Sitagliptin/Metformin hydrochloride Grindeks 50 mg/850 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metformin Hydrochloride; Sitagliptin Hydrochloride Monohydrate

Available from:

AS Grindeks

ATC code:

A10BD07

INN (International Name):

Metformin Hydrochloride; Sitagliptin Hydrochloride Monohydrate

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

metformin and sitagliptin

Authorization status:

Not marketed

Authorization date:

2022-09-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE GRINDEKS 50 MG/850 MG FILM-COATED
TABLETS
SITAGLIPTIN/METFORMIN HYDROCHLORIDE GRINDEKS 50 MG/1000 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 Grindeks is and what it is
used for
2.
What you need to know before you take Sitagliptin/Metformin
hydrochloride Grindeks
3.
How to take Sitagliptin/Metformin hydrochloride Grindeks
4.
Possible side effects
5.
How to store Sitagliptin/Metformin hydrochloride Grindeks
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE GRINDEKS IS AND WHAT IT IS
USED FOR
Sitagliptin/Metformin hydrochloride Grindeks 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 conditi

Summary of Product characteristics

Health Products Regulatory Authority
07 March 2023
CRN00D8WF
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin hydrochloride Grindeks 50 mg/850 mg film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains sitagliptin hydrochloride monohydrate
equivalent to 50 mg sitagliptin and 850 mg of
metformin hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange, oval, biconvex film-coated tablets, marked "SM85" on one side.
The size of tablet is approximately 20 mm x 6.7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin hydrochloride Grindeks 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 Grindeks 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
Grindeks
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.
Sitagliptin/Metformin hydrochloride Grindeks 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of antihyperglycaemic therapy with Sitagliptin/Metformin
hydrochloride Grindeks should be individu