Sitagliptin/Metformin Merck 50 mg/850 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Available from:

Merck Healthcare KGaA Frankfurter Strasse 250, 64293 Darmstadt, Germany

ATC code:

A10BD07

INN (International Name):

METFORMIN HYDROCHLORIDE 850 mg SITAGLIPTIN 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

METFORMIN HYDROCHLORIDE 850 mg SITAGLIPTIN 50 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:

2020-11-09

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN MERCK 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 Merck is and what it is used for
2.
What you need to know before you take Sitagliptin/Metformin Merck
3.
How to take Sitagliptin/Metformin Merck
4.
Possible side effects
5.
How to store Sitagliptin/Metformin Merck
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN MERCK IS AND WHAT IT IS USED FOR
Sitagliptin/Metformin Merck 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 body produces does not work as well as it should. Your body can
also make too much sugar.
When this happens, s

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin Merck 50 mg/850 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of
sitagliptin and 850 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, oblong oval-shaped film-coated tablets with a score line on one
side and ‘SA’ on
the other side.
Tablet diameter: 19.5 ± 0.5mm
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin Merck 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 Merck 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
Merck
is
indicated
as
triple
combination
therapy
with
a
peroxisome
proliferator-activated
receptor
gamma
(PPAR

)
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 PPAR

agonist.
Sitagliptin/Metformin
Merck
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.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of antihyperglycaemic therapy with Sitagliptin/Metformin
Merck should be
individualised on the basis of the patient’s current regimen,
effectiveness, and tolerability
while not exceedi