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SODIUM VALPROATE SYRUP

Active substance: SODIUM VALPROATE

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LIQUID MANUFACTURIN

G

Packaging code : 302131
Old packaging code : 301464

Format : 157x210-TCRL
Plant barcode : 131

Update : 12/02/2015 - V8
Product : EPILIM 12G/300ML SYR

Colors :
Pantone Reflex Blue
Black

Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : K.Lemaire - C.R.
Plant : Colomiers

Logo version :

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Epilim Syrup
sodium valproate

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 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.

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 any
time you have these thoughts, immediately contact
your doctor.

302131 - 131

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
What is in this leaflet
erythematosus (SLE)” - a disease of the immune
1. What Epilim Syrup is and what it is used for
system which affects skin, bones, joints and
2. What you need to know before you take Epilim Syrup
internal organs
3. How to take Epilim Syrup
▲You know that there is a genetic problem caused
4. Possible side effects
by a mitochondrial disorder in your family.
5. How to store Epilim Syrup
If you are not sure if any of the above apply to you,
6. Contents of the pack and other information
talk to your doctor or pharmacist before taking
Epilim Syrup.
1. What Epilim Syrup is and what it is
used for
Weight gain
Taking Epilim Syrup may make you put on weight.
What Epilim Syrup is
Talk to your doctor about how this will affect you.
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.

Blood tests
Your doctor may wish to do blood tests before you
start taking Epilim Syrup and during your treatment.

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

Other medicines and Epilim Syrup
Please tell your doctor or pharmacist if you
are taking or have recently taken any other

1

LIQUID MANUFACTURIN

G

Packaging code : 302131
Old packaging code : 301464

Format : 157x210-TCRL
Plant barcode : 131

Update : 12/02/2015 - V8
Product : EPILIM 12G/300ML SYR

Colors :
Pantone Reflex Blue
Black

Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : K.Lemaire - C.R.
Plant : Colomiers

Logo version :

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

2

LIQUID MANUFACTURIN

G

Packaging code : 302131
Old packaging code : 301464

Format : 157x210-TCRL
Plant barcode : 131

Update : 12/02/2015 - V8
Product : EPILIM 12G/300ML SYR

Colors :
Pantone Reflex Blue
Black

Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : K.Lemaire - C.R.
Plant : Colomiers

Logo version :

• Tell your doctor at once if you are pregnant or
think you might be pregnant.

should be given to you and discussed with you
by your doctor or pharmacist.

CONTINUING TREATMENT AND CONSIDERING
TRYING FOR A BABY

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.

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.

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

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 3. How to take Epilim Syrup
the risks to your baby are reduced.
• Tell your doctor at once when you know or think Always take Epilim Syrup exactly as your doctor
has told you. You should check with your doctor or
you might be pregnant.
pharmacist if you are not sure.
UNPLANNED PREGNANCY WHILST CONTINUING
Epilim Syrup treatment must be started and
TREATMENT
supervised by a doctor specialised in the treatment
of epilepsy.
Babies born to mothers who have been on
valproate are at serious risk of birth defects and
Taking this medicine
problems with development which can be seriously • Your doctor will decide how much Epilim Syrup to
debilitating. If you are taking valproate and you
give you or your child depending on you or your
think you are pregnant or might be pregnant
child’s body weight
contact your doctor at once. Do not stop taking your • Take this medicine by mouth
medicine until your doctor tells you to.
• Take Epilim Syrup with or after food. This will help
to stop the feelings of sickness that may happen
Ask your doctor about taking folic acid. Folic acid
after taking Epilim Syrup
can lower the general risk of spina bifida and
• Only dilute the syrup if your doctor or pharmacist
early miscarriage that exists with all pregnancies.
tells you to.
However, it is unlikely that it will reduce the risk of
• If you feel the effect of your medicine is too weak
birth defects associated with valproate use.
or too strong, do not change the dose yourself but
ask your doctor
Key messages:
• Take this in 2 separate doses - half in the morning
• Tell your doctor at once if you know you are
and half in the evening.
pregnant or think you might be pregnant.
• You will be able to measure the dose in the
• Do not stop taking valproate unless your doctor
marked measuring cup supplied with the syrup.
tells you to.
• The marks of the cup show you how to measure
Make sure you read the patient booklet and
between 5ml (200mg) and 15ml (600mg).
sign the Acknowledgement of Risk form which
• If the dose is less than 5ml (200mg), talk to 3

LIQUID MANUFACTURIN

G

Packaging code : 302131
Old packaging code : 301464

Format : 157x210-TCRL
Plant barcode : 131

Update : 12/02/2015 - V8
Product : EPILIM 12G/300ML SYR

Colors :
Pantone Reflex Blue
Black

Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : K.Lemaire - C.R.
Plant : Colomiers

Logo version :

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 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.

