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 being given Epilim IV?
Epilim IV contains the active ingredient sodium valproate. Epilim IV is used for the
treatment of epilepsy in adults and children and mania in adults.
2. What should I know before I am given Epilim IV?
You should not be given Epilim IV if you have ever had an allergic reaction to Epilim
IV or any of the ingredients listed at the end of the CMI.
Epilim IV can seriously harm an unborn child when taken during pregnancy. If you are
a female able to have a baby, you must use an effective method of birth control (contraception)
during your entire treatment with Epilim IV. Schedule an urgent appointment with your
doctor if you want to become pregnant or if you think you became pregnant. Do not
stop taking Epilim IV unless your doctor tells you to, as it may be dangerous for
you.
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 Epilim IV and affect how it works.
4. How am I given Epilim IV?
If you are not currently taking Epilim or any other form of sodium valproate by mouth,
your doctor will decide what dose you will receive, depending on your condition and
other factors such as your weight.
Epilim IV will be given to you as an infusion or injection into the veins.
5. What should I know while I am being given Epilim IV?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Epilim IV.
Plan annual appointments with your specialist.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist.
Ensure you use effective contraception and if you become pregnant while you are being
given this medicine, tell your doctor immediately
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Things you should not do
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If you suffer from mania, do not use Epilim IV if you are pregnant.
If you suffer from epilepsy, do not use Epilim IV if you are pregnant, unless your
doctor has determined that no other treatment works for you
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.
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Driving or using machines
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Epilim IV may cause drowsiness, light-headedness dizziness or sleepiness,
Make sure you know how you react to it before you drive a car, operate machinery or
any activity that requires alertness.
Children should not ride a bike, climb trees or do anything else that could be dangerous
if they are feeling drowsy or sleepy.
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Drinking alcohol
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Avoid alcohol while you are being treated with Epilim IV
Combining Epilim IV and alcohol can make you more sleepy, dizzy or lightheaded.
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Looking after your medicine
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If you need to store Epilim IV before taking it to hospital, make sure it is stored
in a dry place where the temperature does not exceed 30°C.
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6. 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 IV.
Tell your doctor immediately or go to the Accident and Emergency department of your
nearest hospital:
If you or your child develops a sudden illness and particularly if it includes repeated
vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, loss of appetite,
upper stomach pain, nausea, jaundice (yellowing of the skin or whites of the eyes),
swelling of the legs or worsening of your epilepsy or a general feeling of being unwell
If you or your child taking Epilim IV develops problems with balance and co-ordination,
feeling lethargic or less alert, vomiting,
If seizures become worse or happen more frequently
If you have any thoughts of harming yourself or committing suicide
If you think you are pregnant
Active ingredient: sodium valproate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Epilim IV. Read the entire
leaflet carefully before you start taking this medicine. 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 IV.
Where to find information in this leaflet:
1. Why am I being given Epilim IV?
Epilim IV contains the active ingredient sodium valproate. Epilim IV belongs to a group of medicines called anticonvulsants.
Epilim IV is used for the treatment of 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 IV may also be used to control mania, a mental condition with episodes of overactivity,
elation or irritability. Epilim IV should not be used in children and adolescents
under 18 years of age for the treatment of mania.
Epilim IV may be used alone or in combination with other medicines to treat your condition.
Epilim IV may be used short-term in place of oral Epilim tablets or liquid when the
medicine cannot be given by mouth.
Your doctor, however, may have prescribed Epilim IV for another reason.
Ask your doctor if you have any questions about why it has been prescribed for you.
Epilim IV has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their symptoms seem to be the same as yours.
There is no evidence that Epilim IV is addictive.
This medicine is available only with a doctor's prescription.
