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EPILIM CHRONO 200MG CONTOLLED RELEASE TABLETS

Active substance(s): SODIUM VALPROATE / VALPROIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

The following medicines can increase the
chance of you getting side effects, when taken
with Epilim Chrono:



Other strengths 300mg & 500mg are also available.

▼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.

What is in this leaflet

1.
2.
3.
4.
5.
6.

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

Epilim Chrono may increase the effect of the
following medicines:













Alcohol intake is not recommended during treatment.

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

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.

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.

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 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:



3. How to take Epilim Chrono

















Warning and precautions



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.

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.

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.



Pregnancy, breast feeding and fertility
Important advice for women

What Epilim Chrono is used for

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

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

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.

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:

What Epilim Chrono is

The name of your medicine is Epilim Chrono 200mg 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.

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.

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.

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.

Page 1 of 2

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







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)





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.

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.

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.

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.

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

5. How to store Epilim Chrono

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
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










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.

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): 23.09.15
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

Other formats

To request a copy of this leaflet in Braille, large print or audio
format please call 01302 365000 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product name: Epilim Chrono 200mg Controlled Release Tablets
Reference number: 21828/0441

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.
Page 2 of 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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