Jimandin 100 mg Filmdragerad tablett

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

sitagliptinfosfatmonohydrat

Dostupné z:

Medochemie Ltd

ATC kód:

A10BH01

INN (Medzinárodný Name):

sitagliptin phosphate monohydrate

Dávkovanie:

100 mg

Forma lieku:

Filmdragerad tablett

Zloženie:

sitagliptinfosfatmonohydrat 128,5 mg Aktiv substans

Typ predpisu:

Receptbelagt

Prehľad produktov:

Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 84 tabletter; Blister, 90 tabletter; Blister, 98 tabletter

Stav Autorizácia:

Godkänd

Dátum Autorizácia:

2017-08-18

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JIMANDIN 25 MG FILM-COATED TABLETS
JIMANDIN 50 MG FILM-COATED TABLETS
JIMANDIN 100 MG FILM-COATED TABLETS
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Jimandin is and what it is used for
2.
What you need to know before you take Jimandin
3.
How to take Jimandin
4.
Possible side effects
5.
How to store Jimandin
6.
Contents of the pack and other information
1.
WHAT JIMANDIN IS AND WHAT IT IS USED FOR
Jimandin 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 improve the levels of insulin 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.
2
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 di

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Jimandin 25 mg film-coated tablets
Jimandin 50 mg film-coated tablets
Jimandin 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Jimandin 25 mg film-coated tablet contains sitagliptin phosphate
monohydrate, equivalent to
25mg sitagliptin.
Each Jimandin 50 mg film-coated tablet contains sitagliptin phosphate
monohydrate, equivalent to 50
mg sitagliptin.
Each Jimandin 100 mg film-coated tablet contains sitagliptin phosphate
monohydrate, equivalent to
100 mg sitagliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg/tablet: Yellow round, biconvex film coated tablets, with
diameter approximately 6mm
50 mg/tablet: Pale red round, biconvex film coated tablets, with
diameter approximately 8mm
100 mg/tablet: Light brown, round, biconvex film coated tablets with
diameter approximately 10.3mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus, Jimandin 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. a 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.