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EPILIM 200MG/5ML SYRUP

Active substance(s): SODIUM VALPROATE

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Patient information leaflet

Epilim® 200mg/5ml Syrup
(sodium valproate)
▼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 child
bearing 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 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.
The name of your medicine is Epilim 200mg/5ml
Syrup but will be referred as Epilim Syrup
throughout this leaflet.
What is in this leaflet:
1. What Epilim Syrup is and what it is used for
2. What you need to know before you take
Epilim Syrup
3. How to take Epilim Syrup
4. Possible side effects
5. How to store Epilim Syrup
6. Contents of the pack and other information
1. What Epilim Syrup is and what it is
used for
What Epilim Syrup is
The name of your medicine is Epilim Syrup.
What Epilim Syrup contains
Epilim Syrup contains a medicine called sodium
valproate. This belongs to a group of medicines
called anti-convulsants or anti-epileptic agents. It
works by helping to calm the brain down.
What Epilim Syrup is used for
Epilim Syrup is used to treat epilepsy (fits) in
adults and children.
2. What you need to know before you take
Epilim Syrup
Do not take Epilim Syrup and tell your
doctor if:
× You are allergic (hypersensitive) to sodium
valproate or any of the other ingredients of
Epilim Syrup (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
× You have liver problems or you or your
family have a history of liver problems
× You have a rare illness called porphyria
× If you have a genetic problem caused by a
mitochondrial disorder
(e.g. Alpers- Huttenlocher syndrome)
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 Syrup.
Warnings and precautions
A small number of people being treated with
anti-epileptics such as sodium valproate have
had thoughts of harming or killing themselves. If
at anytime you have these thoughts, immediately
contact your doctor.
Talk to your doctor or pharmacist before
taking Epilim Syrup:
▲ You have diabetes. This medicine may affect
the results of urine tests
▲ You have kidney problems. Your doctor may
give you a lower dose
▲ You have fits (epilepsy), brain disease or a
metabolic condition affecting your brain
▲ You have a ‘urea cycle disorder’ where too
much ammonia builds up in the body.
▲ You have an illness called ‘systemic lupus
erythematosus (SLE)’ - a disease of the
immune system which affects skin, bones,
joints and internal organs
▲ You know that there is a genetic problem
caused by a mitochondrial disorder in your
family.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Epilim Syrup.
Weight gain
Taking Epilim Syrup 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 Syrup and during your
treatment.
Other medicines and Epilim Syrup
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 Syrup can
affect the way some other medicines work. Also
some medicines can affect the way Epilim Syrup
works.
The following medicines can increase the
chance of you getting side effects, when
taken with Epilim Syrup:
Some medicines used for pain and
inflammation (salicylates) such as aspirin.
Some other medicines used to treat fits
(epilepsy). This includes medicines such as
phenobarbital, primidone, phenytoin,
carbamazepine, lamotrigine and felbamate.
Epilim Syrup 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 Syrup 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 Syrup and
carbapenems should be avoided because it
may decrease the effect of your medicine
Colestyramine used to lower blood fat
(cholesterol) levels
Taking Epilim Syrup with food and drink
Alcohol intake is not recommended during
treatment.
Pregnancy, breast-feeding and fertility
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
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 Syrup 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 Syrup. 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.
Important information about some of the
ingredients of Epilim Syrup
This medicine contains:
A colour called ‘ponceau 4R aluminium
lake (E124)’: This may cause allergic
reactions including asthma in some people.
You are more likely to have an allergy if you
are also allergic to aspirin
Sucrose (3.6g in 5ml): People with diabetes
need to take this into account

Sodium methyl hydroxybenzoate and
sodium propyl hydroxybenzoate: This
may cause allergic reactions (may not
happen straight away)
Sorbitol: This is a type of sugar. If you have
been told by your doctor that you cannot
tolerate some sugars, talk to your doctor
before taking the syrup

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

3. How to take Epilim Syrup

4. Possible side effects

Always take Epilim Syrup exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.

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

Epilim Syrup 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
Syrup to give you or your child depending on
you or your child’s body weight.
Take this medicine by mouth.
Take Epilim Syrup with or after food. This will
help to stop the feelings of sickness that may
happen after taking Epilim Syrup.
Only dilute the syrup if your doctor or
pharmacist tells you to.
If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself but ask your doctor.
Take this in 2 separate doses-half in the
morning and half in the evening.
You will be able to measure the dose in the
marked measuring cup supplied with the
syrup.
The marks of the cup show you how to
measure between 5ml (200mg) and 15ml
(600mg).
If the dose is less than 5ml (200mg), talk to
your doctor or pharmacist about how to
measure the dose.
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 Syrup. If so, your doctor should
gradually initiate treatment depending on you
or your child’s condition
Your doctor may increase the dose of Epilim
Syrup 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 Syrup than you
should
If you take more Epilim Syrup 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 Syrup
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 Syrup
Keep taking until your doctor tells you to stop.
Do not stop taking Epilim Syrup 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 Syrup can change the
levels of liver enzymes shown up in blood tests.

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 Syrup. 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
Syrup 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, hyperactive and unusual or inappropriate
behaviour. This is more likely if other
medicine to treat fits such as phenobarbital
are taken at the same time or if the Epilim
Syrup 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 Epilim Syrup with food or
by taking Epilim Gastro-resistant Tablets
instead
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
anti-epileptic medication, have a history of
osteoporosis, or take steroids.
Blood tests
Epilim Syrup can change levels of liver enzymes,
salts or sugars shown up on blood and urine
tests.
Male Fertility
Taking Epilim Syrup 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 Syrup
Keep out of the sight and reach of children
Do not use after the expiry date stated on the
carton and bottle label after ‘Exp’. The expiry
date refers to the last day of that month.
Do not store above 25°C.
Store in original package in order to protect from
light. Keep the bottle tightly closed.
Epilim Syrup should not be diluted.
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.
6. Contents of the pack and other
information
What Epilim Syrup contains
Each 5ml contains 200mg sodium valproate. The
other ingredients are sorbitol (E420), sodium
methyl hydroxybenzoate (E219), sodium propyl
hydroxybenzoate (E217), saccharin sodium,
sucrose, purified water, ponceau 4R (E124) and
cherry flavor.
What Epilim Syrup looks like
Epilim is a red, cherry flavoured syrup supplied
in amber glass bottles containing 300ml of syrup.
Manufactured by: Unither Liquid Manufacturing,
1-3 allee de la Neste, Z.l.d’en Sigal,31770
Colomiers, France.
Procured from within the EU and repackaged
by the Product Licence Holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Epilim® 200mg/5ml Syrup;

POM

PL No: 18799/2382
Leaflet date: 23.06.2015
Epilim is a registered trademark of SanofiAventis.
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

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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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