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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Available from:

Galenicum Health, S.L. Avenida Diagonal 123, 11ª Planta, 08005, Barcelona, Spain

ATC code:

A10BD07

INN (International Name):

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SITAGLIPTIN 50 milligram(s) ; METFORMIN HYDROCHLORIDE 850 milligram(s)

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 GALENICUM 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 Galenicum is and what it is used for
2.
What you need to know before you take Sitagliptin/Metformin Galenicum
3.
How to take Sitagliptin/Metformin Galenicum
4.
Possible side effects
5.
How to store Sitagliptin/Metformin Galenicum
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN GALENICUM IS AND WHAT IT IS USED FOR
Sitagliptin/Metformin Galenicum 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

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin Galenicum 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 Galenicum 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 Galenicum 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 Galenicum is indicated as triple combination
therapy with a peroxisome proliferator-
activated receptor gamma (PPAR
γ
) 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
γ
agonist.
Sitagliptin/Metformin Galenicum 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
Galenicum should be individualised on
the basis of the patient’s current regimen, effectiveness, and
tolerability while n