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 PROGOUT VIATRIS?
PROGOUT VIATRIS contains the active ingredient allopurinol. PROGOUT VIATRIS is used
to treat: gouty arthritis or gout kidney stones rare conditions where high levels
of uric acid occur in the blood (for example, Lesch-Nyhan syndrome). For more information,
see Section
1. Why am I taking PROGOUT VIATRIS? in the full CMI.
2. What should I know before I take PROGOUT VIATRIS?
Do not take if you have ever had an allergic reaction to PROGOUT VIATRIS 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.
For more information, see Section
2. What should I know before I take PROGOUT VIATRIS? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with PROGOUT VIATRIS and affect how it works.
4. How do I take PROGOUT VIATRIS?
Swallow the tablets whole with a full glass of water.
5. What should I know while taking PROGOUT VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking PROGOUT VIATRIS
Drink at least two litres (8-10 glasses) of fluid each day
Tell your doctor if you have an acute attack of gout while you are taking PROGOUT
VIATRIS
Tell your doctor immediately if you become pregnant or plan to breastfeed while taking
PROGOUT VIATRIS.
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Things you should not do
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Do not take this medicine to treat any other complaints unless your doctor tells you
to
Do not stop taking this medicine or lower the dosage without checking with your doctor
Do not give this medicine to anyone else, even if they have the same condition as
you
Do not take PROGOUT VIATRIS to treat an acute attack of gout.
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Driving or u machines
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PROGOUT VIATRIS may cause dizziness, drowsiness, lack of co-ordination in some people.
Make sure you know how you are affected by this medicine before you drive or use machinery.
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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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Keep PROGOUT VIATRIS in a cool dry place where the temperature will stay below 25°C.
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6. Are there any side effects?
Stomach upsets, including nausea, vomiting, dizziness, drowsiness, headache, change
in taste sensation, sleeplessness, hair loss.
Serious side effects: changes in vision, tingling or numbness of the hands or feet, a change in the amount
of urine passed, yellowing of the skin and eyes (jaundice), generally feeling of being
unwell or depressed, frequent infections such as fever, severe chills, sore throat
or mouth ulcers, bleeding or bruising more easily, angina or palpitations, swelling
of the hands, ankles or legs.
Very serious side effects: asthma, wheezing or shortness of breath, swelling of the face, lips, tongue or throat
which may cause difficulty in breathing, sudden or severe itching, skin rash or hives,
other skin problems, fainting, seizures or fits, pain or tightness in the chest. For
more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
allopurinol
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking PROGOUT VIATRIS. 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 PROGOUT VIATRIS.
Where to find information in this leaflet:
1. Why am I taking PROGOUT VIATRIS?
PROGOUT VIATRIS contains the active ingredient allopurinol.
PROGOUT VIATRIS is used to treat:
gouty arthritis or gout
kidney stones
rare conditions where high levels of uric acid occur in the blood (for example, Lesch-Nyhan
syndrome).
It belongs to a group of medicines called anti-uricaemic agents.
PROGOUT VIATRIS works by reducing the production of uric acid in the body, therefore
helping to prevent the formation of deposits of uric acid crystals. Deposits of uric
acid crystals in the body can cause a variety of medical problems.
High levels of uric acid may cause gout attacks or kidney stones. PROGOUT VIATRIS
is used to prevent gout attacks, not to treat them once they occur.
Ask your doctor if you have any questions about why this PROGOUT VIATRIS has been
prescribed for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I take PROGOUT VIATRIS?
Warnings
Do not take PROGOUT VIATRIS if:
you are allergic to any medicine containing allopurinol, or 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
rash, itching or hives on the skin
muscle pain or tenderness or joint pain
If you think you are having an allergic reaction, do not take any more of the medicine
and contact your doctor immediately or go to the Emergency department at the nearest
hospital.
Always check the ingredients to make sure you can take this medicine.
you or a member of your immediate family has been diagnosed with haemochromatosis
(a disease involving too much iron in the body) and you are taking iron salts.
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking PROGOUT VIATRIS, talk to your
doctor.
Check with your doctor if you:
have or have had any other medical conditions including:
kidney problems, including kidney stones
liver problems
high blood pressure
heart problems
conditions where the levels of uric acid are abnormally high
cancer or tumours
thyroid problems
diabetes
epilepsy
have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you are currently having an attack of gout.
Treatment with PROGOUT VIATRIS should not be started until the attack has stopped,
otherwise more attacks may occur.
(However, if an attack of gout occurs when a person is already taking allopurinol,
it can be continued).
If you have not told your doctor about any of the above, tell him/her before you start
taking PROGOUT VIATRIS.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
PROGOUT VIATRIS passes into breast milk and may affect your baby. Your doctor can
discuss with you the risks and benefits involved.
Use in children
There is not enough information to recommend the use of this medicine for children.
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.
Some medicines may interfere with PROGOUT VIATRIS and affect how it works. These include:
some medicines used to treat high blood pressure or heart problems
thiazide diuretics (a certain type of water tablet)
mercaptopurine, azathioprine or ciclosporin - medicines used to suppress the immune
system
aspirin and other medicines known as salicylates
probenecid, a medicine used to treat gout or hyperuricaemia (high levels of uric acid
in the blood)
warfarin and other coumarin type anticoagulant medicines, used to help prevent blood
clots
chlorpropamide, a medicine used to treat diabetes
phenytoin, a medicine used to treat epilepsy
certain antibiotics such as ampicillin and amoxicillin
theophylline, a medicine used to treat asthma
aluminium hydroxide, a medicine used to treat the symptoms of too much stomach acid
adenine arabinoside ('Vidarabine'), an anti-viral medicine
medicines used for cancer (e.g. cyclophosphamide, doxorubicin)
didanosine, used to treat HIV infection.
