Incresync

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

alogliptin, pioglitazone

Διαθέσιμο από:

Takeda Pharma A/S

Φαρμακολογική κατηγορία (ATC):

A10BD09

INN (Διεθνής Όνομα):

alogliptin, pioglitazone

Θεραπευτική ομάδα:

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

Θεραπευτική περιοχή:

Diabetes Mellitus, Type 2

Θεραπευτικές ενδείξεις:

Incresync is indicated as a second- or third-line treatment in 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 (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. , In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination. After initiation of therapy with Incresync, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).,

Περίληψη προϊόντος:

Revision: 13

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-09-19

Φύλλο οδηγιών χρήσης

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INCRESYNC 12.5 MG/30 MG FILM-COATED TABLETS
INCRESYNC 25 MG/30 MG FILM-COATED TABLETS
INCRESYNC 25 MG/45 MG FILM-COATED TABLETS
alogliptin/pioglitazone
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 Incresync is and what it is used for
2.
What you need to know before you take Incresync
3.
How to take Incresync
4.
Possible side effects
5.
How to store Incresync
6.
Contents of the pack and other information
1.
WHAT INCRESYNC IS AND WHAT IT IS USED FOR
WHAT INCRESYNC IS
Incresync contains two different medicines called alogliptin and
pioglitazone 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.
-
pioglitazone belongs to a group of medicines called
thiazolidinediones. It helps your body make
better use of the insulin it produces.
Both of these groups of medicines are “oral anti-diabetics”.
WHAT INCRESYNC IS USED FOR
Incresync 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.
Incresync is taken when your blood sugar cannot be adequately
controlled by diet, exercise and other
oral anti-diabetic medicines such as pioglitazone; or pioglitazone and
metformin taken together. Your
doctor will check whether Incresync is working 3 to 6 months afte

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Incresync 12.5 mg/30 mg film-coated tablets
Incresync 25 mg/30 mg film-coated tablets
Incresync 25 mg/45 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Incresync 12.5 mg/30 mg film-coated tablets
Each tablet contains alogliptin benzoate and pioglitazone
hydrochloride equivalent to 12.5 mg
alogliptin and 30 mg pioglitazone.
_Excipient(s) with known effect_
Each tablet contains 121 mg of lactose (as monohydrate).
Incresync 25 mg/30 mg film-coated tablets
Each tablet contains alogliptin benzoate and pioglitazone
hydrochloride equivalent to 25 mg alogliptin
and 30 mg pioglitazone.
_Excipient(s) with known effect_
Each tablet contains 121 mg of lactose (as monohydrate).
Incresync 25 mg/45 mg film-coated tablets
Each tablet contains alogliptin benzoate and pioglitazone
hydrochloride equivalent to 25 mg alogliptin
and 45 mg pioglitazone.
_Excipient(s) with known effect_
Each tablet contains 105 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Incresync 12.5 mg/30 mg film-coated tablets
Pale peach, round (approximately 8.7 mm in diameter), biconvex,
film-coated tablets with both “A/P”
and “12.5/30” printed in red ink on one side.
Incresync 25 mg/30 mg film-coated tablets
Peach, round (approximately 8.7 mm in diameter), biconvex, film-coated
tablets with both “A/P” and
“25/30” printed in grey ink on one side.
Incresync 25 mg/45 mg film-coated tablets
Red, round (approximately 8.7 mm in diameter), biconvex, film-coated
tablets with both “A/P” and
“25/45” printed in grey ink on one side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Incresync is indicated as a second or third line treatment in 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 (particularly
overweight patients) inadequately controlled on pio