Forxiga

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dapagliflozin propanediol monohydrate

Available from:

AstraZeneca AB

ATC code:

A10BK01

INN (International Name):

dapagliflozin

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic

Therapeutic indications:

Type 2 diabetes mellitusForxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseForxiga is indicated in adults for the treatment of chronic kidney disease.

Product summary:

Revision: 29

Authorization status:

Authorised

Authorization date:

2012-11-11

Patient Information leaflet

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FORXIGA 5 MG FILM-COATED TABLETS
FORXIGA 10 MG FILM-COATED TABLETS
dapagliflozin
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 Forxiga is and what it is used for
2.
What you need to know before you take Forxiga
3.
How to take Forxiga
4.
Possible side effects
5.
How to store Forxiga
6.
Contents of the pack and other information
1.
WHAT FORXIGA IS AND WHAT IT IS USED FOR
WHAT FORXIGA IS
Forxiga contains the active substance dapagliflozin. It belongs to a
group of medicines called “sodium
glucose co-transporter-2 (SGLT2) inhibitors”. They work by blocking
the SGLT2 protein in your
kidney. By blocking this protein, blood sugar (glucose), salt (sodium)
and water are removed from
your body via the urine.
WHAT FORXIGA IS USED FOR
Forxiga is used to treat:

TYPE 2 DIABETES
-
in adults and children aged 10 years and older.
-
if your type 2 diabetes cannot be controlled with diet and exercise.
-
Forxiga can be used on its own or together with other medicines to
treat diabetes.
-
It is important to continue to follow the advice on diet and exercise
given to you by your
doctor, pharmacist or nurse.

HEART FAILURE
-
in adults (aged 18 years and older) when the heart does not pump blood
as well as it
should.

CHRONIC KIDNEY DISEASE
-
in adults with reduced kidney function.
WHAT IS TYPE 2 DIABETES AND HOW DOES FORXIGA HELP?

In type 2 diabetes your body does not make enough insulin or is not
able to use the insulin i

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Forxiga 5 mg film-coated tablets
Forxiga 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Forxiga 5 mg film-coated tablets
Each tablet contains dapagliflozin propanediol monohydrate equivalent
to 5 mg dapagliflozin.
_Excipient with known effect_
Each 5 mg tablet contains 25 mg of lactose.
Forxiga 10 mg film-coated tablets
Each tablet contains dapagliflozin propanediol monohydrate equivalent
to 10 mg dapagliflozin.
_Excipient with known effect_
Each 10 mg tablet contains 50 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Forxiga 5 mg film-coated tablets
Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with
“5” engraved on one side and
“1427” engraved on the other side.
Forxiga 10 mg film-coated tablets
Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally
diamond-shaped, film-coated tablets with
“10” engraved on one side and “1428” engraved on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Type 2 diabetes mellitus
Forxiga is indicated in adults and children aged 10 years and above
for the treatment of insufficiently
controlled type 2 diabetes mellitus as an adjunct to diet and exercise
-
as monotherapy when metformin is considered inappropriate due to
intolerance.
-
in addition to other medicinal products for the treatment of type 2
diabetes.
For study results with respect to combination of therapies, effects on
glycaemic control, cardiovascular
and renal events, and the populations studied, see sections 4.4, 4.5
and 5.1.
Heart failure
Forxiga is indicated in adults for the treatment of symptomatic
chronic heart failure.
3
Chronic kidney disease
Forxiga is indicated in adults for the treatment of chronic kidney
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Type 2 diabetes mellitus_
The recommended dose is 10 mg dapagliflozin once daily.
When dapagliflozin is used in combination with