Ristaben
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
21-09-2023
Karatteristiċi tal-prodott
(SPC)
21-09-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
09-03-2015
Ingredjent attiv:
sitagliptin
Disponibbli minn:
Merck Sharp & Dohme B.V.
Kodiċi ATC:
A10BH01
INN (Isem Internazzjonali):
sitagliptin
Grupp terapewtiku:
Drugs used in diabetes
Żona terapewtika:
Diabetes Mellitus, Type 2
Indikazzjonijiet terapewtiċi:
For adult patients with type-2 diabetes mellitus, Ristaben 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;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Sommarju tal-prodott:
Revision: 27
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2010-03-15
Fuljett ta 'informazzjoni
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: I
NFO
RMATION FOR THE PATIENT
RISTABEN 25 MG FILM-
COATED TABLETS
RISTABEN 50 MG FILM-COATED TABLETS
RISTABEN 100 MG FILM-
COATED TABLETS
sitagliptin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORM
ATION FOR YOU.
-
Keep t
his leaflet. You may need to read it again.
-
If you ha
ve any furth
er 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, phar
macist, or nurse. This
includes any possible
side effects not listed in this leaflet.
See section 4.
WHAT IS I
N THIS LEAFLET
1.
What Ristaben is and what it is used for
2.
What you need to know b
efore you take Ristaben
3.
How to take Ristaben
4.
Possible
side effects
5.
How t
o store Ristaben
6.
Contents of the pack and other
information
1.
WHAT RISTABEN IS AND WHAT IT IS USED FOR
Ristaben contains the active substance
sitagliptin which is
a member of a class of medicines called
DPP-4 inhibi
tors (dipept
idyl peptidase
-4 inhib
itors) that lowers blood sugar levels in adult patients
with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produc
ed after a meal and d
ecreases the amount
of sugar made by the body.
Your
doctor has p
rescribed 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
oth
er medicine
s
(insu
lin, metformin, sulphonylureas, or glitazones) that l
ower blood s
ugar, which you may al
ready 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 bod
y d
oes not mak
e enoug
h insulin, and the insulin that
your body produces do
es not work
as well as it should.
Your body can also make too much sugar.
When this happens, sugar (glucose)
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ristaben 25 mg film-
coated tablets
Ristaben 50 mg film-
coated tablets
Ristaben 100 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ristaben 25 mg film-
coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent to
2
5
mg sitagliptin.
Ristaben 50 mg film-
coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent to
50
mg sitagliptin.
Ristaben 100 mg film-
coated tablets
Each 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 (tablet)
.
Ristaben 25 mg film-coated tablets
Round, pink film
-
coated tablet with “221” on one side.
Ritaben 50 mg film-
coated tablets
Round, light beige film
-
coated table
t with “112” on one side
.
Ristaben 100 mg film-
coated tablets
Round, beige f
ilm-
coated tablet with “277” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients w
ith type 2 diabetes mellitus, Ristaben is indicated to improve
glycaemic control:
as
monotherapy
:
•
in patients inadequately controlled by diet and exercise alone and for
whom metfo
rmin 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
t
olerated dose of a sulphonylurea alone do
not provide adequate glycaemic
co
ntrol and when metformin is inappropriate due to
contraindications or intolerance.
3
•
a
peroxisome proliferator
-
activated receptor gamma (PPAR
)
agonist (i.e. a thiazolidinedione)
whe
n use of a PPAR
agonist is appropriate and when diet and exercise plus t
he PPAR
agonist
alone do not provide adequate glycaemic control.
as triple oral therapy in combination with
:
•
a sulphonylurea and metformin when diet and ex
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