COMPETACT 15 MG 850 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

METFORMIN HYDROCHLORIDE; PIOGLITAZONE AS HYDROCHLORIDE

Beschikbaar vanaf:

TZAMAL BIO-PHARMA LTD

ATC-code:

A10BA02

farmaceutische vorm:

FILM COATED TABLETS

Samenstelling:

METFORMIN HYDROCHLORIDE 850 MG; PIOGLITAZONE AS HYDROCHLORIDE 15 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY

Therapeutische categorie:

METFORMIN

Therapeutisch gebied:

METFORMIN

therapeutische indicaties:

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 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.

Autorisatie datum:

2018-07-31

Bijsluiter

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
COMPETACT 15 MG/850 MG
FILM-COATED TABLETS
ACTIVE INGREDIENTS AND QUANTITIES:
Each tablet contains:
pioglitazone (as hydrochloride) 15 mg
metformin hydrochloride 850 mg
For information about inactive ingredients and allergens in this
medicine, see section 2 under
'Important information about some of this medicine’s ingredients',
and section 6 'Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
USE OF THIS MEDICINE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE
IS NOT
RECOMMENDED.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is intended for treating type 2 diabetes mellitus
(non-insulin dependent) in adults
with blood sugar levels that cannot be controlled with metformin
treatment alone.
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 properly 3 to 6 months after you
start taking it.
Competact helps control the level of sugar in your blood by helping
your body make better use
of the insulin it produces.
THERAPEUTIC GROUP:
Pioglitazone: a thiazolidinedione.
Metformin: a biguanide.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredients (pioglitazone
and metformin) or to any
of the other ingredients in this medicine (see section 6).
•
You have heart failure or have had heart failure in th

Productkenmerken

COMPETACT 15 MG/850 MG
Film-coated tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Competact 15 mg/850 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850
mg of metformin
hydrochloride.
Excipient with known effect:
Each tablet contains
5
-
3.3
mg of sodium.
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, convex, 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.
2
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 t