Sitagliptine/Metformine HCl Sandoz 50/1000 mg, filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

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

Aktiva substanser:

METFORMINEHYDROCHLORIDE 1000 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 779,6 mg/stuk ; SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

INN (International namn):

METFORMINEHYDROCHLORIDE 1000 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 779,6 mg/stuk ; SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; NATRIUMLAURILSULFAAT ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505)

Administreringssätt:

Oraal gebruik

Tillstånd datum:

1900-01-01

Bipacksedel

Sandoz B.V.
Page 1/9
Sitagliptine/Metformine Sandoz 50/850, 50/1000 mg,
filmomhulde tabletten
RVG 125723-4
1313-v3b
1.3.1.3 Leaflet
Mei 2023
SITAGLIPTINE/METFORMINE HCL SANDOZ
® 50/850 MG, FILMOMHULDE TABLETTEN
SITAGLIPTINE/METFORMINE HCL SANDOZ
® 50/1000 MG, FILMOMHULDE TABLETTEN
sitagliptine/metforminehydrochloride
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 {[Nationally completed name]} is and what it is used for
2. What you need to know before you take {Nationally completed name]}
3. How to take {Nationally completed name]}
4. Possible side effects
5. How to store {Nationally completed name]}
6. Contents of the pack and other information
1. WHAT {NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR
{[Nationally completed name]} 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 yo

Produktens egenskaper

Sandoz B.V.
Page 1/25
Sitagliptine/Metformine Sandoz 50/850, 50/1000 mg,
filmomhulde tabletten
RVG 125723-4
1311-v2
1.3.1.1 Summary of Product Characteristics
Maart 2022
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptine/Metformine HCl Sandoz 50/850 mg, filmomhulde tabletten
Sitagliptine/Metformine HCl Sandoz 50/1000 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[NATIONALLY COMPLETED NAME] 50 MG/850 MG FILM-COATED TABLETS}:
Each film-coated tablet contains sitagliptin hydrochloride monohydrate
equivalent to 50 mg of
sitagliptin, and 850 mg of metformin hydrochloride.
{[NATIONALLY COMPLETED NAME] 50 MG/1,000 MG FILM-COATED TABLETS}:
Each film-coated 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).
{[NATIONALLY COMPLETED NAME] 50 MG/850 MG FILM-COATED TABLETS}:
Light orange film-coated tablet of oval, biconvex shape (approximately
10x20 mm), debossed with
“SM 2” on one side.
{[NATIONALLY COMPLETED NAME] 50 MG/1,000 MG FILM-COATED TABLETS}:
Light red film-coated tablet of oval, biconvex shape (approximately
10.5x21 mm), debossed with “SM
3” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
{[Nationally completed name]} 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.
Sandoz B.V.
Page 2/25
Sitagliptine/Metformine Sandoz 50/850, 50/1000 mg,
filmomhulde tabletten
RVG 125723-4
1311-v2
1.3.1.1 Summary of Product Characteristics
Maart 2022
{[Nationally completed name]} 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 m