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 using Sabril?
Sabril contains the active ingredient vigabatrin. Sabril is used in addition to other
medicines to treat epilepsy.
2. What should I know before I take Sabril?
Do not take if you have ever had an allergic reaction to Sabril 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 Sabril and affect how it works.
4. How do I take Sabril?
Sabril tablets and sachets are taken by mouth either once or twice a day.
Take Sabril at about the same time each day.
5. What should I know while using Sabril?
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Things you should do
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Tell all the doctors, dentists and pharmacists that are treating you that you are
taking Sabril.
Tell your Doctor immediately or go to the Accident and Emergency department of your
nearest hospital if you have any thoughts of harming yourself or committing suicide.
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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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Be careful before you drive or use any machines or tools until you know how Sabril
affects you.
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Looking after your medicine
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Keep your tablets or sachets in the container until it is time to take them.
Keep Sabril in a cool dry place where the temperature stays below 30°C.
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6. Are there any side effects?
The less serious side effects are drowsiness, nervousness, irritability, depression,
dizziness, confusion, headache, tiredness difficulty sleeping, joints pain, impaired
concentration, weight gain, difficulty in speaking or slurred speech, lack of coordination
agitation, excitation, aggression, tremors, nausea, vomiting, abdominal pain and unusual
hair loss or thinning. Serious side effects are an increase in the number of seizures,
changes in your behaviour or mood, severe tiredness or confusion, changes in your
eyesight and suicidal thoughts/attempts.
Active ingredient(s): vigabatrin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Sabril. 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 Sabril.
Where to find information in this leaflet:
1. Why am I using Sabril?
Sabril contains the active ingredient vigabatrin.
Sabril is a medicine used to help control epilepsy, a condition where you have repeated
fits or convulsions.
Sabril is an anticonvulsant. It works by stopping the breakdown of an important chemical
transmitter ("messenger") in the brain and this helps reduce seizure activity.
Sabril is used in addition to other medicines to treat epilepsy.
Your doctor, however, may have prescribed Sabril for another reason.
Ask your doctor if you have any questions about why it has been prescribed for you.
2. What should I know before I take Sabril?
Warnings
Do not take Sabril if:
you are allergic to vigabatrin, or any of the ingredients listed at the end of this
leaflet.
you are pregnant or intend to become pregnant unless your doctor tells you to. It
may affect your developing baby if you take it during pregnancy.
you are breast-feeding or planning to breast-feed unless your doctor tells you to.
Sabril passes into breast milk and there is a possibility your baby may be affected.
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
plan to have surgery
have any other medical conditions, especially the following:
kidney problems
nervous or mental illness
depression
psychosis, a severe mental condition in which the person is unable to think and judge
clearly.
have allergies to:
any of the ingredients listed at the end of this leaflet
any other medicines
any other substances, such as 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
Tell your doctor if you are pregnant or intend to become pregnant.
Like most medicines for epilepsy, Sabril may affect your unborn baby. However, it
is very important to control your epilepsy while you are pregnant since seizures may
also affect your baby. Your doctor will help you decide whether you should take Sabril
during pregnancy
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Sabril passes into breast milk. Your doctor will discuss the risks and benefits of
using it if you are breast-feeding or planning to breast-feed.
Eyesight
Your doctor may want to test your eyesight before you start taking Sabril and during
the course of your treatment so that any changes in your sight can be detected.
Some anti-epilepsy medicines may affect eyesight. In rare cases, patients treated
with Sabril have experienced changes to their peripheral vision (i.e., they had trouble
seeing things that were not directly in front of them).
Please ask your doctor if you want more information about this.
If you have not told your doctor about any of the above, tell them before you take
Sabril.
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 the absorption of Sabril.
These include phenytoin, a medicine used to treat seizures.
Other medicines can increase the drowsiness that Sabril causes.
These include clonazepam, a medicine used as a sedative or to treat anxiety.
These medicines may be affected by Sabril. You may need to use different amounts of
your medicine or 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 Sabril.
4. How do I take Sabril?
How much to take
Sabril tablets and sachets are taken by mouth either once or twice a day.
The dose of Sabril varies between patients. Your doctor may have prescribed a different
dose.
Follow all directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in this leaflet.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
If you take the wrong dose, Sabril may not work as well and your problem may not improve.
When to take Sabril
Take Sabril at about the same time each day.
Taking Sabril at the same time each day will have the best effect. It will also help
you remember when to take it.
