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EPILIM CHRONO 500 MG CONTROLLED RELEASE TABLETS

Active substance(s): SODIUM VALPROATE / VALPROIC ACID

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Variation 0006: To correct the reason for variation 4 to:
To add a new manufacturer `Sanofi Winthrop Industrie, 1, Rue de la Vierge, Ambares et Lagrave - F-33565 Carbon Blanc cedex, France' to the licence, with consequential
changes to the labels and leaflet.
No other changes approved
Previously ssessed
against
UK PIL dated February 2015
PACKAGE
LEAFLET:
The following medicines can affect the way Epilim

INFORMATION FOR THE USER

Epilim® Chrono® 200 mg Controlled
Release Tablets,
Epilim® Chrono® 300 mg Controlled
Release Tablets and Epilim® Chrono®
500 mg Controlled Release Tablets
(sodium valproate)

▼ 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

Chrono works:

By BeeharryN at 2:29 pm, Apr 22, 2016

 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

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.

 Valproate can be harmful to unborn children when taken

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

 If you take valproate during pregnancy you have a higher




Keep this leaflet. You may need to read it again



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 have further questions, please ask your doctor or
pharmacist

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.

Your medicine may be called by any of the above names, but
will be referred to as Epilim Chrono throughout 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

1. What Epilim Chrono is and what it is used for
What Epilim Chrono is
The name of your medicine is Epilim Chrono 200, 300 and 500 mg
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.
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

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.

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.
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

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.
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.
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.
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:
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.

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



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

 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

 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 cr ush 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

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

 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

How much to take
Adults (including the elderly)

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:

 The starting dose is 600mg daily. Your doctor will gradually

 Feeling sick, stomach ache or diarrhoea, especially when



This medicine can be taken once or twice daily

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

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

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

 Hair, including body or facial hair grows more than normal



This may be further increased to 35mg for each kilogram
of body weight each day depending on your child’s illness

 Skin rash caused by narrow or blocked blood vessels (vasculitis)
 Changes in women’s periods and increased hair growth in

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.
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)

in women

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.
United Kingdom
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/
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. Keep the blister strips in outer carton in order to protect
from moisture
If the tablets become discoloured or show 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.

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

 Each 200 mg controlled release tablet contains a mixture of
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 a mixture of
199.8 mg sodium valproate and 87 mg valproic acid, equivalent
to 300 mg of active substance sodium valproate

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

 The other ingredients are: hypromellose (E464), ethylcellulose,
hydrated silica, titanium dioxide (E171), erythrosine BS (E127),
indigo carmine (E132), iron oxide black (E172), macrogol 400
What Epilim Chrono looks like and contents of the pack
Epilim Chrono tablets are oval shaped and violet coloured, there are no
markings on either side of the tablet. The tablets are supplied in blister
packs of 100.
Manufacturer
Sanofi Winthrop Industrie
1, Rue de la Vierge
Ambarés et Lagrave - F-33565 Carbon Blanc cedex, France
Fawdon Manufacturing Centre,
Edgefield Avenue, Fawdon, Newcastle-upon-Tyne Tyne & Wear,
NE3 3TT, UK
Procured from within the EU. Product Licence Holder and repackaged
by: S.C.A.C. Ltd., Unit 2a, Bandeath Industrial Estate, Throsk, Stirling,
FK7 7NP.
POM

PL 30984/0200 Epilim Chrono 200 mg
Controlled Release Tablets
PL 30984/0201 Epilim Chrono 300 mg
Controlled Release Tablets
PL 30984/0202 Epilim Chrono 500 mg
Controlled Release Tablets

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.
This leaflet was last revised in 09.03.2016
Epilim® and Chrono® are registered trademarks of Sanofi-Synthelabo
UK Limited.



Underactive thyroid gland, which may cause tiredness or
weight gain (hypothyroidism)

There are two organisations that will also be happy to try and answer
any general questions on epilepsy. They can be contacted at:



Breathing difficulty and pain due to inflammation of the
lungs (pleural effusion)

Epilepsy Action, New Anstey House, Gate Way Dr ive, 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

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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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