Epilim(R) Sodium Valproate
Consumer Medicine Information
What is in this leaflet This leaflet answers some common questions about Epilim.
It does not contain all of 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 your taking Epilim against the benefits they expect it
will have for you.
Plea read this leaflet very carefully before you start to take your Epilim, even if you have taken Epilim before.
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 Epilim is ud for Epilim is a medicine ud to for the treatment of epilepsy in adults and children.
Epilepsy is a condition where you have repeated izures (fits). There are many different types of izures, ranging from mild to vere.
Epilim belongs to a group of medicines called anticonvulsants. The medicines are thought to work by controlling brain chemicals which nd signals to nerves so that izures do not happen. Epilim may also be ud to control
mania, a mental condition with
episodes of overactivity, elation or
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irritability.
Epilim may be ud alone or in
combination with other medicines to
treat your condition.
Your doctor, however, may have
prescribed Epilim for another reason.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
There is no evidence that Epilim is
addictive.
This medicine is available only with
a doctor's prescription.
Before you take it
When you must not take it
Do not take it if you have or have
had any of the following medical
conditions:
*liver dia (hepatic
dysfunction) or vere hepatitis.
* a family history of hepatitis,
especially when caud by
medicines. Medicines ud in the
treatment of epilepsy, including
Epilim may have adver 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
dia of blood pigments
*known ornithine
transcarbamyla deficiency or a
family history of ornithine
transcarbamyla deficiency.
Do not take Epilim if you are
allergic to it or any of the
ingredients listed at the end of this
leaflet.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cau
difficulty in swallowing or
breathing.
Do not take it after the expiry date
(EXP) printed on the pack.
If you take this medicine after the
expiry date has pasd, it may not
work as well.
Do not take it if the packaging is torn
ppt插入动图or shows signs of tampering.
Before you start to take it
Tell your doctor or pharmacist if
you have allergies to:
*any of the ingredients listed at the
end of this leaflet
*any other medicines
*any other substances, such as
foods, prervatives or dyes
If you are a female patient of
child-bearing age, make sure that
you talk to your doctor about the
risks associated with taking Epilim
during pregnancy.
Tell your doctor if you are
pregnant or intend to become
pregnant.
Like most medicines of this kind,
Epilim may affect your developing
baby if taken in the first trimester of
pregnancy, as it is suspected of
causing an incread risk of malformations in the expod foetus. 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.
Tell your doctor if you are breastfeeding or planning to breastfeed.
Medicines ud in the treatment of epilepsy, including Epilim, pass into breast milk. Your doctor will discuss the risks and benefits of taking it if you are breastfeeding or planning to breastfeed.
Tell your doctor if you drink alcohol. If you have more than 2 drinks per day, you may be putting your
lf at risk of a izure, or fit. Tell your doctor if you have or have had any medical conditions, especially the following:
*liver problems (hepatic花开头成语
insufficiency, hepatic damage) *kidney problems
*urea cycle disorders
*ornithine transcarbamyla
(OTC) deficiency
Tell your doctor if you plan to have surgery.
If you have not told your doctor about any of the above, tell them before you take Epilim.
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 store.
Some medicines and Epilim may interfere with each other. The include:
*aspirin (and other salicylates) *medicines ud to prevent clots
(anticoagulants) e.g. warfarin.
*other medicines ud to treat
phenobarbitone,
methylphenobarbitone,
primidone, phenytoin,
carbamazepine, clonazepam,
felbamate, lamotrigine, diazepam,
lorazepam, oxcarbamazepine and
ethosuximide
*medicines ud to treat
monoamine
oxida inhibitors (MAOIs),
lective rotonin reuptake
inhibitors (SSRIs), tricyclic
antidepressants.
*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 (a medicine ud to
treat viral infections).
*neuroleptic agents including
clozapine (a medicine ud to
treat schizophrenia).
*mefloquine (a medicine ud to
treat malaria).
*cimetidine (ud to treat stomach
ulcers).
*erythromycin and carbapenem
antibiotics such as Invanz and
Merram.
The 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 advi 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 ud to treat
epilepsy.
Children, especially young children,
can be more nsitive to some of the
side effects of Epilim.
Your doctor and pharmacist have
more information on medicines to be
careful with or avoid while taking
Epilim.
How to take it
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 do of Epilim
and slowly increa the do to the
lowest amount needed to control
your condition.
Ask your doctor or pharmacist if
you are unsure of the correct do
for you.
They will tell you exactly how much
to take.
Follow the instructions they give
you.
If you take the wrong do, Epilim
may not work as well.
How to take it
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 to stop them dissolving until
they have gone through the stomach
and into the intestines . If you 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 do into a medicine measure before taking it. Shaking the bottle and using a medicine measure will make sure you get the correct do. You can get a medicine measure from your pharmacist.
When to take it
Your doctor will advi you when to take Epilim.
Always follow your doctor's instructions.
Take Epilim at about the same time each day.
Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.
If you are not sure when to take it, ask your doctor.
How long to take it
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.
If you forget to take it
Always remember to take your prescribed do otherwi you may find that either your izures or manic symptoms may return.
If you forget a do, take your next do as usual. Do not take a double do to make up for the do that you misd.
This may increa the chance of your getting unwanted side effects.
