Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nateglinide
Novartis Pharmaceuticals UK Ltd
A10BX03
Nateglinide
60mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010203; GTIN: 5010678919103
1 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 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 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 Starlix belongs to a group of medicines called oral anti-diabetics. WHAT STARLIX IS USED FOR Starlix is used to treat patients with type 2 diabetes. It lowers blood sugar (glucose). Your doctor will prescribe Starlix together with another oral anti-diabetic medicine containing metformin. HOW STARLIX WORKS Insulin is a substance produced 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. This helps to control your blood sugar after meals. Starlix tablets start to act quickly after you take them and are eliminated from the body rapidly. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STARLIX 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 STARLIX - if you are allergic to nateglinide or any of the other ingredients of this medicine (list Прочитать полный документ
OBJECT 1 STARLIX 60MG FILM COATED TABLETS Summary of Product Characteristics Updated 30-Jun-2015 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product STARLIX ® 60 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 60 mg nateglinide. Excipient with known effect: Lactose monohydrate: 141.5 mg per tablet. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet 60 mg pink, round, bevelled-edge tablets with STARLIX marked on one side and 60 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 Posology 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 Starlix is to reduce mealtime glucose, (a contributor to HbA 1c ), the therapeutic response to Starlix may also be monitored with 12 hour post-meal glucose. The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals. Special populations _Elderly_ The clinical experience in patients over 75 years of age is limited. _Paediatric population _ 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 Прочитать полный документ