Xigduo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

metformin hydrochloride, dapagliflozin propanediol monohydrate

Available from:

AstraZeneca AB

ATC code:

A10BD15

INN (International Name):

dapagliflozin, metformin

Therapeutic group:

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

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

Xigduo 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 metformin alone •    in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products•    in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Product summary:

Revision: 21

Authorization status:

Authorised

Authorization date:

2014-01-16

Patient Information leaflet

52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XIGDUO 5 MG/850 MG FILM-COATED TABLETS
XIGDUO 5 MG/1,000 MG FILM-COATED TABLETS
dapagliflozin/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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xigduo is and what it is used for
2.
What you need to know before you take Xigduo
3.
How to take Xigduo
4.
Possible side effects
5.
How to store Xigduo
6.
Contents of the pack and other information
1.
WHAT XIGDUO IS AND WHAT IT IS USED FOR
This medicine contains two different substances called dapagliflozin
and metformin. Both belong to a
group of medicines called oral anti-diabetics. These are medicines
taken by mouth for diabetes.
Xigduo is used for a type of diabetes called “type 2 diabetes” in
adult patients (aged 18 years and
older) and usually occurs when you are older. If you have type 2
diabetes, your pancreas does not
make enough insulin or your body is not able to use the insulin it
produces properly. This leads to a
high level of sugar (glucose) in your blood.

Dapagliflozin works by removing excess sugar from your body via your
urine and lowers the
amount of sugar in your blood. It can also help prevent heart disease.

Metformin works mainly by inhibiting glucose production in the liver.
To treat diabetes:

This medicine is taken in combination with diet and exercise.

This medicine is used if your diabetes cannot be controlled with other
medicines used to treat
diabetes.

Your doctor may ask you to take this medicine on its o

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/850 mg film-coated tablets
Xigduo 5 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xigduo 5 mg/850 mg film-coated tablets
Each tablet contains dapagliflozin propanediol monohydrate equivalent
to 5 mg dapagliflozin and
850 mg of metformin hydrochloride.
Xigduo 5 mg/1,000 mg film-coated tablets
Each tablet contains dapagliflozin propanediol monohydrate equivalent
to 5 mg dapagliflozin and
1,000 mg of metformin hydrochloride.
Excipient(s) with known effect:
Xigduo contains less than 1 mmol sodium (23 mg) per dose, i.e. is
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Xigduo 5 mg/850 mg film-coated tablets
Brown, biconvex, 9.5 x 20 mm oval, film-coated tablets engraved with
“5/850” on one side and
“1067” engraved on the other side.
Xigduo 5 mg/1,000 mg film-coated tablets
Yellow, biconvex, 10.5 x 21.5 mm oval, film-coated tablets engraved
with “5/1000” on one side and
“1069” engraved on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xigduo 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 metformin alone

in combination with other medicinal products for the treatment of
diabetes in patients
insufficiently controlled with metformin and these medicinal products

in patients already being treated with the combination of
dapagliflozin and metformin as
separate tablets.
For study results with respect to combination of therapies, effects on
glycaemic control and
cardiovascular events, and the populations studied, see sections 4.4,
4.5 and 5.1.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (glomerular filtration rate [GFR]
≥ 90 mL/min)_
The recommended dose is one tablet twice daily. Each tablet contain