JANECLUC 50 mg/850 mg filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

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

Aktiva substanser:

METFORMINEHYDROCHLORIDE 850 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 662,7 mg/stuk ; SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

INN (International namn):

METFORMINEHYDROCHLORIDE 850 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 662,7 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)) ; MACROGOL 3350 ; NATRIUMLAURILSULFAAT ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 90 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; MACROGOL 3350 ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 90 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Administreringssätt:

Oraal gebruik

Tillstånd datum:

2021-12-21

Bipacksedel

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

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
JANECLUC 50 mg/850 mg filmomhulde tabletten
JANECLUC 50 mg/1000 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The following information applies solely to product JANECLUC 50 mg/850
mg
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin
and 850 mg of metformin hydrochloride.
The following information applies solely to product JANECLUC 50
mg/1000 mg
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).
The following information applies solely to product JANECLUC 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.
The following information applies solely to product JANECLUC 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.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
JANECLUC
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.
JANECLUC
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.
JANECLUC
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