Dapagliflozin Viatris

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dapagliflozin

Available from:

Viatris Limited

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 mellitusDapagliflozin Viatris 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 failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.

Authorization status:

Authorised

Authorization date:

2023-03-24

Patient Information leaflet

55
B. PACKAGE LEAFLET
56
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPAGLIFLOZIN VIATRIS 5 MG FILM-COATED TABLETS
DAPAGLIFLOZIN VIATRIS 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 Dapagliflozin Viatris is and what it is used for
2.
What you need to know before you take Dapagliflozin Viatris
3.
How to take Dapagliflozin Viatris
4.
Possible side effects
5.
How to store Dapagliflozin Viatris
6.
Contents of the pack and other information
1.
WHAT DAPAGLIFLOZIN VIATRIS IS AND WHAT IT IS USED FOR
WHAT DAPAGLIFLOZIN VIATRIS IS
Dapagliflozin Viatris 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 DAPAGLIFLOZIN VIATRIS
IS USED FOR
Dapagliflozin Viatris 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.
-
Dapagliflozin Viatris 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) with symptoms due to a weak pump
function of the
heart.
•
CHRONIC KIDNEY DISEASE
-
in adults with reduce

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dapagliflozin Viatris 5 mg film-coated tablets
Dapagliflozin Viatris 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dapagliflozin Viatris 5 mg film-coated tablets
Each film-coated tablet contains 5 mg of dapagliflozin.
_ _
_Excipient with known effect _
Each 5 mg tablet contains 24 mg of lactose.
Dapagliflozin Viatris 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of dapagliflozin.
_ _
_Excipient with known effect _
Each 10 mg tablet contains 48 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Dapagliflozin Viatris 5 mg film-coated tablet
Yellow coloured, round shaped, biconvex film-coated tablet with
diameter of approximetely 7.2 mm.
Debossed with ‘5’ on one side and plain on the other side.
Dapagliflozin Viatris 10 mg film-coated tablet
Yellow coloured, diamond shaped, biconvex with dimensions of
approximately 11 x 8 mm. Debossed
with ‘10’ on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Type 2 diabetes mellitus
Dapagliflozin Viatris 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.
3
Heart failure
Dapagliflozin Viatris is indicated in adults for the treatment of
symptomatic chronic heart failure with
reduced ejection fraction.
Chronic kidney disease
Dapagliflozin Viatris is indicated in adults for the treatment of
chronic kidney disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Type 2 diabetes mellitus _
The reco