Janeo 50 mg, filmomhulde tabletten

Šalis: Nyderlandai

kalba: olandų

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

Veiklioji medžiaga:

SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,68 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

INN (Tarptautinis Pavadinimas):

SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,68 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

Vaisto forma:

Filmomhulde tablet

Sudėtis:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Vartojimo būdas:

Oraal gebruik

Leidimo data:

2021-12-22

Pakuotės lapelis

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JANEO 50 MG, FILMOMHULDE TABLETTEN
JANEO 100 MG, FILMOMHULDE TABLETTEN
Sitagliptin
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 Janeo is and what it is used for
2.
What you need to know before you take Janeo
3.
How to take Janeo
4.
Possible side effects
5.
How to store Janeo
6.
Contents of the pack and other information
1.
WHAT JANEO IS AND WHAT IT IS USED FOR
Janeo 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 enough
insulin, and the
insulin that your body produces does not work as well as it should.
Your body can also
make too much sugar. When this happens, sugar (glucose) builds up in
the blood. This can
lead to serious medical problems like heart disease,

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Janeo 50 mg, filmomhulde tabletten
Janeo 100 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Janeo 50 mg film-coated tablets
Each film-coated tablet contains 50mg sitagliptin (as hydrochloride)
Janeo 100 mg film-coated tablets
Each film-coated tablet contains 100mg sitagliptin (as hydrochloride)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Janeo 50 mg film-coated tablets
Round, pink film-coated tablets, approx. 7.9 mm in diameter and 3.6 mm
thick, debossed with
“S16” on one side and “H” on the other side.
Janeo 100 mg film-coated tablets
Round, pink film-coated tablets, approx. 9.9 mm in diameter and 4.7 mm
thick, debossed with
“S15” on one side and “H” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, Janeo 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.
•
a peroxisome proliferator-activated receptor gamma (PPARγ) agonist
(i.e.
thiazolidinedione) when use of a PPARγ agonist is appropriate and
when diet and exercise
plus the PPARγ agonist alone do not provide adequate glycaemic
control.
as triple oral therapy in combination with
•
a sulphonylurea and metformin when diet and exercise plus dual therapy
with these
medicinal products do not provide adequate glycaemic control.
•
a PPARγ agonist and metformin when use of a PPARγ agonist is
appropriate and when
diet and exercise plus