EPILIM 200 GASTRO-RESISTANT TABLETS

Active substance: SODIUM VALPROATE

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Tell your doctor or pharmacist if any of the following side
effects get serious or lasts longer than a few days, or if you
notice any side effects not listed in this leaflet:
• Feeling sick, stomach ache or diarrhoea, especially when
starting treatment. This may be helped by taking the tablets
with food
• Fainting
• Hearing loss
• Skin problems such as rashes. These happen rarely, but
more often in people also taking lamotrigine
• Acne
• Hair loss which is usually temporary. When it grows back it
may be more curly than before
• Hair, including body or facial hair grows more than normal
in women
• Skin rash caused by narrow or blocked blood vessels
(vasculitis)
• Changes in women's periods and increased hair growth in
women
• Breast enlargement in men
• Swelling of the feet and legs (oedema)
• Weight gain - as your appetite may be increased
• Kidney problems, bedwetting or increased need to pass urine
• Headache
• Aggression, agitation, disturbance in attention, abnormal
behaviour, restlessness/hyperactivity, and learning disorder
• Tingling or numbness in the hands and feet
Bone Disorders
There have been reports of bone disorders including osteopenia
and osteoporosis (thinning of the bone) and fractures. Check with
your doctor or pharmacist if you are on long-term antiepileptic
medication, have a history of osteoporosis, or take steroids.
Blood tests
Epilim can change levels of liver enzymes, salts or sugars
shown up on blood and urine tests.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

6. Further information
What Epilim contains
• Each 200mg gastro-resistant tablet contains 200mg of the
active substance, sodium valproate
• Each 500mg gastro-resistant tablet contains 500mg of the
active substance, sodium valproate
• The other ingredients are povidone (E1201), talc, calcium
silicate (E552), magnesium stearate (E572), hypromellose (E464),
citric acid anhydrous (E330), macrogol 6000, polyvinyl
acetate phthalate, diethyl phthalate, stearic acid (E570),
violet lake solids (containing titanium dioxide (E171),
amaranth lake (E123), indigo carmine lake (E132) and
hydroxypropyl cellulose (E463))
What Epilim looks like and contents of the pack
Epilim tablets are round and lilac coloured. The tablets are
supplied in blister packs of 100
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com

Keep out of the reach and sight of children.

What Epilim contains
Epilim contains sodium valproate. It belongs to a group of
medicines called anti-convulsants or anti-epileptic agents.
It works by helping to calm the brain down.

There are two organisations that will also be happy to try and
answer any general questions on epilepsy. They can be
contacted at:

Do not take this medicine after the expiry date shown on the
blister and carton after EXP. The expiry date refers to the
last day of that month.

Epilepsy Action, New Anstey House, Gate Way Drive, Yeadon,
Leeds, LS19 7XY
Telephone: 0808 800 5050. Website: www.epilepsy.org.uk

Do not remove the tablets from the foil until just before you take
them. Do not cut the blister strips. Store in a dry place below 30°C.
Medicines should not be disposed of via household wastewater
or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help protect
the environment.

Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them even if their symptoms are the
same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

What Epilim is
The name of your medicine is Epilim 200mg and 500mg
Gastro-resistant Tablets (called Epilim in this leaflet). Epilim
200mg and 500mg Gastro-resistant Tablets are "enteric coated"
this means that the tablets have a protective coating that allows
it to reach the intestines (gut) without being dissolved in the
stomach first. This helps stop it from causing a stomach upset.

This leaflet was last revised in November 2012
© Sanofi 2006-2012

5. How to store Epilim

Is this leaflet hard to see or read?
Phone 01483 505515 for help

1. What Epilim is and what it is used
for

This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.

