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EPILIM CHRONO 200MG CONTOLLED RELEASE TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Epilim® Chrono
200mg Controlled Release Tablets
(sodium valproate)

Epilim Chrono Controlled Release Tablets are also available in
the following strengths: 300mg & 500mg.
Your medicine is available as Epilim Chrono 200mg Controlled
Release Tablets, but will be referred to as Epilim Chrono
throughout this 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.
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.

Weight gain

Taking Epilim Chrono may make you put on weight. Talk to
your doctor about how this will affect you.

What Epilim Chrono is and what it is used for
What you need to know before you take Epilim Chrono
How to take Epilim Chrono
Possible side effects
How to store Epilim Chrono
Contents of the pack and other information

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

“Controlled release” means that the active ingredient sodium
valproate is slowly released from the tablets over a period of
time.

What Epilim Chrono contains


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:



Epilim Chrono is used to treat epilepsy (fits) in adults and
children.








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

You have a known metabolic disorder, i.e. a urea cycle
disorder

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.







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.


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.

Alcohol intake is not recommended during treatment.

Key messages:

Pregnancy, breast feeding and fertility Important
advice for women


















Warning and precautions

As with other antiepileptic drugs, convulsions may become
worse or happen more frequently whilst taking this medicine.
If this happens contact your doctor immediately.

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



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.

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:

2. What you need to know before you take
Epilim Chrono
Do not take Epilim Chrono and tell your doctor if:

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:

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



Blood tests

What is in this leaflet
1.
2.
3.
4.
5.
6.

Key messages:



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.



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 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.

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.

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.

Taking this medicine










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.
Page 1 of 2

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
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)




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.



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

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

Epilim Chrono is not recommended in children that weigh less
than 20 kilograms. Epilim Liquid (sugar free) or Epilim Syrup
is recommended instead.

Tell your doctor as soon as possible if you have any
of the following side effects:


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 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

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.

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.

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.









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:











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.

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 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)

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
An increase in the number and severity of convulsions

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
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 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.

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 Chrono













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.
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.
Do not store above 30°C.
Store in the original package.
Protect from moisture.
If your doctor decides to stop your treatment, take any
tablets you have left back to the pharmacy.
If your tablets appear to be discoloured or show any
other signs of deterioration, take them back to your
pharmacist who will advise 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.

6. Contents of the pack and other
information
What Epilim Chrono contains




The active ingredient is sodium valproate.
Each prolonged release tablet contains a mixture of
133.2mg sodium valproate and 58mg valproic acid,
equivalent to 200mg of the active substance
sodium valproate.
The other ingredients are: hypromellose (E464),
ethylcellulose, hydrated silica, titanium dioxide (E171),
erythrosine BS (E127), indigo carmine (E132),
black iron oxide (E172) and macrogol 400.

Page 2 of 2

What Epilim Chrono looks like and contents of the
pack
Epilim Chrono tablets are oval shaped and lilac coloured
without any markings on either side.

Your medicine is available in blister packs of 100 tablets.

Manufacturer

Manufactured by:
Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon,
Newcastle-upon-Tyne, Tyne & Wear, NE3 3TT, UK.
Or
Sanofi Winthrop Industrie, 1, Rue de la Vierge,
Ambarès et Lagrave – F-33565 Carbon Blanc Cedex, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0441

POM

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.
Leaflet revision & issue date (Ref): 09.12.16
Epilim® is a registered trademark of Sanofi-Synthelabo UK
Ltd.
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

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 01302 365000 (Regulatory)
Please be ready to give the following
information:
Product name: Epilim Chrono 200mg
Controlled Release Tablets
Reference No: 21828/0441

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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