglinide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Trazec is and what it is used for 2. Before you take Trazec 3. How to take Trazec 4. Possible side effects 5. How to store Trazec 6. Further information 1. WHAT TRAZEC IS AND WHAT IT IS USED FOR Trazec is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are also known as oral anti-diabetics). It is used by people with type 2 diabetes. (This kind of diabetes is also called non-insulin-dependent diabetes mellitus.) Insulin is a substance produced by a body organ called the pancreas. It helps to decrease blood sugar levels, especially after meals. In patients with type 2 diabetes, the body may not start producing insulin quickly enough after meals. Trazec works by stimulating the pancreas to produce insulin more quickly. This helps to keep the blood sugar controlled after meals. Your doctor will prescribe Trazec together with another oral anti-diabetic containing metformin. Trazec tablets start to act quickly after you take them and are eliminated from the body rapidly. 2. BEFORE YOU TAKE TRAZEC Follow all instructions given to you by your doctor and pharmacist carefully, even if they are different from what is in this leaflet. DO NOT TAKE TRAZEC - if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Traz Przeczytaj cały dokument
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT TRAZEC 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg nateglinide. Excipients: Lactose monohydrate: 141.5 mg per tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 60 mg pink, round, bevelled-edge tablets with “NVR” marked on one side and “TS” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner). The dosage of nateglinide should be determined by the physician according to the patient’s requirements. The recommended starting dose is 60 mg three times daily before meals, particularly in patients who are near goal HbA 1c . This may be increased to 120 mg three times daily. Dose adjustments should be based on periodic glycosylated haemoglobin (HbA 1c ) measurements. Since the primary therapeutic effect of Trazec is to reduce mealtime glucose, (a contributor to HbA 1c ), the therapeutic response to Trazec may also be monitored with 1–2 hour post-meal glucose. The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals. Specific patient groups _Elderly _ The clinical experience in patients over 75 years of age is limited. _Children and adolescents _ There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended. _Patients with hepatic impairment _ No dose adjustment is necessary for patients with mild to moderate hepatic impairment. As patients with severe liver disease were not studied, nateglinid Przeczytaj cały dokument