Sitagliptin SUN

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

sitagliptin fumarate

MAH:

Sun Pharmaceutical Industries Europe B.V.

ATC_code:

A10BH01

INN:

sitagliptin fumarate

therapeutic_group:

Drugs used in diabetes

therapeutic_area:

Diabetes Mellitus, Type 2

therapeutic_indication:

For adult patients with type 2 diabetes mellitus, Sitagliptin SUN 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 (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ 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 PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Sitagliptin SUN 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.

leaflet_short:

Revision: 1

authorization_status:

Authorised

authorization_date:

2021-12-09

PIL

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN SUN 25 MG FILM-COATED TABLETS
SITAGLIPTIN SUN 50 MG FILM-COATED TABLETS
SITAGLIPTIN SUN 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 SUN is and what it is used for
2.
What you need to know before you take Sitagliptin SUN
3.
How to take Sitagliptin SUN
4.
Possible side effects
5.
How to store Sitagliptin SUN
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN SUN IS AND WHAT IT IS USED FOR
Sitagliptin SUN 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
also make too much sugar.
When

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin SUN 25 mg film-coated tablets
Sitagliptin SUN 50 mg film-coated tablets
Sitagliptin SUN 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin SUN 25 mg film-coated tablets
Each film-coated tablet contains sitagliptin fumarate, equivalent to
25 mg sitagliptin.
Excipient(s) with known effect
Each film-coated tablet contains 4 mg of hydrogenated castor oil.
Sitagliptin SUN 50 mg film-coated tablets
Each film-coated tablet contains sitagliptin fumarate, equivalent to
50 mg sitagliptin.
Excipient(s) with known effect
Each film-coated tablet contains 8 mg of hydrogenated castor oil.
Sitagliptin SUN 100 mg film-coated tablets
Each film-coated tablet contains sitagliptin fumarate, equivalent to
100 mg sitagliptin.
Excipient(s) with known effect
Each film-coated tablet contains 16 mg of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Sitagliptin SUN 25 mg film-coated tablets
Light pink colour, round film-coated tablets, dimensions approximately
6 mm x 3 mm, debossed with
F1 on one side and plain on the other side.
Sitagliptin SUN 50 mg film-coated tablets
Light beige colour, round film-coated tablets, dimensions
approximately 8 mm x 4 mm, debossed with
F2 on one side and plain on the other side.
Sitagliptin SUN 100 mg film-coated tablets
Beige colour, round film-coated tablets, dimensions approximately 10
mm x 4.5 mm, debossed with
F3 on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
3
For adult patients with type 2 diabetes mellitus, Sitagliptin SUN 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