2. What should I know before I am given Epilim IV?
Warnings
You should not receive Epilim IV if:
Treatment of mania: if you are pregnant
Treatment of epilepsy: if you are pregnant, unless your doctor has determined that
no other treatment works for you
unless you use an effective method of birth control (contraception) at all times during
your treatment with Epilim IV
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 severe hepatitis, especially when caused by medicines. Medicines
used in the treatment of epilepsy, including Epilim IV 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.
hepatic 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 for
example Alpers-Huttenlocher syndrome.
inborn deficiency in carnitine, a very rare metabolic disorder that is untreated.
you are pregnant, unless your doctor has determined no alternative treatment works
for you.
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
liver problems (hepatic insufficiency, hepatic damage)
impaired kidney function as your doctor may want to monitor the valproate level or
adjust your dose
urea cycle disorders because of a risk of increased ammonia level in the blood
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 because you are
at increased risk of muscle disorders
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 because of a risk
of damage to your liver
put on weight as your appetite may be increased
take any medicines for any other condition
If you have not told your doctor about any of the above, tell them before you take
Epilim IV.
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 IV 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 IV during pregnancy. Your doctor will
explain what might happen to your baby if you become pregnant whilst taking Epilim
IV.
You must not take Epilim IV unless you use an effective method of birth control (contraception)
at all times during your treatment with Epilim IV. If you decide later you want to
have a baby, you must not stop taking Epilim IV or your contraception until you have
discussed this with your doctor. Your doctor will advise you further on alternative
treatment options. Your doctor may decide to change the dose of Epilim IV or switch
you to another medicine or stop treatment with Epilim IV several months before you
become pregnant.
If you are a parent or carer, tell your doctor when your child using Epilim IV experiences
her first period.
Epilim IV can be harmful to unborn children when taken by a woman during pregnancy.
It can cause serious birth defects that require medical treatment and can affect physical
and mental development of the child as it grows after birth. The most frequently reported
birth defects include spina bifida (where the bones of the spine are not properly
developed), facial and skull malformations, heart, kidney, urinary and sexual organ
malformations, limb defect, and multiple associated malformations affecting several
organs and parts of the body.
Birth defects may result in disabilities which may be severe. As valproate has been
used for many years, it is known that in women who take valproate during pregnancy
around 11 babies in every 100 will have birth defects. This compares to 2 to 3 babies
in every 100 born to women from the general population. It is estimated that up to
30-40% of children whose mothers took valproate during pregnancy may have problems
with early childhood development. Children affected can be slow to walk and talk,
be intellectually less able than other children, and have difficulties with language
and memory.
Hearing problems or deafness as well as eye malformations in association with other
congenital malformations which may affect vision, have been reported in children exposed
to valproate during pregnancy.
Autistic spectrum disorders are more often diagnosed in children exposed to valproate
during pregnancy and there is some evidence that children exposed to valproate during
pregnancy are at increased risk of developing Attention Deficit Hyperactivity Disorder
(ADHD).
There may also be blood clotting problems, hypoglycemia and hypothyroidism in the
newborn children of mothers who have taken Epilim IV during pregnancy.
Children born to mothers who take Epilim IV throughout their pregnancy may be at risk
of impaired cognitive development or withdrawal syndrome (agitation, irritability,
hyperexcitability, jitteriness, hyperkinesia, tonicity disorders, tremor, seizures
and feeding problems) if Epilim IV is taken during the last trimester of pregnancy.
However, do not stop taking Epilim IV 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 when trying for a baby. Folic acid can lower the general risk of spina bifida
and early miscarriage that exists with all pregnancies. However it is unlikely that
it will reduce the risk of birth defects associated with valproate use.
In exceptional circumstances when Epilim IV is the only available treatment option
during pregnancy, you will be monitored very closely both for the management of your
underlying condition and to check how your unborn child is developing. You and your
partner should receive counselling and support regarding the valproate exposed pregnancy.
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. The
higher the dose, the higher the risks but all doses carry a risk.
