Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
empagliflozin, linagliptin
Boehringer Ingelheim International GmbH
A10BD19
empagliflozin, linagliptin
Drugs used in diabetes
Diabetes Mellitus, Type 2
Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.
Revision: 16
Authorised
2016-11-11
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GLYXAMBI 10 MG/5 MG FILM-COATED TABLETS GLYXAMBI 25 MG/5 MG FILM-COATED TABLETS empagliflozin/linagliptin 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 Glyxambi is and what it is used for 2. What you need to know before you take Glyxambi 3. How to take Glyxambi 4. Possible side effects 5. How to store Glyxambi 6. Contents of the pack and other information 1. WHAT GLYXAMBI IS AND WHAT IT IS USED FOR WHAT GLYXAMBI IS Glyxambi contains two active substances called empagliflozin and linagliptin. Each belongs to a group of medicines called “oral anti-diabetics”. These are medicines taken by mouth to treat type 2 diabetes. WHAT IS TYPE 2 DIABETES? Type 2 diabetes is a condition that comes from both your genes and your lifestyle. If you have type 2 diabetes, your pancreas may not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This results in high levels of sugar in your blood, which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs. HOW GLYXAMBI WORKS Empagliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. It works by blocking the SGLT2 protein in your kidneys. This causes blood sugar (glucose) to be removed in your urine. Linagliptin works in a different way, namely by enabling the pancreas to produce more insulin to lower blo Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Glyxambi 10 mg/5 mg film-coated tablets Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin. Glyxambi 25 mg/5 mg film-coated tablets Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Glyxambi 10 mg/5 mg film-coated tablets Pale yellow, arc triangular, flat faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “10/5” (tablet dimensions: 8 mm each side). Glyxambi 25 mg/5 mg film-coated tablets Pale pink, arc triangular, flat faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “25/5” (tablet dimensions: 8 mm each side). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control when already being treated with the free combination of empagliflozin and linagliptin (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose is one film-coated tablet of Glyxambi 10 mg/5 mg (10 mg empagliflozin plus 5 mg linagliptin) once daily. In patients who tolerate this starting dose and require additional glycaemic control, the dose can be increased to one film-coated tablet of Glyxambi 25 mg/5 mg (25 mg empagliflozin plus 5 mg 3 linagliptin) once daily. When Glyxambi is used in combination with metformin, the met Przeczytaj cały dokument