Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
ertugliflozin l-pyroglutamic acid, metformin hydrochloride
Merck Sharp & Dohme B.V.
A10BD23
ertugliflozin, metformin hydrochloride
Drugs used in diabetes, Combinations of oral blood glucose lowering drugs
Diabetes Mellitus, Type 2
Segluromet 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:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.
Revision: 7
Authorised
2018-03-23
56 B. PACKAGE LEAFLET 57 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SEGLUROMET 2.5 MG/850 MG FILM- COATED TABLETS SEGLUROMET 2.5 MG/1 000 MG FILM- COATED TABLETS SEGLUROMET 7.5 MG/850 MG FILM- COATED TABLETS SEGLUROMET 7.5 MG/1 000 MG FILM- COATED TABLETS ertugliflozin/metformin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPO RTANT INFORMATION FOR YOU. - Keep this leaflet. Y ou 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 Segluromet is and wha t it is used for 2. What you need to know before you take Segluromet 3. How to take Segluromet 4. Possible side effects 5. How to store Segluromet 6. Contents of the pack and other information 1. WHAT SEGLUROMET IS AND WHAT IT IS USED FOR WHAT SEGLUROMET IS Segluromet contains two active substances , ertugliflozin and metformin. 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 ca lled sodium glucose co -transporter-2 (SGLT2) inhibitors. - Metformin belongs to a group of medicines called biguanides. WHAT SEGLUROMET IS USED FOR - Segluromet lowers blood sugar levels in adult patients (aged 18 years and older) with type 2 diabetes. - It can also help prevent heart failure in patients with type 2 diabetes . - Segluromet can be used instead of taking both ertugliflozin and metformin as separate tablets. - Segluromet 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 Segluromet. HOW SEGLUROMET WORKS - Ertuglifl Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Segluromet 2.5 mg/850 mg film-coated tablets Segluromet 2.5 mg/1 000 mg film-coated tablets Segluromet 7.5 mg/850 mg film-coated tablets Segluromet 7.5 mg/1 000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Segluromet 2.5 mg/850 mg film-coated tablets Each tablet contains ertugliflozin L - pyroglutamic acid , equivalent to 2.5 mg of ertugliflozin , and 850 mg of metformin hydrochloride. Segluromet 2.5 mg/1 000 mg film-coated tablets Each tablet contains ertugliflozin L - pyroglutamic acid , equivalent to 2.5 mg of ertugliflozin , and 1 000 mg of metformin hy drochloride. Segluromet 7.5 mg/850 mg film-coated tablets Each tablet contains ertugliflozin L - pyroglutamic acid , equivalent to 7.5 mg of ertugliflozin , and 850 mg metformin hydrochloride. Segluromet 7.5 mg/1 000 mg film-coated tablets Each tablet contains ertugliflozin L - pyroglutamic acid , equivalent to 7.5 mg of ertugliflozin, and 1 000 mg metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Segluromet 2.5 mg/850 mg film-coated tablets Beige, 18 x 10 mm oval, film - coated tablet debossed with “2.5/850” on one side and plain on the other side. Segluromet 2.5 mg/1 000 mg film-coated tablets Pink, 19.1 x 10.6 mm oval, film - coated tablet debossed with “2.5/1000” on one side and plain on the other side. Segluromet 7.5 mg/850 mg film-coated tablets Dark brown, 18 x 10 mm oval, film - coated tablet debossed with “7.5/850” on one side and plain on the other side. Segluromet 7.5 mg/1 000 mg film-coated tablets Red, 19.1 x 1 0.6 mm oval, film - coated tablet debossed with “7.5/1000” on one side and plain on the other side. 3 4. C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Segluromet is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: • in patients insufficiently controlled on their maximally tolerated dose of me Pročitajte cijeli dokument