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

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

Pieejams no:

Rafarm S.A. 12, Korinthou Str., 15451 Neo Psihiko, Athens, Greece

ATĶ kods:

A10BD07

SNN (starptautisko nepatentēto nosaukumu):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Zāļu forma:

FILM-COATED TABLET

Kompozīcija:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Receptes veids:

POM

Ārstniecības joma:

DRUGS USED IN DIABETES

Produktu pārskats:

Licence number in the source country: NOT APPLICAPABLE

Autorizācija statuss:

Authorised

Autorizācija datums:

2022-02-02

Lietošanas instrukcija

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

Produkta apraksts

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