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.
Why am I using Epilim?
Epilim contains the active ingredient sodium valproate. Epilim is used to treat epilepsy
in adults and children.
What should I know before I use Epilim?
Do not use if you have ever had an allergic reaction to Epilim 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.
What if I am taking other medicines?
Some medicines may interfere with Epilim and affect how it works.
How do I use Epilim?
Your doctor will tell you how much to take. This may depend on your age, your condition
and whether or not you are taking any other medicines.
What should I know while using Epilim?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Epilim.
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 this medicine, tell your doctor immediately
|
|
Things you should not do
|
Do not stop using this medicine suddenly or lower the dosage, without checking with
your doctor.
Do not take more than the recommended dose unless your doctor tells you to.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how Epilim affects you.
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
|
The effects of alcohol could be made worse while taking Epilim.
Combining Epilim and alcohol can make you more sleepy, dizzy or lightheaded.
|
|
Looking after your medicine
|
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Keep your tablets in the blister pack until it is time to take them.
|
Are there any side effects?
All medicines have some unwanted side effects. Mostly these are mild and short-lived.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Epilim.
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.
Active ingredient:
sodium valproate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Epilim. 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 Epilim.
Where to find information in this leaflet:
Why am I using Epilim?
Epilim contains the active ingredient sodium valproate. Epilim belongs to a group of medicines called anticonvulsants.
Epilim is used to treat epilepsy in adults and children.
Epilepsy is a condition where you have repeated seizures (fits). There are many different
types of seizures, ranging from mild to severe. These medicines are thought to work
by controlling brain chemicals which send signals to nerves so that seizures do not
happen.
Epilim may also be used to control mania, a mental condition with episodes of overactivity,
elation or irritability. Epilim may be used alone or in combination with other medicines
to treat your condition. Your doctor, however, may have prescribed Epilim for another
reason.
There is no evidence that Epilim is addictive.
What should I know before I use Epilim?
Warnings
Do not use Epilim if:
you are allergic to sodium valproate, or any of the ingredients listed at the end
of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have or have had any of the following medical conditions:
liver disease (hepatic dysfunction) or severe hepatitis.
a family history of hepatitis, especially when caused by medicines. Medicines used
in the treatment of epilepsy, including Epilim may have adverse effects on the liver
and the kidneys
a urea cycle disorder or a family history of urea cycle disorders.
a family history of unexplained infant deaths.
porphyria which is a rare blood disease of blood pigments.
known ornithine transcarbamylase deficiency or a family history of ornithine transcarbamylase
deficiency.
known or suspected of having a genetic problem causing a mitochondrial disorder.
you are pregnant, unless your doctor has determined no alternative treatment works
for you.
Check with your doctor if you:
have any other medical conditions, especially the following:
liver problems (hepatic insufficiency, hepatic damage)
kidney problems
urea cycle disorders
ornithine transcarbamylase (OTC) deficiency
an inborn deficiency in carnitine (a very rare metabolic disease) that is untreated,
also called carnitine palmitoyltransferase (CPT) type II deficiency
an inborn deficiency in carnitine and are taking carnitine
have impaired dietary intake in carnitine, found in meat and dairy products, especially
in children less than 10 years old
systemic lupus erythematosus (SLE) (a disease affecting the skin, joints and kidneys)
family history of a genetic problem causing mitochondrial disorder
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
Tell your doctor immediately if you are pregnant or intend to become pregnant.
You must not use Epilim if you are pregnant, unless your doctor has determined that
no alternative treatment works for you.
If you are a girl or woman of childbearing age, make sure that you talk to your doctor
about the risks associated with taking Epilim during pregnancy.
You must not take Epilim unless you use an effective method of birth control (contraception)
at all times during your treatment with Epilim. Do not stop taking Epilim or your
contraception until you have discussed this with your doctor. Your doctor will advise
you further.
If you are a parent or carer, tell your doctor when your child using Epilim experiences
her first period.
