NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
ZARONTIN
ethosuximide
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Zarontin.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking Zarontin against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Zarontin is used for
Zarontin is used to control epilepsy in children and adults. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe.
Zarontin is used to control petit mal seizures.
Zarontin belongs to a group of medicines called anticonvulsants. These drugs are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.
Zarontin may be used alone, or in combination with other medicines, to treat your condition.
Your doctor may have prescribed Zarontin for another reason. Ask your doctor if you have any questions about why Zarontin has been prescribed for you.
There is no evidence that Zarontin is addictive.
This medicine is available only with a doctor’s prescription.
Before you take Zarontin
When you must not take it
Do not take Zarontin if you have an allergy to ethosuximide, the active ingredient in Zarontin, other medicines which contain succinimides or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Zarontin 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.
Do not take Zarontin after the expiry date (EXP) printed on the pack.
Do not take Zarontin 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 Zarontin, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
any other medicines, especially barbiturates or any other anticonvulsant medicines
any other substances, such as foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
liver problems
kidney problems
Systemic Lupus Erythematosus
frequent infections such as fever, chills, sore throat or mouth ulcers.
Tell your doctor if you are pregnant or intend to become pregnant.
If it is necessary for you to take Zarontin your doctor can help you decide whether or not to take it during pregnancy. Zarontin may affect your developing baby if you take it during pregnancy. However, it is very important to control your fits while you are pregnant.
Tell your doctor if you are breastfeeding or plan to breastfeed.
Your doctor will discuss the possible risks and benefits of taking Zarontin during breastfeeding.
If you do breastfeed, watch your baby carefully.
If your baby develops a skin rash, becomes sleepy or has unusual symptoms, do not breastfeed again until you speak to your doctor.
If you have not told your doctor or pharmacist about any of the above, tell him or her before you start taking Zarontin.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Zarontin may interfere with each other. These include other medicines used to treat fits and convulsions, such as phenytoin and valproic acid.
These medicines may be affected by Zarontin, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Zarontin.
How to take Zarontin
How much to take
Your doctor will tell you how much syrup or how many capsules you will need to take each day. This may depend on your age, the severity of your condition and whether or not you are taking any other medicines.
Your doctor may recommend that you start with a low dose of Zarontin and slowly increase the dose to the lowest amount needed to control your epilepsy/convulsions.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.
How to take it
If you are taking Zarontin capsules
Swallow Zarontin capsules whole with a full glass of water.
If you or your child are taking Zarontin syrup
Shake the bottle well and accurately pour the dose with a medicine measure before taking it.
Shaking the bottle and using a medicine measure will make sure that you get the correct dose. You can get a medicine measure from your pharmacist. Ask your pharmacist for ways to accurately measure the dose.
When to take it
Take the daily dose of Zarontin in two divided doses.
Take Zarontin at about the same time each day.
Taking Zarontin at the same time each day will have the best effect. It will also help you remember when to take the capsules or syrup.
It does not matter if you take Zarontin before or after food.
If you forget to take it
If it is almost time for your next dose (within 4 hours), skip the dose you missed and take your next dose when you are meant to.
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 that 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.
How long to take it
Continue taking Zarontin for as long as your doctor tells you to.
Zarontin helps control your condition, but does not cure it. Therefore you must take your medicine every day, even if you feel well.
Do not stop taking Zarontin, or lower the dosage, without checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.
Stopping Zarontin suddenly may cause unwanted effects or make your condition worse. Your doctor will slowly reduce your dose before you can stop taking it completely.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (in Australia telephone 13 11 26; in New Zealand telephone 0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Zarontin. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking Zarontin
Things you must do
Tell your doctor immediately if you notice any of the following:
increase in seizures (fits)
itchy red skin rash or hives, fever, enlarged lymph glands
These symptoms may mean that you have a severe hypersensitivity reaction to this medicine. You may need urgent medical attention.
yellowing of the skin and/or eyes, swelling of the face, strong stomach pains, generally feeling unwell with tiredness, weakness and vomiting
These symptoms may mean that you have a serious condition affecting your liver. You may need urgent medical attention.
Tell your doctor immediately if you have any thoughts about suicide or self-harm, any unusual changes in mood or behaviour, or you show signs of depression.
Some people being treated with anti-epileptics such as Zarontin have thoughts of harming or killing themselves.
Patients and caregivers should be alert and monitor for these effects.
Signs and symptoms of suicide include:
thoughts or talk of death or suicide.
thoughts or talk of self-harm or harm to others
any recent attempts of self-harm
increase in aggressive behaviour, irritability or agitation
feelings of depression.
Mention of suicide or violence must be taken seriously.
If you or someone you know is demonstrating these warning signs of suicide while taking Zarontin, contact your doctor or a mental health professional right away.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Zarontin.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used.
