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EPILIM CHRONO 500 CONTROLLED RELEASE TABLETS

Active substance: VALPROIC ACID

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Patient Information Leaflet

Epilim® Chrono® 200 Controlled Release Tablets
Epilim® Chrono® 300 Controlled Release Tablets
Epilim® Chrono® 500 Controlled Release Tablets
(sodium valproate/valproic acid)
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. 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 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.
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

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
Taking Epilim Chrono with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy, breast feeding and fertility
Important advice for women
• 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.
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.



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 foil until just before you take them. Do
not cut the blister strips. Store in a dry place. Store in the original package.
Do not store above 30°C
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
• Each 200mg controlled release tablet contains sodium valproate and
valproic acid, equivalent to 200mg of sodium valproate
• Each 300mg controlled release tablet contains sodium valproate and
valproic acid, equivalent to 300mg of sodium valproate
• Each 500mg controlled release tablet contains sodium valproate and
valproic acid, equivalent to 500mg of sodium valproate
• The other ingredients are: hypromellose, colloidal hydrated silica,
ethylcellulose, titanium dioxide (E171), erythrosine (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 lilac coloured, film coated,
prolonged release tablets with no markings.
The tablets are supplied in blister packs of 100
Manufacturer
Sanofi-Synthelabo Ltd.,
Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon,
Newcastle-upon-Tyne, Northumberland, NE3 3TT UK
Procured within the E.U. and re-packaged by Munro Wholesale Medical
Supplies Ltd., 3 Young Place, East Kilbride, G75 0TD.
Product Licence holder: Ecosse Pharmaceuticals Ltd.,
3 Young Place, East Kilbride, G75 0TD.
PL 19065/0284 Epilim® Chrono® 200 Controlled Release Tablets
PL 19065/0285 Epilim® Chrono® 300 Controlled Release Tablets
PL 19065/0286 Epilim® Chrono® 500 Controlled Release Tablets
This leaflet was revised: 01/04/2015
E0284-6
® is a registered trademark of sanofi-synthelabo UK Limited

POM

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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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