ACTOS 30 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PIOGLITAZONE AS HYDROCHLORIDE

متاح من:

TZAMAL BIO-PHARMA LTD

ATC رمز:

A10BG03

الشكل الصيدلاني:

TABLETS

تركيب:

PIOGLITAZONE AS HYDROCHLORIDE 30 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY

المجموعة العلاجية:

PIOGLITAZONE

المجال العلاجي:

PIOGLITAZONE

الخصائص العلاجية:

Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. as triple oral therapy in combination with- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance .

تاريخ الترخيص:

2018-03-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS
(PREPARATIONS) – 1986
THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
ACTOS
®
15 MG
ACTOS
®
30 MG
ACTOS
®
45 MG
TABLETS
TABLETS
TABLETS
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet contains:
Each tablet contains:
Each tablet contains:
pioglitazone (as HCl) 15 mg
pioglitazone (as HCl) 30 mg
pioglitazone (as HCl) 45 mg
For information about inactive ingredients and allergens in the
medicine, see section 2
“Important information about some of the ingredients of the
medicine” and section 6 -
“Additional information”.
The medicine contains lactose, see section 2
“SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE”
.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist.
This medicine has been prescribed for the treatment of your ailment.
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.
THE MEDICINE IS NOT INTENDED FOR CHILDREN AND ADOLESCENTS UNDER 18
YEARS OF AGE.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of type 2 diabetes
(non-insulin dependent) in
patients whose blood sugar level cannot be controlled by treatment
with metformin alone.
Actos is given as monotherapy in patients who are unable to take
metformin and whose
blood sugar level cannot be controlled by diet or exercise. Likewise,
Actos is also given in
combination with other medicines for treatment of diabetes (such as
metformin,
sulphonylurea or insulin) when adequate control of the blood sugar
level has not been
achieved.
Actos helps control blood sugar levels by improving the response of
the body cells to insulin
produced in the body.
THERAPEUTIC GROUP:
The medicine belongs to the group of thiazolidinediones for treatment
of diabetes.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE PREPARATION IF:
•
Ther

خصائص المنتج

PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Actos 15 mg
Actos 30 mg
Actos 45 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Actos 15 mg tablets _
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
_Excipient with known effect: _
Each tablet contains 92.87 mg of lactose monohydrate (see section
4.4).
_Actos 30 mg tablets _
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
_Excipient with known effect: _
Each tablet contains 76.34 mg of lactose monohydrate (see section
4.4).
_Actos 45 mg tablets _
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
_Excipient with known effect: _
Each tablet contains 114.51 mg of lactose monohydrate (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
_Actos 15 mg tablets _
The tablets are white to off-white, round, convex and marked ‘15’
on one face and ‘ACTOS’ on the
other face.
_Actos 30 mg tablets _
The tablets are white to off-white, round, flat and marked ‘30’ on
one face and ‘ACTOS’ on the
other face.
_Actos 45 mg tablets _
The tablets are white to off-white, round, flat and marked ‘45’ on
one face and ‘ACTOS’ on the
other face.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pioglitazone is indicated as second or third line treatment of type 2
diabetes mellitus as described
below:
as
MONOTHERAPY
-
in
adult
patients
(particularly
overweight
patients)
inadequately
controlled
by
diet
and
exercise for whom metformin is inappropriate because of
contraindications or intolerance
as
DUAL ORAL THERAPY
in combination with
-
metformin,
in
adult
patients
(particularly
overweight
patients)
with
insufficient
glycaemic
control despite maximal tolerated dose of monotherapy with metformin
-
a sulphonylurea, only in adult patients who show intolerance to
metformin or for whom
metformin is contraindicated, with insufficient glycaemic control
despite maximal tolerated dose of
monotherapy with a sulphonylurea.
as
TRIPLE ORAL THERAPY
in combination with
-
metformin
and
a