Other medicines not listed above may also interact with PROGOUT VIATRIS.
You may need different amounts of your medicines, or you may need to take different
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PROGOUT VIATRIS.
4. How do I take PROGOUT VIATRIS?
How much to take
Your doctor will tell you how much PROGOUT VIATRIS you should take. This will depend
on your condition and whether you are taking any other medicines.
Follow the instructions provided and take PROGOUT VIATRIS until your doctor tells
you to stop.
The usual adult dose range is:
100 - 200 mg per day for mild conditions
300 - 600 mg per day for moderately severe conditions
700 - 900 mg per day for severe conditions.
People over 65 years of age, and those with kidney and/or liver problems should be
started on the lowest dose possible to control uric acid production.
Children under 15 years of age usually take 100 - 400 mg per day.
How to take PROGOUT VIATRIS
Swallow the tablets whole with a full glass of water.
When to take PROGOUT VIATRIS
PROGOUT VIATRIS should be taken immediately after food, as this will lessen the chance
of a stomach upset.
Take PROGOUT VIATRIS at the same time each day. Taking your medicine at the same time
each day will have the best effect. It will also help you remember when to take it.
PROGOUT VIATRIS is usually taken once daily. However, if your dose is more than 300
mg, your doctor may advise you to take your medicine twice a day. Then, it should
be taken morning and night, after breakfast and dinner.
How to long to take PROGOUT VIATRIS
Continue taking PROGOUT VIATRIS for as long as your doctor tells you.
PROGOUT VIATRIS helps to control your condition, but does not cure it. It is important
to keep taking PROGOUT VIATRIS even if you feel well.
Make sure you have enough to last over weekends and holidays.
If you forget to take PROGOUT VIATRIS
If it is less than 4 hours to your next dose, skip the dose you missed and take your
next dose at the usual time.
Otherwise, take it as soon as you remember and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much PROGOUT VIATRIS
If you think that you or anyone else has taken too much PROGOUT VIATRIS, urgent medical
attention maybe needed.
You should immediately:
phone the Poisons Information Centre
(by calling 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.
You may need urgent medical attention.
Symptoms of an overdose may include:
nausea
vomiting
diarrhoea
dizziness.
5. What should I know while taking PROGOUT VIATRIS?
Things you should do
You should drink at least two litres (8 - 10 glasses) of fluid each day.
This will assist in reducing the uric acid levels in your body and prevent kidney
stones from forming.
Tell your doctor if you have an acute attack of gout while you are taking PROGOUT
VIATRIS.
Your doctor may prescribe a medicine to relieve the acute attack. You can continue
taking PROGOUT VIATRIS.
If you are about to start any new medicine, remind your doctor and pharmacist that
you are taking PROGOUT VIATRIS.
Remind any doctor, dentist or pharmacist you visit that you are taking PROGOUT VIATRIS.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
PROGOUT VIATRIS.
If you become pregnant or plan to breastfeed while taking PROGOUT VIATRIS, tell your
doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking PROGOUT
VIATRIS.
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.
Things you should not do
Do not take PROGOUT VIATRIS to treat any other complaints unless your doctor tells
you to.
Do not give PROGOUT VIATRIS to anyone else, even if they have the same condition as
you.
Do not stop taking PROGOUT VIATRIS or lower the dosage without checking with your
doctor.
If you stop taking it suddenly, your condition may worsen. If possible, your doctor
will gradually reduce the amount you take each day before stopping PROGOUT VIATRIS
completely.
Do not take PROGOUT VIATRIS to treat an acute attack of gout.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PROGOUT
VIATRIS affects you.
PROGOUT VIATRIS may cause dizziness, drowsiness, lack of co-ordination in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your medicine in its original packaging until it is time to take it.
If you take the tablets out of their original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place 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.
Heat and dampness can destroy the medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
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.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking PROGOUT VIATRIS.
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.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Less serious side effects
Very 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.
Some of these side effects can only be found when your doctor does tests from time
to time to check your progress.
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 PROGOUT VIATRIS contains
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Active ingredient
(main ingredient)
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allopurinol
(100 mg and 300 mg)
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Other ingredients
(inactive ingredients)
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lactose monohydrate
maize starch
povidone
sodium starch glycollate type A
sunset yellow FCF (300 mg only)
stearic acid
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Potential allergens
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sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What PROGOUT VIATRIS looks like
PROGOUT VIATRIS 100 mg tablets: White to off-white coloured, round biconvex, uncoated tablets with 'AL' & '100' separated
by breakline on one side and plain on the other side (AUST R 269653).
Available in bottles of 200 tablets.
PROGOUT VIATRIS 300 mg tablets: Peach coloured, round, biconvex uncoated tablets with 'AL' & '300' separated by breakline
on one side and plain on the other side (AUST R 269642).
Available in blister packs of 60 tablets.
Who distributes PROGOUT VIATRIS
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.
PROGOUT® is a Viatris company trade mark
PROGOUT VIATRIS_cmi\May25/00