You can take Sabril with or without food.
If you are not sure when to take it, ask your doctor or pharmacist.
How to take Sabril
Tablets
Swallow your tablet(s) whole with plenty of water. Do not crush or chew the tablet(s).
Sachets
The contents of the sachets should be dissolved in half a glass of water, juice or
soft drink just before you plan to take it.
Once dissolved, the solution should be taken immediately. It will dissolve easily
and has no taste or smell.
Once mixed, any remaining solution should be discarded within 24 hours.
How long to take Sabril
Do not stop taking Sabril until your doctor tells you to.
Ask your doctor or pharmacist if you are not sure how long to take the medicine for.
If you forget to take Sabril
Do not take a double dose to make up for the dose you missed.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
If there is still a long time to go before your next dose, take it as soon as you
remember, and then go back to taking your dose as you would normally.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
hints.
If you take too much Sabril
If you think that you have taken too much Sabril, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (by calling 13 11 26 in Australia or 0800 764 766 in New Zealand), 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 Sabril?
Things you should do
Tell all the doctors, dentists and pharmacists that are treating you that you are
taking Sabril.
If you are about to start taking any new medicine, tell your doctor and pharmacist
that you are taking Sabril.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking this medicine.
If you become pregnant while you are taking Sabril, tell your doctor immediately.
Tell your Doctor immediately or go to the Accident and Emergency department of your
nearest hospital if you have any thoughts of harming yourself or committing suicide.
Things you should not do
Do not stop taking Sabril until your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not take more than the recommended dose unless your doctor or pharmacist tells
you to.
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Sabril
affects you.
Sabril may cause dizziness or light-headedness in some people. Make sure you know
how you react to Sabril before you drive a car, operate machinery or do anything else
that could be dangerous if you are dizzy or light-headed. This effect decreases with
time.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your tablets or sachets in the container until it is time to take them.
Keep Sabril in a cool dry place where the temperature stays below 30°C.
Do not store Sabril or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
Do not take it after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not take it if the packaging is torn or shows signs of tampering.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking Sabril tablets or sachets or the expiry date
has passed, ask your pharmacist what to do with any tablets or sachets that are left
over.
Return any unused medicine to your pharmacist.
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
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Less serious side effects
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What to do
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Head and neurology related
drowsiness
nervousness, irritability, depression
dizziness
confusion
headache
tiredness
difficulty sleeping
impaired concentration
difficulty in speaking or slurred speech
lack of coordination
agitation, excitation
aggression
tremors
abnormal changes in brain pictures taken by MRI , particularly in infants
swelling of part of the brain, particularly in infants
Stomach related
nausea
vomiting
abdominal pain
Muscle related
joint pain
Hair related
unusual hair loss or thinning
General
weight gain
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Allergic reaction
swelling of the face, lips, mouth, or throat, which may cause difficultly in swallowing
or breathing
hives
Neurology related
an increase in the number of seizures
Mood and self-harm
changes in your usual behaviour or mood
severe sedation or confusion
suicidal thoughts (thoughts of self-harm)
suicide attempts
Eyesight
changes in your eyesight (e.g.: blurred vision, tunnel vision)
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Stop taking the Sabril if you have signs of an allergic reaction.
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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
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 Sabril contains
Sabril does not contain gluten, sucrose, tartrazine or any other azo dyes.
Tablets
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Active ingredient
(main ingredient)
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Each tablet contains:
500 mg of vigabatrin.
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Other ingredients
(inactive ingredients)
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povidone
microcrystalline cellulose
sodium starch glycollate
magnesium stearate
hypromellose
titanium dioxide
macrogol 8000
Opadry White OY-S-7298
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Sachets
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Active ingredient
(main ingredient)
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Each sachet contains:
500 mg of vigabatrin.
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Other ingredients
(inactive ingredients)
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povidone
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Do not take this medicine if you are allergic to any of these ingredients.
What Sabril looks like
Tablets
Sabril 500 mg are white to off-white, oval biconvex, film-coated tablets with a break-mark
on one side and “SABRIL” or “SABRILEX” engraved on the other side. They come in a
blister pack of 100 tablets (AUST R 150021).
Sachets
Sabril sachets contain 500 mg of vigabatrin. They come in a pack of 60 sachets (AUST
R 52985).
Who distributes Sabril
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in October 2024.
sabril-ccdsv14-cmiv13-02oct24