COMPETACT 15 MG 850 MG

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

METFORMIN HYDROCHLORIDE; PIOGLITAZONE AS HYDROCHLORIDE

Inapatikana kutoka:

ABIC MARKETING LTD, ISRAEL

ATC kanuni:

A10BA02

Dawa fomu:

FILM COATED TABLETS

Tungo:

METFORMIN HYDROCHLORIDE 850 MG; PIOGLITAZONE AS HYDROCHLORIDE 15 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

TAKEDA PHARMA A/S, DENMARK

Eneo la matibabu:

METFORMIN

Matibabu dalili:

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.

Idhini ya tarehe:

2019-11-12

Taarifa za kipeperushi

•
يف لكاشم كيدل تناك اذإ وأ انسم تنك اذإ
رثكأ ةبيرق نايحأ يف( ،لقلأا ىلع ،ةنسلا
يف ةرم بيبطلا كنم بلطي فوس
.داتعملاك نلامعت كاتيلك تناك اذإ
ةفرعمل صحف ءارجإ )ىلكلا ىلعأ ةعرج تلوانت اذإ
ىلإ هجوت ،ءاودلا نم ةيمك لفط وأ أطخلا
قيرط نع رخآ صخش علتبا اذإ وأ أطخلا قيرط
نع ةطرفم ةعرج تلوانت اذإ
.كعم ءاودلا ةوبع ا
ً
بحطصم ،ا
ً
روف ىفشتسملل ةعباتلا ئراوطلا ةفرغ ىلإ
وأ بيبطلا
نأ نسحتس
ُ
ي .ركسلا لوانت للاخ نم هعفر كنكمي ،كلذ
ثدح اذإ ،ميلسلا ىوتسملا نود كمد يف
ركسلا ىوتسم ضفخني دق
.ولحلا ةهكافلا ريصع وأ ،تيوكسبلا
،تايولحلا ،ركسلا صارقأ ضعب كعم ذخأت
ضامحلل ضرعتلا رطخ" - 2 دنبلا رظنا(
يكيتكلالا ضامحلاب باصت دق ،تكاتيپموك
نم ةطرفم ةعرج تلوانت اذإ
.)"يكيتكلالا ءاودلا لوانت تيسن اذإ
لوانتو ،ةيسنملا ةعرجلا ىطخت ،ةعرج
لوانت تيسن اذإ ،اذه مغر .بيبطلا ةيصوتل
اعبت ايموي تكاتيپموك لوانت كيلع
.اهت
ّ
وف يتلا ةعرجلا نع اضيوعت ةفعاضم ةعرج
لوانت عنم
ُ
ي .داتعملاك ةيلاتلا ةعرجلا
.بيبطلا ةيصوتل ا
ً
قفو جلاعلا ىلع ةبظاوملا كيلع ءاودلا لامعتسا نع تفقوت اذإ
.كمد يف ركسلا ىوتسم عفتري فوس
،تكاتيپموك لوانت نع تفقوت اذإ .يغبني
امك لمعي يكل ايموي تكاتيپموك لوانت
كيلع
.جلاعلا اذه فاقيإ لبق كبيبط رشتسا .ءاود اهيف لوانتت ة
ّ
رم
ّ
لك يف ة
ّ
يئاودلا ةعرجلا نمو ءاودل�

Tabia za bidhaa

Competact 15mg/850mg MF 05/2019 Certification
COMPETACT 15 MG/850 MG
Film-coated tablets
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Excipient with known effect:
Each tablet contains
3.3-5
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).
Competact 15mg/850mg MF 05/2019 Notification
2
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