Dapagliflozin Krka 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dapagliflozin

Available from:

KRKA, d.d., Novo mesto

ATC code:

A10BK01

INN (International Name):

Dapagliflozin

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Dapagliflozin

Authorization status:

Not marketed

Authorization date:

2023-12-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPAGLIFLOZIN KRKA 5 MG FILM-COATED TABLETS
DAPAGLIFLOZIN KRKA 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 or pharmacist.
-
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 Krka is and what it is used for
2.
What you need to know before you take Dapagliflozin Krka
3.
How to take Dapagliflozin Krka
4.
Possible side effects
5.
How to store Dapagliflozin Krka
6.
Contents of the pack and other information
1.
WHAT DAPAGLIFLOZIN KRKA IS AND WHAT IT IS USED FOR
WHAT DAPAGLIFLOZIN KRKA IS
Dapagliflozin Krka 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 KRKA IS USED FOR
Dapagliflozin Krka 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 Krka 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 DAPAGLIFLOZIN

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2023
CRN00CW3K
Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dapagliflozin Krka 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg dapagliflozin (from
dapagliflozin propanediol monohydrate form).
Excipient with known effect:
Each film-coated tablet contains 97.4 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light brownish yellow, oval, biconvex, film-coated tablets, scored on
one side. One side of score line is marked with "1" and the
other with "0". The tablet can be divided into equal doses. Tablet
dimension: approx. 13 x 6.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Type 2 diabetes mellitus
Dapagliflozin Krka 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
Dapagliflozin Krka is indicated in adults for the treatment of
symptomatic chronic heart failure.
Chronic kidney disease
Dapagliflozin Krka 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 insulin or an insulin
secretagogue, such as a sulphonylurea, a lower dose of
insulin or insulin secretagogue may be considered to reduce the risk
of hypoglycaemia (see sections 4.5 and 4.8).
_Heart failure_
The recommended dose is 10 mg dapagliflozin once daily.
_Chronic kidney disease_
The