Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking VEXAZONE?
VEXAZONE contains the active ingredient pioglitazone hydrochloride. VEXAZONE is used
in the management of type 2 diabetes not controlled by diet.
2. What should I know before I take VEXAZONE?
Do not use if you have ever had an allergic reaction to VEXAZONE or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with VEXAZONE and affect how it works.
4. How do I take VEXAZONE?
VEXAZONE should be taken at the same time every day to ensure it works effectively.
Follow all instructions given to you by your doctor.
5. What should I know while taking VEXAZONE?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking VEXAZONE.
Monitor your health and contact your doctor if you notice any changes.
Keep all of your doctor’s appointments and go for regular check-ups.
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Things you should not do
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Do not stop using this medicine suddenly.
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Driving or using machines
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VEXAZONE may cause dizziness in some people. Do not drive or operate machines until
you know how this medicine affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Store VEXAZONE in a cool dry place, out of direct light, where the temperature is
below 25°C.
Keep VEXAZONE in the original packaging, in a safe place, away from children.
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6. Are there any side effects?
Less serious side effects include weight gain, signs of low blood sugar (hypoglycaemia),
eye problems, bone fracture and impaired liver function. Serious side effects may
include dark urine, pale stools, yellowing skin or eyes, severe stomach cramps, nausea
or vomiting, weight loss, tiredness, shortness of breath with swelling of legs, feet
and hands, with rapid increase in weight, signs of bladder cancer, and oedema (signs
of heart failure).
Active ingredient(s):
pioglitazone hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking VEXAZONE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking VEXAZONE.
Where to find information in this leaflet:
1. Why am I taking VEXAZONE?
Why am I taking VEXAZONE?
VEXAZONE contains the active ingredient pioglitazone hydrochloride. VEXAZONE belongs to a group of medicines called glitazones. Glitazones decrease insulin
resistance.
VEXAZONE is used in the management of type 2 diabetes not controlled by diet.
VEXAZONE is a tablet that is used to improve the action of the body's naturally produced
insulin. 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,
certain oral medications and occasionally insulin. VEXAZONE can be used alone (when
diet and exercise is not enough to treat your diabetes) or together with other anti-diabetic
medicines.
Your doctor may have prescribed it for another purpose.
7. What should I know before I take VEXAZONE?
Warnings
Do not take VEXAZONE if:
you are allergic to pioglitazone hydrochloride, or any of the ingredients listed at
the end of this leaflet. Always check the ingredients to make sure you can take this
medicine.
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; rash, itching or hives on the skin.
you have heart failure requiring treatment. Talk to your doctor if you have heart
failure.
you have type 1 diabetes or diabetic ketoacidosis (often caused by very high blood
glucose levels).
Check with your doctor if you:
heart disease with shortness of breath after minimal physical activity
heart disease with severe symptoms at rest
swelling of hands, ankles or feet
bladder cancer or symptoms associated with bladder cancer such as blood in the urine
(hematuria) often accompanied by pain and burning
problems with your liver
problems with your kidneys that require dialysis. VEXAZONE is not recommended for
use if you are on dialysis
some women who do not have monthly periods and have not been through menopause may
restart their periods when taking VEXAZONE. These women may be at increased risk of
pregnancy.
bone fractures, usually in the hand, upper arm or foot, have been seen in some women
when taking VEXAZONE. Talk to your doctor about the risk of fracture and for advice
on how to keep your bones healthy.
allergies to any other medicines, foods, preservatives or dyes.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
VEXAZONE is not recommended for use during pregnancy. If there is a need to consider
VEXAZONE during your pregnancy, your doctor will discuss with you the benefits and
risks of taking VEXAZONE.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is recommended you do not breastfeed while taking VEXAZONE and it is not known
whether VEXAZONE passes into breast milk.
Use in children
The use of VEXAZONE has not been studies in children.
8. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with VEXAZONE and affect how it works. These include:
chlorpropamide
glibenclamide
gliclazide
insulin
metformin
oral contraceptives
gemfibrozil
rifampicin
tolbutamide
If you are taking any of these medicines you may need to adjust your dose or take
different medicines. Your doctor will be able to provide information.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VEXAZONE.