Potential risk to children of fathers taking valproate in the 3 months prior to conception
A study suggests that if you take valproate in the 3 months prior to conception, your
child may have a higher risk for impaired mental and/or motor development compared
to children born to fathers who used lamotrigine or levetiracetam, other medicines
that can be used to treat your disease. In this study, around 5 children in 100 had
such disorders when born from fathers treated with valproate, and around 3 children
in 100 when born from fathers treated with the other medicines. There are no data
on this potential risk to children fathered more than 3 months after stopping valproate
treatment (the time needed for new sperm to be formed).
As a precautionary measure, your doctor will discuss with you
The potential risk when fathering a child if you are treated with valproate,
The need to use effective contraception (birth control) for you and your female partner
during the treatment and for 3 months after stopping valproate
The need to consult your doctor to discuss alternative treatment options, as soon
as you are planning to father a child and before discontinuing contraception (birth
control),
To not donate sperm during treatment and for 3 months after stopping treatment.
Do not stop your treatment without talking to your doctor. If you stop your treatment,
your symptoms may become worse. If your female partner becomes pregnant while you
used valproate in the 3 months prior to conception, both of you should contact the
doctor for counseling.
You should get regular (at least annual) appointments with your doctor. During this
visit your doctor will make sure you understand the risk and precautions associated
with valproate use.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Medicines used in the treatment of epilepsy, including Epilim IV, pass into breast
milk. Your doctor will discuss the risks and benefits of taking Epilim IV if you are
breastfeeding or planning to breastfeed.
Contraception use
Use an effective method of contraception and consult your doctor before planning pregnancy.
Epilim IV 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 IV. Some birth control pills (oestrogen containing birth control pills) may
lower valproate levels in your blood. Your doctor should discuss with you the most
appropriate method of contraception for you.
Epilim IV should have little effect on the oral contraceptive pill, however, you should
let your doctor know that you are taking it.
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 Epilim IV 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)
oestrogen containing products or oral contraceptives. Epilim IV 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)
antipsychotic medicines 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. The
combination of Epilim IV and carbapenems should be avoided because it may decrease
the effect of Epilim IV.
rufinamide
colestyramine (Questran Lite)
acetazolamide (Diamox)
protease inhibitors such as lopinavir and ritonavir (used to treat HIV)
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 IV, or worsen adverse reactions,
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
they are given Epilim IV, for example, aspirin or any other drugs used to treat epilepsy.
If your child is under 3 years of age, Epilim IV should not be administered together
with aspirin. Epilim IV can affect the liver and rarely the pancreas in a very small
number of patients. The risk of liver damage is increased if Epilim IV is taken by
your child under 3 years who is taking other antiepileptic medicine at the same time
or has other neurological or metabolic disease and severe form of epilepsy.
Children, especially young children, can be more sensitive to some of the side effects
of Epilim IV.
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 IV.
4. How am I given Epilim IV?
How it is given
Epilim IV will be given to you as an infusion or injection into the veins.
Adults:
If you are currently taking an oral formulation of Epilim (tablets, liquid or syrup)
and are now changing over to Epilim IV, the total daily dose of Epilim IV should remain
the same. In these circumstances, Epilim IV may be given as several separate injections,
drips or infusions throughout the day, or as one long continuous drip or infusion
lasting 24 hours a day.
If you are not currently taking Epilim or any other form of sodium valproate by mouth,
your doctor will decide what dose you will receive, depending on your condition and
other factors such as your weight.
Children:
The dose for children is usually 20 to 30mg for each kg of body weight every day.
If epilepsy is not controlled the dose may be increased up to 40mg for each kg of
body weight every day, as long as blood tests are done to check the amount of Epilim
IV in the blood. If higher doses are needed, further blood tests must be done to check
that Epilim IV is not causing side effects.
If you use too much Epilim IV
Your doctor will decide what dose of Epilim IV you need, and this will be given under
close supervision, usually in a hospital setting.
The risk of an overdosage in these circumstances is low. In the event of an overdose
occurring, your doctor will decide on the treatment necessary.
