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EPILIM CHRONOSPHERE 100 MG MODIFIED RELEASE GRANULES

Active substance(s): SODIUM VALPROATE / VALPROIC ACID

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504096/PL1c

Epilim® Chronosphere® 100 mg
Modified Release Granules
(sodium valproate & valproic acid)
Patient Information Leaflet

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 Chronosphere is and what it is used for
2. What you need to know before you take Epilim
Chronosphere
3. How to take Epilim Chronosphere
4. Possible side effects
5. How to store Epilim Chronosphere
6. Contents of the pack and other information
1) WHAT EPILIM CHRONOSPHERE IS AND WHAT IT IS
USED FOR
What Epilim Chronosphere is
The name of your medicine is Epilim Chronosphere 100 mg
Modified Release Granules, (called Epilim Chronosphere in
this leaflet. Other strengths are available). “Modified release”
means that the active ingredients (sodium valproate and
valproic acid) are slowly released from the granules over a long
period of time.
What Epilim Chronosphere contains
Epilim Chronosphere contains two medicines called sodium
valproate and valproic acid. Both belong to a group of
medicines called anti-convulsants or anti-epileptic agents.
They work by helping to calm the brain down.
What Epilim Chronosphere is used for
Epilim Chronosphere is used to treat epilepsy (fits) in adults
and children.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EPILIM CHRONOSPHERE
Do not take Epilim Chronosphere and tell your doctor if:
• You are allergic (hypersensitive) to sodium valproate,
valproic acid or any of the other ingredients of Epilim
Chronosphere (listed in Section 6 below).
• You have liver problems or you and 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 Chronosphere.
Warnings 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
Chronosphere 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 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 Chronosphere
Weight gain
Taking Epilim Chronosphere 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 Chronosphere and during your treatment.
Other medicines and Epilim Chronosphere
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 Chronosphere can affect the way some other
medicines work. Also some medicines can affect the way
Epilim Chronosphere works.
The following medicines can increase the chance of you
getting side effects, when taken with Epilim
Chronosphere:
• Some medicines used for pain and inflammation
(salicylates) such as aspirin
• Some other medicines used to treat fits (epilepsy) - see
section 3, “Patients taking other medicines for
‘fits’”. This includes medicines such as phenobarbital,
primidone, phenytoin, carbamazepine, topiramate,
lamotrigine and felbamate
Epilim Chronosphere 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
Chronosphere 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
Chronosphere and carbapenems should be avoided
because it may decrease the effect of your medicine.
• Colestyramine used to lower blood fat (cholesterol)
levels
Taking Epilim Chronosphere 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 Chronosphere 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 Chronosphere. 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 problems may increase sleepiness.
3) HOW TO TAKE EPILIM CHRONOSPHERE
Always take Epilim Chronosphere exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
Epilim Chronosphere 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 Chronosphere
to give you or your child depending on your or your
child’s body weight
• Take this medicine by mouth
• Do not crush or chew the granules
• Do not store partially used sachets or a mixture of the
granules with liquid or food for future use. Always use
the full contents of each sachet
• Do not sprinkle Epilim Chronosphere on warm or hot
foods and drinks, such as soup, coffee, tea, or
something similar
• The granules should not be given in babies bottles. This
is because they can block the nipple
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself but ask your
doctor
Continued overleaf

How to take this medicine
• This medicine can be taken once or twice daily
• The granules should be sprinkled on a small amount of
soft food or drink which should be cold or at room
temperature
• This medicine can be taken with soft food or drink such
as yoghurt, mousse, jam, ice cream, milk shake and
orange juice
• When the granules are put onto food, you must swallow
all the food with the granules to make sure you get the
correct dose of medicine
• When the granules are swallowed in a drink, the empty
glass should be rinsed with a small amount of water.
This water should be swallowed because some
granules may stick to the glass
• The mixture of granules with food or drink should be
swallowed immediately
How much to take
Adults
• The starting dose is 600 mg daily. Your doctor will
gradually increase this dose by 200 mg every 3 days
depending on your condition
• The usual dose is generally between 1000 mg and
2000 mg (20-30 mg per kilogram of body weight) each
day
• This may be increased to 2500 mg each day depending
on your illness
Children over 20 kilograms
• The starting dose should be 400 mg daily. Your doctor
should increase this dose depending on your child’s
illness
• The usual dose is usually between 20 and 30 mg for
each kilogram of body weight
• This may be increased to 35 mg for each kilogram of
body weight each day depending on your child’s illness
Children under 20 kilograms
• The usual dose is 20 mg for each kilogram of body weight
• Depending on the child’s condition your child’s doctor
may decide to increase this dose
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 Chronosphere. If so,
your doctor should gradually initiate treatment
depending on you or your child’s condition
• Your doctor may increase the dose of Epilim
Chronosphere by 5 to 10 mg for each kilogram of body
weight each day depending on which other medicines
you are taking
If you take more Epilim Chronosphere than you should
If you take more Epilim Chronosphere 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, breathing
problems, headaches, memory loss and unusual or
inappropriate behaviour.
If you forget to take Epilim Chronosphere
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 Chronosphere
Keep taking until your doctor tells you to stop. Do not stop
taking Epilim Chronosphere 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 Chronosphere 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 Chronosphere.
You may see what appears to be complete granules in your
stool. This is normal as the matrix of the Epilim Chronosphere
granules is not digested by the body. It does not mean that the
medicine is not working.
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 Chronosphere 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 Chronosphere. 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 Chronosphere
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
Chronosphere starting dose is high or has been suddenly
increased
• High levels 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. Feeling sick may be made better by
taking the granules with food
• 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 Chronosphere can change levels of liver enzymes,
salts or sugars shown up on blood and urine tests.
Male Fertility
Taking Epilim Chronosphere can be a contributing factor in
male infertility.
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 CHRONOSPHERE
• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry date shown on
the sachet and the pack after EXP. The expiry date
refers to the last day of that month.
• Do not store above 25°C.
• Store in the original packaging.
• Do not refrigerate or freeze.
• 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.
• If the sachets become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will
tell you what to do.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Epilim Chronosphere contains
• Each sachet contains a mixture of 66.66 mg sodium
valproate and 29.03 mg valproic acid, equivalent to
100 mg of the active substance sodium valproate
• The other ingredients are paraffin hard, glycerol
dibehenate and silica colloidal hydrated.
What Epilim Chronosphere looks like and contents of the
pack
• The sachets contain small off-white to slightly yellow,
waxy microgranules.
• These modified release granules are supplied in cartons
of 30 sachets.
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.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Sanofi Winthrop Industrie, 196 Rue du Maréchal Juin, Amilly,
F-45200, France.
Epilim® Chronosphere®
Granules
PL No: 18067/0412

100

mg

Modified

Release

POM

Epilim® and Chronosphere® are registered trademarks.
This leaflet was last approved on 7th May 2015.
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
Epilepsy Action and The National Society for Epilepsy (NSE)
are not associated with Ginova Ltd or Ginova UK Ltd.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

504096/PL1c

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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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