Sitagliptin / Metformin hydrochloride Accord

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

metformin hydrochloride, sitagliptin hydrochloride monohydrate

Available from:

Accord Healthcare S.L.U.

ATC code:

A10BD07

INN (International Name):

sitagliptin, metformin hydrochloride

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

For adult patients with type 2 diabetes mellitus:It 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.It 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.It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) 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 PPARγ agonist.It 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: 1

Authorization status:

Authorised

Authorization date:

2022-07-22

Patient Information leaflet

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE ACCORD 50 MG/850 MG
FILM-COATED TABLETS
SITAGLIPTIN/METFORMIN HYDROCHLORIDE ACCORD 50 MG/1,000 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 Accord is and what it is used
for
2.
What you need to know before you take Sitagliptin/Metformin
hydrochloride Accord
3.
How to take Sitagliptin/Metformin hydrochloride Accord
4.
Possible side effects
5.
How to store Sitagliptin/Metformin hydrochloride Accord
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE ACCORD IS AND WHAT IT IS USED
FOR
This medicine 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg film-coated
tablets
Sitagliptin/Metformin hydrochloride Accord 50 mg/1,000 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin/Metformin hydrochloride Accord 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 Accord 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 Accord 50 mg/850 mg film-coated
tablets
Pink colored, capsule shaped, film coated tablet debossed with 'SM2'
on one side and plain on other
side. Dimension: 20x10 mm.
Sitagliptin/Metformin hydrochloride Accord 50 mg/1,000 mg film-coated
tablets
Red colored, capsule shaped, film coated tablet debossed with 'SM3' on
one side and plain on other
side. Dimension: Length: 21x10 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
It 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.
It 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.
It is indicated as triple combination therapy with a peroxisome
proliferator-activated receptor gamma
(PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and
exercise in patients inadequately
controlled on their maximal tolerated dose of metf