EPILIM 200 GASTRO-RESISTANT TABLETS

Active substance: SODIUM VALPROATE

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Transcript
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 monohydrate (E330), macrogol 6000,
polyvinyl acetate phthalate, diethyl phthalate, stearic acid
(E570), titanium dioxide (E171), Amaranth aluminium lake
(E123), indigo carmine lake (E132) and hydroxypropyl
cellulose (E463))

Epilim® 200mg and 500mg
Gastro-resistant Tablets
sodium valproate
Is this leaflet hard to see or read?
Phone 01483 505515 for help
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 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

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.

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 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.

1. What Epilim is and what it is used
for

This leaflet was last revised in October 2013
© Sanofi 2006-2013

Keep out of the reach and sight of children.

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.

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.

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

5. How to store Epilim

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.

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.

LLET RFED EPILIM UK

LEAFLET
514
30514210
30514209
60101300

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.

396162
09-OCT-13
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RFL 22
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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
Over
felbamate
1

30514210
514

• 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

000
8pt
1
PANTONE
Reflex Blue C

30514210
60101300

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
Over
has been suddenly increased
3

30514210
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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

LLET RFED EPILIM UK

LEAFLET
514
30514210
30514209
60101300
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2 of 2
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RFL 22
N/A
N/A
N/A
000
8pt
1
PANTONE
Reflex Blue C

30514210
60101300

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Epilim® 200mg and 500mg
Gastro-resistant Tablets

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

sodium valproate

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

ammonia builds up in the body
SS 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.

Taking Epilim Crushable 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
felbamate

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

Epilim may increase the effect of the following
medicines:
• Medicines used for thinning the blood (such as
warfarin)
• Zidovudine - used for 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

1. What Epilim is and what it is used for
What Epilim is
The name of your medicine is Epilim 200mg or 500mg
Gastro-resistent Tablets (called Epilim in this leaflet). Epilim
200mg or 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.

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

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

2. Before you take Epilim
Do not take Epilim and tell your doctor if:
xx 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
xx You have liver problems or you or your family have a
history of liver problems
xx You have a rare illness called porphyria

Taking Epilim with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy and breast-feeding

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.

4

PAG 4

Check with your doctor or pharmacist before taking
your medicine if:
SS You have diabetes. This medicine may affect the results
of urine tests.
SS You have kidney problems. Your doctor may give you a
lower dose
SS You have fits (epilepsy), brain disease or a metabolic
condition affecting your brain
SS You have a ‘urea cycle disorder’ where too much

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
1

PAG 1

Sanofi
Riells Packaging Team

For sanofi use only

678608

170 x 315 mm

Take special care with Epilim
A small number of people being treated with antiepileptics such as sodium valproate have had thoughts
of harming or killing themselves. If at any time you have
these thoughts, immediately contact your doctor.

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.

Code :
678608
Update : V3- 6/5/14
Local code :
Current item code:----Product/Item type : EPILIM 200/500 MG
Country :UK
Artwork by : M.Pacho
Plant : Riells
Supplier code :

Technical Data

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 any 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.

UNWIND DIRECTION

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

Blood tests
Your doctor may wish to do blood tests before you start
taking Epilim and during your treatment.

Format : 170 x 315 mm (DC)
Plant barcode :533
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Fonts :Ocean Sans Pro SAN (9pt)
Assembly Card : UHLMANN 1040
Layout of Cutting :
Technical Card :
Technical Constraint :

Reason for change: TRANSFER

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 tube 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).


ome babies born to mothers who took Epilim during
S
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.

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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 this 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 is 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
others 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 agressive, 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 has been suddenly increased
• 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 allucinations or fits
• Blisters with the skin flaking away
• Rapid, uncontrollable movement of the eyes
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

2

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.
Male Fertility
Taking Epilim can be a contributing factor in male
infertility.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Epilim
Keep out of the reach and sight of children.
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.
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 wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.

6. Further Information
What Epilim contain
• 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 monohydrate (E330),
macrogol 6000, polyvinyl acetate phthalate, diethyl
phthalate, stearic acid (E570), titanium dioxide (E171),
amaranth aluminium lake (E123), indigo carmine lake
(E132) and hyfroxypropyl 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: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi-aventis S.A,
Carretera C-35 (La Batlloria-Hostalric), Km 63.09
17404 Riells i Viabrea (Girona)
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.
This leaflet was last revised in May 2014
© Sanofi, 2006-2014

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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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