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.
1. Why am I taking ACAMPROSATE VIATRIS?
ACAMPROSATE VIATRIS contains the active ingredient acamprosate calcium. ACAMPROSATE
VIATRIS is used in the treatment of alcohol dependence. It helps people who are dependent
on alcohol to abstain from drinking alcoholic beverages.
2. What should I know before I take ACAMPROSATE VIATRIS?
Do not take if you have ever had an allergic reaction to acamprosate calcium 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 ACAMPROSATE VIATRIS and affect how it works.
4. How do I take ACAMPROSATE VIATRIS?
The usual dose for adults weighing 60 kg or more is 2 tablets three times daily with
meals.
For adults weighing less than 60 kg, the recommended dose is 2 tablets in the morning,
1 tablet at midday and 1 tablet at night. These doses are also to be taken with meals.
Swallow the tablets whole with a glass of water. Do not break, crush or chew the tablets.
ACAMPROSATE VIATRIS is usually taken for one year. Continue taking your medicine for
as long as your doctor tells you.
5. What should I know while taking ACAMPROSATE VIATRIS?
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Things you should do
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It is important to continue taking ACAMPROSATE VIATRIS even if you have a short relapse.
Remind any doctor, dentist or pharmacist you visit that you are taking ACAMPROSATE
VIATRIS.
Keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you become pregnant while taking ACAMPROSATE VIATRIS.
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Things you should not do
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Do not take ACAMPROSATE VIATRIS to treat any other complaints unless your doctor tells
you to.
Do not give ACAMPROSATE VIATRIS to anyone else, even if they have the same condition
as you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
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Drinking alcohol
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Drinking alcohol while taking ACAMPROSATE VIATRIS will not make you feel sick. However,
you are advised not to drink alcohol at all during your treatment with ACAMPROSATE
VIATRIS. Even if you only drink a little alcohol, you run the risk of making your
treatment fail.
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Looking after your medicine
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Keep your tablets in the pack until it is time to take them.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
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6. Are there any side effects?
Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you: diarrhoea; nausea (feeling sick), vomiting, upset stomach; itching, skin rash; changes
in sex drive.
Active ingredient(s):
acamprosate calcium
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ACAMPROSATE 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 ACAMPROSATE VIATRIS.
Where to find information in this leaflet:
1. Why am I taking ACAMPROSATE VIATRIS?
ACAMPROSATE VIATRIS contains the active ingredient acamprosate calcium.
ACAMPROSATE VIATRIS is used in the treatment of alcohol dependence. It helps people
who are dependent on alcohol to abstain from drinking alcoholic beverages.
Alcohol dependence is an illness that can and should be treated. Drinking too much
alcohol may harm your health and cause physical, psychological and social problems.
If this happens to you, your doctor may advise you to stop drinking alcohol altogether.
If you drink too much alcohol, your body and nervous system adapt to its effects.
When you suddenly stop drinking, you may experience some unpleasant symptoms (known
as alcohol withdrawal syndrome or the "shakes"), which can last up to 2 weeks.
During alcohol withdrawal, you may feel shaky, have an upset stomach, a fast heart
beat and high blood pressure. You may also feel anxious, down or be in a bad mood.
Sometimes, you may see things that are not there, or suffer from a headache or not
be able to sleep. If these symptoms are severe, you may need observation in hospital.
After going through this difficult period, your doctor will encourage you to live
without alcohol through counselling. ACAMPROSATE VIATRIS, in combination with counselling
from a general practitioner, psychiatrist, psychologist, or a drug and alcohol counsellor,
will help you to stop yourself from starting to drink again.
ACAMPROSATE VIATRIS works by acting on certain chemical changes that have taken place
in your brain over the time that you have been drinking alcohol.
ACAMPROSATE VIATRIS is not recommended for use in children or elderly patients.
There is no evidence that ACAMPROSATE VIATRIS is addictive.
2. What should I know before I take ACAMPROSATE VIATRIS?
As ACAMPROSATE VIATRIS does not treat the symptoms of alcohol withdrawal, it is recommended
that you start taking ACAMPROSATE VIATRIS:
after you have stopped drinking; and
as soon as the withdrawal symptoms have ended.
