Sitagliptin Mylan 50 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sitagliptin

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

A10BH01

INN (International Name):

Sitagliptin

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

sitagliptin

Authorization status:

Marketed

Authorization date:

2021-06-25

Patient Information leaflet

33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Sitagliptin Mylan 25 mg film-coated tablets
Sitagliptin Mylan 50 mg film-coated tablets
Sitagliptin Mylan 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 or 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 Sitagliptin Mylan is and what it is used for
2.
What you need to know before you take Sitagliptin Mylan
3.
How to take Sitagliptin Mylan
4.
Possible side effects
5.
How to store Sitagliptin Mylan
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN MYLAN IS AND WHAT IT IS USED FOR
Sitagliptin Mylan 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 happe

Summary of Product characteristics

Health Products Regulatory Authority
30 March 2022
CRN00CTXQ
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sitagliptin Mylan 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains sitagliptin hydrochloride
monohydrate, equivalent to 50 mg sitagliptin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, biconvex light brown film-coated tablet with "M" on one side
and "SL2" on the other side, 8.1 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, Sitagliptin Mylan 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 Mylan 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 A