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EPILIM 200 GASTRO-RESISTANT TABLETS

Active substance: SODIUM VALPROATE

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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 eff
ects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the Yellow
Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing
Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more
information on the safety of this medicine.
.

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 December 2014
© Sanofi, 2006-2014
There are two organisations that will also be happy to
try and answer any general questions on epilepsy. They
can be
contacted at:
Epilepsy Action, New Anstey House, Gate Way Drive,
Yeadon, Leeds, LS19 7XY
Telephone: 0808 800 5050. Website:
www.epilepsy.org.uk
National Society for Epilepsy (NSE), Chesham Lane,
Chalfont St Peter, Bucks, SL9 0RJ
Telephone: 01494 601400.
Website:www.epilepsynse.org.uk

Epilim® 200mg and 500mg
Gastro-resistant Tablets

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.

sodium valproate

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.

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

‚

This medicine is subject to additional
monitoring. This will allow quick identification of new
safety information. You can help by reporting any side
effects you may get. See the end of section 4 for how to
report side effects
WARNING
Valproate can cause birth defects and problems with
early development of the child if it is taken during
pregnancy. If you are a female of childbearing age
you should use an effective method of contraception
throughout your treatment.
Your doctor will discuss this with you but you should
also follow the advice in section 2 of this leaflet. Tell
your doctor at once if you become pregnant or think
you might be pregnant.
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Epilim is and what it is used for
2. What you need to know before you take Epilim
3. How to take Epilim
4. Possible side effects
5. How to store Epilim
6. Contents of the pack and other information

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.

5. How to store Epilim
Keep out of the sight and reach 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.

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.

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.

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

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.

678907

170 x 315 mm

2. What you need to know before you take
Epilim

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xx You have a rare illness called porphyria

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: Contents of the pack and other 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

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
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.
Blood tests
Your doctor may wish to do blood tests before you start
taking Epilim and during your treatment.
Other medicines and Epilim
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
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
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
Taking Epilim with food and drink
Alcohol intake is not recommended during treatment.
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Sanofi
Riells Packaging Team
Code :
678907
Update : V6- 17/12/14
Local code :
Current item code: 678608
Product/Item type : EPILIM 200/500 MG
Country :UK
Artwork by : M.Pacho
Plant : Riells
Supplier code :

Technical Data

Blood tests
Epilim can change levels of liver enzymes, salts or
sugars shown up on blood and urine tests.

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)

PACKAGE LEAFLET: INFORMATION FOR THE USER

UNWIND DIRECTION

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.

6. Contents of the pack and other information

For sanofi use only

• 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

Format : 2 x 170 x 315 mm (DC)
Plant barcode :833
Colours : 2
- REFLEX BLUE
- BLACK
Fonts : Ocean Sans Pro SAN (9pt)
Assembly Card : UHLMANN 1040/1
Layout of Cutting :
Technical Card :
Technical Constraint :

Reason for change: R.Text

Pregnancy and breast-feeding
Important advice for women
• Valproate can be harmful to unborn children
when taken by a woman during pregnancy.
• Valproate carries a risk if taken during pregnancy.
The higher the dose, the higher the risks but all
doses carry a risk.
• It can cause serious birth defects and can affect
the way in which the child develops as it grows.
Birth defects which have been reported include
spina bifida (where the bones of the spine
are not properly developed); facial and skull
malformations; heart, kidney, urinary tract and
sexual organ malformations; limb defects.
• If you take valproate during pregnancy you have
a higher risk than other women of having a child
with birth defects that require medical treatment.
Because valproate has been used for many years
we know that in women who take valproate
around 10 babies in every 100 will have birth
defects. This compares to 2-3 babies in every 100
born to women who don’t have epilepsy.
• It is estimated that up to 30-40% of preschool
children whose mothers took valproate during
pregnancy may have problems with early
childhood development. Children affected can
be slow to walk and talk , intellectually less able
than other children, and have difficulty with
language and memory.
• Autistic spectrum disorders are more often
diagnosed in children exposed to valproate and
there is some evidence children may be more
likely to develop symptoms of Attention Deficit
Hyperactivity Disorder (ADHD).
• If you are a woman capable of becoming
pregnant your doctor should only prescribe
valproate for you if nothing else works for you.
• Before prescribing this medicine to you, your
doctor will have explained what might happen to
your baby if you become pregnant whilst taking
valproate. If you decide later you want to have a
child you should not stop taking your medicine
until you have discussed this with your doctor
and agreed a plan for switching you onto another
product if this is possible.
• Ask your doctor about taking folic acid 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.
FIRST PRESCRIPTION
If this is the first time you have been prescribed
valproate your doctor will have explained the risks to an
unborn child if you become pregnant. Once you are of
childbearing age, you will need to make sure you use
an effective method of contraception throughout your
treatment. Talk to your doctor or family planning clinic
if you need advice on contraception.
Key messages:
• Make sure you are using an effective method of
contraception.
• Tell your doctor at once if you are pregnant or
think you might be pregnant.
CONTINUING TREATMENT AND NOT TRYING FOR A
BABY
If you are continuing treatment with valproate but
you don’t plan to have a baby make sure you are using
an effective method of contraception. Talk to your
doctor or family planning clinic if you need advice on
contraception.
Key messages:
• Make sure you are using an effective method of
contraception.
• Tell your doctor at once if you are pregnant or
think you might be pregnant.
CONTINUING TREATMENT AND CONSIDERING TRYING
FOR A BABY
If you are continuing treatment with valproate and
you are now thinking of trying for a baby you must not
stop taking either your valproate or your contraceptive
medicine until you have discussed this with your
prescriber. You should talk to your doctor well before
you become pregnant so that you can put several
actions in place so that your pregnancy goes as smoothly

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as possible and any risks to you and your unborn child
are reduced as much as possible.
Your doctor may decide to change the dose of valproate
or switch you to another medicine before you start
trying for a baby.
If you do become pregnant you will be monitored very
closely both for the management of your underlying
condition and to check how your unborn child is
developing.
Ask your doctor about taking folic acid 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.
Key messages:
• Do not stop using your contraception before you
have talked to your doctor and worked together
on a plan to ensure your epilepsy is controlled
and the risks to your baby are reduced
• Tell your doctor at once when you know or think
you might be pregnant.
UNPLANNED PREGNANCY WHILST CONTINUING
TREATMENT
Babies born to mothers who have been on valproate
are at serious risk of birth defects and problems with
development which can be seriously debilitating. If you
are taking valproate and you think you are pregnant or
might be pregnant contact your doctor at once. Do not
stop taking your medicine until your doctor tells you to.
Ask your doctor about taking folic acid. 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.
Key messages:
• Tell your doctor at once if you know you are
pregnant or think you might be pregnant.
• Do not stop taking valproate unless your doctor
tells you to.
Make sure you read the patient booklet and sign
the Acknowledgement of Risk form which should be
given to you and discussed with you by your doctor
or pharmacist.
Breast-feeding
Very little Epilim gets into the breast milk. However,
talk to your doctor about whether you should breastfeed 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.
Epilim treatment must be started and supervised by a
doctor specialised in the treatment of epilepsy.
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.

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

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 flulike 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
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
hallucinations 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

Like all medicines, Epilim can cause side effects,
although not everybody gets them.

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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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