EPILIM 200MG/5ML SYRUP

Active substance: SODIUM VALPROATE

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Ref: LTT0005/250314/1/F

®

Epilim 200mg/5ml Syrup
(sodium valproate)
Patient Information Leaflet
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.
Your medicine is called Epilim 200mg/5ml Syrup but will be referred to as
Epilim Syrup throughout this leaflet.
In this leaflet:
1 What Epilim Syrup is and what it is used for
2 Before you take Epilim Syrup
3 How to take Epilim Syrup
4 Possible side effects
5 How to store Epilim Syrup
6 Further information

1

What Epilim Syrup is and what it is used for

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

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: 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 Syrup.
Take special care with Epilim Syrup
A small number of people being treated with anti-epileptics such as sodium
valproate have had thoughts of harming or killing themselves. If at any time
you have these thoughts, immediately contact your doctor.
Check with your doctor or pharmacist before taking this medicine if:
* 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
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.
Taking Epilim Syrup 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 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

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 Syrup, your doctor should discuss with you the
possible problems when it is taken in pregnancy.
* Unplanned pregnancy is not desirable in women taking Epilim Syrup.
* You should use an effective method of contraception and talk to
your doctor before planning pregnancy. Epilim Syrup 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 Syrup 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 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 Syrup 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 Syrup 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 Syrup 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 Syrup if you want to become pregnant. Do not stop taking
Epilim Syrup 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 Syrup, 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 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

3

How to take Epilim Syrup

Always take Epilim Syrup 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 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
How to take this medicine

* Medicines used to calm emotional and mental conditions such as

* 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

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

* The marks of the cup show you how to measure between 5ml (200mg)

diazepam and olanzapine

Taking Epilim Syrup with food and drink
Alcohol intake is not recommended during treatment.

supplied with the syrup.
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

Ref: LTT0005/250314/1/B

®

Epilim 200mg/5ml Syrup
(sodium valproate)
Patient Information Leaflet (continued)
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 20 mg 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. 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.

4

Possible side effects

Like all medicines, Epilim Syrup 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 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, hyper-active 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 EC 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 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 the 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 this medicine out of the sight and reach of children.
Do not store above 25°C
Store it in the original container
Protect from light.
The diluted product has a 14-day shelf-life.
Do not take this medicine after the month shown on the bottle label and
outer carton.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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

Further information

What Epilim Syrup contains
Each 5 ml of Epilim Syrup contains 200 mg Sodium Valproate.
The syrup also contains sucrose, sorbitol (E420), sodium methyl
parahydroxybenzoate, sodium propyl parahydroxybenzoate, saccharin
sodium, purified water, ponceau 4R (E124) and cherry flavour.
What this medicine looks like and contents of the pack
Epilim Syrup is a red, cherry flavoured oral solution, supplied in amber
bottles of 300 ml with a child resistant cap and a clear seal. Also with a small
clear plastic measuring cup.
Manufacturer and Licence Holder
Your medicine is manufactured by Unither Liquid Manufacturing, 1-3 allee de
la Neste Z.I. d’en Sigal, 31770 Colomiers, France and is procured from
within the EU by the Product Licence Holder: LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, B98 0RE, UK.
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 33723/0005

Epilim 200mg/5ml Syrup

Epilim is a registered trademark of Sanofi Synthelabo UK Ltd.
Revision date: 25/03/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) 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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