Edistride

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

dapagliflozin propanediol monohydrate

Διαθέσιμο από:

AstraZeneca AB

Φαρμακολογική κατηγορία (ATC):

A10BK01

INN (Διεθνής Όνομα):

dapagliflozin

Θεραπευτική ομάδα:

Drugs used in diabetes

Θεραπευτική περιοχή:

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

Θεραπευτικές ενδείξεις:

Type 2 diabetes mellitusEdistride 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 failureEdistride is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseEdistride is indicated in adults for the treatment of chronic kidney disease.

Περίληψη προϊόντος:

Revision: 22

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-11-09

Φύλλο οδηγιών χρήσης

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EDISTRIDE 5 MG FILM-COATED TABLETS
EDISTRIDE 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 Edistride is and what it is used for
2.
What you need to know before you take Edistride
3.
How to take Edistride
4.
Possible side effects
5.
How to store Edistride
6.
Contents of the pack and other information
1.
WHAT EDISTRIDE IS AND WHAT IT IS USED FOR
WHAT EDISTRIDE IS
Edistride 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 EDISTRIDE IS USED FOR
Edistride 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.
-
Edistride 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 EDISTRIDE HELP?

In type 2 diabetes your body does not make enough insulin or is not

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Edistride 5 mg film-coated tablets
Edistride 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Edistride 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.
Edistride 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).
Edistride 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.
Edistride 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
Edistride 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
Edistride is indicated in adults for the treatment of symptomatic
chronic heart failure.
3
Chronic kidney disease
Edistride 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 us