Sitagliptine/Metformine Hetero 50 mg/850 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE ; SITAGLIPTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; SITAGLIPTINE

Beschikbaar vanaf:

Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)

INN (Algemene Internationale Benaming):

METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE ; SITAGLIPTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; SITAGLIPTINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 90 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-10-20

Bijsluiter

PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTINE/METFORMINE HETERO 50 MG/850 MG FILMOMHULDE TABLETTEN
SITAGLIPTINE/METFORMINE HETERO 50 MG/1000 MG FILMOMHULDE TABLETTEN
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 Sitagliptine/Metformine Hetero is and what it is used for
2.
What you need to know before you take Sitagliptine/Metformine Hetero
3.
How to take Sitagliptine/Metformine Hetero
4.
Possible side effects
5.
How to store Sitagliptine/Metformine Hetero
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTINE/METFORMINE HETERO IS AND WHAT IT IS USED FOR
Sitagliptine/Metformine Hetero 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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptine/Metformine Hetero 50 mg/850 mg filmomhulde tabletten
Sitagliptine/Metformine Hetero 50 mg/1000 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and 850 mg
of metformin hydrochloride.
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and 1000
mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
50 mg/850 mg: Capsule-shaped, white to off- white film-coated tablets
debossed with "S18" and break
line on one side and "H" on the other side.
50 mg/1000 mg: Capsule-shaped, yellow film-coated tablets debossed
with "S19" and break line on one
side and "H" on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sitagliptine/Metformine Hetero 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.
Sitagliptine/Metformine Hetero 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.
Sitagliptine/Metformine Hetero is indicated as triple combination
therapy with a peroxisome
proliferator-activated receptor gamma (PPARγ) 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
PPARγ agonist.
Sitagliptine/Metformine Hetero 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
a