Vipdomet

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

alogliptin benzoate, metformin hydrochloride

Διαθέσιμο από:

Takeda Pharma A/S

Φαρμακολογική κατηγορία (ATC):

A10BD13

INN (Διεθνής Όνομα):

alogliptin, metformin

Θεραπευτική ομάδα:

Drugs used in diabetes, Combinations of oral blood glucose lowering drugs

Θεραπευτική περιοχή:

Diabetes Mellitus, Type 2

Θεραπευτικές ενδείξεις:

Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus:as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin;in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone;in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.

Περίληψη προϊόντος:

Revision: 11

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-09-18

Φύλλο οδηγιών χρήσης

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIPDOMET 12.5 MG/850 MG FILM-COATED TABLETS
VIPDOMET 12.5 MG/1000 MG FILM-COATED TABLETS
alogliptin/metformin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 doctor or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vipdomet is and what it is used for
2.
What you need to know before you take Vipdomet
3.
How to take Vipdomet
4.
Possible side effects
5.
How to store Vipdomet
6.
Contents of the pack and other information
1.
WHAT VIPDOMET IS AND WHAT IT IS USED
FOR
WHAT VIPDOMET IS
Vipdomet contains two different medicines called alogliptin and
metformin in one tablet:
-
alogliptin belongs to a group of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4
inhibitors). Alogliptin works to increase the levels of insulin in the
body after a meal and
decrease the amount of sugar in the body.
-
metformin belongs to a group of medicines called biguanides which also
help to lower blood
sugar by lowering the amount of sugar made in the liver and helping
insulin to work more
effectively.
Both of these groups of medicines are “oral anti-diabetics”.
WHAT VIPDOMET IS USED FOR
Vipdomet is used to lower blood sugar levels in adults with type 2
diabetes. Type 2 diabetes is also
called non-insulin-dependent diabetes mellitus or NIDDM.
Vipdomet is taken when your blood sugar cannot be adequately
controlled by diet, exercise and other
anti-diabetic medicines such as metformin alone; insulin alone; or
metformin and pioglitazone taken
together.
If you are already taking both aloglipti

Αρχείο Π.Χ.Π.

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vipdomet 12.5 mg/850 mg film-coated tablets
Vipdomet 12.5 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vipdomet 12.5 mg/850 mg film-coated tablets
Each tablet contains alogliptin benzoate equivalent to 12.5 mg
alogliptin and 850 mg metformin
hydrochloride.
Vipdomet 12.5 mg/1,000 mg film-coated tablets
Each tablet contains alogliptin benzoate equivalent to 12.5 mg
alogliptin and 1000 mg metformin
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Vipdomet 12.5 mg/850 mg film-coated tablets
Light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide),
biconvex, film-coated tablets
with “12.5/850” debossed on one side and “322M” debossed on
the other side.
Vipdomet 12.5 mg/1,000 mg film-coated tablets
Pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide),
biconvex, film-coated tablets
with “12.5/1000” debossed on one side and “322M” debossed on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vipdomet is indicated in the treatment of adult patients aged 18 years
and older with type 2 diabetes
mellitus:
-
as an adjunct to diet and exercise to improve glycaemic control in
adult patients, inadequately
controlled on their maximal tolerated dose of metformin alone, or
those already being treated
with the combination of alogliptin and metformin.
-
in combination with pioglitazone (i.e. triple combination therapy) as
an adjunct to diet and
exercise in adult patients inadequately controlled on their maximal
tolerated dose of metformin
and pioglitazone.
-
in combination with insulin (i.e. triple combination therapy) as an
adjunct to diet and exercise to
improve glycaemic control in patients when insulin at a stable dose
and metformin alone do not
provide adequate glycaemic control.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
For the different dose regimens Vipdomet is available in str