9. How do I take VEXAZONE?
How much to take
Your doctor will tell you how many VEXAZONE tablets you should take.
The dose your doctor will prescribe for you will usually be in the range of 15 mg
to 45 mg per day.
Your doctor may increase or decrease your dose in order to find the appropriate dose
for your condition.
Follow the instructions provided by your doctor as they might be different to the
information in this leaflet.
When to take VEXAZONE
Take VEXAZONE once a day the same time each day as advised by your doctor.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How to take VEXAZONE
VEXAZONE tablets should be swallowed whole with a glass of water.
VEXAZONE tablets can be taken before or after food.
How long to take VEXAZONE for
Continue taking your medicine until your doctor tells you to stop.
This medicine helps to control your condition but does not cure it. It is important
to keep taking your medicine even if you feel well.
If you forget to take VEXAZONE
VEXAZONE should be used regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your pharmacist for help. Your pharmacist can
also provide some hints If you have trouble remembering.
If you take too much VEXAZONE
If you think that you have used too much VEXAZONE, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
10. What should I know while taking VEXAZONE?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked. Your
doctor may do some tests from time to time to make sure the medicine is working and
to prevent unwanted side effects.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking VEXAZONE.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. VEXAZONE may affect other medicines used during surgery.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine. It may interfere with the results of some tests.
Call your doctor straight away if you:
become pregnant while taking this medicine
Things you should not do
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen or you may have unwanted
side effects.
Do not take VEXAZONE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Hypoglycaemia (low blood sugar)
If you are taking VEXAZONE with other medications used to treat diabetes such as a
sulfonylurea or insulin you may at risk for hypoglycaemia.
Signs of hypoglycaemia (low blood sugar), which may include sweating, weakness, hunger,
dizziness, trembling or shaking, light-headedness, headache, lack of concentration,
tearfulness or crying, irritability, numbness around the lips and fingers.
You should tell your doctor as soon as possible if you notice the above side effects.
Heart failure
If you are taking VEXAZONE in combination with insulin you may be at risk of heart
failure which may show as localised swelling of the ankles, feet and hands (oedema)
and/or fluid in the lungs (pulmonary oedema).
Tell your doctor if you have gained weight since taking VEXAZONE. Weight gain can
be associated with improved blood sugar control; however, it may also be a symptom
of heart failure.
You should tell your doctor as soon as possible if you notice the above side effects.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VEXAZONE
affects you.
If your blood glucose level becomes too low, you may feel dizzy, light headed, weak
or tired and your reaction time may be slower than usual.
If you experience any side effects which impact your ability to drive or operate machinery
when taking this medicine, do not drive or do anything else that could be dangerous
and contact your doctor.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place below 25°C, away from moisture, heat or sunlight; for
example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
11. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Some side effects may be related to the dose of VEXAZONE. Accordingly, it is important
that you tell your doctor as soon as possible about any unwanted effects. Your doctor
may then decide to adjust the dose of VEXAZONE you are taking.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
12. Product details
This medicine is only available with a doctor's prescription.
What VEXAZONE contains
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Active ingredient
(main ingredient)
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pioglitazone (as hydrochloride)
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Other ingredients
(inactive ingredients)
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lactose monohydrate
hypromellose
colloidal anhydrous silica
croscarmellose sodium
polysorbate 80
magnesium stearate
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Potential allergens
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Contains sugars as lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
What VEXAZONE looks like
VEXAZONE tablets come in 3 strengths:
VEXAZONE 15 mg - white to off-white, round, bi-convex, uncoated tablet debossed with
"PG" over 15 on one side and "G" on the other side (AUST R 164345)
VEXAZONE 30 mg - white to off-white, round, bi-convex, uncoated tablet debossed with
"PG" over 30 on one side and "G" on the other side (AUST R 164344)
VEXAZONE 45 mg - white to off-white, round, bi-convex, uncoated tablet debossed with
"PG" over 45 on one side and "G" on the other side. (AUST R 164343).
Who distributes VEXAZONE
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in May 2025.
VEXAZONE® is a Viatris company trade mark
VEXAZONE_cmi\May25/00