Januvia

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

sitagliptin

Διαθέσιμο από:

Merck Sharp and Dohme B.V

Φαρμακολογική κατηγορία (ATC):

A10BH01

INN (Διεθνής Όνομα):

sitagliptin

Θεραπευτική ομάδα:

Drugs used in diabetes

Θεραπευτική περιοχή:

Diabetes Mellitus, Type 2

Θεραπευτικές ενδείξεις:

For adult patients with type-2 diabetes mellitus, Januvia 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;a 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.Januvia 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.

Περίληψη προϊόντος:

Revision: 32

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2007-03-20

Φύλλο οδηγιών χρήσης

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INF
ORMATION FOR THE PATIENT
JANUVIA 25 MG FILM-
COATED TABLETS
JANUVIA 50 MG FILM-
COATED TABLETS
JANUVIA 100 MG FILM-
COATED TABLETS
sitagliptin
READ ALL OF THIS LEAFL
ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONT
AINS
I
MPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may
need to read it again.
-
If you have a
ny fur
ther questions, ask your doctor, pharmacist, or nurse.
-
This medicine has
been prescri
bed for you only. Do not pass it on to others. It may harm them,
even if
their signs of illn
ess
are the same as yours.
-
If you get
any side effects, talk to your doct
or, ph
armacist, or nurse. This includes any possible
side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Januvia is and
what
it is used for
2.
What y
ou need to know before you take J
anuvia
3.
How to take Januvia
4.
Possible
side effects
5.
How to store Januvia
6.
Contents of the pack and other in
formation
1.
WHAT
JANUVIA IS
AND WHAT IT IS USED FOR
Januvia
contains the a
ctive
substance sitaglipti
n which is
a member of a class of med
icines called
DPP-
4 inhibitors (dipe
ptidyl 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 suga
r made by the body.
Your doctor ha
s pres
cribed this medicine to help lower your blood sugar, which is too high
be
cause of
you
r type 2 diabetes. This medicine
can be
used alone or in combinati
on wit
h certain other medi
cines
(insulin, metformin, sulphonylu
reas, or glitazones) that lower bloo
d suga
r, 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 i
n whic
h your body does not
mak
e enough insulin, and the insulin
that
your body produces does not wo
rk as
well as it should. Your body can also make too much sugar.
When this happ
ens, sugar (
glucose) bu

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Januvia 25 mg film-
coated tablets
Januvia 50 mg film-
coated tablets
Januvia 100 mg film-
coated tablets
2.
QUALITATIV
E AND QUANTITATIVE COMPOSITION
Januvia 25 mg film-
coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent to
25
mg sitagliptin.
Januvia 50 mg film-coated tablets
Each tablet conta
ins sitagliptin phosphate monohydrate, equivalent
to 50
mg sitagliptin
.
Januvia 100 mg film-
coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent to
100
mg sitagliptin
.
F
or the full list of
excipients, se
e section 6.1.
3.
PH
ARMACEUTICAL
FORM
Film-
coated tablet (tablet).
Januvia 25 mg film-
coated tablets
Rou
nd, pink film
-
coated tablet with “221” on one side.
Januvia 50 mg film-
coated tablets
Round, light beige film
-
coated table
t with “112” on one side
.
Januvia 100 mg film-
coated tablets
Round, beige f
ilm-
coated tablet wi
th “277” on one side.
4.
CLINICAL PA
RTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients w
ith type
2 diabetes mellitus, Januvia is indicated to improve glycaemic
control:
as monotherapy:
•
in patient
s inadequately controlled by diet and exercise al
one and
for whom metform
in is
inapprop
riate due to contraindications or intolerance.
as dual oral
t
herapy 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
nt
rol and when metformin is inappropriate due to
contraindications or intolerance.
3
•
a
peroxisome proliferato
r-
activated receptor gamma (PPAR

) agonist (i.e.
a thiazolidinedione)
when use of a PPAR

agonist is appropriate and when diet and exercise plus the
PPAR

agonist
alone do not provide adequate glycaemic control.
as triple oral therap
y in combination with
:
•
a sulphonylurea and metformin when diet and