Talk to your doctor or pharmacist if any of the side effects gets
serious or lasts longer than a few days, or if you notice any side
effects not listed in this leaflet.

sodium valproate

In this leaflet:
1. What Epilim is and what it is used for
2. Before you take Epilim
3. How to take Epilim
4. Possible side effects
5. How to store Epilim
6. Further information

Manufacturer
Fawdon Manufacturing Centre,
Edgefield Avenue
Fawdon
Newcastle-upon-Tyne
Tyne & Wear
NE3 3TT
UK

Male Fertility
Taking Epilim can be a contributing factor in male infertility.

Epilim® 200mg and 500mg
Gastro-resistant Tablets

What Epilim is used for
Epilim is used to treat epilepsy (fits) in adults and children.

2. Before you take Epilim

National Society for Epilepsy (NSE), Chesham Lane, Chalfont
St Peter, Bucks, SL9 0RJ
Telephone: 01494 601400. Website: www.epilepsynse.org.uk
4

Do not take Epilim and tell your doctor if:
 You are allergic (hypersensitive) to sodium valproate or any
of the other ingredients of Epilim (see Section 6: Further
information)

Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
 You have liver problems or you or your family have a history
of liver problems
 You have a rare illness called porphyria
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Epilim.

Take special care with Epilim
A small number of people being treated with anti-epileptics
such as sodium valproate have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.
Check with your doctor or pharmacist before taking this
medicine if:
L You have diabetes. This medicine may affect the results of
urine tests
L You have kidney problems. Your doctor may give you a
lower dose
L You have fits (epilepsy), brain disease or a metabolic
condition affecting your brain.
L You have a ‘urea cycle disorder’ where too much ammonia
builds up in the body.
L You have an illness called “systemic lupus erythematosus
(SLE)” - a disease of the immune system which affects skin,
bones, joints and internal organs
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Epilim.
Weight gain
Taking Epilim may make you put on weight. Talk to your doctor
about how this will affect you.
Blood tests
Your doctor may wish to do blood tests before you start taking
Epilim and during your treatment.

Taking Epilim with other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines you
buy without a prescription, including herbal medicines. This is
because Epilim can affect the way some other medicines work.
Also some medicines can affect the way Epilim works.
The following medicines can increase the chance of you
getting side effects, when taken with Epilim:
• Some medicines used for pain and inflammation
(salicylates) such as aspirin
• Some other medicines used to treat fits (epilepsy) – see
page 2, section 3, “Patients taking other medicines
for ‘fits’”. This includes medicines such as
phenobarbital, primidone, phenytoin,
carbamazepine, topiramate, lamotrigine and Turn
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• Changes in the amount of ammonia in the blood.
Symptoms of this condition are being sick, problems with
balance and co-ordination, feeling lethargic or less alert
• Feeling shaky (tremor), sleepy or unsteady when walking or
jerky muscle movements
• Feeling tired or confused with loss of consciousness
sometimes accompanied by hallucinations or fits
• Blisters with the skin flaking away
• Rapid, uncontrollable movement of the eyes

Taking Epilim with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy and breast-feeding
Women who could become pregnant
You should not take this medicine if you are pregnant
or a women of child-bearing age unless explicitly
advised by your doctor.
Before you start taking Epilim, your doctor should discuss
with you the possible problems when it is taken in pregnancy.
• Unplanned pregnancy is not desirable in women taking
Epilim
• You should use an effective method of contraception
and talk to your doctor before planning pregnancy.
Epilim has no effect on how well the oral contraceptive
pill works.
Well before you become pregnant it is important to
discuss pregnancy and epilepsy with your doctor and, if
you have one, your epilepsy specialist. This is to make
sure that you and your doctor agree that you should
have Epilim if you become pregnant.
Women taking Epilim during pregnancy have a higher
risk than other women of having a child with an
abnormality. The chance of abnormalities is increased if
you are also taking other medicines for epilepsy at the
same time. These abnormalities include:
• Head and face deformities including cleft palate (a gap
or depression in the lip)
• Deformities of the bones, including hip dislocation
• Malformations of the arms and legs
• Deformities of the tubes from the bladder to the
penis, where the opening is formed in a different place
• Heart and blood vessel malformations, including heart
defects
• Defects of the lining of the spinal cord
• An abnormality of the spinal cord called ‘Spina bifida’
• Malformations of the urethra

