Vipidia

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

alogliptin

Διαθέσιμο από:

Takeda Pharma A/S

Φαρμακολογική κατηγορία (ATC):

A10BH04

INN (Διεθνής Όνομα):

alogliptin benzoate

Θεραπευτική ομάδα:

Drugs used in diabetes, Dipeptidyl peptidase 4 (DPP-4) inhibitors

Θεραπευτική περιοχή:

Diabetes Mellitus, Type 2

Θεραπευτικές ενδείξεις:

Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Περίληψη προϊόντος:

Revision: 10

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-09-18

Φύλλο οδηγιών χρήσης

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIPIDIA 25 MG FILM-COATED TABLETS
VIPIDIA 12.5 MG FILM-COATED TABLETS
VIPIDIA 6.25 MG FILM-COATED TABLETS
alogliptin
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 Vipidia is and what it is used for
2.
What you need to know before you take Vipidia
3.
How to take Vipidia
4.
Possible side effects
5.
How to store Vipidia
6.
Contents of the pack and other information
1.
WHAT VIPIDIA IS AND WHAT IT IS USED FOR
Vipidia contains the active substance alogliptin which belongs to a
group of medicines called DPP-4
inhibitors (dipeptidyl peptidase-4 inhibitors) which are “oral
anti-diabetics”. It 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.
Vipidia works to increase the levels of insulin in the body after a
meal and decrease the amount of
sugar in the body. It must be taken together with other anti-diabetic
medicines, which your doctor will
have prescribed for you, such as sulphonylureas (e.g. glipizide,
tolbutamide, glibenclamide),
metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin
and/or insulin.
Vipidia is taken when your blood sugar cannot be adequately controlled
by diet, exercise and one or
more of these other oral anti-diabetic medicines. It is important that
you continue to take your other
anti-diabetic medicine, and continue to follow the advice on diet and
exercise that your nurse or doctor
has given yo

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vipidia 6.25 mg film-coated tablets
Vipidia 12.5 mg film-coated tablets
Vipidia 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vipidia 6.25 mg film-coated tablets
Each tablet contains alogliptin benzoate equivalent to 6.25 mg
alogliptin.
Vipidia 12.5 mg film-coated tablets
Each tablet contains alogliptin benzoate equivalent to 12.5 mg
alogliptin.
Vipidia 25 mg film-coated tablets
Each tablet contains alogliptin benzoate equivalent to 25 mg
alogliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Vipidia 6.25 mg film-coated tablets
Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex,
film-coated tablets with
“TAK” and “ALG-6.25” printed in grey ink on one side.
Vipidia 12.5 mg film-coated tablets
Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex,
film-coated tablets with
“TAK” and “ALG-12.5” printed in grey ink on one side.
Vipidia 25 mg film-coated tablets
Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex,
film-coated tablets with
“TAK” and “ALG-25” printed in grey ink on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vipidia is indicated in adults aged 18 years and older with type 2
diabetes mellitus to improve
glycaemic control in combination with other glucose lowering medicinal
products including insulin,
when these, together with diet and exercise, do not provide adequate
glycaemic control (see
sections 4.4, 4.5 and 5.1 for available data on different
combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
For the different dose regimens, Vipidia is available in strengths of
25 mg, 12.5 mg and 6.25 mg
film-coated tablets.
3
_Adults (≥ 18 years old) _
The recommended dose of alogliptin is one tablet of 25 mg once daily
as add-on therapy to metformin,
a thiazolidinedione, a sulphonylurea, or insulin or as triple therapy
with metformin and a
thiazo