Sitagliptin/Metformin Auxilto 50 mg/1000 mg film-coated tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Verfügbar ab:

Auxilto Healthcare s.r.o. Bucharova 2657/12, Stodulky 158 00 Praha 5 , Czech Republic

ATC-Code:

A10BD07

INN (Internationale Bezeichnung):

METFORMIN HYDROCHLORIDE 1000 mg SITAGLIPTIN 50 mg

Darreichungsform:

FILM-COATED TABLET

Zusammensetzung:

METFORMIN HYDROCHLORIDE 1000 mg SITAGLIPTIN 50 mg

Verschreibungstyp:

POM

Therapiebereich:

DRUGS USED IN DIABETES

Produktbesonderheiten:

Licence number in the source country: NOT APPLICAPABLE

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2023-05-18

Gebrauchsinformation

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

Fachinformation

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1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin/Metformin Auxilto 50 mg/850 mg film-coated tablets
Sitagliptin/Metformin Auxilto 50mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin/Metformin Auxilto 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 Auxilto 50mg/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 Auxilto 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
Sitagliptin/Metformin Auxilto 50mg/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 Auxilto 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
Auxilto
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 Auxilto is indicated as triple combination
therapy with a peroxisome
proliferator-activated receptor gamma (PPAR

) agonist (i.e., a thiazolidinedione) as an adjunct to
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