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EPILIM CHRONO 200 MG CONTROLLED RELEASE TABLETS

Active substance(s): SODIUM VALPROATE / VALPROIC ACID

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Page 1

Page 4

• 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.

Manufacturer and Product Licence
Holder
This product is manufactured by Sanofi
Winthrop Industrie 1, Rue de la vierge,
Ambares et lagrave-F-33565, Carbon Blanc
cedex, France. It is procured from within the
EU by the Product Licence Holder:
Swinghope Ltd, Brandon House, Marlowe
Way, Croydon CR0 4XS UK and
repackaged by Interport Ltd, Brandon
House, Marlowe Way, Croydon CR0 4XS
UK.

T05602

Epilim® Chrono® 200 mg Controlled Release Tablets/
Epilim® Chrono® 300 mg Controlled Release Tablets/
Epilim® Chrono® 500 mg Controlled Release Tablets
(sodium valproate)
Patient Information Leaflet

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

POM
PLPI 10380/1525 Epilim® Chrono® 500 mg
Controlled-release
tablets
PLPI 10380/1531 Epilim® Chrono® 200 mg
Controlled-release
tablets
PLPI 10380/1532 Epilim® Chrono® 300 mg
Controlled-release
tablets

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.

Leaflet revision date: 04/08/2015
Epilim® Chrono® is registered trademark of
Sanofi-Synthelabo UK Limited.

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.

Blood tests
Epilim Chrono can change levels of liver
enzymes, salts or sugars shown up on blood
and urine tests.
Male Fertility
Taking Epilim Chrono 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.

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

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.

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

5. How to store Epilim Chrono

What Epilim Chrono is
The name of your medicine is Epilim Chrono
200, 300 and 500mg Controlled Release
Tablets (called Epilim Chrono in this leaflet).
“Controlled release” means that the active
ingredient sodium valproate is slowly
released from the tablets over a period of
time.

• Keep out of the sight and reach of
children.
• Do not store above 30°C. Store in the
original package to protect from
moisture. Store in a dry place.
• Do not use after the expiry date stated
on the packaging. The expiry date refers
to the last day of that month.
• Do not remove the tablets from the foil
until just before you take them. Do not
cut the blister strips.
• If the medicine becomes discoloured or
shows any other signs of deterioration,
you should seek the advice of your
pharmacist who will tell you what to do.
• 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 Chrono contains
Epilim Chrono contains 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.
What Epilim Chrono is used for
Epilim Chrono is used to treat epilepsy (fits)
in adults and children.

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

The other ingredients are: hypromellose
(E464), ethylcellulose, hydrated silica,
titanium dioxide (E171), erythrosine BS
(E127), indigo carmine (E132), iron oxide
black (E172), macrogol 400.

Do not take Epilim Chrono and tell
your doctor if:
• You are allergic (hypersensitive) to
sodium valproate or any of the other
ingredients of Epilim Chrono (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
Chrono.

What Epilim Chrono looks like and
contents of the pack
Epilim Chrono tablets are violet, oblong,
biconvex film coated tablets with no
markings on either side. Supplied in a carton
box of 100 tablets.

Warning 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.

6. Further information
What Epilim Chrono contains
Each 200 mg controlled release tablet
contains 133.2 mg sodium valproate and 58
mg valproic acid, equivalent to 200 mg of the
active substance sodium valproate.
Each 300 mg controlled release tablet
contains 199.8 mg sodium valproate and 87
mg valproic acid, equivalent to 300 mg of the
active substance sodium valproate.

Fold

Each 500 mg controlled release tablet
contains 333 mg sodium valproate and 145
mg valproic acid, equivalent to 500 mg of the
active substance, sodium valproate.

Talk to your doctor or pharmacist before
taking Epilim Chrono 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
• 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 Chrono
Weight gain
Taking Epilim Chrono 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 Chrono and
during your treatment.
Other medicines and Epilim Chrono
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 Chrono
can affect the way some other
medicines work. Also some medicines can
affect the way Epilim Chrono works.
The following medicines can increase
the chance of you getting side effects,
when taken with Epilim Chrono:
• 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 Chrono 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 Chrono 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
Chrono and carbapenems should be
avoided because it may decrease the
effect of your medicine.
• Colestyramine used to lower blood fat
(cholesterol) levels
Taking Epilim Chrono 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.

Page 3

Page 2

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.

• Take Epilim Chrono with or after food.
This will help to stop the feelings of
sickness that may happen after taking
Epilim Chrono.
• Do not crush or chew the tablets
• 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
• This medicine can be taken once or
twice daily
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 generally 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

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.

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

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.

Children under 20 kilograms
Epilim Chrono is not recommended in
children that weigh less than 20 kilograms.
Epilim Liquid (sugar free) or Epilim Syrup is
recommended instead.
Patients with kidney problems
• Your doctor may decide to adjust your or
your child’s dose

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.

Patients taking other medicines for ‘fits’
(epilepsy)
• You or your child may be taking other
medicines for epilepsy at the same time
as Epilim Chrono. If so, your doctor
should gradually initiate treatment
depending
on
your
or
your
child’s condition
• Your doctor may increase the dose of
Epilim Chrono by 5 to 10mg for each
kilogram of body weight each day
depending on which other medicines
you are taking

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.

If you take more Epilim Chrono than you
should
If you take more Epilim Chrono 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.

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

If you forget to take Epilim Chrono
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.

Breast-feeding
Very little Epilim Chrono 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 stop taking Epilim Chrono
• Keep taking until your doctor tells you
to stop.
• Do not stop taking Epilim Chrono just
because you feel better.
• If you stop your fits may come back.

Driving and using machines:
You may feel sleepy when taking Epilim
Chrono. 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.

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
Chrono 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 Chrono.

3. How to take Epilim Chrono
Always take Epilim Chrono exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
Epilim Chrono treatment must be started
and supervised by a doctor specialised in
the treatment of epilepsy.

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

Taking this medicine
• Your doctor will decide how much Epilim
Chrono to give you or your child
depending on your or your child’s body
weight
• Take this medicine by mouth

4. Possible side effects
Like all medicines, Epilim Chrono 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
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
Chrono. 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 Chrono 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 other medicine to treat fits such
as phenobarbital and topiramate are
taken at the same time or if the Epilim
Chrono 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
T05602

Fold

• 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.

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.

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