Skip to Content

UK Edition. Click here for US version.

EPILIM 100MG CRUSHABLE TABLET

Active substance(s): SODIUM VALPROATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.

Blood tests
Epilim Crushable can change levels of liver enzymes,
salts or sugars shown up on blood and urine tests.
Male Fertility
Taking Epilim Crushable 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 eff
ects not listed in this leaflet.

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.

sodium valproate

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

This leaflet was last revised in Feburary 2015
© Sanofi, 2006-2015

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

United Kingdom
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

‚

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 any 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 Crushable is and what it is used for
2. What you need to know before you take Epilim
Crushable
3. How to take Epilim Crushable
4. Possible side effects
5. How to store Epilim Crushable
6. Contents of the pack and other information

5. How to store Epilim Crushable
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown
on the blister and carton after EXP. The expiry date
refers to the last day of that month.

1. What Epilim Crushable is
and what it is used for

Do not remove the tablets from the foil until just before
you take them. Do not cut the blister strips. Store in a
dry place below 30°C.

What Epilim Crushable is
The name of your medicine is Epilim 100mg Crushable
Tablets (called Epilim Crushable in this leaflet).

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.

What Epilim Crushable contains
Epilim Crushable contains a medicine called sodium
valproate. It belongs to a group of medicines called
anti-convulsants or anti-epileptic agents. It works by
helping to calm the brain down.

6. Contents of the pack and other information
What Epilim Crushable contains
• Each crushable tablet contains 100mg of the
active substance, sodium valproate
• The other ingredients are maize starch, kaolin
light (natural), silica colloidal hydrated and
magnesium stearate

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

2. What you need to know before you take
Epilim Crushable

170 x 315 mm
678906

What Epilim Crushable looks like and contents of
the pack
Epilim Crushable tablets are white to off-white. The
tablets are supplied in blister packs of 100

4

PAG 4

Epilim® 100mg
Crushable Tablets

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 Crushable.

Do not take Epilim Crushable:
xx You are allergic (hypersensitive) to sodium valproate
or any of the other ingredients of Epilim Crushable
(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
xx You have liver problems or you or your family have a
history of liver problems
xx You have a rare illness called porphyria
xx If you have a genetic problem caused by a
mitochondrial disorder (e.g. Alpers-Huttenlocher
syndrome)

Talk to your doctor or pharmacist before taking
Epilim Crushable if:
SS You have diabetes. This medicine may affect the
results of urine tests.
SS You have kidney problems. Your doctor may give you
a lower dose
SS You have fits (epilepsy), brain disease or a metabolic
condition affecting your brain
SS You have a ‘urea cycle disorder’ where too much
ammonia builds up in the body
SS You have an illness called ‘systemic lupus
erythematosus (SLE)’ - a disease of the immune
system which affects skin, bones, joints and internal
organs
SS 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
Crushable.
Weight gain
Taking Epilim Crushable 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 Crushable and during your treatment.
Other medicines and Epilim Crushable
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 Crushable can
affect the way some other medicines work. Also some
medicines can affect the way Epilim Crushable works.
The following medicines can increase the chance
of you getting side effects, when taken with Epilim
Crushable:
• Some medicines used for pain and inflammation
(salicylates) such as aspirin.
• Some other medicines used to treat fits (epilepsy)
– see page 2, section 3, “Patients taking other
medicines for ‘fits’”. This includes medicines
such as phenobarbital, primidone, phenytoin,
carbamazepine, topiramate, lamotrigine and
felbamate
Epilim Crushable may increase the effect of the
following medicines:
• Medicines used for thinning the blood (such as
warfarin)
• Zidovudine - used for 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
Crushable 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 Crushable and
carbapenems should be avoided because it may
decrease the effect of your medicine
• Colestyramine used to lower blood fat
(cholesterol) levels
Taking Epilim Crushable with food and drink
Alcohol intake is not recommended during treatment.
1

PAG 1

Sanofi
Riells Packaging Team
Code :
678906
Update : V7- 12/02/2015
Local code :
Current item code: 678606
Product/Item type : EPILIM 100 MG
Country :UK
Artwork by : M.Pacho
Plant : Riells
Supplier code :

Technical Data

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.