Epilim can be harmful to unborn children when taken by a woman during pregnancy. It
can cause serious birth defects and can affect physical and mental development of
the child as it grows after birth. Also, children born to mothers who take Epilim
throughout their pregnancy may be at risk of impaired cognitive development or withdrawal
syndrome. However, do not stop taking Epilim unless your doctor says so as there are
risks to the mother and child from uncontrolled epilepsy or uncontrolled mania episodes.
Your doctor may want to adapt your treatment and/or prescribe dietary supplements
of folate.
Your doctor will discuss the risks and benefits of taking it if you are pregnant including
when valproate is used in combination with other medicines to treat epilepsy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Medicines used in the treatment of epilepsy, including Epilim, pass into breast milk.
Your doctor will discuss the risks and benefits of taking Epilim if you are breastfeeding
or planning to breastfeed.
Contraception use
Use an effective method of contraception and consult your doctor before planning pregnancy.
Epilim can seriously harm an unborn child when taken during pregnancy. If you are
a girl or woman of childbearing age, you must use at least one effective method of
birth control (contraception) without interruption during your entire treatment with
Epilim. Your doctor should discuss with you the most appropriate method of contraception
for you.
Epilim should have little effect on the oral contraceptive pill, however, you should
let your doctor know that you are taking it.
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 Epilim and affect how it works.
These include:
aspirin (and other salicylates)
medicines used to prevent clots (anticoagulants) e.g. warfarin.
other medicines used to treat epilepsy e.g. phenobarbital (phenobarbitone), methylphenobarbitone,
primidone, phenytoin, carbamazepine, clonazepam, felbamate, lamotrigine, topiramate,
diazepam, lorazepam, oxcarbamazepine, rifunamide and ethosuximide
medicines used to treat depression e.g. monoamine oxidase inhibitors (MAOIs), selective
serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants
benzodiazepines (medicines used as sedatives or to treat anxiety)
oral contraceptives. Epilim should have little effect on the oral contraceptive pill,
however, you should let your doctor know that you are taking it.
zidovudine or any other anti-viral medications
cannabidiol (used to treat epilepsy and other conditions)
neuroleptic agents including clozapine (a medicine used to treat schizophrenia)
quetiapine or olanzapine (medicines used to treat bipolar disorder and schizophrenia)
mefloquine (a medicine used to treat malaria)
propofol (a medicine used before and during general anaesthesia)
nimodipine (a medicine used to help blood flow to the brain)
cimetidine (used to treat stomach ulcers)
erythromycin, rifampicin and carbapenem antibiotics such as Invanz and Merrem
colestyramine (Questran Lite)
acetazolamide (Diamox)
metamizole (a medicine used to treat pain and fever)
methotrexate (used to treat cancer and inflammatory diseases)
some anti-infectives that contain pivalate (e.g., pivampicillin, adefovir dipivoxil)
These medicines and others may be affected by Epilim, 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.
Tell your doctor or pharmacist if your child is taking any other medicines before
you start giving them Epilim, for example, aspirin or any other drugs used to treat
epilepsy.
Children, especially young children, can be more sensitive to some of the side effects
of Epilim.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Epilim.
How do I use Epilim?
How much to take
Your doctor will tell you how much to take and in what form (liquids or tablets) you
should take it. This may depend on your age, your condition and whether or not you
are taking any other medicines.
Your doctor may recommend that you start with a low dose of Epilim and slowly increase
the dose to the lowest amount needed to control your condition.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take
Follow the instructions provided and use Epilim until your doctor tells you to stop.
If you take the wrong dose, Epilim may not work as well.
When to take Epilim
Epilim should be taken at about the same time each day.
Taking your tablets at the same time each day will have the best effect. It will help
you remember when to take the tablets.
Continue taking your medicine for as long as your doctor tells you.
Epilim helps control your condition but does not cure it. Therefore, you must take
it every day.
How to take Epilim
Epilim Tablets (white tablets)
Epilim tablets may be taken twice a day.
Swallow the tablets whole with a full glass of water or other liquid or take them
with food.
