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

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

ATC code:

A10BD07

INN (International Name):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 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:

2022-06-17

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN/METFORMIN DIAGONALIS 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 Diagonalis is and what it is used for
2.
What you need to know before you take Sitagliptin/Metformin Diagonalis
3.
How to take Sitagliptin/Metformin Diagonalis
4.
Possible side effects
5.
How to store Sitagliptin/Metformin Diagonalis
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN/METFORMIN DIAGONALIS IS AND WHAT IT IS USED FOR
Sitagliptin/Metformin Diagonalis 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 t

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin Diagonalis 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 scoreline on one
side and ‘SA’ on the other side.
Tablet diameter: 19.5 ± 0.5mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptin/Metformin Diagonalis 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 Diagonalis 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 Diagonalis 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 Diagonalis 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
Diagonalis
should
be
individualised on the basis of the patient’s c