If you become pregnant while taking Zarontin, tell your doctor.
Tell your doctor if you are breastfeeding or plan to breastfeed.
If you do breastfeed, watch your baby carefully.
Tell your doctor if you feel Zarontin is not helping your condition.
Your doctor may need to change your medicine.
Tell your doctor if, for any reason, you have not taken Zarontin exactly as prescribed.
Otherwise, your doctor may change your treatment unnecessarily.
Be sure to keep all of your doctor’s appointments so that your progress can be checked.
Your doctor will check your progress and may want to take some tests from time to time. This helps to prevent unwanted side effects.
Things you must not do
Do not give Zarontin to anyone else, even if their symptoms seem similar to yours or they have the same condition as you.
Do not take Zarontin to treat any other complaints unless your doctor tells you to.
Do not stop taking it unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Zarontin affects you.
Zarontin may cause dizziness, light-headedness, tiredness, drowsiness and affect alertness. Make sure you know how you react to Zarontin before you drive a car, operate machinery, or do anything else that could be dangerous if you are affected.
Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling drowsy or sleepy.
Drinking alcohol when taking Zarontin can make you more sleepy, dizzy or lightheaded. Your doctor may advise you to avoid alcohol while you are being treated with Zarontin.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Zarontin.
Zarontin helps most people with epilepsy, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. If you are over 65 years of age you may have an increased chance of getting side effects.
Ask your doctor or pharmacist to answer any questions you may have.
If you get any side effects, do not stop taking Zarontin without first talking to your doctor or pharmacist.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
dizziness or light-headedness
feeling tired or drowsy
headache
weakness, unsteadiness when walking
mood changes such as feelings of extreme happiness, irritability or excitement
hiccoughs
loss of concentration
disturbance of sleep
frightening dreams
abnormally suspicious thoughts
increased libido
indigestion, stomach pain or discomfort
nausea (feeling sick) or vomiting
cramps
loss of appetite
loss of weight
diarrhoea
swollen gums or tongue
itchy red skin rash or hives
excessive hairiness, especially in women
short sightedness
vaginal bleeding
allergic reaction
blood in the urine.
These are the more common side effects of Zarontin.
Tell your doctor as soon as possible if…
Tell your doctor as soon as possible if you:
have any thoughts of suicide or self-harm
notice any unusual changes in your mood or behaviour
show signs of depression.
Go to hospital if…
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
more frequent or more severe seizures (fits)
severe depression, apparent intentions of suicide
aggressive behaviour
frequent infections with fever, chills, sore throat, swollen glands and mouth ulcers
frequent nosebleeds, unusual bleeding or bruising,
tiredness, headache, shortness of breath when exercising, dizziness or pale skin
persistent nausea or vomiting, loss of appetite, generally feeling unwell, fever, itching, yellowing of the skin and/or eyes, dark coloured urine, light coloured bowel motions, pain in the abdomen. These may be signs of a liver problem.
sudden signs of allergy such as rash, itching or hives, swelling of the face, lips, wheezing or difficulty breathing
severe skin rash, itching, hives, blisters or peeling skin, which may be accompanied by fever, chills, headache, swollen glands, stomach pain or aching joints and muscles
severe whole body skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell.
After taking Zarontin
Storage
Keep your capsules in the pack until it is time to take them.
If you take the capsules out of the pack they will not keep well.
Keep your capsules or syrup in a cool dry place where the temperature stays below 25°C.
Do not store Zarontin or any other medicine in the bathroom or near a sink.
Do not leave it on a window sill or in the car on hot days.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor or pharmacist tells you to stop taking Zarontin or the capsules or syrup have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
Zarontin capsules 250 mg are clear orange soft gelatin capsules, available in bottles of 200 capsules.
Zarontin syrup is a clear yellow to pink solution, available in a 200 mL bottle.
Ingredients
Zarontin capsules contain:
Ethosuximide 250 mg as the active ingredient.
The capsules also contain:
macrogol 400
gelatin
glycerol
sorbitol
vanillin
methyl hydroxybenzoate
propyl hydroxybenzoate
sunset yellow FCF.
Zarontin Syrup contains:
Ethosuximide 250 mg/5 mL as the active ingredient.
The syrup also contains:
sodium citrate
sodium benzoate
saccharin sodium
sucrose
glycerol
imitation raspberry flavour
purified water
citric acid monohydrate.
Supplier
Zarontin is supplied by:
Clinect Pty Ltd
120-132 Atlantic Drive
Keysborough VIC 3173
Australia
Free Call Australia:
1800 899 005
Free Call New Zealand:
0800 138 803
Australian Registration Numbers:
250 mg capsules: AUST R 94175
250 mg/5 mL syrup: AUST R 79031
This leaflet was revised in October 2016
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