Xelevia

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sitagliptin

Available from:

Merck Sharp & Dohme B.V.

ATC code:

A10BH01

INN (International Name):

sitagliptin

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

For adult patients with type-2 diabetes mellitus, Xelevia 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.Xelevia 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.

Product summary:

Revision: 39

Authorization status:

Authorised

Authorization date:

2007-03-21

Patient Information leaflet

23
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON
1.
NAME OF THE
MEDICINAL PRODUCT
Xelevia 25 mg film-
coated tablets
sitagliptin
2.
STATEMENT OF ACTIVE
SUBSTANCE(S)
Each tablet contains sitagliptin phosphate monohydrate equivalent
to 25 mg
of sitagliptin.
3.
LIST OF EXCIPIENTS
4.
PHARMACEU
TICAL
FORM AND CONTENT
S
14 film-coated tablets
28 film-coated tablets
30 film-coated tablets
56 film-coated tablets
84 film-
coated tablets
90 film-
coated tablets
98 film-
coated tablets
50 x 1 film-coated tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read
the package leaf
let before use.
Oral use.
6.
SPECIAL
WARNING THAT THE MEDI
CINAL PRODUCT MUST BE STORED O
UT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of childr
en.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
9.
SPECIAL STO
RAGE CONDITIONS
Store below 25
°C.
24
10.
SPECIAL PREC
AUTION
S FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WAS
TE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.
NAME AND ADDRESS
OF THE MARKETING AUTHORISATION HO
LDER
Merck Sharp & Dohme B.V.
Waarderweg 3
9
2031 BN Haarlem
The Netherlands
12.
M
ARKETING AUTHORISATION NUMBER(S)
EU/1/07/382/001
14 film-
coated tablets
EU/1/07/382/002 28 film
-
coated tablets
EU/1/07/382/019
30 film-c
oated tablets
EU/1/07/382/003 56
film-c
oated tablets
EU/1/07/382/004 84 film
-
coated tablets
EU/1/07
/382/020 90
film-c
oated tablets
EU/1/07/382/005 98 film
-coated tablets
EU/1/07/382/006 50 x 1 film
-
coated tablets
13.
BATCH NUMBER
Lot
14.
GENERAL CLASS
IFICATION FOR SUPPLY
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
Xelevia 25 mg
17.
UN
IQUE IDENTIF
IER
–
2D BARCODE
2D barcode carrying the unique identif
ier included.
18.
UNIQUE IDENTIFIER
-
HUMAN READABLE DATA
PC
SN
NN
25
MINIMUM PARTIC
ULARS TO APPEAR ON BLISTERS OR ST
RIPS
BLISTERS
1.
NAME OF THE MEDICINAL P
RODUCT
Xelevia 25 mg tablets
sitagliptin
2.
NAME OF THE MARKETING AUTHORISATION HOLD
ER
MSD
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
OTHER
26
PARTICULARS TO A
PPEAR ON
THE O

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xelevia 25 mg film-
coated tablets
Xelevia 50 mg film-
coated tablets
Xelevia 100 mg film-
coated tablets
2.
QUALITATIV
E AND QUANTITATIVE COMPOSITION
Xelevia 25 mg film-
coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent to
25
mg sitagliptin.
Xelevia 50 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate, equivalent
to 50
mg sitagliptin
.
Xelevia 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).
Xelevia 25 mg film-
coated tablets
Rou
nd, pink film
-
coated tablet with “221” on one side.
Xelevia 50 mg film-
coated tablets
Round, light beige film
-
coated table
t with “112” on one side
.
Xelevia 100 mg film-
coated tablets
Round, beige f
ilm-
coated tablet wi
th “277” on one side.
4.
CLINICAL P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients w
ith type
2 diabetes mellitus,
Xelevia
is indicated to improve glycaemic control:
as monotherapy:
•
in patients inadequately controlled by diet and exercise al
one and
for whom metform
in is
inappro
priate 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 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 proliferator
-
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 thera
py in combination with
:
•
a sulphonylurea and metformin when diet and exe