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EPILIM 200MG/5ML SYRUP

Active substance(s): SODIUM VALPROATE / SODIUM VALPROATE / SODIUM VALPROATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Epilim® 200mg/5ml Syrup
(sodium valproate)
▼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.
The name of your medicine is Epilim 200mg/5ml
Syrup but will be referred to as Epilim Syrup
throughout this leaflet.
What is in this leaflet
1. What Epilim Syrup is and what it is used for
2. What you need to know before you take Epilim
Syrup
3. How to take Epilim Syrup
4. Possible side effects
5. How to store Epilim Syrup
6. Contents of the pack and other 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. 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 known metabolic disorder, i.e a
urea cycle disorder
× You have a rare illness called porphyria
× You have a genetic problem caused by a
mitochondrial disorder (e.g. AlpersHuttenlocher 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 antiepileptics such as sodium valproate have had
thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately
contact your doctor.
As with other antiepileptic drugs, convulsions may
become worse or happen more frequently whilst
taking this medicine. If this happens contact your
doctor immediately.
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
erythematosus (SLE)’ - a disease of the
immune system which affects skin, bones,
joints and internal organs
▲ You know that there is a genetic problem
caused by a mitochondrial disorder in your
family.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Epilim 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.
Other medicines and Epilim Syrup
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, 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.
 Tell your doctor at once if you are pregnant or
think you might be pregnant.
CONTINUING TREATMENT AND
CONSIDERING TRYING FOR A BABY
If you are continuing treatment with valproate and
you are now thinking of trying for a baby you must
not stop taking either your valproate or your
contraceptive medicine until you have discussed
this with your prescriber. You should talk to your
doctor well before you become pregnant so that
you can put several actions in place so that your
pregnancy goes as smoothly as possible and any
risks to you and your unborn child are reduced as
much as possible.
Your doctor may decide to change the dose of
valproate or switch you to another medicine
before you start trying for a baby.
If you do become pregnant you will be monitored
very closely both for the management of your
underlying condition and to check how your
unborn child is developing.
Ask your doctor about taking folic acid when trying
for a baby. Folic acid can lower the general risk of
spina 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:
 Do not stop using your contraception before
you have talked to your doctor and worked
together on a plan to ensure your epilepsy is
controlled and the risks to your baby are
reduced.
 Tell your doctor at once when you know or
think you might be pregnant.
UNPLANNED PREGNANCY WHILST
CONTINUING TREATMENT
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 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.
Epilim Syrup 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
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.
 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 (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 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 flulike 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)
 An increase in the number and severity of
convulsions
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, hyperactive 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
anti-epileptic 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 the syrup after the expiry date which
is 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
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help protect the
environment.
6. Contents of the pack and other
information
What Epilim 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 flavour.
What Epilim Syrup looks like
Epilim syrup 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 200mg/5ml Syrup; PL 18799/2382
Leaflet date: 15.02.2017

POM

Epilim is a registered trademark of Sanofi-Aventis.
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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sighted?
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or read?
Call 0208 515 3763 to
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Expand Transcript

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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