国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
sitagliptin fumarate
Sun Pharmaceutical Industries Europe B.V.
A10BH01
sitagliptin fumarate
Drugs used in diabetes
Diabetes Mellitus, Type 2
For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Revision: 1
Authorised
2021-12-09
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN SUN 25 MG FILM-COATED TABLETS SITAGLIPTIN SUN 50 MG FILM-COATED TABLETS SITAGLIPTIN SUN 100 MG FILM-COATED TABLETS sitagliptin 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 Sitagliptin SUN is and what it is used for 2. What you need to know before you take Sitagliptin SUN 3. How to take Sitagliptin SUN 4. Possible side effects 5. How to store Sitagliptin SUN 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN SUN IS AND WHAT IT IS USED FOR Sitagliptin SUN contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body. Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan. What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sitagliptin SUN 25 mg film-coated tablets Sitagliptin SUN 50 mg film-coated tablets Sitagliptin SUN 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sitagliptin SUN 25 mg film-coated tablets Each film-coated tablet contains sitagliptin fumarate, equivalent to 25 mg sitagliptin. Excipient(s) with known effect Each film-coated tablet contains 4 mg of hydrogenated castor oil. Sitagliptin SUN 50 mg film-coated tablets Each film-coated tablet contains sitagliptin fumarate, equivalent to 50 mg sitagliptin. Excipient(s) with known effect Each film-coated tablet contains 8 mg of hydrogenated castor oil. Sitagliptin SUN 100 mg film-coated tablets Each film-coated tablet contains sitagliptin fumarate, equivalent to 100 mg sitagliptin. Excipient(s) with known effect Each film-coated tablet contains 16 mg of hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Sitagliptin SUN 25 mg film-coated tablets Light pink colour, round film-coated tablets, dimensions approximately 6 mm x 3 mm, debossed with F1 on one side and plain on the other side. Sitagliptin SUN 50 mg film-coated tablets Light beige colour, round film-coated tablets, dimensions approximately 8 mm x 4 mm, debossed with F2 on one side and plain on the other side. Sitagliptin SUN 100 mg film-coated tablets Beige colour, round film-coated tablets, dimensions approximately 10 mm x 4.5 mm, debossed with F3 on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 3 For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control: as monotherapy: • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with: • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control 阅读完整的文件