Sitagliptine Sandoz 50 mg, filmomhulde tabletten

国: オランダ

言語: オランダ語

ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

有効成分:

SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

INN（国際名）:

SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

医薬品形態:

Filmomhulde tablet

構図:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL (E 1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

投与経路:

Oraal gebruik

承認日:

1900-01-01

情報リーフレット

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Sandoz B.V.
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Sitagliptine Sandoz 2,5/5/10/20 mg, filmomhulde tabletten
RVG 127493-94-95
1313-V2a
1.3.1.3 Leaflet
maart 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTINE SANDOZ® 25 MG, FILMOMHULDE
TABLETTEN
SITAGLIPTINE SANDOZ® 50 MG, FILMOMHULDE
TABLETTEN
SITAGLIPTINE SANDOZ® 100 MG, FILMOMHULDE
TABLETTEN
sitagliptine
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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains the active substance sitagliptin which is a
member of a class of medicines
called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that
lowers blood sugar levels in adult
patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a
meal and decreases the amount
of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood
sugar, which is too high because of
your type 2 diabetes. This medicine can be used alone or in
combination with certain other medicines
(insulin, metformin, sulphonylureas, or glitazones) that lower blood
sugar, which you may already be
taking for your diabetes together with a food and exercise plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enoug

製品の特徴

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Sandoz B.V.
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Sitagliptine Sandoz
®
25, 50, 100 mg, filmomhulde
tabletten
RVG 127493-94-95
1311-V1
1.3.1.1 Summary of Product Characteristics
Maart 2022
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptine Sandoz 25 mg, filmomhulde tabletten
Sitagliptine Sandoz 50 mg, filmomhulde tabletten
Sitagliptine Sandoz 100 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 25 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 25 mg sitagliptin.
[Product name] 50 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 50 mg sitagliptin.
[Product name] 100 mg film-coated tablets
Each tablet contains sitagliptin hydrochloride monohydrate, equivalent
to 100 mg sitagliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
[Product name] 25 mg film-coated tablets
Round, pink film-coated tablet with engraved “25” on one side with
dimensions 6.2 ± 0.2 mm.
[Product name] 50 mg film-coated tablets
Round, light beige, film-coated tablet with engraved “50” on one
side with dimensions 8.0 ± 0.2 mm.
[Product name] 100 mg film-coated tablets
Round, beige, film-coated tablet with engraved “100” on one side
with dimensions 9.9 ± 0.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, [Product name] is
indicated to improve glycaemic
control: as monotherapy:
•
in patients inadequately controlled by diet and exercise alone and for
whom metformin is
inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
•
metformin when diet and exercise plus metformin alone do not provide
adequate glycaemic
control.
•
a sulphonylurea when diet and exercise plus maximal tolerated dose of
a sulphonylurea alone do
not provide adequate glycaemic control and when metformin is
inappropriate due to
contraindications or intolerance.
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Sitagliptine Sandoz
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