SODIUM VALPROATE 200MG/5ML LIQUID

Active substance: SODIUM VALPROATE

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LIQUID MANUFACTURIN

G

Packaging code : 301968
Old packaging code : 301803

Format : 157x210-TCRL
Plant barcode : 968

Update : 18/12/2014 - V4
Product : EPILIM 12MG/300ML SLB

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 : JL-C.R.
Plant : Colomiers

Logo version :

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Epilim 200mg/5ml Liquid
sodium valproate

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.

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
2. What you need to know before you take

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.
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. 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).

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
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.
Take special care with Epilim Liquid
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 Liquid.
Weight gain
Taking Epilim Liquid may make you put on
weight.
Talk to your doctor about how this will affect
you.

301968 - 968

▼ This medicine is subject to additional

1

LIQUID MANUFACTURIN

G

Packaging code : 301968
Old packaging code : 301803

Format : 157x210-TCRL
Plant barcode : 968

Update : 18/12/2014 - V4
Product : EPILIM 12MG/300ML SLB

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 : JL-C.R.
Plant : Colomiers

Logo version :

Blood tests
Your doctor may wish to do blood tests before
you start taking Epilim Liquid and during your
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
Other medicines and Epilim Liquid
doses carry a risk.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines. • It can cause serious birth defects and can affect
the way in which the child develops as it grows.
This includes medicines you buy without a
Birth defects which have been reported include
prescription, including herbal medicines. This is
spina bifida (where the bones of the spine
because Epilim Liquid can affect the way some
are not properly developed); facial and skull
other medicines work. Also some medicines can
malformations; heart, kidney, urinary tract and
affect the way Epilim Liquid works.
sexual organ malformations; limb defects.
The following medicines can increase the
• If you take valproate during pregnancy you have
chance of you getting side effects, when taken
a higher risk than other women of having a child
with Epilim Liquid:
with birth defects that require medical treatment.
• Some medicines used for pain and inflammation
Because valproate has been used for many years
(salicylates) such as aspirin.
we know that in women who take valproate
• Some other medicines used to treat fits
around 10 babies in every 100 will have birth
(epilepsy) – see section 3, “Patients taking other
defects. This compares to 2-3 babies in every 100
medicines for ‘fits’”. This includes medicines
born to women who don’t have epilepsy.
such as phenobarbital, primidone, phenytoin,
• It is estimated that up to 30-40% of preschool
carbamazepine,topiramate, lamotrigine and
children whose mothers took valproate during
felbamate.
pregnancy may have problems with early
Epilim Liquid may increase the effect of the
childhood development. Children affected can be
following medicines:
slow to walk and talk , intellectually less able than
• Medicines used for thinning the blood (such as
other children, and have difficulty with language
warfarin)
and memory.
• Zidovudine used to treat HIV infection
• Autistic spectrum disorders are more often
• Temozolomide used to treat cancer
diagnosed in children exposed to valproate and
• Medicines for depression
there is some evidence children may be more
• Monoamine oxidase inhibitors (MAOI) such as
likely to develop symptoms of Attention Deficit
moclobemide, selegiline, linezolid
Hyperactivity Disorder (ADHD).
• Medicines used to calm emotional and mental
• If you are a woman capable of becoming pregnant
conditions such as diazepam and olanzapine
your doctor should only prescribe valproate for
you if nothing else works for you.
The following medicines can affect the way
• Before prescribing this medicine to you, your
Epilim Liquid works:
doctor will have explained what might happen to
• Some medicines used for the prevention and
your baby if you become pregnant whilst taking
treatment of malaria such as mefloquine and
valproate. If you decide later you want to have a
chloroquine
child you should not stop taking your medicine
• Cimetidine used for stomach ulcers
until you have discussed this with your doctor
• Carbapenem agents (antibiotics used to
and agreed a plan for switching you onto another
treat bacterial infections) such as imipenem,
product if this is possible.
meropenem, rifampicin and erythromycin. The
• Ask your doctor about taking folic acid when
combination of Epilim Liquid and Carbapenems
trying for a baby. Folic acid can lower the general
should be avoided because it may decrease the
risk of spina bifida and early miscarriage that
effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol) exists with all pregnancies. However, it is unlikely
that it will reduce the risk of birth defects
levels
associated with valproate use.
Taking Epilim Liquid with food and drink
FIRST PRESCRIPTION
Alcohol intake is not recommended during
treatment
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 2

LIQUID MANUFACTURIN

G

Packaging code : 301968
Old packaging code : 301803

Format : 157x210-TCRL
Plant barcode : 968

Update : 18/12/2014 - V4
Product : EPILIM 12MG/300ML SLB

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 : JL-C.R.
Plant : Colomiers