Manufacturer
Sanofi-aventis S.A,
Carretera C-35 (La Batlloria-Hostalric), Km 63.09
17404 Riells i Viabrea (Girona)

PACKAGE LEAFLET: INFORMATION FOR THE USER

UNWIND DIRECTION

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 08453727101
email: uk-medicalinformation@sanofi.com

For sanofi use only

• 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

Format : 2 x 170 x 315 mm (DC)
Plant barcode :832
Colours : 2
- REFLEX BLUE
- BLACK
Fonts : Ocean Sans Pro SAN (9pt)
Assembly Card : UHLMANN 1040/1
Layout of Cutting :
Technical Card :
Technical Constraint :

Reason for change: R.Text

Pregnancy, breast feeding and fertility

are reduced as much as possible.

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 it unlikely
that it will reduce the risk of birth defects
associated with valproate use.

Your doctor may decide to change the dose of valproate
or switch you to another medicine before you start
trying for a baby.

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

PAG 2

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.

How to take this medicine
Take this in 2 separate doses - half in the morning and
half in the evening.
How much to take
Adults (including the elderly)
• The starting dose is 600mg daily. Your doctor
will 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

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.

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

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 Crushable 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 Crushable. 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.

3. How to take Epilim Crushable
Always take Epilim Crushable exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Epilim Crushable 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 Crushable
to give you or your child depending on your or your
child’s body weight
• Take this medicine by mouth
• Take Epilim Crushable with or after food. This will
help to stop the feelings of sickness that may happen
after taking Epilim Crushable.
• The tablets may be crushed if necessary
• If you feel the effect of your medicine is too weak or
too strong, do not change the dose yourself but ask
your doctor

Patients taking other medicines for ‘fits’
(epilepsy)
• You or your child may be taking other
medicines for epilepsy at the same time as
Epilim Crushable. If so, your doctor should
gradually initiate treatment depending on you
or your child’s condition
• Your doctor may increase the dose of Epilim
Crushable 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 Crushable than you should
If you take more Epilim Crushable 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 Crushable
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 Crushable
Keep taking until your doctor tells you to stop. Do not
stop taking Epilim Crushable 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 Crushable 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
Crushable.




If you have any further questions on the use
of this product, ask your doctor or pharmacist.

4. Possible side effects
2

Like all medicines, Epilim Crushable can cause side
effects, although not everybody them.

PAG 3

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 others 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 Crushable. 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 Crushable immediately
if you have these symptoms Your doctor may tell you
to stop taking Epilim Crushable immediately if you
have these symptoms
• You have a skin rash or skin lesions with a pink/red
ring and a pale centre which may be itchy, scaly or
filled with fluid. The rash may appear especially on
the palms or soles of your feet. These could be signs
of a serious allergy to the medicine called ‘erythema
multiforme’
• Blistering or bleeding of the skin around the
lips, eyes, mouth, nose and genitals. Also flu-like
symptoms and fever. This may be something called
‘Stevens-Johnson syndrome’
• Severe blistering rash where layers of the skin may
peel off to leave large areas of raw exposed skin
over the body. Also a feeling of being generally
unwell, fever, chills and aching muscles. This may be
something called ‘Toxic epidermal necrolysis’
• Bruising more easily and getting more infections
than usual. This could be a blood problem called
‘thrombocytopenia’. It can also be due to a fall in the
number of white blood cells, bone marrow depression
or another condition that affects red blood cells,
white blood cells and platelets (pancytopenia) or how
the blood clots
• Blood clotting problems (bleeding for longer than
normal), bruising or bleeding for no reason
• Changes in mood, loss of memory, lack of
concentration and deep loss of consciousness (coma)
• Underactive thyroid gland, which may cause
tiredness or weight gain (hypothyroidism)
• Breathing difficulty and pain due to inflammation of
the lungs (pleural effusion)
Tell your doctor as soon as possible if you have any
of the following side effects:
• Changes in behaviour including being very alert, and
sometimes also aggressive, hyper-active and unusual
or inappropriate behaviour. This is more likely if
othermedicine to treat fits such as phenobarbital
and topiramate are taken at the same time or if the
Epilim Crushable 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 the tablets with food or taking the 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
3

Expand view ⇕

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.

Hide