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EPILIM 200MG/5ML LIQUID

Active substance(s): SODIUM VALPROATE

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Ref: LTT0006/270415/1/F

®

Epilim 200mg/5ml Liquid
(sodium valproate)
Patient Information Leaflet

▼This medicine is subject to additional monitoring. This will allow quick
identification of new safety information. You can help by reporting
any side eff ects you may get. See the end of section 4 for how to report
side effects.

Taking Epilim Liquid with food and drink
Alcohol intake is not recommended during treatment
Pregnancy, breast feeding and fertility
Important advice for women

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 leafl et 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.
What is in this leaflet
1 What Epilim Liquid is and what it is used for
2 What you need to know before you take Epilim Liquid
3 How to take Epilim Liquid
4 Possible side effects
5 How to store Epilim Liquid
6 Contents of the pack and other information

1

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 aff ected 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 bifi da 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.

What Epilim Liquid is and what it is used for

What Epilim Liquid is
The name of your medicine is Epilim 200mg/5ml Liquid (called Epilim Liquid
in this leaflet).
What Epilim Liquid contains
Epilim Liquid 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 Liquid is used for
Epilim Liquid is used to treat epilepsy (fits) in adults and children.

2

* Valproate can be harmful to unborn children when taken by a woman

What you need to know before you take Epilim Liquid

Do not take Epilim Liquid and tell your doctor if:
* You are allergic (hypersensitive) to sodium valproate or any of the other
ingredients of Epilim Liquid (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 Liquid.
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 any time
you have these thoughts, immediately contact your doctor.
Talk to your doctor or pharmacist before taking Epilim Liquid if:
* 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 Liquid.

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 eff
ective 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 eff ective 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 eff ective 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 bifi da 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

Weight gain
Taking Epilim Liquid 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 Liquid
and during your treatment.
Other medicines and Epilim Liquid
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 Liquid can affect the way some other
medicines work. Also some medicines can affect the way Epilim Liquid
works.
The following medicines can increase the chance of you getting side
effects, when taken with Epilim Liquid:
* Some medicines used for pain and inflammation (salicylates) such as
aspirin.
* Some other medicines used to treat fits (epilepsy) – see section 3,
“Patients taking other medicines for ‘fits’”. This includes medicines such as
phenobarbital, primidone, phenytoin, carbamazepine, topiramate,
lamotrigine and felbamate
Epilim Liquid 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 Liquid 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 Liquid and Carbapenems should be avoided because it may
decrease the effect of your medicine.
* Colestyramine used to lower blood fat (cholesterol) levels

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 Liquid 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 Liquid. 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 Liquid
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
* 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
liquid

®

Ref: LTT0006/270415/1/B

Epilim 200mg/5ml Liquid
(sodium valproate)
Patient Information Leaflet (continued)
3

How to take Epilim Liquid

Always take Epilim Liquid exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Epilim Liquid 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 Liquid to give you or your child
depending on you or your child’s body weight
* Take this medicine by mouth
* Take Epilim Liquid with or after food. This will help to stop the feelings of
sickness that may happen after taking Epilim Liquid
* Do not mix Epilim Liquid with any other liquids. Do not dilute it
* 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
* 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 liquid.
* 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 Liquid. If so, your doctor should gradually initiate treatment
depending on you or your child’s condition
* Your doctor may increase the dose of Epilim Liquid 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 Liquid than you should
If you take more Epilim Liquid 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 Liquid
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 Liquid
Keep taking until your doctor tells you to stop. Do not stop taking Epilim
Liquid 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 Liquid 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 Liquid.
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 Liquid 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 Liquid. 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 Liquid 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 medicines to treat fits such as phenobarbital and
topiramate are taken at the same time or if the Epilim Liquid 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 Liquid 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 antiepileptic medication, have a history of
osteoporosis, or take steroids.
Blood tests
Epilim Liquid can change levels of liver enzymes, salts or sugars shown up
on blood and urine tests.
Male Fertility
Taking Epilim Chrono 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 eff ects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/ yellowcard

5

How to store Epilim Liquid

Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the label and
carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package. Protect from light.
Epilim Liquid should not be diluted. Keep the bottle tightly closed.
If your Liquid show any sign of deterioration or discolouration, consult your
pharmacist for advice.
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 Liquid contains
Each 5ml of the liquid contains 200mg of the active substance, sodium
valproate.
The other ingredients are hydroxyethyl cellulose, sorbitol, sodium methyl
parahydroxybenzoate, sodium propyl parahydroxybenzoate, saccharin
sodium, water, ponceau 4R (E124), cherry flavour and citric acid anhydrous
What Epilim Liquid looks like and contents of the pack
Epilim is a red, cherry flavoured sugar-free liquid supplied in amber glass
bottles of 300ml.
Manufacturer and Licence Holder
This medicine is manufactured by Unither Liquid Manufacturing, 1-3 allee de
la Neste 31770 Colomiers France, and is

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. They will have additional information about this medicine and
will be able to advise you.

POM

PL No: 33723/0006

Epilim is a registered trademarks of Sanofi-Synthelabo UK Ltd.
Revision date: 27/04/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited, Tel: 01527 505414
for help.
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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