EPILIM CHRONOSPHERE 750MG PROLONGED RELEASE GRANULES

Active substance: VALPROIC ACID

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

history of liver problems
• You have a rare illness called porphyria

• Medicines used to calm emotional and mental conditions such
as diazepam and olanzapine

Epilim® Chronosphere® 750mg Prolonged Release
Granules

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.

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

Sodium valproate and Valproic acid

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Phone 01483 505515 for help
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Epilim Chronosphere is and what it is used for
2. Before you take Epilim Chronosphere
3. How to take Epilim Chronosphere
4. Possible side effects
5. How to store Epilim Chronosphere
6. Further information

Take special care with Epilim Chronosphere
A small number of people being treated with antiepileptics 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 your
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 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 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.

What Epilim Chronosphere is
The name of your medicine is Epilim Chronosphere 750mg
Prolonged Release Granules (called Epilim Chronosphere in this
leaflet). “Prolonged release” means that the active ingredients
(sodium valproate and valproic acid) are slowly released from the
granules over a long period of time.
Epilim Chronosphere Prolonged Release Granules are also
available in strengths 100mg, 250mg, 500mg and 1000mg.
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.

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

Taking Epilim Chronosphere 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 Chronosphere
can affect the way some other medicines work. Also some
medicines can affect the way Epilim Chronosphere works.

Taking Epilim Chronosphere 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 Chronosphere, your doctor should
discuss with you the possible problems when it is taken in
pregnancy.
• Unplanned pregnancy is not desirable in women taking Epilim
Chronosphere
• You should use an effective method of contraception and
talk to your doctor before planning pregnancy. Epilim
Chronosphere 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
The following medicines can increase the chance of you
depression in the lip)
getting side effects, when taken with Epilim Chronosphere:
• Deformities of the bones, including hip dislocation
• Some medicines used for pain and inflammation (salicylates)
• Malformations of the arms and legs
such as aspirin
• Deformities of the tube from the bladder to the penis, where the
• Some other medicines used to treat fits (epilepsy) – see page 2,
opening is formed in a different place
section 3, “Patients taking other medicines for „fits‟. This
• Heart and blood vessel malformations, including heart defects
includes medicines such as phenobarbital, primidone,
• Defects of the lining of the spinal cord
phenytoin, carbamazepine, topiramate, lamotrigine and
• An abnormality of the spinal cord called „Spina bifida‟
felbamate
Women who take Epilim Chronosphere during pregnancy may be
Epilim Chronosphere may increase the effect of the
more likely to have a baby with spina bifida. Taking folic acid
following medicines:
5mg each day as soon as you stop contraception may lower
the risk of having a baby with spina bifida.
• Medicines used for thinning the blood (such as warfarin)
• Zidovudine used to treat HIV infection
• Temozolomide used to treat cancer
There is also an increased risk of other birth defects. These other
• Medicines for depression
defects can usually be detected in the first 3 months of the
• Monoamine oxidase inhibitors (MAOI) such as moclobemide,
pregnancy using routine antenatal screening blood tests and
selegiline, linezolid
ultrasound scans.

Pregnant mothers who take Epilim Chronosphere 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)
Some babies born to mothers who took Epilim Chronosphere
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 Chronosphere if
you want to become pregnant. Do not stop taking Epilim
Chronosphere 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 Chronosphere, 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 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.

Always take Epilim Chronosphere 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 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

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 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 usually between 20 and 30mg for each
kilogram of body weight
• This may be increased to 35mg for each kilogram of body weight
each day depending on your child‟s illness
Children under 20 kilograms
• The usual dose is 20mg 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 10mg 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 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.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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, 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)
• 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)
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, hyperactive 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

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 to protect from moisture. 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.

What Epilim Chronosphere contains
• Each sachet of 2273mg prolonged release granules contains a
mixture of 500.06mg Sodium Valproate and 217.75mg Valproic
Acid, equivalent to 750mg of the active substance Sodium
Valproate
• The other ingredients are paraffin hard, glycerol dibehenate and
silica colloidal hydrated.

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

What Epilim Chronosphere looks like and contents of the
pack
• The sachets contain small off -white to slightly yellow, waxy
microgranules.
• These prolonged release granules are supplied in cartons of 30
sachets.

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.

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

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. 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.

Product Licence Holder and Manufacturer
This product is procured from within the EU by the Product
Licence Holder: IMED Healthcare Ltd, New Road, Buncrana, Co.
Donegal, Ireland.
Manufacturer: Sanofi Winthrop Industrie, 196, avenue du Maréchal
Juin, 45200 Amilly, France
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.
PL: 40854/0012 POM
This leaflet was last revised on 28/11/2012

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

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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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