APOTEX-PIOGLITAZONE pioglitazone 45 mg (as hydrochloride) tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

pioglitazone hydrochloride, Quantity: 49.9 mg (Equivalent: pioglitazone, Qty 45 mg)

Beschikbaar vanaf:

Arrotex Pharmaceuticals Pty Ltd

INN (Algemene Internationale Benaming):

Pioglitazone hydrochloride

farmaceutische vorm:

Tablet

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

98, 28, 7, 50

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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 or in combination with insulin; as triple therapy to improve glycaemic control: in combination with metformin and sulfonylurea.

Product samenvatting:

Visual Identification: white to off-white, round, flat, bevelled edge, uncoated tablets embossed "45" on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2010-11-11

Bijsluiter

APO- APOTEX- CHEMMART TERRY WHITE CHEMISTS PIOGLITAZONE
1
APOTEX- PIOGLITAZONE
_Pioglitazone hydrochloride _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about pioglitazone. 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 risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Pioglitazone is used to treat type 2
diabetes not controlled by diet and
exercise. It helps to improve the
action of insulin produced by your
body.
Pioglitazone belongs to a group of
medicines called glitazones.
Glitazones decrease insulin
resistance and help 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
usually controlled by diet, certain
oral medications and occasionally
insulin.
Pioglitazone can be used alone (when
diet and exercise is not enough to
treat your diabetes) or together with
other anti-diabetic medicines.
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 available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
pioglitazone
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•

Productkenmerken

1
AUSTRALIAN PRODUCT INFORMATION – APOTEX-
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Pioglitazone hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as
hydrochloride) as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
15 MG TABLETS
White to off-white, round, biconvex, uncoated tablet embossed “15”
on one side and plain on
the other side.
30 MG TABLETS
White to off-white, round, flat, bevelled edged, uncoated tablets
embossed “30” on one side
and plain on the other side.
45 MG TABLETS
White to off-white, round, flat, bevelled edged, uncoated tablet
embossed “45” on one side
and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus inadequately controlled by diet
and exercise:

as monotherapy

as dual therapy to improve glycaemic control
o
in combination with metformin or sulfonylurea
o
in combination with insulin

as triple therapy to improve glycaemic control
o
in combination with metformin and sulfonylurea
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Pioglitazone should be taken once daily with or without food.
After initiation of pioglitazone or with dose increase, patients
should be carefully monitored for
adverse events related to fluid retention (see 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 development of oedema.
MONOTHERAPY
The recommended dose of pioglitazone is 15 mg or 30 mg once daily,
increasing after four
weeks, if greater therapeutic effect is needed, to 45 mg once daily.
DUAL THERAPY
The recommended dose of pioglitazone is 30 mg once daily in
combination with sulfonylureas,
insulin or metformin. It may be possible to achieve metabolic control
at a reduced dose of the