Competact

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

pioglitazone, metformin hydrochloride

Saatavilla:

CHEPLAPHARM Arzneimittel GmbH

ATC-koodi:

A10BD05

INN (Kansainvälinen yleisnimi):

pioglitazone, metformin

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus, Type 2

Käyttöaiheet:

Competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.

Tuoteyhteenveto:

Revision: 21

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-07-28

Pakkausseloste

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COMPETACT 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 Competact is and what it is used for
2.
What you need to know before you take Competact
3.
How to take Competact
4.
Possible side effects
5
How to store Competact
6.
Contents of the pack and other information
1.
WHAT COMPETACT IS AND WHAT IT IS USED FOR
Competact contains pioglitazone and metformin. It is an anti-diabetic
medicine 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. Your doctor will check whether
Competact is working 3 to 6 months after you start taking it.
Competact 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COMPETACT
DO NOT TAKE COMPETACT
-
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.
-
if you recently had a heart attack, have severe circulatory problems
including shock, or
b

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Competact 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
Competact 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 Competact is 30 mg/day pioglitazone plus 1,700
mg/day of metformin
hydrochloride (this dose is achievable with one tablet of Competact 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 Competact.
When clinically appropriate, direct change from metformin monotherapy
to Competact 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 Competact should have their renal
function monitored regularly (see
sections 4.3 and 4.4).
3
Physicians should start tre