The tablets may be crushed and taken with food or drinks
Do not take them with "fizzy" water, soda or soft drinks.
Epilim EC Tablets (lilac tablets)
Swallow the lilac tablets (EC200 and EC500) whole with a glass of water or other liquid.
Do not crush or chew the tablets.
The lilac tablets have a special coating If you crush or chew them the coating is
destroyed.
Epilim Syrup and Liquid
Epilim Syrup and Sugar-Free Liquid should be taken 2-3 times a day.
Shake the bottle well and accurately pour the dose into a medicine measure before
taking it.
Shaking the bottle and using a medicine measure will make sure you get the correct
dose. You can get a medicine measure from your pharmacist.
If you forget to use Epilim
Epilim should be used regularly at the same time each day. If you miss your dose at
the usual time, take your next dose as usual.
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. This may increase the
chance of you getting unwanted side effects.
Always remember to take your prescribed dose otherwise you may find that either your
seizures or manic symptoms may return.
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
some hints.
If you use too much Epilim
If you think that you have used too much Epilim, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia), or (by calling 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.
If you take too much Epilim, you may experience:
reduction in consciousness possibly leading into coma
shortness of breath
muscle weakness
shrinking of the pupil in the eye
too much acid in the body, causing fast breathing, confusion, tiredness, headache,
yellowing of the skin (jaundice) and increased heart rate
dizziness, lightheadedness
collapse due to very low blood pressure
convulsions
severe headache, blurred vision, blind spot or vision loss
tiredness, confusion, excessive thirst
death
What should I know while using Epilim?
Things you should do
If you are about to be started on any new medicine, tell your doctor that you are
taking Epilim.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking this medicine.
Be sure to keep all of your doctors' 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 prevent unwanted side effects.
Call your doctor straight away if you:
If you become pregnant while you are taking this medicine
Remind any doctor, dentist or pharmacist you visit that you are using Epilim.
All mentions of suicide or violence must be taken seriously. Tell your doctor or a
mental health professional immediately if you have any suicidal thoughts or other
mental/mood changes.
Things you should not do
Do not stop using this medicine suddenly, or lower the dosage, without checking with
your doctor.
Do not take more than the recommended dose unless your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
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 Epilim
affects you.
Epilim may cause drowsiness or light-headedness in some people, especially at the
beginning of treatment. Make sure you know how you react to it before you drive a
car, operate machinery, or do anything else that could be dangerous if you are drowsy
or light-headed.
Children should not ride a bike, climb trees or do anything else that could be dangerous
if they are feeling drowsy or sleepy.
Epilim may cause drowsiness, dizziness or sleepiness in some people and affect alertness.
Diabetics are advised that Epilim Syrup contains 3.6 g/5 mL of sucrose (sugar).
Drinking alcohol
Tell your doctor if you drink alcohol.
If you have more than 2 drinks per day, you may be putting yourself at risk of a seizure,
or fit.
The effects of alcohol could be made worse while taking Epilim.
Combining Epilim and alcohol can make you more sleepy, dizzy or lightheaded. Your
doctor may suggest you avoid alcohol while you are being treated with Epilim.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the box or the blister pack they may not keep well.
Keep Epilim and Epilim EC tablets in a cool dry place where the temperature stays
below 30°C.
Keep Epilim Syrup and Liquid in a cool dry place where the temperature stays 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.
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 (EXP) printed on the pack. If you take
this medicine after the expiry date has passed, it may not work as well.
Do not use it if the packaging is torn or shows signs of tampering.