Logo version :

you are of childbearing age, you will need to make
sure you use an effective method of contraception
throughout your treatment. Talk to your doctor
or family planning clinic if you need advice on
contraception.
Key messages:
• Make sure you are using an effective method of
contraception.
• Tell your doctor at once if you are pregnant or
think you might be pregnant.
CONTINUING TREATMENT AND NOT TRYING FOR
A BABY
If you are continuing treatment with valproate but
you don’t plan to have a baby make sure you are
using an effective method of contraception. Talk to
your doctor or family planning clinic if you need
advice on contraception.
Key messages:
• Make sure you are using an effective method of
contraception
• Tell your doctor at once if you are pregnant or
think you might be pregnant.
CONTINUING TREATMENT AND CONSIDERING
TRYING FOR A BABY
If you are continuing treatment with valproate
and you are now thinking of trying for a baby you
must not stop taking either your valproate or your
contraceptive medicine until you have discussed
this with your prescriber. You should talk to your
doctor well before you become pregnant so that
you can put several actions in place so that your
pregnancy goes as smoothly as possible and any
risks to you and your unborn child are reduced as
much as possible.
Your doctor may decide to change the dose of
valproate or switch you to another medicine before
you start trying for a baby.
If you do become pregnant you will be monitored
very closely both for the management of your
underlying condition and to check how your
unborn child is developing.

• Tell your doctor at once when you know or think
you might be pregnant.
UNPLANNED PREGNANCY WHILST CONTINUING
TREATMENT
Babies born to mothers who have been on
valproate are at serious risk of birth defects and
problems with development which can be seriously
debilitating. If you are taking valproate and you
think you are pregnant or might be pregnant
contact your doctor at once. Do not stop taking your
medicine until your doctor tells you to.
Ask your doctor about taking folic acid. Folic acid
can lower the general risk of spina bifida and
early miscarriage that exists with all pregnancies.
However, it is unlikely that it will reduce the risk of
birth defects associated with valproate use.
Key messages:
• Tell your doctor at once if you know you are
pregnant or think you might be pregnant.
• Do not stop taking valproate unless your doctor
tells you to.
Make sure you read the patient booklet and
sign the Acknowledgement of Risk form which
should be given to you and discussed with you
by your doctor or pharmacist.
Breast-feeding
Very little Epilim 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:
Ask your doctor about taking folic acid when trying • A colour called ‘ponceau 4R aluminium
lake (E124)’: This may cause allergic reactions
for a baby. Folic acid can lower the general risk of
including asthma in some people. You are more
spina bifida and early miscarriage that exists with
likely to have an allergy if you are also allergic to
all pregnancies. However, it is unlikely that it will
aspirin
reduce the risk of birth defects associated with
• Sodium methyl hydroxybenzoate and sodium
valproate use.
propyl hydroxybenzoate: This may cause allergic
Key messages:
reactions (may not happen straight away)
• Sorbitol: This is a type of sugar. If you have been
• Do not stop using your contraception before you
told by your doctor that you cannot tolerate some
have talked to your doctor and worked together
on a plan to ensure your epilepsy is controlled and sugars, talk to your doctor before taking
the liquid
3
the risks to your baby are reduced.

LIQUID MANUFACTURIN

G

Packaging code : 301968
Old packaging code : 301803

Format : 157x210-TCRL
Plant barcode : 968

Update : 18/12/2014 - V4
Product : EPILIM 12MG/300ML SLB

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 : JL-C.R.
Plant : Colomiers

Logo version :

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 4

LIQUID MANUFACTURIN

G

Packaging code : 301968
Old packaging code : 301803

Format : 157x210-TCRL
Plant barcode : 968

Update : 18/12/2014 - V4
Product : EPILIM 12MG/300ML SLB

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 : JL-C.R.
Plant : Colomiers

Logo version :

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)

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 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

Male Fertility
Taking Epilim Chrono can be a contributing factor
in male infertility.

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.

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.
5

LIQUID MANUFACTURIN

G

Packaging code : 301968
Old packaging code : 301803

Format : 157x210-TCRL
Plant barcode : 968

Update : 18/12/2014 - V4
Product : EPILIM 12MG/300ML SLB

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 : JL-C.R.
Plant : Colomiers

Logo version :

United Kingdom
You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard
Malta
ADR Reporting, the Medicines Authority, PostLicensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

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 December 2014
By reporting side effects you can help provide more © Sanofi, 1983-2014
information on the safety of this medicine.
There are two organisations that will also be happy
to try and answer any general questions on
5. How to store Epilim Liquid
epilepsy. They can be contacted at:
Keep out of the sight and reach of children.
Epilepsy Action, New Anstey House,
Do not take this medicine after the expiry date
Gate Way Drive, Yeadon, Leeds, LS19 7XY
shown on the label and carton after EXP. The expiry Telephone: 0808 800 5050.
date refers to the last day of that month.
Website: www.epilepsy.org.uk
Store below 30°C and away from direct sunlight.
Epilim Liquid 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.

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

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 hydroxybenzoate, sodium
propyl hydroxybenzoate, saccharin sodium,
Ponceau 4R (E124), Flavour IFF cherry 740 and
citric acid anhydrous

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

301968 - 968

What Epilim Liquid looks like and contents of
the pack
Epilim is a red, cherry flavoured liquid supplied in
amber glass bottles of 300ml.
Each bottle is fitted with a child-proof cap and
includes a marked measuring cup.

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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