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EPILIM CHRONO 200MG CONTROLLED RELEASE TABLETS

Active substance: VALPROIC ACID

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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
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.
5. How to store Epilim Chrono

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. Further information
What Epilim Chrono contains
• Each 200mg controlled release tablet contains a mixture of
133.2mg sodium valproate and 58mg Valproic Acid,
equivalent to 200mg of the active substance sodium
valproate
• Each 300mg controlled release tablet contains a mixture of
199.8mg sodium valproate and 87mg valproic acid,
equivalent to 300mg of the active substance sodium
valproate
• Each 500mg controlled release tablet contains a mixture of
333mg sodium valproate and 145mg valproic acid,
equivalent to 500mg of the active substance, sodium
valproate
• The other ingredients are: hypromellose (E464),
ethylcellulose, hydrated silica, titanium dioxide (E171),
erythrosine BS aluminium lake (E127), indigo carmine
aluminium lake FD and C Blue No 2 (E132), iron oxide
black (E172), macrogol 400
What Epilim Chrono looks like and contents of the pack
Epilim Chrono tablets are oval shaped and lilac coloured. The
tablets are supplied in blister packs of 100
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com

Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you start taking this
medicine.
• 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 any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist

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

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.

This leaflet was last revised in November 2012
© Sanofi 2006-2012
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

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.

sodium valproate

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.

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.

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.

Epilim® Chrono 200mg, 300mg
and 500mg Controlled Release
Tablets

In this leaflet:
1. What Epilim Chrono is and what it is used for
2. Before you take Epilim Chrono
3. How to take Epilim Chrono
4. Possible side effects
5. How to store Epilim Chrono
6. Further information

Manufacturer
Fawdon Manufacturing Centre,
Edgefield Avenue
Fawdon
Newcastle-upon-Tyne
Tyne & Wear,
NE3 3TT
UK

Keep out of the reach and sight of children.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

2. Before you take Epilim Chrono

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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:
Further 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
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.

Take special care with 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.
Check with your doctor or pharmacist before taking this
medicine if:
L You have diabetes. This medicine may affect the results of
urine tests
L You have kidney problems. Your doctor may give you a lower dose
L You have fits (epilepsy), brain disease or a metabolic
condition affecting your brain
L You have a ‘urea cycle disorder’ where too much ammonia
builds up in the body.
L You have an illness called “systemic lupus erythematosus
(SLE)” - a disease of the immune system which affects skin,
bones, joints and internal organs
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.
Taking Epilim Chrono with other medicines
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 Turn
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conditions such as diazepam and olanzapine
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• 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

Taking Epilim Chrono with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy and breast-feeding
Women who could become pregnant
You should not take this medicine if you are pregnant or
a women of child-bearing age unless explicitly advised
by your doctor.
Before you start taking Epilim Chrono, your doctor should
discuss with you the possible problems when it is taken in
pregnancy.
• Unplanned pregnancy is not desirable in women taking
Epilim Chrono
• You should use an effective method of contraception
and talk to your doctor before planning pregnancy.
Epilim Chrono has no effect on how well the oral
contraceptive pill works.
Well before you become pregnant it is important to
discuss pregnancy and epilepsy with your doctor and, if
you have one, your epilepsy specialist. This is to make
sure that you and your doctor agree that you should have
Epilim if you become pregnant.
Women taking Epilim during pregnancy have a higher risk
than other women of having a child with an abnormality.
The chance of abnormalities is increased if you are also
taking other medicines for epilepsy at the same time.
These abnormalities include:
• Head and face deformities including cleft palate (a gap
or depression in the lip)
• Deformities of the bones, including hip dislocation
• Malformations of the arms and legs
• Deformities of the tube from the bladder to the penis,
where the opening is formed in a different place
• Heart and blood vessel malformations with heart defects
• Defects of the lining of the spinal cord
• An abnormality of the spinal cord called ‘Spina bifida’
• Malformations of the urethra
Women who take Epilim Chrono during pregnancy may be
more likely to have a baby with spina bifida. Taking folic
acid 5mg each day as soon as you stop contraception
may lower the risk of having a baby with spina bifida.
There is also an increased risk of other birth defects. These
other defects can usually be detected in the first 3 months of
the pregnancy using routine antenatal screening blood tests
and ultrasound scans.

Pregnant mothers who take Epilim Chrono may have babies
with:
• blood clotting problems (such as blood not clotting or not
clotting very well). This may appear as bruising or
bleeding which takes a long time to stop.
• Hypoglycaemia (low blood sugar)
• Hypothyroidism (underactive thyroid gland, which can
cause tiredness or weight gain).
Some babies born to mothers who took Epilim Chrono
during pregnancy may develop less quickly than normal or
have autistic disorders. These children may require
additional educational support.

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

Talk to your doctor before you stop taking Epilim Chrono if
you want to become pregnant. Do not stop taking Epilim
Chrono suddenly, as it is likely that your fits will come back.
Women who are planning to get Pregnant
If you become pregnant, think you may be pregnant or plan
to become pregnant while taking Epilim Chrono, you must
tell your doctor straight away.
• Your doctor will give you appropriate counselling and
will suggest changes to your treatment or dose
• He or she will also want to check your progress while
you are pregnant
It is very important that you discuss your treatment with
your doctor well before you become pregnant.
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.
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
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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 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.
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 may include: a rash,
joint pain, fever (systemic lupus erythematosus), swallowing
or breathing problems, swelling of your lips, face, throat or
tongue. Hands, feet or genitals may also be affected. More
severe allergic reactions can lead to lymph node enlargement
and possible impairment of other organs.
• Liver problems and problems of the pancreas may show as
a sudden illness which may happen in the first six months
of treatment. This happens in a very small number of
people taking Epilim 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
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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

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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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