Sitagliptin Accord

Pajjiż: Unjoni Ewropea

Lingwa: Ingliż

Sors: EMA (European Medicines Agency)

Ingredjent attiv:

sitagliptin hydrochloride

Disponibbli minn:

Accord Healthcare S.L.U.

Kodiċi ATC:

A10BH01

INN (Isem Internazzjonali):

sitagliptin

Grupp terapewtiku:

Drugs used in diabetes

Żona terapewtika:

Diabetes Mellitus, Type 2

Indikazzjonijiet terapewtiċi:

For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPARy) agonist (i.e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy agonist alone do not provide adequate glycaemic control.as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Sitagliptin Accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2022-04-25

Fuljett ta 'informazzjoni

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN ACCORD 25 MG FILM-COATED TABLETS
SITAGLIPTIN ACCORD 50 MG FILM-COATED TABLETS
SITAGLIPTIN ACCORD 100 MG FILM-COATED TABLETS
sitagliptin
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, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sitagliptin Accord is and what it is used for
2.
What you need to know before you take Sitagliptin Accord
3.
How to take Sitagliptin Accord
4.
Possible side effects
5.
How to store Sitagliptin Accord
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN ACCORD IS AND WHAT IT IS USED FOR
Sitagliptin Accord contains the active substance sitagliptin which is
a member of a class of medicines
called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that
lowers blood sugar levels in adult
patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a
meal and decreases the amount
of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood
sugar, which is too high because of
your type 2 diabetes. This medicine can be used alone or in
combination with certain other medicines
(insulin, metformin, sulphonylureas, or glitazones) that lower blood
sugar, which you may already be
taking for your diabetes together with a food and exercise plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough
insulin, and the insulin that
your body produces does not work as well as it should. Your body can
als

Karatteristiċi tal-prodott

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin Accord 25 mg film-coated tablets
Sitagliptin Accord 50 mg film-coated tablets
Sitagliptin Accord 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin Accord 25 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 25 mg sitagliptin.
Sitagliptin Accord 50 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 50 mg sitagliptin.
Sitagliptin Accord 100 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 100 mg sitagliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Sitagliptin Accord 25 mg film-coated tablets
Pink coloured, round, leveled edge, film-coated tablet debossed with
‘S3’ on one side and plain on the
other side. Diameter 6 mm to 6.40 mm.
Sitagliptin Accord 50 mg film-coated tablets
Light beige coloured, round, beveled edge, film-coated tablet debossed
with ‘S4’ on one side and plain
on the other side. Diameter 8 mm to 8.40 mm
Sitagliptin Accord 100 mg film-coated tablets
Beige coloured, round, beveled edge, film-coated tablet debossed with
‘S7’ on one side and plain on
the other side. Diameter 10 mm to 10.40 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, Sitagliptin Accord
is indicated to improve glycaemic
control:
as monotherapy:
•
in patients inadequately controlled by diet and exercise alone and for
whom metformin is
inappropriate due to contraindications or intolerance.
3
as dual oral therapy in combination with:
•
metformin when diet and exercise plus metformin alone do not provide
adequate glycaemic
control.
•
a sulphonylurea when diet and exercise plus maximal tolerated dose of
a sulphonylurea alone do
not provide adequate glycaemic control and when metformin is
inappropriate due to
contraindications or intolerance.
•