Sitagliptin RAFARM 100 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SITAGLIPTIN

Available from:

Rafarm S.A. 12, Korinthou Str., 15451 Neo Psihiko, Athens, Greece

ATC code:

A10BH01

INN (International Name):

SITAGLIPTIN 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SITAGLIPTIN 100 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-04-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN RAFARM 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 RAFARM is and what it is used for
2.
What you need to know before you take Sitagliptin RAFARM
3.
How to take Sitagliptin RAFARM
4.
Possible side effects
5.
How to store Sitagliptin RAFARM
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN RAFARM IS AND WHAT IT IS USED FOR
Sitagliptin RAFARM 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 this happens, sugar (glucose) builds up in the blood. This can
lead to serious medical

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin RAFARM 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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).
Round, beige film-coated tablets of approximately 10 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, Sitagliptin RAFARM
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
sulphonylurea
alone do not provide adequate glycaemic control and when metformin is
inappropriate
due to contraindications or intolerance.
•
A peroxisome proliferator-activated receptor gamma (PPAR

) agonist (i.e. a
thiazolidinedione) when use of a PPAR

agonist is appropriate and when diet and
exercise plus the PPAR

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 adequately glycaemic control.
•
A PPAR

agonist and metformin when use of a PPAR

agonist is appropriate and when
diet and exercise plus dual therapy with these medicinal products do
not provide
adequate glycaemic control.
PAGE 2 OF 18
Sitagliptin RAFARM 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is 100 mg sitagliptin once daily. When used in combination
with metformin and/or a