Women who take Epilim during pregnancy may be more
likely to have a baby with spina bifida. Taking folic acid
5mg each day as soon as you stop contraception may
lower the risk of having a baby with spina bifida.
There is also an increased risk of other birth defects. These
other defects can usually be detected in the first 3 months
of the pregnancy using routine antenatal screening blood
tests and ultrasound scans.
Pregnant mothers who take Epilim may have babies with:
• blood clotting problems (such as blood not clotting or not
clotting very well). This may appear as bruising or bleeding
which takes a long time to stop.
• Hypoglycaemia (low blood sugar)
• Hypothyroidism (underactive thyroid gland, which can cause
tiredness or weight gain).
Some babies born to mothers who took Epilim during
pregnancy may develop less quickly than normal or have
autistic disorders. These children may require additional
educational support.
Talk to your doctor before you stop taking Epilim if you
want to become pregnant. Do not stop taking Epilim
suddenly, as it is likely that your fits will come back.
Women who are planning to get Pregnant
If you become pregnant, think you may be pregnant or plan
to become pregnant while taking Epilim, you must tell your
doctor straight away.
• Your doctor will give you appropriate counselling
and will suggest changes to your treatment or dose
• He or she will also want to check your progress
while you are pregnant
It is very important that you discuss your treatment with
your doctor well before you become pregnant.
Breast-feeding
Very little Epilim gets into the breast milk. However, talk to
your doctor about whether you should breast-feed your baby.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines:
You may feel sleepy when taking Epilim. If this happens to you,
do not drive or use any tools or machines. Taking other
medicines used to treat fits or calm emotional and mental
health problems may increase sleepiness.

3. How to take Epilim
Always take Epilim exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Your doctor will decide how much Epilim to give you or
your child depending on your or your child’s body weight
• Take this medicine by mouth
• Do not crush or chew the tablets
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself but ask your doctor
How to take this medicine
• The dose is normally split and given half in the morning and
half in the evening
2

