PIOGLITAZONE SANDOZ pioglitazone (as hydrochloride) 30mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

pioglitazone hydrochloride, Quantity: 33.07 mg

זמין מ:

Sandoz Pty Ltd

INN (שם בינלאומי):

Pioglitazone hydrochloride

טופס פרצבטיות:

Tablet, uncoated

הרכב:

Excipient Ingredients: magnesium stearate; lactose monohydrate; carmellose calcium; hyprolose

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

28

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise: as monotherapy; as dual therapy to improve glycaemic control: in combination with metformin or sulfonylurea, in combination with insulin; as triple therapy to improve glycaemic control: in combination with metformin and sulfonylurea.

leaflet_short:

Visual Identification: white, round tablet, with imprint "PGT 30" on one side and with score line on both sides; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

מצב אישור:

Licence status A

תאריך אישור:

2011-02-18

עלון מידע

PIOGLITAZONE SANDOZ
®
1
PIOGLITAZONE SANDOZ
®
_pioglitazone hydrochloride tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Pioglitazone Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you taking this medicine
against the benefits it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PIOGLITAZONE
SANDOZ IS USED
FOR
Pioglitazone Sandoz helps to control
the level of glucose in your blood
when you have type 2 diabetes. This
is the 'adult onset' type of diabetes
and is controlled by diet, certain oral
medications and occasionally insulin.
This medicine is used:
•
to improve the action of the
body's naturally produced insulin.
•
in the management of type 2
diabetes not controlled by diet.
•
alone (when diet and exercise is
not enough to treat your diabetes)
or together with other anti-
diabetic medicines.
It contains the active ingredients
Pioglitazone hydrochloride.
Pioglitazone hydrochloride belongs
to a group of medicines called
glitazones.
It works by decreasing insulin
resistance.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
The use of Pioglitazone Sandoz has
not been studied in children.
BEFORE YOU TAKE
PIOGLITAZONE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
Pioglitazone hydrochloride, the
active ingredient, or to any of the
other ingredients listed at the end
of this leaflet under Product
Description.
•
any other similar medicines
(Rosiglitazone maleate).
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•

מאפייני מוצר

190108-pioglitazone-sandoz-pi
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
PIOGLITAZONE SANDOZ
® (PIOGLITAZONE HYDROCHLORIDE) TABLETS
1.
NAME OF THE MEDICINE
Pioglitazone hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pioglitazone Sandoz 15 mg tablets contains 16.535 mg pioglitazone
hydrochloride
equivalent to 15 mg pioglitazone.
Each Pioglitazone Sandoz 30 mg tablets contains 33.07 mg pioglitazone
hydrochloride
equivalent to 30 mg pioglitazone.
Each Pioglitazone Sandoz 45 mg tablets contains 49.605 mg pioglitazone
hydrochloride
equivalent to 45 mg pioglitazone.
_Excipient(s) with known effect:_
lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablets
Pioglitazone Sandoz 15 mg tablets
are white, round tablet, with imprint “PGT 15” on one side.
Pioglitazone Sandoz 30 mg tablets
are white, round tablet, with imprint “PGT 30” on one side
and with score line on both sides.
Pioglitazone Sandoz 45 mg tablets are white, round tablet, with
imprint “PGT 45” on one side.
_Not all strengths may be marketed. _
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Pioglitazone Sandoz is indicated for the treatment of type 2 diabetes
mellitus inadequately
controlled by diet and exercise:
•
As monotherapy
•
As dual therapy to improve glycaemic control:
-
in combination with metformin or sulfonylurea
-
in combination with insulin
•
As triple therapy to improve glycaemic control:
-
in combination with metformin and sulfonylurea.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Pioglitazone Sandoz should be taken once daily with or without food.
190108-pioglitazone-sandoz-pi
Page 2 of 22
After initiation of Pioglitazone Sandoz or with dose increase,
patients should be carefully
monitored for adverse events related to fluid retention (see Section
4.4 Special warnings and
precautions for use).
_FEMALE PATIENTS _
Oedema has been reported more often in women. Dosage should start at
15 mg and be increased
cautiously, paying attention to the