EPILIM 200MG/5ML SYRUP

Active substance: SODIUM VALPROATE

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Patient information leaflet

Epilim® 200mg/5ml Syrup
(sodium valproate)
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
The name of your medicine is Epilim 200mg/5ml Syrup but
will be referred 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 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. 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
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 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 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 diff erent 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 if you
want to become pregnant. Do not stop taking Epilim
suddenly, as it is likely that your fits will come back.
Women who are planning to get Pregnant
If you become pregnant, think you may be pregnant
or plan to become pregnant while taking Epilim 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
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 (2030mg 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. 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 fl u-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
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 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.
Talk to your doctor or pharmacist if any of the side
effects gets serious or lasts longer than a few days, or if
you notice any side effects not listed in this leaflet.
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. Further 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® Syrup, PL No: 18799/2382
POM
Leaflet date: 29.09.2014
Epilim is a registered trademark of Sanofi-Aventis

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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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