Sitagliptin / Metformin hydrochloride Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sitagliptin hydrochloride monohydrate, metformin hydrochloride

Available from:

Mylan Ireland Limited

ATC code:

A10BD07

INN (International Name):

sitagliptin hydrochloride monohydrate, metformin hydrochloride

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

For adult patients with type 2 diabetes mellitus:Sitagliptin/Metformin hydrochloride Mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Sitagliptin/Metformin hydrochloride Mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Sitagliptin/Metformin hydrochloride Mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARg agonist.Sitagliptin/Metformin hydrochloride Mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2022-02-16

Patient Information leaflet

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE MYLAN 50 MG/850 MG FILM-COATED
TABLETS
sitagliptin/metformin hydrochloride
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/Metformin hydrochloride Mylan is and what it is used
for
2.
What you need to know before you take Sitagliptin/Metformin
hydrochloride Mylan
3.
How to take Sitagliptin/Metformin hydrochloride Mylan
4.
Possible side effects
5.
How to store Sitagliptin/Metformin hydrochloride Mylan
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE MYLAN IS AND WHAT IT IS USED
FOR
Sitagliptin/Metformin hydrochloride Mylan contains two different
medicines called sitagliptin and
metformin.
•
sitagliptin belongs to a class of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4
inhibitors)
•
metformin belongs to a class of medicines called biguanides.
They work together to control blood sugar levels in adult patients
with a form of diabetes called
‘type 2 diabetes mellitus’. This medicine helps to increase the
levels of insulin produced after a meal
and lowers the amount of sugar made by your body.
Along with diet and exercise, this medicine helps lower your blood
sugar. This medicine can be used
alone or with certain other medicines for diabetes (insulin,
sulphonylureas, or glitazones).
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin hydrochloride Mylan 50 mg/850 mg film-coated
tablets
Sitagliptin/Metformin hydrochloride Mylan 50 mg/1,000 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin/Metformin hydrochloride Mylan 50 mg/850 mg film-coated
tablets
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and
850 mg of metformin hydrochloride.
Sitagliptin/Metformin hydrochloride Mylan 50 mg/1,000 mg film-coated
tablets
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and
1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Sitagliptin/Metformin hydrochloride Mylan 50 mg/850 mg film-coated
tablets
A pink, capsule shaped, biconvex, bevelled edge tablet, debossed with
‘M’ on one side of the tablet
and ‘SM5’ on the other side. Dimension: approximately 20 mm X 10
mm.
Sitagliptin/Metformin hydrochloride Mylan 50 mg/1,000 mg film-coated
tablets
A peach to brown, capsule shaped, biconvex, bevelled edge tablet,
debossed with ‘M’ on one side of
the tablet and ‘SM7’ on the other side. Dimension: approximately
21 mm X 10 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin hydrochloride Mylan is indicated as an adjunct
to diet and exercise to improve
glycaemic control in patients inadequately controlled on their maximal
tolerated dose of metformin
alone or those already being treated with the combination of
sitagliptin and metformin.
Sitagliptin/Metformin hydrochloride Mylan is indicated in combination
with a sulphonylurea (i.e.,
triple combination therapy) as an adjunct to diet and exercise in
patients inadequately controlled on
their maximal tolerated dose of metformin and a sulphonylurea.
Sitagliptin/Metformin hydrochloride Mylan is indicated as triple
combination ther