Vexazone

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pioglitazone hydrochloride 33.06mg equivalent to 30 mg pioglitazone;  

Available from:

Viatris Limited

INN (International Name):

Pioglitazone hydrochloride 33.06 mg (equiv to 30 mg pioglitazone)

Dosage:

30 mg

Pharmaceutical form:

Tablet

Composition:

Active: Pioglitazone hydrochloride 33.06mg equivalent to 30 mg pioglitazone   Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Polysorbate 80 Purified water

Units in package:

Blister pack, OPA/Al/PVC/Al, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Indicated for the treatment of type 2 diabetes mellitus inadequately controlled by diet. It is effective as a single agent and may also be used in combination with sulfonylureas, metformin or insulin when diet plus the single agent does not result in adequate glycaemic control.

Product summary:

Package - Contents - Shelf Life: Blister pack, OPA/Al/PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture. Store in original container - Blister pack, OPA/Al/PVC/Al - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture. Store in original container - Blister pack, OPA/Al/PVC/Al - 250 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture. Store in original container - Bottle, plastic, High density polyethylene, polypropylene cap - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture

Authorization date:

2006-06-23

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
VEXAZONE
_PIOGLITAZONE (AS PIOGLITAZONE HYDROCHLORIDE) TABLETS 15 MG, 30 MG &
45 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vexazone.
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 taking Vexazone
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 need to read it
again.
WHAT VEXAZONE IS
USED FOR
Vexazone is used to improve the
action of the body's naturally
produced insulin. It is used to treat
type 2 diabetes mellitus not
adequately controlled by diet and
exercise.
Vexazone 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, exercise, certain
oral medications and occasionally
insulin.
This medicine is also called
pioglitazone hydrochloride and
belongs to a group of medicines
called glitazones. These medicines
decrease insulin resistance.
Vexazone may be used on its own
(when diet and exercise is not
enough to treat your diabetes) or in
combination with metformin and/or
a sulphonylurea which are also oral
anti-diabetic medicines.
It may also be used in combination
with insulin.
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.
The use of this medicine in children
has not been studied.
BEFORE YOU TAKE
VEXAZONE
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE VEXAZONE IF YOU HAVE
AN ALLERGY TO:

any medicine containing
pioglitazone hydrochloride

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

Summary of Product characteristics

Page 1 of 17
NEW ZEALAND DATA SHEET
VEXAZONE
1. PRODUCT NAME
Vexazone, 15 mg, 30 mg & 45 mg, tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone as
pioglitazone hydrochloride.
Excipient with known effect: sugars as lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Vexazone 15 mg: white to off-white, round, biconvex, uncoated tablet
debossed “PG” over “15” on
one side and “G” on the other side.
Vexazone 30 mg: white to off-white, round, biconvex, uncoated tablet
debossed “PG” over “30” on
one side and “G” on the other side.
Vexazone 45 mg: white to off-white, round, biconvex, uncoated tablet
debossed “PG” over “45” on
one side and “G” on the other side.
Do not halve the tablets. Dose equivalence when a tablet is divided
has not been established.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Vexazone is indicated for the treatment of type 2 diabetes mellitus
inadequately controlled by diet.
Vexazone is effective as a single agent and may also be used in
combination with sulfonylureas,
metformin or insulin when diet plus the single agent does not result
in adequate glycaemic control.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
After initiation of Vexazone or with dose increase, patients should be
carefully monitored for adverse
events related to fluid retention (see section 4.4).
_MONOTHERAPY_
The recommended dosage of Vexazone is 15 mg or 30 mg once daily,
increasing after four weeks,
if greater therapeutic effect is needed, to 45 mg once daily.
Page 2 of 17
_COMBINATION THERAPY_
The recommended dose of Vexazone 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 sulfonylurea,
insulin or metformin. If there is a particular risk of hypoglycaemia,
Vexazone can be introduced at a
dose of 15 mg. For patients already on insulin, Vexazone should be
introduced at a dose of 15 mg
once dai