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
|
Less serious side effects
|
What to do
|
|
Gastrointestinal related:
nausea or vomiting
abdominal cramps or pain
changes in appetite
changes in your weight
diarrhoea
Mouth related:
bleeding, tender or enlarged gums
Head and neurology related:
headache
unusual movements, including tremor and shaking
rapid uncontrollable movements of the eye or double vision
unsteadiness when walking, dizziness or light-headedness
depression
feeling tired or drowsy
memory impairment
confusion
hallucinations
disturbance in attention
changes in behaviour including aggression and agitation
Hormone related:
irregular menstrual periods
Other side effects:
hair loss
nail and nail bed disorders
loss of bladder control
decrease in carnitine levels (shown in blood or muscular tests)
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Gastrointestinal related:
severe upper stomach pain, often with nausea and vomiting
Blood related:
blood clotting problems
spontaneous bruising or bleeding
signs of decreased white blood cells or bone marrow problems such as fever and breathing
difficulty
signs of increased ammonia in the blood such as problems with balance and co-ordination,
feeling lethargic or less alert, vomiting
Head and neurology related:
more frequent or more severe seizures (fits)
fainting
bizarre behaviour
suicidal thoughts
suicide attempts
Liver related:
signs of liver and pancreas problems such as vomiting, loss of appetite, generally
feeling unwell, tiredness, yellowing of the skin and/or eyes, dark urine or blood
in urine, pain in the abdomen
Other side effects:
rashes
joint pain
passing a lot of urine and feeling thirsty (Fanconi syndrome)
swelling of the feet and legs, weight increase due to fluid build up
|
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 or if you have any
thoughts of harming yourself or committing suicide.
You may need urgent medical attention or hospitalisation.
|
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 as follows: Australia: 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.
Product details
This medicine is only available with a doctor's prescription.
What Epilim contains
|
Active ingredient
(main ingredient)
|
Epilim 100 mg Crushable tablets - 100 mg sodium valproate
Epilim EC200 - 200 mg sodium valproate
Epilim EC500 - 500 mg sodium valproate
Epilim Syrup - 200 mg/5 mL sodium valproate
Epilim Liquid Sugar Free - 200 mg/5 mL sodium valproate
|
|
Other ingredients
(inactive ingredients)
|
Epilim 100 mg Crushable tablets - Maize starch, silicon dioxide, kaolin, magnesium
stearate
Epilim EC200 - Povidone, purified talc, magnesium stearate, calcium silicate, citric
acid monohydrate, macrogol 6000, hypromellose, polyvinyl acetate phthalate, hyprolose,
diethyl phthalate, stearic acid, amaranth aluminium lake, indigo carmine aluminium
lake, titanium dioxide
Epilim EC500 - Povidone, purified talc, magnesium stearate, calcium silicate, citric
acid monohydrate, macrogol 6000, hypromellose, polyvinyl acetate phthalate, hyprolose,
diethyl phthalate, stearic acid, amaranth aluminium lake, indigo carmine aluminium
lake, titanium dioxide
Epilim Syrup - Sucrose, sorbitol, saccharin sodium, sodium methyl hydroxybenzoate,
sodium propyl hydroxybenzoate, brilliant scarlet 4R, imitation cherry flavour, purified
water.
Epilim Liquid Sugar Free - Sorbitol, saccharin sodium, citric acid, hyetellose, sodium
methyl hydroxybenzoate, sodium propyl hydroxybenzoate, brilliant scarlet 4R, imitation
cherry flavour, purified water
|
|
Potential allergens
|
-
|
Do not take this medicine if you are allergic to any of these ingredients.
What Epilim looks like
Epilim 100 mg Crushable tablets - White, round, scored tablets.
Epilim EC200 - Lilac, round, enteric-coated tablets.
Epilim EC500 - Lilac, round, enteric-coated tablets.
Epilim Syrup - Red, cherry flavoured syrup.
Epilim Liquid Sugar Free - Red, cherry flavoured liquid.
The tablets are available in boxes of 100 tablets.
Epilim Syrup and Liquid are available in 300 mL bottles.
(Epilim 100 mg Crushable tablets - AUST R 15373)
(Epilim EC200 - AUST R 15369)
(Epilim EC500 - AUST R 15370)
(Epilim Syrup - AUST R 15372)
(Epilim Liquid Sugar Free - AUST R 74711)
Who distributes Epilim
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 September 2022
epilim-ccdsv31-34-35-cmiv19-01sep22
®Registered trademark