Dapagliflozin Ascend 5 mg film-coated tablets

Country: Malta

Language: English

Source: Malta Medicines Authority

Available from:

Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany

ATC code:

A10BK

INN (International Name):

DAPAGLIFLOZIN 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DAPAGLIFLOZIN 5 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Authorised

Authorization date:

2023-09-11

Patient Information leaflet

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
DAPAGLIFLOZIN ASCEND 5 MG FILM-COATED TABLETS
DAPAGLIFLOZIN ASCEND 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 Ascend is and what it is used for
2.
What you need to know before you take Dapagliflozin Ascend
3.
How to take Dapagliflozin Ascend
4.
Possible side effects
5.
How to store Dapagliflozin Ascend
6.
Contents of the pack and other information
1.
WHAT DAPAGLIFLOZIN ASCEND IS AND WHAT IT IS USED FOR
WHAT DAPAGLIFLOZIN ASCEND IS
Dapagliflozin Ascend 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 ASCEND IS USED FOR
DAPAGLIFLOZIN ASCEND
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.
-
This medicine 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.
WHAT IS TYPE 2 DIABETES AND HOW DOES DAPAGLIFLOZIN ASCEND HELP?
•
In type 2 diabetes your body does not make enough insulin or is not
able to use the insulin it
makes properly. This leads

Summary of Product characteristics

Page
1
of
25
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dapagliflozin Ascend 5 mg film-coated tablets
Dapagliflozin Ascend
10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dapagliflozin Ascend 5 mg film-coated tablets
Each film coated tablet contains 5 mg dapagliflozin
_Excipient with known effect: _
Each 5 mg tablet contains 25 mg of lactose monohydrate.
Dapagliflozin Ascend 10 mg film-coated tablets
Each film coated tablet contains 10 mg dapagliflozin
_Excipient with known effect: _
Each 10 mg tablet contains 50 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Dapagliflozin Ascend 5 mg film-coated tablets
Round, film-coated, yellow coloured biconvex tablets with bevelled
edges debossed with “DP” on
one side and “5” on other side.
Dapagliflozin Ascend 10 mg film-coated tablets
Round, film-coated, yellow coloured biconvex tablets with bevelled
edges debossed with “DP” on
one side and “10” on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Type 2 diabetes mellitus
Dapagliflozin 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.
Page
2
of
25
- in addition to other medicinal products for the treatment of type 2
diabetes.
For study results with respect to combination of therapies, effect on
glycaemic control, and the
populations studied, see sections 4.4, 4.5 and 5.1.
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).
_Special populations _
_Renal impairment _
No