How much to take
Adults (including the elderly)
• The starting dose is 600mg daily. Your doctor should
gradually increase this dose by 200mg every 3 days
depending on your condition
• The usual dose is between 1000mg and 2000mg
(20-30mg per kilogram of body weight) each day
• This may be increased to 2500mg each day depending
on your illness
Children over 20 kilograms
• The starting dose should be 400mg daily. Your doctor
should increase this dose depending on your child’s illness
• The usual dose is then between 20mg and 30mg for
each kilogram of body weight each day
• This may be further increased to 35mg for each kilogram
of body weight each day depending on your child’s illness
Children under 20 kilograms
• The usual dose is 20mg for each kilogram of body weight
each day
• Depending on the child’s condition your child’s doctor
may decide to increase the dose
Patients with kidney problems
• Your doctor may decide to adjust your or your child’s dose
Patients taking other medicines for ‘fits’ (epilepsy)
• You or your child may be taking other medicines for
epilepsy at the same time as Epilim. If so, your doctor
should gradually initiate treatment depending on you or
your child’s condition
• Your doctor may increase the dose of Epilim by 5 to
10mg for each kilogram of body weight each day
depending on which other medicines you are taking
If you take more Epilim than you should
If you take more Epilim than you should, tell a doctor or go to
a hospital casualty department straight away. Take the
medicine pack with you. This is so the doctor knows what you
have taken.
The following effects may happen: feeling sick or being sick,
pupils of the eye become smaller, dizziness, loss of
consciousness, weak muscles and poor reflexes, breathing
problems, headaches, fits (seizures), confusion, memory loss
and unusual or inappropriate behaviour.
If you forget to take Epilim
If you forget to take a dose, take it as soon as you remember.
However, if it nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Epilim
Keep taking until your doctor tells you to stop. Do not stop
taking Epilim just because you feel better. If you stop your fits
may come back.
Tests
Make sure you or your child keep your regular appointments
for a check up. They are very important as your or your child’s
dose may need to be changed. Epilim can change the levels of
liver enzymes shown up in blood tests. This can mean that your
or your child’s liver is not working properly.
If you or your child go into hospital or visit another doctor or a
dentist, tell them you are taking Epilim.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Epilim can cause side effects, although not
everybody gets them.
Tell your doctor straight away if you notice any of the
following serious side effects - you may need urgent
medical treatment:
• You have an allergic reaction. The signs may include: a rash,
joint pain, fever (systemic lupus erythematosus), swallowing
or breathing problems, swelling of your lips, face, throat or
tongue. Hands, feet or genitals may also be affected. More
severe allergic reactions can lead to lymph node
enlargement and possible impairment of other organs.
• Liver problems and problems of the pancreas may show as a
sudden illness which may happen in the first six months of
treatment. This happens in a very small number of people
taking Epilim. It includes feeling and being sick many times,
being very tired, sleepy and weak, stomach pain including very
bad upper stomach pain, jaundice (yellowing of the skin or
whites of the eyes), loss of appetite, swelling (especially of the
legs and feet but may include other parts of the body),
worsening of your fits or a general feeling of being unwell
Your doctor may tell you to stop taking Epilim immediately if
you have these symptoms
• You have a skin rash or skin lesions with a pink/red ring and
a pale centre which may be itchy, scaly or filled with fluid.
The rash may appear especially on the palms or soles of
your feet. These could be signs of a serious allergy to the
medicine called ‘erythema multiforme’
• Blistering or bleeding of the skin around the lips, eyes,
mouth, nose and genitals. Also flu-like symptoms and fever.
This may be something called ‘Stevens-Johnson syndrome’
• Severe blistering rash where layers of the skin may peel off to
leave large areas of raw exposed skin over the body. Also a feeling
of being generally unwell, fever, chills and aching muscles. This
may be something called ‘Toxic epidermal necrolysis’
• Bruising more easily and getting more infections than usual.
This could be a blood problem called ‘thrombocytopenia’.
It can also be due to a fall in the number of white blood cells,
bone marrow depression or another condition that affects
red blood cells, white blood cells and platelets (pancytopenia)
or how the blood clots
• Blood clotting problems (bleeding for longer than normal),
bruising or bleeding for no reason
• Changes in mood, loss of memory, lack of concentration
and deep loss of consciousness (coma)
• Underactive thyroid gland, which may cause tiredness or
weight gain (hypothyroidism)
• Breathing difficulty and pain due to inflammation of the
lungs (pleural effusion)
Tell your doctor as soon as possible if you have any of the
following side effects:
• Changes in behaviour including being very alert, and sometimes
also aggressive, hyper-active and unusual or inappropriate
behaviour. This is more likely if other medicine to treat fits
such as phenobarbital and topiramate are taken at the
same time or if the Epilim starting dose is high or
Turn
has been suddenly increased
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Epilim may increase the effect of the following
medicines:
• Medicines used for thinning the blood (such as warfarin)
• Zidovudine used to treat HIV infection
• Temozolomide used to treat cancer
• Medicines for depression
• Monoamine oxidase inhibitors (MAOI) such as
moclobemide, selegiline, linezolid
• Medicines used to calm emotional and mental
conditions such as diazepam and olanzapine
The following medicines can affect the way Epilim works:
• Some medicines used for the prevention and treatment
of malaria such as mefloquine and chloroquine
• Cimetidine used for stomach ulcers
• Carbapenem agents (antibiotics used to treat bacterial
infections) such as imipenem, meropenem, rifampicin
and erythromycin. The combination of Epilim and
carbapenems should be avoided because it may decrease
the effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol) levels

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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