If you have been given too much Epilim IV, 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
seizures
convulsions
severe headache, blurred vision, blind spot or vision loss
tiredness, confusion, excessive thirst
death
5. What should I know while I am being given Epilim IV?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Epilim IV.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking this medicine.
Call your doctor or nurse straight away if you do not feel well while Epilim IV is
being given to you.
Call your doctor straight away:
If you are or your child develops an allergic reaction, especially with effects on
skin mucosa, and/or fever 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
IV affects you.
Epilim IV may cause drowsiness or light-headedness in some people, especially at the
beginning of treatment or in combination with other antiepileptic medicines or benzodiazepines.
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 IV may cause drowsiness, dizziness or sleepiness in some people and affect
alertness.
Diabetics are advised that Epilim IV 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 you are receiving Epilim IV.
Combining Epilim IV and alcohol can make you more sleepy, dizzy or lightheaded. Your
doctor may suggest you avoid alcohol while you are being treated with Epilim IV.
Looking after your medicine
If you need to store Epilim IV before taking it to hospital, make sure it is stored
in a dry place where the temperature does not exceed 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 a windowsill.
Heat and damp 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 (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.
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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Gastrointestinal related:
nausea or vomiting
abdominal cramps or pain
changes in appetite
changes in your weight
diarrhoea
Mouth related:
bleeding, tender or enlarged gums
sore, swollen mouth, mouth ulcers and burning feeling of mouth
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
tingling or numbness of the hands and feet
hearing problems or deafness
depression
feeling tired or drowsy
memory impairment
confusion
hallucinations
disturbance in attention
changes in behaviour including aggression and agitation
learning disorder
Hormone related:
irregular menstrual periods
acne
male infertility
Other side effects:
hair loss
nail and nail bed disorders
loss of bladder control
decrease in carnitine levels (shown in blood or muscular tests)
reduced levels of vitamin B8
bedwetting
excessive hairiness
decrease in body temperature
inflammation of small blood vessels
bone disorders and fractures
darker areas of skin and mucous membranes (hyperpigmentation)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
These are the more common side effects of Epilim IV. Mostly these are mild and short-lived.
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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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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
drowsiness, change in conscious level (including coma), confusion, sluggishness or
abnormal behaviour and memory loss with or without more frequent or severe fits particularly
if phenobarbital and topiramate are taken at the same time or if the dose of Epilim
IV has been suddenly increased
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 or skin lesions with a pink/red ring and a pale center which may be itchy,
scaly of filled with fluid, especially on the palms or soles of your feet
blisters with skin peeling or bleeding with sometimes flu-like symptoms such as fever,
chills or aching muscle
joint pain
passing a lot of urine and feeling thirsty (Fanconi syndrome)
swelling due to an allergy with painful itchy welts often around the eyes, lips, throat
and sometimes hands and feet
swelling of the feet and legs, weight increase due to fluid build up
syndrome with skin rash, fever, lymph node enlargement and possible impairment of
other organs. These may be signs of a condition called DRESS (Drug Rash with Eosinophilia
and Systemic Symptoms)
underactive thyroid gland which may cause tiredness or weight gain
kidney disease resulting in reduced urinary output
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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 or if you have any
thoughts of harming yourself or committing suicide.
You may need urgent medical attention or hospitalisation.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
If you get any side effects, talk to your doctor or pharmacist immediately. 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.
7. Product details
This medicine is only available with a doctor's prescription.
What Epilim IV contains
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Active ingredient
(main ingredient)
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Each vial contains the active ingredient sodium valproate 400mg.
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Other ingredients
(inactive ingredients)
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Water for injections
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Potential allergens
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None
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Do not take this medicine if you are allergic to any of these ingredients.
What Epilim IV looks like
Epilim IV comes as a white powder in a glass vial.
Each box of Epilim IV contains one glass vial and one ampoule of solvent (water for
injections).
(AUST R 104416)
Who distributes Epilim IV
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
This leaflet was prepared in July 2024
epilim-iv-ccdsv39-cmiv12-05jul24
®Registered trademark