Glubrava

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

metformin hydrochloride, pioglitazone hydrochloride

Saatavilla:

Takeda Pharma A/S

ATC-koodi:

A10BD05

INN (Kansainvälinen yleisnimi):

pioglitazone, metformin

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus, Type 2

Käyttöaiheet:

Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.After initiation of therapy with pioglitazone, 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, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

Tuoteyhteenveto:

Revision: 19

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2007-12-11

Pakkausseloste

27
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLUBRAVA 15 MG/850 MG FILM-COATED TABLETS
pioglitazone/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 Glubrava is and what it is used for
2.
What you need to know before you take Glubrava
3.
How to take Glubrava
4.
Possible side effects
5
How to store Glubrava
6.
Contents of the pack and other information
1.
WHAT GLUBRAVA IS AND WHAT IT IS USED FOR
Glubrava contains pioglitazone and metformin which are anti-diabetic
medicines, used to control
blood sugar level.
It is used in adults to treat type 2 (non-insulin dependent) diabetes
mellitus when treatment with
metformin alone is not sufficient. This type 2 diabetes usually
develops in adulthood particularly as a
result of the person being overweight and where the body either does
not produce enough insulin (a
hormone that controls blood sugar levels), or cannot effectively use
the insulin it produces.
Glubrava helps control the level of sugar in your blood when you have
type 2 diabetes by helping your
body make better use of the insulin it produces. If 3 to 6 months
after starting Glubrava your sugar
control is not improved, the medicine should be discontinued.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLUBRAVA
DO NOT TAKE GLUBRAVA
-
if you are allergic to pioglitazone, metformin or any of the other
ingredients of this medicine
(listed in section 6).
-
if you have heart failure or have had heart failure in the past.

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Glubrava 15 mg/850 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850
mg of metformin
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The tablets are white to off-white, oblong, film-coated, embossed
‘15 / 850’ on one face and ‘4833M’
on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glubrava is indicated as second line treatment of type 2 diabetes
mellitus adult patients, particularly
overweight patients, who are unable to achieve sufficient glycaemic
control at their maximally
tolerated dose of oral metformin alone.
After initiation of therapy with pioglitazone, patients should be
reviewed after 3 to 6 months to assess
adequacy of response to treatment (e.g. reduction in HbA
1c
). In patients who fail to show an adequate
response, pioglitazone should be discontinued. In light of potential
risks with prolonged therapy,
prescribers should confirm at subsequent routine reviews that the
benefit of pioglitazone is maintained
(see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Adults with normal renal function (GFR ≥ 90 mL/min)_
_ _
The recommended dose of Glubrava is 30 mg/day pioglitazone plus 1,700
mg/day of metformin
hydrochloride (this dose is achievable with one tablet of Glubrava 15
mg/850 mg, taken twice a day).
Dose titration with pioglitazone (added to the optimal dose of
metformin) should be considered before
the patient is switched to Glubrava.
When clinically appropriate, direct change from metformin monotherapy
to Glubrava may be
considered.
_Special populations _
_Elderly _
As metformin is excreted via the kidney, and elderly patients have a
tendency to decreased renal
function, elderly patients taking Glubrava should have their renal
function monitored regularly (see
sections 4.3 and