Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using VEOZA?
VEOZA contains the active substance fezolinetant. VEOZA is not a hormone. This medicine
is used in menopausal women to reduce moderate to severe vasomotor symptoms (VMS),
associated with menopause. VMS are also known as hot flushes or night sweats.
2. What should I know before I use VEOZA?
Talk to your doctor if you have any other medical conditions or if you take any other
medicines.
3. What if I am taking other medicines?
Some medicines may interfere with VEOZA and affect how it works.
4. How do I use VEOZA?
The recommended dose is one tablet by mouth once daily.
5. What should I know while using VEOZA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using VEOZA.
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Things you should not do
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Do not stop taking this medicine unless your doctor tells you to do so.
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Driving or using machines
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VEOZA has no effect on the ability to drive or use machines.
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Looking after your medicine
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Store below 30°C.
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6. Are there any side effects?
There are side effects associated with this medicine. It is important to be aware
of them so that you can identify any symptoms if they occur (see the full CMI for
more details). The most common side effects are diarrhoea, difficulty sleeping (insomnia),
increased liver laboratory values and abdominal pain.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
fezolinetant
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VEOZA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using VEOZA.
Where to find information in this leaflet:
1. Why am I using VEOZA?
VEOZA contains the active substance fezolinetant.
VEOZA is not a hormone.
This medicine is used in menopausal women to reduce moderate to severe vasomotor symptoms
(VMS), associated with menopause. VMS are also known as hot flushes or night sweats.
Before menopause, there is a balance between oestrogen, a female sex hormone, and
a brain chemical known as neurokinin B (NKB) that regulates your body’s temperature
control center located in a specific area of the brain. As your body goes through
menopause, oestrogen declines and this balance is disrupted, which can lead to hot
flushes and night sweats, also known as VMS. VEOZA helps to restore the balance by
blocking NKB in your temperature control center to reduce the number and intensity
of hot flushes. VEOZA is a non-hormonal medicine.
2. What should I know before I use VEOZA?
Warnings
Do not use VEOZA if:
you are allergic to fezolinetant, or any of the ingredients listed at the end of this
leaflet.
you are taking certain medicines known as moderate or strong CYP1A2 inhibitors (e.g.,
ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine).
These medicines can reduce the breakdown of Veoza in the body, leading to more side
effects.
you have moderate or severe liver dysfunction.
you have severe kidney dysfunction.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
take any medicines for any other condition.
have any other medical conditions.
currently have or previously had breast cancer or another oestrogen-related cancer.
During treatment, your doctor may not prescribe this medicine to you.
are taking hormone replacement therapy with oestrogens (medicines used to treat oestrogen
deficiency symptoms). Your doctor may not prescribe this medicine to you.
have kidney problems, your doctor may not prescribe this medicine to you.
have liver problems, your doctor may want to monitor your liver enzymes periodically.
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
Do not take this medicine if you are pregnant or breast-feeding, or if you think you
might be pregnant. This medicine is for use only by menopausal women.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because
this medicine is only for menopausal women.
3. 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.
VEOZA may affect the way these medicines work, or these medicines may affect how VEOZA
works. This includes medicines known to moderately and strongly reduce the activity
of an enzyme (called cytochrome P450 1A2), such as fluvoxamine. If you normally take
any of these medicines, your doctor might change it and prescribe a different medicine
for you during your treatment with VEOZA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VEOZA.
4. How do I use VEOZA?
Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
How much to take
The recommended dose is one tablet by mouth once daily.
When to take VEOZA
Take this medicine at about the same time each day.
How to take VEOZA
Swallow the tablet whole with liquids. Do not break, crush, or chew tablet.
Take with or without food.
If you forget to take VEOZA
VEOZA should be used regularly at the same time each day. If you miss your dose at
the usual time, take the missed dose as soon as you remember on the same day, with
at least 12 hours before the next scheduled dose. Return to your regular schedule
the following day.
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 miss several doses, tell your doctor and follow the advice given to you.
If you take too much VEOZA
If you think that you have used too much VEOZA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), 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.
5. What should I know while using VEOZA?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking VEOZA.
If you are going to have surgery, tell the surgeon or anesthetist that you are taking
this medicine.
Keep all of your doctor's appointments so that your progress can be checked. Remind
any doctor, dentist or pharmacist you visit that you are using VEOZA.
Things you should not do
Do not stop using this medicine suddenly.
Driving or using machines
VEOZA has no effect on the ability to drive or use machines.
Be careful before you drive or use any machines or tools until you know how VEOZA
affects you.
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 where the temperature stays below 30°C and 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.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. 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.
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.
7. Product details
This medicine is only available with a doctor's prescription.
What VEOZA contains
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Active ingredient
(main ingredient)
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fezolinetant
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Other ingredients
(inactive ingredients)
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mannitol
hyprolose
microcrystalline cellulose
magnesium stearate
hypromellose
purified talc
macrogol 8000
titanium dioxide
ferric oxide (iron oxide red)
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Do not take this medicine if you are allergic to any of these ingredients.
What VEOZA looks like
VEOZA 45 mg tablets are round, light red, film-coated tablets debossed with the Astellas
logo and ‘645’ on the same side.
(AUST R 401401).
Who distributes VEOZA
VEOZA is supplied in Australia by:
Astellas Pharma Australia Pty Ltd
Suite 2.01, 2 Banfield Road
Macquarie Park NSW 2113
Medical Information:
1800 751 755
VEOZA™ is a trademark of Astellas US LLC.
This leaflet was prepared in February 2024.