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
Patients with kidney problems
tongue. Hands, feet or genitals may also be
• Your doctor may decide to adjust your or your
affected. More severe allergic reactions can
child’s dose
lead to lymph node enlargement and possible
Patients taking other medicines for ‘fits’
impairment of other organs.
(epilepsy)
• Liver problems and problems of the pancreas may
• You or your child may be taking other medicines
show as a sudden illness which may happen in the
for epilepsy at the same time as Epilim Syrup. If
first six months of treatment. This happens in a
so, your doctor should gradually initiate treatment very small number of people taking Epilim Syrup.
depending on you or your child’s condition
It includes feeling and being sick many times,
• Your doctor may increase the dose of Epilim Syrup being very tired, sleepy and weak, stomach pain
by 5 to 10mg for each kilogram of body weight
including very bad upper stomach pain, jaundice
each day depending on which other medicines
(yellowing of the skin or whites of the eyes), loss
you are taking.
of appetite, swelling (especially of the legs and
feet but may include other parts of the body),
If you take more Epilim Syrup than you should
worsening of your fits or a general feeling of being
If you take more Epilim Syrup than you should, tell
unwell
a doctor or go to a hospital casualty department
Your doctor may tell you to stop taking Epilim Syrup
straight away. Take the medicine pack with you.
immediately if you have these symptoms
This is so the doctor knows what you have taken.
• You have a skin rash or skin lesions with a pink/
The following effects may happen: feeling sick
red ring and a pale centre which may be itchy,
or being sick, pupils of the eye become smaller,
scaly or filled with fluid. The rash may appear
dizziness, loss of consciousness, weak muscles and
especially on the palms or soles of your feet. These
poor reflexes, breathing problems, headaches, fits
could be signs of a serious allergy to the medicine
(seizures), confusion, memory loss and unusual or
called ‘erythema multiforme’
inappropriate behaviour.
• Blistering or bleeding of the skin around the
lips, eyes, mouth, nose and genitals. Also flu-like
If you forget to take Epilim Syrup
symptoms and fever. This may be something
If you forget to take a dose, take it as soon as you
called ‘Stevens-Johnson syndrome’
remember. However, if it is nearly time for the next
• Severe blistering rash where layers of the skin may
dose, skip the missed dose.
peel off to leave large areas of raw exposed skin
Do not take a double dose to make up for a
over the body. Also a feeling of being generally
forgotten dose.
unwell, fever, chills and aching muscles. This may
If you stop taking Epilim Syrup
be something called ‘Toxic epidermal necrolysis’
Keep taking until your doctor tells you to stop. Do
• Bruising more easily and getting more infections
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

4

LIQUID MANUFACTURIN

G

Packaging code : 302131
Old packaging code : 301464

Format : 157x210-TCRL
Plant barcode : 131

Update : 12/02/2015 - V8
Product : EPILIM 12G/300ML SYR

Colors :
Pantone Reflex Blue
Black

Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : K.Lemaire - C.R.
Plant : Colomiers

Logo version :

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

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 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 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.
Store this medicine below 25oC.
Tell your doctor or pharmacist if any of the
The diluted product has a 14-day shelf life.
following side effects get serious or lasts longer Medicines should not be disposed of via household
than a few days, or if you notice any side effects wastewater or household waste. Ask your
not listed in this leaflet:
pharmacist how to dispose of medicines no longer
• Feeling sick, stomach ache or diarrhoea, especially required. These measures will help protect the
when starting treatment. This may be helped by
environment.
taking Epilim Syrup with food or by taking Epilim
6. Contents of the pack and other information
Gastro-resistant Tablets instead
• Fainting
What Epilim Syrup contains
• Hearing loss
• Each 5ml of the Syrup contains 200mg of the
• Skin problems such as rashes. These happen
active substance, sodium valproate
rarely, but more often in people also taking
• The other ingredients are sucrose, sorbitol (E420),
lamotrigine
sodium methyl hydroxybenzoate (E219), sodium
• Acne
propyl hydroxybenzoate (E217), saccharin sodium,
• Hair loss which is usually temporary. When it
water, Ponceau 4R (E124) and cherry flavour.
grows back it may be more curly than before
• Hair, including body or facial hair grows more
What Epilim Syrup looks like and contents of the
than normal in women
pack
• Skin rash caused by narrow or blocked blood
Epilim Syrup is a red, cherry flavoured Syrup
vessels (vasculitis)
supplied in bottles of 300ml.
• Changes in women’s periods and increased hair
Marketing Authorisation Holder and
growth in women
Manufacturer
• Breast enlargement in men
Marketing Authorisation Holder
• Swelling of the feet and legs (oedema)
Sanofi
• Weight gain - as your appetite may be increased
• Kidney problems, bedwetting or increased need to One Onslow Street
Guildford
5

LIQUID MANUFACTURIN

G

Packaging code : 302131
Old packaging code : 301464

Format : 157x210-TCRL
Plant barcode : 131

Update : 12/02/2015 - V8
Product : EPILIM 12G/300ML SYR

Colors :
Pantone Reflex Blue
Black

Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages : EN

Min font size used : 9 pt

Graphic designer : K.Lemaire - C.R.
Plant : Colomiers

Logo version :

Surrey
GU1 4YS
UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Unither Liquid Manufacturing,
1-3 allee de la Neste
31770 Colomiers
France
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 February 2015
© Sanofi, 1976 - 2015
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

302131 - 131

National Society for Epilepsy (NSE), Chesham
Lane, Chalfont St Peter, Bucks, SL9 0RJ
Telephone: 01494 601400. Website: www.
epilepsynse.org.uk

6

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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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