Xigduo 5 mg/850 mg film-coated tablets

Country: European Union

Language: English

Source: myHealthbox

Active ingredient:

Metformin Hydrochloride, Dapagliflozin Propanediol Monohydrate

Available from:

AstraZeneca AB

ATC code:

A10BD15

INN (International Name):

Dapagliflozin, Metformin

Dosage:

5 mg/850 mg

Pharmaceutical form:

Film-coated tablet (tablet)

Administration route:

Oral use

Units in package:

14,28,56,60,196

Prescription type:

Subject to medical prescription

Manufactured by:

AstraZeneca GmbH, Bristol-Myers Squibb Company

Therapeutic group:

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

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

Indicated in adults aged 18 years and older 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 glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products - in patients already being treated with the combination of dapagliflozin and metformin as separate tablets

Authorization status:

Authorized

Authorization date:

2014-01-16

Patient Information leaflet

73 
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 

 This medicinal product is subject to additional monitoring. This
will allow quick identification of new 
safety information. You can help by reporting any side effects
you may get. See the end of section 4 for 
how to report side effects. 

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. 

This medicine 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 yo

Summary of Product characteristics

1 

ANNEX I 

SUMMARY OF PRODUCT CHARACTERISTICS 

2 
 This medicinal product is subject to additional monitoring. This
will allow quick identification of new 
safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See 
section 4.8 for how to report adverse reactions. 

1. 
NAME OF THE MEDICINAL PRODUCT 

Xigduo 5 mg/850 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains dapagliflozin propanediol monohydrate
equivalent to 5 mg dapagliflozin and 850 mg 
of metformin hydrochloride. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet (tablet). 

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. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Xigduo 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  
• in patients inadequately controlled on their
maximally tolerated dose of

metformin alone  
• in combination with other glucose-lowering medicinal
products, 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
dapagliflozin and metformin as separate tablets. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 
_ _
Posology 
_For patients inadequately controlled on metformin monotherapy
or metformin in combination with other _
_glucose-lowering medicinal products including insulin _
The recommended dose is one tablet twice daily.
Each tablet contains a fixed dose of dapaglif