Warnings
Do not take ACAMPROSATE VIATRIS if:
you are allergic to any medicine containing acamprosate calcium, 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 kidney disease
you have severe liver disease.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
Check with your doctor if you:
have allergies to any other medicines, foods, dyes or preservatives
have any other health problems or medical conditions
take any medicines for any other condition.
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.
The safety of ACAMPROSATE VIATRIS has not been established in pregnant women.
Check with your doctor if you are pregnant or intend to become pregnant. Your doctor
can discuss with you the risks and benefits involved.
Do not take this medicine if you are breastfeeding.
Like many other medicines, ACAMPROSATE VIATRIS can pass into breast milk and may affect
your baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
If you have not told your doctor about any of the above, tell them before you start
taking ACAMPROSATE VIATRIS.
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 ACAMPROSATE VIATRIS and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ACAMPROSATE VIATRIS.
4. How do I take ACAMPROSATE VIATRIS?
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
How much to take
The usual dose for adults weighing 60 kg or more is 2 tablets three times daily with
meals.
For adults weighing less than 60 kg, the recommended dose is 2 tablets in the morning,
1 tablet at midday and 1 tablet at night. These doses are also to be taken with meals.
How to take ACAMPROSATE VIATRIS
Swallow the tablets whole with a glass of water.
Do not break, crush or chew the tablets. The tablets have a special coating to prevent
a stomach upset.
How long to take it
ACAMPROSATE VIATRIS is usually taken for one year.
Continue taking your medicine for as long as your doctor tells you.
If you forget to take ACAMPROSATE VIATRIS
If you miss your dose at the usual time and
it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take the missed dose 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.
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 ACAMPROSATE VIATRIS
If you think that you or anyone else have taken too much ACAMPROSATE VIATRIS, urgent
medical attention may be needed.
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.
5. What should I know while taking ACAMPROSATE VIATRIS?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are taking ACAMPROSATE
VIATRIS.
It is important to continue taking ACAMPROSATE VIATRIS even if you have a short relapse.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ACAMPROSATE VIATRIS.
Keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
become pregnant while taking ACAMPROSATE VIATRIS.
Things you should not do
Do not take ACAMPROSATE VIATRIS to treat any other complaints unless your doctor tells
you to.
Do not give ACAMPROSATE VIATRIS to anyone else, even if they have the same condition
as you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
Drinking alcohol
Drinking alcohol while taking ACAMPROSATE VIATRIS will not make you feel sick. However,
you are advised not to drink alcohol at all during your treatment with ACAMPROSATE
VIATRIS. Even if you only drink a little alcohol, you run the risk of making your
treatment fail.
Looking after your medicine
Keep your tablets in the pack until it is time to take them. If you take the tablets
out of the pack they may not keep well.
Store below 30°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 some 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 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?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ACAMPROSATE VIATRIS.
This medicine helps most people with alcohol dependence, but it may have unwanted
side effects in a few people.
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.
Do not be alarmed by this list of side effects. You may not experience any of them.
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
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 ACAMPROSATE VIATRIS contains
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Active ingredient
(main ingredient)
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acamprosate calcium 333 mg per enteric coated tablet
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Other ingredients
(inactive ingredients)
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crospovidone
microcrystalline cellulose
magnesium silicate dihydrate
sodium starch glycollate
colloidal anhydrous silica
magnesium stearate
purified talc
propylene glycol
EUDRAGIT L30D-55 (ARTG PI No: 3700)
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Potential allergens
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N/A
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Do not take this medicine if you are allergic to any of these ingredients.
What ACAMPROSATE VIATRIS looks like
ACAMPROSATE VIATRIS 333 mg enteric coated tablet is a 10 mm round, white, coated tablet,
debossed "333" on one side (AUST R 298641).
Available in blister packs of 180 tablets.
Who distributes ACAMPROSATE 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 March 2024.
ACAMPROSATE VIATRIS_cmi\Mar24/00