Komboglyze

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

metformin hydrochloride, saxagliptin hydrochloride

Tillgänglig från:

AstraZeneca AB 

ATC-kod:

A10BD10

INN (International namn):

saxagliptin, metformin hydrochloride

Terapeutisk grupp:

Drugs used in diabetes, Combinations of oral blood glucose lowering drugs

Terapiområde:

Diabetes Mellitus, Type 2

Terapeutiska indikationer:

Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.

Produktsammanfattning:

Revision: 20

Bemyndigande status:

Authorised

Tillstånd datum:

2011-11-24

Bipacksedel

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KOMBOGLYZE 2.5 MG/850 MG FILM-COATED TABLETS
saxagliptin/metformin hydrochloride
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 Komboglyze is and what it is used for
2.
What you need to know before you take Komboglyze
3.
How to take Komboglyze
4.
Possible side effects
5.
How to store Komboglyze
6.
Contents of the pack and other information
1.
WHAT KOMBOGLYZE IS AND WHAT IT IS USED FOR
This medicine contains two different substances called:
saxagliptin, part of a class of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4 inhibitors),
and metformin, part of a class of medicines called biguanides.
Both belong to a group of medicines called oral anti-diabetics.
WHAT KOMBOGLYZE IS USED FOR
This medicine is used to treat a type of diabetes called ‘type 2
diabetes’.
HOW KOMBOGLYZE WORKS
Saxagliptin and metformin work together to control your blood sugar.
They increase the levels of
insulin after a meal. They also lower the amount of sugar made by your
body. Along with diet and
exercise, this helps lower your blood sugar. This medicine can be used
alone or together with other
antidiabetic medicines, including insulin.
To control your diabetes, you still need to diet and exercise, even
when you are taking this medicine.
So it is important to keep following the advice about diet and
exercise from your doctor or nurse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOMBOGLYZE
DO NOT TAKE KOMBOGLYZE
-
If you are alle

Produktens egenskaper

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Komboglyze 2.5 mg/850 mg film-coated tablets
Komboglyze 2.5 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Komboglyze 2.5 mg/850 mg film-coated tablets
Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 850
mg of metformin hydrochloride.
Komboglyze 2.5 mg/1,000 mg film-coated tablets
Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and
1,000 mg of metformin
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Komboglyze 2.5 mg/850 mg film-coated tablets
Light brown to brown, biconvex, round, film-coated tablets, with
“2.5/850” printed on one side and
“4246” printed on the other side, in blue ink.
Komboglyze 2.5 mg/1,000 mg film-coated tablets
Pale yellow to light yellow, biconvex, oval shaped, film-coated
tablets, with “2.5/1000” printed on one
side and “4247” printed on the other side, in blue ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Komboglyze is indicated in adults with type 2 diabetes mellitus as an
adjunct to diet and exercise to
improve glycaemic control:

in patients inadequately controlled on their maximally tolerated dose
of metformin alone

in combination with other medicinal products for the treatment of
diabetes, including insulin, in
patients inadequately controlled with metformin and these medicinal
products (see sections 4.4,
4.5 and 5.1 for available data on different combinations)

in patients already being treated with the combination of saxagliptin
and metformin as separate
tablets.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR ≥ 90 mL/min)_
_For patients inadequately controlled on maximal tolerated dose of
metformin monotherapy_
Patients not adequately controlled on metformin alone should receive a
dose of this medicinal product
equivalent to the total daily dose of saxagliptin 5 mg, dosed as 2.5
mg twice daily,