Forxiga 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dapagliflozin propanediol monohydrate

Available from:

AstraZeneca UK Ltd

ATC code:

A10BK01

INN (International Name):

Dapagliflozin propanediol monohydrate

Dosage:

5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203; GTIN: 5012712004189

Patient Information leaflet

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
Forxiga contains the active substance dapagliflozin. It belongs to a
group of medicines called “oral
anti-diabetics”.
•
These are medicines taken by mouth for diabetes.
•
They work by lowering the amount of sugar (glucose) in your blood.
Forxiga is used for a type of diabetes called “type 2 diabetes
mellitus” in adult patients (aged 18 years
and older). “Type 2 diabetes mellitus” is the type of diabetes
that usually starts when you are older. If
you have type 2 diabetes, your pancreas does not make enough insulin
or your body is not able to use
the insulin it produces properly. This leads to a high level of sugar
in your blood. Forxiga works by
removing excess sugar from your body via your urine.
•
Forxiga is used if your diabetes cannot be controlled with other
medicines for diabetes, diet and
exercise.
•
Your doctor may ask you to take Forxiga on its own if you are
intolerant to metformin or
together with other medicines to treat diabetes. This may be another
medicine taken by mouth
and/or a medicine given by injection, such as insulin or a GLP-1
receptor

Summary of Product characteristics

OBJECT 1
FORXIGA 5 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 20-Oct-2017 | AstraZeneca
UK Limited
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 anhydrous.
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 anhydrous.
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
Forxiga is indicated in adults aged 18 years and older with type 2
diabetes mellitus to improve glycaemic
control as:
Monotherapy
When diet and exercise alone do not provide adequate glycaemic control
in patients for whom use of
metformin is considered inappropriate due to intolerance.
Add-on combination therapy
In combination with other glucose-lowering medicinal products
including insulin, when these, together
with diet and exercise, do not provide adequate glycaemic control (see
sections 4.4, 4.5 and 5.1 for
available data on different combinations).
4.2 Posology and method of administration
Posology
_Monotherapy and add-on combination therapy _
The recommended dose is 10 mg dapagliflozin once daily for monotherapy
and add-on combination
therapy with other glucose-lowering medicinal products including
insulin. Whe