Ristaben

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

sitagliptin

זמין מ:

Merck Sharp & Dohme B.V.

קוד ATC:

A10BH01

INN (שם בינלאומי):

sitagliptin

קבוצה תרפויטית:

Drugs used in diabetes

איזור תרפויטי:

Diabetes Mellitus, Type 2

סממני תרפויטית:

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.

leaflet_short:

Revision: 27

מצב אישור:

Authorised

תאריך אישור:

2010-03-15

עלון מידע

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)

מאפייני מוצר

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