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
消毒隔离制度(overdo)
Immediately telephone your
doctor, or the Poisons Information
Centre (telephone Australia 13 11
26 or New Zealand 0800 POISON
or 0800 764 766), or go to Accident
and Emergency at your nearest
hospital, if you think that you or
anyone el may have taken too
much Epilim.
Do this even if there are no signs of
discomfort or poisoning.
You may need urgent medical
attention.
If you take too much Epilim you may
feel dizzy, drowsy or have cramps in
the abdomen.
While you are taking it
Things you must do
Tell all the doctors, dentists and
pharmacists who are treating you
that you are taking Epilim.
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.
If you become pregnant while you
are taking this medicine, tell your
doctor immediately.
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.
Things you must not do
Do not take more than the
recommended do unless your
doctor tells you to.
Do not give this medicine to
anyone el, even if they have the
same condition as you.
Do not u this medicine to treat
any other complaints unless your
doctor tells you to.
Do not stop taking Epilim, or
lower the dosage, without checking
with your doctor.
Things to be careful of
Be careful driving or operating
machinery until you know how
Epilim affects you.叶欣的故事
It may cau drowsiness or
light-headedness in some people,
祝福词语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
el that could be dangerous if you
are drowsy or light headed.
Children should not ride a bike,
climb trees or do anything el that
could be dangerous if they are
feeling drowsy or sleepy.
Epilim may cau drowsiness,
dizziness or sleepiness in some
people and affect alertness.
Diabetics are advid that Epilim
Syrup contains 3.6 g/5 mL of sucro
(sugar).
The effects of alcohol could be
made wor while taking Epilim.
Combining it and alcohol can make
you more sleepy, dizzy or
lightheaded. Your doctor may
suggest you avoid alcohol while you
are treated with Epilim.
What do I need to consider
about contraception?
Unplanned pregnancy may not be
desirable in patients receiving
medicines for epilepsy or mania.
You should u an effective method
of contraception and consult your
doctor before planning pregnancy;
for example, your doctor may want
you to start taking folate tablets.
Epilim should have little effect on
the oral contraceptive pill, however,
you should let your doctor know that
you are taking it.
Side effects
All medicines have some unwanted side effects. Sometimes they are rious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Epilim.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
*naua or vomiting
*abdominal cramps
*changes in appetite
*changes in your weight
*diarrhoea
*headache
*tremor
*unsteadiness when walking,
dizziness or light-headedness
*depression
*hair loss
*feeling tired or drowsy
The are the more common side effects of Epilim. Mostly the are mild and short-lived.
Tell your Doctor immediately or
go to the Accident and Emergency department of your nearest hospital if you have any thoughts
of harming yourlf or committing suicide.
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 vere izures (fits)
贴怎么组词*blood clotting problems
*spontaneous bruising or bleeding *rashes
*signs of liver 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
*swelling of the feet and legs,
weight increa due to fluid build
up
*fainting
*bizarre behaviour
*suicidal thoughts
*suicide attempts
*vere upper stomach pain, often
with naua and vomiting
The are very rious side effects.
You may need urgent medical
attention or hospitalisation.
The side effects are rare.
Tell your doctor if you notice
anything el that is making you
feel unwell.
Other side effects not listed above
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may also happen in some patients.
Some of the side effects can only
be found when your doctor does tests
from time to time to check your
progress.
Ask your doctor to answer any
questions you may have.
After taking it
If you have any queries about any
aspect of your medicine, or any
questions regarding the
information in this leaflet, discuss
them with your doctor or
pharmacist.
Storage
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
degrees C.
Keep Epilim Syrup and Liquid in a
cool dry place where the
temperature stays below 25
degrees C.
Do not store it or any other
medicine in the bathroom, near a
sink, or on a windowsill.
Do not leave it in the car.
Heat and damp 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 tells you to stop
taking Epilim, or the medicine has
pasd its expiry date, ask your
pharmacist what to do with any
that are left over.
Return any unud medicine to
your pharmacist.
Product description
What it 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.
Ingredients
Active 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
Inactive Ingredients:
Epilim 100 mg Crushable tablets -Maize starch, silicon dioxide, kaolin, magnesium stearate
Epilim EC200 - Povidone, talc, magnesium stearate, calcium silicate, citric acid, macrogol, hypromello, polyvinyl acetate phthalate, diethyl phthalate, stearic acid, amaranth, indigo carmine, titanium dioxide Epilim EC500 - Povidone, talc, magnesium stearate, calcium silicate, citric acid, macrogol, hypromello, polyvinyl acetate phthalate, diethyl phthalate, stearic acid, amaranth, indigo
carmine, titanium dioxide Epilim Syrup - Sucro, sorbitol, saccharin sodium, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, brilliant scarlet
4R, imitation cherry flavour, water. Epilim Liquid Sugar Free - Sorbitol, saccharin sodium, citric acid, hydroxyethylcellulo, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, brilliant scarlet 4R, imitation cherry flavour, water.
Manufacturer/Sponsor
Epilim is supplied in Australia by: sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113 Epilim is supplied in New Zealand
by:
sanofi-aventis new zealand limited Level 8, James & Wells Tower
56 Cawley Street
Ellerslie
Auckland
This document was prepared in March 2009. Australian Register Numbers: 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
(R)Registered trademark
