SITAGLIPTIN/METFORMIN DOC 50 mg/1000 mg film-coated tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Disponible depuis:

Doc Generici srl Via Turati, 40-20121, Milano, Italy

Code ATC:

A10BD07

DCI (Dénomination commune internationale):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

forme pharmaceutique:

FILM-COATED TABLET

Composition:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

DRUGS USED IN DIABETES

Descriptif du produit:

Licence number in the source country: NOT APPLICAPABLE

Statut de autorisation:

Authorised

Date de l'autorisation:

2021-09-13

Notice patient

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

Résumé des caractéristiques du produit

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1.
NAME OF THE MEDICINAL PRODUCT
SITAGLIPTIN/METFORMIN DOC 50 mg/850 mg film-coated tablets
SITAGLIPTIN/METFORMIN DOC 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SITAGLIPTIN/METFORMIN DOC 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 DOC 50 mg/1000 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 DOC 50 mg/850 mg film-coated tablets
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.
SITAGLIPTIN/METFORMIN DOC 50 mg/1000 mg film-coated tablets
Red to brown, oblong oval-shaped film-coated tablets with a scoreline
in between ‘S’ and ‘B’ on
one side and with a scoreline on the other side.
Tablet diameter: 21.3 ± 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 DOC 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 DOC 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 DOC is indicated as triple combination therapy
with a peroxisome
proliferator-activated receptor gamma (PPAR

) agonist (i.e., a thiazolidinedione) as a