EPILIM CHRONO 500MG CONTROLLED RELEASE TABLETS

Active substance: SODIUM VALPROATE

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Assessed against UK PIL dated December 2013
Package leaflet: Information for the user

Epilim® Chrono® 500mg Controlled Release Tablets
(sodium valproate)
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
®
®
• Epilim Chrono is also available in 200mg and 300mg
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

MOCK UP

1) WHAT EPILIM CHRONO IS AND WHAT IT IS USED FOR
What Epilim Chrono is
The name of your medicine is Epilim Chrono 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.
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.

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

By addisonf at 12:43 pm, Jul 03, 2014

What Epilim Chrono is used for
Epilim Chrono is used to treat epilepsy (fits) in adults and children.
2) 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: 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:
• 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
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.

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.
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

The following medicines can increase the chance of you getting
side effects, when taken with Epilim Chrono:
• Some medicines used for pain and inflammation (salicylates) such as
aspirin.
• Some other medicines used to treat fits (epilepsy) – see page 2,
section 3, “Patients taking other medicines for ‘fits’”. This includes
medicines such as phenobarbital, primidone, phenytoin,
carbamazepine, topiramate, lamotrigine and felbamate
Epilim Chrono may increase the effect of the following medicines:
• Medicines used for thinning the blood (such as warfarin)
• Zidovudine used to treat HIV infection
• Temozolomide used to treat cancer
• Medicines for depression
• Monoamine oxidase inhibitors (MAOI) such as moclobemide,
selegiline, linezolid
• Medicines used to calm emotional and mental conditions such as
diazepam and olanzapine
The following medicines can affect the way Epilim Chrono works:
• Some medicines used for the prevention and treatment of malaria such
as mefloquine and chloroquine
• Cimetidine used for stomach ulcers
• Carbapenem agents (antibiotics used to treat bacterial infections) such
as imipenem, meropenem, rifampicin and erythromycin. The
combination of Epilim Chrono and carbapenems should be avoided
because it may decrease the effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol) levels

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
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.
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)
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
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 protective foil until immediately
before use.
• Do not cut the blister strips.
• Do not store above 30°
C.
• Store in the original package in order to protect from moisture.
• Store in a dry place.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• 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 500mg controlled release tablet contains a mixture of 333mg
sodium valproate and 145mg valproic acid, equivalent to 500mg sodium
valproate.
The other ingredients are: Hypromellose, Ethylcellulose, Colloidal
hydrated silica, Titanium dioxide (E171), Erythrosine BS (E127), Indigo
carmine (E132), Black iron oxide (E172), Macrogol 400
What Epilim Chrono looks like and contents of the pack
Epilim Chrono tablets are violet, oblong, biconvex, film-coated tablets
with no markings.
The tablets are supplied in blister packs of 100
Manufactured by: Fawdon Manufacturing Centre, Edgefield Avenue,
Fawdon, Newcastle upon Tyne. Tyne & Wear, NE3 3TT. UK
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER
Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxx
Epilim Chrono 500mg Controlled Release Tablets PL: 33532/0239
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 date 02 July 2014
Leaflet code xxxxxxxxxx

POM

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
®

®

Epilim Chrono is a registered trademark of Sanofi-Synthelabo UK Ltd

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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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