Glyxambi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

empagliflozin, linagliptin

Available from:

Boehringer Ingelheim International GmbH

ATC code:

A10BD19

INN (International Name):

empagliflozin, linagliptin

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

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.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2016-11-11

Patient Information leaflet

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

Summary of Product characteristics

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