Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate
Merck Sharp & Dohme B.V.
A10BD24
ertugliflozin, sitagliptin
Drugs used in diabetes, Combinations of oral blood glucose lowering drugs
Diabetes Mellitus, Type 2
Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control.in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.
Revision: 11
Authorised
2018-03-23
41 B. PACKAGE LEAFLET 42 PACKAG E LEAFLET: INFORMATION FOR THE PATIENT STEGLUJAN 5 MG/100 MG FILM- COATED TABLETS STEGLUJAN 15 MG/100 MG FILM- COATED TABLETS ertugliflozin/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, ph armacist, 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 illne ss 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 Steglujan is and what it is used for 2. Wh at you need to know before you take Steglujan 3. How to take Steglujan 4. Possible side effects 5. How to store Steglujan 6. Contents of the pack and other information 1. WHAT STEGLUJAN IS AND WHAT IT IS USED FOR WHAT STEGLUJAN IS Steglujan contains two active substances , ertugliflozin and sitagliptin. Each belongs to a group of medicines called “oral anti - diabetics”. These are medicines taken by mouth to treat diabetes. • Ertugliflozin belongs to a group of medicines called sodium glucose co -transporter-2 (SGLT2) inhibitors. • Sitagliptin belongs to a group of medicines called DPP- 4 (dipeptidyl peptidase -4) inhibitors. WHAT STEGLUJAN IS USED FOR • Steglujan lowers blood sugar levels in adult patients (aged 18 years and older) with type 2 diabetes. • Steglujan can be used instead of taking both ertugliflozin and sitagliptin as separate tablets. • Steglujan can be used alone or with some other medicines that lower blood sugar . • You need to keep following your food and exercise plan while taking Steglujan . HOW STEGLUJAN WORKS • Ertugliflozin works b y blocking the SGLT2 protein in your kidney s. This causes blood sugar to be removed in your urine. • Sitagliptin helps to increase Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Steglujan 5 mg/100 mg film- coated tablets Steglujan 15 mg/100 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Steglujan 5 mg/100 mg film- coated tablets Each tablet contains ertugliflozin L- pyroglutamic acid , equivalent to 5 mg of ertugliflozin , and sitagliptin phosphate monohydrate , equivalent to 100 mg of sitagliptin . Steglujan 15 mg/100 mg film- coated tablets Each tablet contains ertugliflozin L- pyroglutamic acid , equivalent to 15 mg of ertugliflozin , and sitagliptin phosphate monohydrate , equivalent to 100 mg of sitagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet) Steglujan 5 mg/100 mg film- coated tablets Beige, 12 x 7.4 mm, almond-shaped, film- coated tablets debossed with “554” on one side and plain on the other side. Steglujan 15 mg/100 mg film- coated tablets Brown, 12 x 7.4 mm, almond-shaped, film- coated tablets debossed with “555” on one side and plain on the other side. 4. C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise : • to improve glycaemic control when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control . • in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets. (For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5, and 5.1) 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose is 5 mg ertugliflozin/100 mg si tagliptin once daily . In patients tolerating the starting dose , the dose may be increased to 15 mg ertugliflozin/100 mg sitagliptin, once daily, if additional glyc a emic control is needed. For patients treated with ertugliflozin who are being switched to Steglujan , the dose of ertugli Прочетете целия документ