Tesavel

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

sitagliptin

Beschikbaar vanaf:

Merck Sharp & Dohme B.V.

ATC-code:

A10BH01

INN (Algemene Internationale Benaming):

sitagliptin

Therapeutische categorie:

Drugs used in diabetes

Therapeutisch gebied:

Diabetes Mellitus, Type 2

therapeutische indicaties:

For patients with type-2 diabetes mellitus, Tesavel 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 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 witha sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control;a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.

Product samenvatting:

Revision: 28

Autorisatie-status:

Authorised

Autorisatie datum:

2008-01-10

Bijsluiter

32
B.
PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORM
ATION
FOR THE PATIENT
TESAVEL 25 MG FILM-
COATED TABLETS
TESAVEL 50 MG FILM-COATED TABLETS
TESAVEL 100 MG FILM-COATED TABLETS
sitagliptin
READ ALL OF THIS LEAFLET CAREFULLY B
EFORE YOU START TA
KING 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 doct
or, pharmacist, or nurse.
-
This medicine has been prescribed for you
only. Do not pass it
on to others. It may
harm them,
e
ven if their s
igns of illness
are the same as yours.
-
If you get
any side effects
, tal
k to your doc
tor, pharma
cist, or nurse. This incl
udes any possible
side effects
not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tesavel is an
d what it is used for
2.
What you need to know b
efore you take
Tesavel
3.
How to take
Tesavel
4.
Possible
side effects
5.
How to store
Tesavel
6.
Contents of the pack and other
information
1.
WHAT TESAVEL IS AND WHAT IT IS USED FOR
Tesavel contains the
active substance sitagliptin which
is a member of a class of med
i
cines called
DPP-4 in
hibitors (dip
eptidyl peptidase-
4 inhibitors) that
lowers bl
ood sugar level
s 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 sugar
made by the body.
Y
our doctor ha
s prescribed
this medicine
to help lower your
blood sugar, wh
ich is too high
because of
your type
2 diabetes.
This medicine
can be used alone or i
n combinati
on with certain other medicines
(insulin, metformin, sulphonylur
e
as, or glitazones) th
at lower bloo
d suga
r, which you may already be
taking for y
our diabetes to
gether with a fo
od and exercise plan.
What is type 2 diabetes?
Type
2 diabetes is a
condition i
n which your body does not make enough insulin, and the insulin
that
your body produce
s does not wo
rk as
well as it should. Your body c
an also ma
ke too much sug
ar.
When this ha
ppens, sugar (glucose

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tesavel 25 mg film-
coated tablet
s
Tesavel 50 mg film-
coated tablet
s
Tesavel 100 mg film-
coated tablet
s
2.
QUALITATIV
E AND QUANTITATIVE COMPOSIT
ION
Tesavel 25 mg film-
coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent to
25
mg sitagliptin.
Tesavel 50 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent
to 50
mg sitagliptin
.
Tesavel 100 mg film-
coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent to
100
mg sitagliptin
.
For the full list of
excipients, s
ee section 6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet
(tablet).
Tesavel 25 mg film-coated tablets
Rou
nd, pink film
-
coated tablet with “221” on one side.
Tesavel 50 mg film-
coated tablets
Round, light beige film
-
coated table
t with “112” on one side
.
Tesavel 100 mg film-
coated tablets
Round, beige f
ilm-
coated tablet wi
th “277” on one side.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type
2 diabetes mellitus,
Tesavel
is indicated to improve glycaemic control:
as monotherapy:
•
in patients inadequately controlled by diet and exercise
alone and for whom metformin is
inapp
ropriate due to contraindications or intolerance.
as dual oral
t
herapy in combination with
:
•
metformin when diet and exercise plus metformin alone d
o not provide adequate glycaemic
control.
•
a sulphonylurea when diet and
exercise plus
maximal tolerated do
se 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 proliferator
-
activated receptor gamma (
PPAR

)
agonist (i.e.
a thiazolidine
dione)
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 thera
py in combination with
:
•
a sulphonylurea and metformin when diet and ex