Country: European Union
Language: English
Source: EMA (European Medicines Agency)
ertugliflozin l-pyroglutamic acid
Merck Sharp & Dohme B.V.
A10BK04
ertugliflozin
Drugs used in diabetes, Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Diabetes Mellitus, Type 2
Steglatro 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:as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.in addition to other medicinal products for the treatment of diabetes.
Revision: 8
Authorised
2018-03-21
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT STEGLATRO 5 MG FILM- COATED TABLETS STEGLATRO 15 MG FILM- COATED TABLETS ertugliflozin 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 o nly. 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 or nurse. This includes any possible side effects not listed in th is leaflet. See sect ion 4. WHAT IS IN THIS LEAFLET 1. What Steglatro is and what it is used for 2. What you need to know before you take Steglatro 3. How to take Steglatro 4. Possible side effects 5. How to store Steglatro 6. Contents of the pack and other information 1. WHAT STEGLATRO IS AND WHAT IT IS USED FOR WHAT STEGLATRO IS Steglatro contains the active substance ertugliflozin. Steglatro is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. WHAT STEGLATRO IS USED FOR Steglatro 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 . Steglatro 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 Steglatro. HOW STEGLATRO WORKS Ertugliflozin works by blocking the SGLT2 protein in your kidney s . This causes blood sugar to be removed in your urine. WHAT IS TYPE 2 DIABETES? Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that your body produces does not work as well as it should. This leads to a high level of sugar in your blood. When this happens, t his can lead to serious medical proble ms like heart disease, kidney disease, blindness a Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Steglatro 5 mg film- coated tablets Steglatro 15 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Steglatro 5 mg film- coated tablets Each tablet contains ertugliflozin L - pyroglutamic acid , equivalent to 5 mg ertugliflozin. Excipient with known effect Each tablet contains 28 mg of lactose (as monohydrate ). Steglatro 15 mg film- coated tablets Each tablet contains ertugliflozin L - pyroglutamic acid , equivalent to 15 mg ertugliflozin . Excipient with known effect Each tablet contains 85 mg of lactose (as monohydrate ). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet) Steglatro 5 mg film- coated tablets Pink, 6.4 x 6.6 mm, triangular-shaped, film- coated tablets debossed with “701” on one side and plain on the other side. Steglatro 15 mg film- coated tablets Red, 9.0 x 9.4 mm, triangular-shaped, film- coated tablets debossed with “702” on one side and plain on the other side. 4. C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Steglatro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise : as monotherapy when metformin is considered inappropriate due to intolerance or contraindications. in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations of therapies, effects on glycaemic control , cardiovascular events, and the populations studied, see sections 4.4, 4.5, and 5.1. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose of ertugliflozin is 5 mg once daily. In patients tolerating ertugliflozin 5 mg once daily, the dose can be increased to 15 mg once daily if additional glycaemic control is needed. When ertugliflozin is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglyca Read the complete document