Velmetia

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sitagliptin, metformin hydrochloride

Available from:

Merck Sharp & Dohme B.V.

ATC code:

A10BD07

INN (International Name):

sitagliptin, metformin

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

For patients with type-2 diabetes mellitus:Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Velmetia is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Velmetia is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.Velmetia is also indicated as add on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.

Product summary:

Revision: 37

Authorization status:

Authorised

Authorization date:

2008-07-16

Patient Information leaflet

37
B. PACKAG
E LEAFLET
38
PACKAGE LEAF
LET: INFORMATION FOR THE PATIENT
VELMETIA 50 MG/850
MG FILM-
COATED TABLETS
VELMETIA 50 MG/1,000
MG FILM-COATED TABLETS
sitaglipti
n/metformin
hydrochloride
READ ALL
OF THIS LEAFL
ET CA
REFULLY BEFORE Y
OU START
TAKING THIS MED
ICINE BECAUSE IT CONTAINS
IMPORTANT INF
ORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you h
ave any further questions, ask
your doctor
, pha
rmacist, or nurse.
-
This medicine has
been prescri
bed f
or you only. Do
not pass
it on to others
. It may harm them,
even if their signs
of illness are the same a
s yours.
-
If you get any side effects, talk to your
doctor, pharmacist or nurse.
This include
s any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Velmetia is a
nd what it is used f
or
2.
What you need to kno
w before yo
u take Velmetia
3.
How to take Velmetia
4.
Possible side effects
5.
How to store Velmetia
6.
Contents of t
he pack and othe
r information
1.
WHAT VELMETIA IS AND WHA
T IT IS USED FO
R
Velmetia contain
s two different medi
cines called sitagliptin a
nd metformi
n.
•
sitagliptin belongs to a class of me
dicines called DPP
-4 inhibitors (dipeptidyl
peptidase-4 inhibitors)
•
metformin belon
gs to a class
of m
edicines called
biguanides.
They work t
ogether to control
blood sugar levels i
n adult patients with a fo
rm of diabetes called
‘
type 2 diabetes mell
itus’.
This medicine helps to
increase the levels of insulin produced after a meal
and low
ers the amoun
t of
sugar made by yo
ur body.
Along with die
t and exercise, thi
s medicine helps lower your blood sugar.
This medicine can be used
alone or with certain other medicines for diabetes (insulin,
sulphonylureas,
or glitazones)
.
What is type 2 diabetes?
Type 2 diab
etes is a condit
ion in wh
ich your body d
oes not make enough
insulin, and the in
sulin that
your body produ
ces does no
t work as well as it should. Your body
can also make too much sugar.
When this ha
ppens
, sugar (glucose) bu
ilds

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MED
ICINAL PRODUCT
Velmetia 50 mg/850 mg film-
coated tablets
Velmetia 50 mg/1,000 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Velmetia 50 mg/850 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate
equivalent to 50
mg of sitagliptin and 850
mg
of metf
ormin hydrochloride.
Velmetia 50 mg/1,000 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate
equivalent to 50
mg of sitagliptin and
1,000 mg of metf
ormin hydrochloride.
For the full li
st of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet (tablet).
Velmetia 50 mg/850 mg film-coated tablets
Capsule-sh
aped, pink film
-coated tablet with
“515” debossed on one side.
Velmetia 50 mg/1,000 mg film-coated tablets
Capsule-shaped, red film-
coated tablet with “
577
” debossed on one side
.
4.
CLINIC
AL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult
patients with type
2 diabetes mellit
us:
Velmetia
is indicated as an adjunct to diet and exercise to improve glycaemic
cont
rol in patients
inadequately controlled on their maximal tolerated dose of m
et
formin alone or those already being
treated with
the combination of
sitagliptin and
metformin.
Velmetia
is indicated in combination with a sulphonylurea (i.e., triple
combinatio
n t
herapy) as an
adjunct to diet and exercise in patients inadequately contr
ol
led on their maximal tolerated dose of
metformin and a sulphonylurea.
Velmetia is indicated as
triple combination therapy with a
peroxisome proliferator
-
activated receptor
gamma (PPAR

)
agonist (i.e., a thiazolidinedione) as an adjunct to diet and exerc
is
e in patients
inadequately controlled on their maximal tolerated dose of metformin
and a PP
AR

agonist.
Velmetia
is also indicated as add
-
on to insulin (i.e., triple combinatio
n t
herapy) as an adjunct to diet
and exercise to improve glycaemic control i
n
patients when stable
dose
of insulin and metformin alone
do not provide adequate glyca