Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
nateglinide
Novartis Europharm Limited
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: 15
Withdrawn
2001-04-03
29 B. PACKAGE LEAFLET Medicinal Product no longer authorised 30 PACKAGE LEAFLET: INFORMATION FOR THE USER STARLIX 60 MG FILM-COATED TABLETS STARLIX 120 MG FILM-COATED TABLETS STARLIX 180 MG FILM-COATED TABLETS nateglinide 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Starlix is and what it is used for 2. What you need to know before you take Starlix 3. How to take Starlix 4. Possible side effects 5. How to store Starlix 6. Contents of the pack and other information 1. WHAT STARLIX IS AND WHAT IT IS USED FOR WHAT STARLIX IS The active substance of Starlix, nateglinide, belongs to a group of medicines called oral antidiabetics. Starlix is used to treat adult patients with type 2 diabetes. It helps to control the level of sugar in the blood. Your doctor will prescribe Starlix together with metformin, if inadequately controlled despite a maximally tolerated dose of metformin. HOW STARLIX WORKS Insulin is a substance produced in the body by the pancreas. It helps to decrease blood sugar levels, especially after meals. If you have type 2 diabetes, your body may not start producing insulin quickly enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly, which helps to keep blood sugar levels under control after meals. Starlix tablets start to act within a very short time after they are swallowed and are eliminated from the body rapidly. Medicinal Product no longer authorised 31 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STARLIX Follow all instructions Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT STARLIX 60 mg film-coated tablets STARLIX 120 mg film-coated tablets STARLIX 180 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION STARLIX 60 mg film-coated tablets Each film-coated tablet contains 60 mg nateglinide. _Excipient with known effect _ Lactose monohydrate: 141.5 mg per tablet. STARLIX 120 mg film-coated tablets Each film-coated tablet contains 120 mg nateglinide. _Excipient with known effect _ Lactose monohydrate: 283 mg per tablet. STARLIX 180 mg film-coated tablets Each film-coated tablet contains 180 mg nateglinide. _Excipient with known effect _ Lactose monohydrate: 214 mg per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. STARLIX 60 mg film-coated tablets 60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on one side and “60” on the other. STARLIX 120 mg film-coated tablets 120 mg yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other. STARLIX 180 mg film-coated tablets 180 mg red, ovaloid tablets with “STARLIX” marked on one side and “180” on the other. Medicinal Product no longer authorised 3 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 Posology _Adults _ 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 t Læs hele dokumentet