Active substance: VALPROIC ACID

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Ref: 1346/260913/1/F

Epilim Chronosphere 100mg modified release granules


(sodium valproate/valproic acid)
Patient Information Leaflet
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.
Your medicine is called Epilim Chronosphere 100mg modified release
granules but will be referred to as Epilim Chronosphere throughout the
leaflet. Please note that the leaflet also contains information about other
strengths of the medicine, Epilim Chronosphere 50mg modified release
granules, Epilim Chronosphere 250mg modified release granules,
Epilim Chronosphere 500mg modified release granules,
Epilim Chronosphere 750mg modified release granules and
Epilim Chronosphere 1000mg modified release granules.
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

Possible side effects


How to store Epilim Chronosphere

6 Further information


What Epilim Chronosphere is and what it is used for

What Epilim Chronosphere is
The name of your medicine is Epilim Chronosphere 100mg modified release
granules. “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.


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
* 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 Chronosphere.
Take special care with Epilim Chronosphere
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 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.
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.
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
* 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 Chronosphere may increase the effect of the following
* 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,
* Medicines used to calm emotional and mental conditions such as
diazepam and olanzapine
The following medicines can affect the way Epilim Chronosphere
* 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 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
* 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 Chronosphere if you become pregnant. Women taking Epilim
Chronosphere 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, including heart defects
* Defects of the lining of the spinal cord
* An abnormality of the spinal cord called ‘Spina bifida’
* Malformations of the urethra
Women who take Epilim Chronosphere 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 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
* Hypoglycaemia (low blood sugar)
* Hypothyroidism (underactive thyroid gland, which can cause tiredness or
weight gain).
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.
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.


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.
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 you 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
How much to take
* 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

Ref: 1346/260913/1/B

Epilim Chronosphere 100mg modified release granules


(sodium valproate/valproic acid)
Patient Information Leaflet (continued)
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
* 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
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.


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
* 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, 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
* Feeling shaky (tremor), sleepy or unsteady when walking or jerky muscle
* 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
* 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.
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


How to store Epilim Chronosphere

Do not store above 25°C.
Store in the original package.
Store in a dry place.
Do not refrigerate or freeze.
Do not take this medicine after the expiry date shown on the carton or
sachet label. If your doctor tells you to stop taking the medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.


Further information

What Epilim Chronosphere contains
Each sachet of 303mg modified release granules contains a mixture of
66.66mg sodium valproate and 29.03mg valproic acid, equivalent to 100mg
of the active substance sodium valproate.
The other ingredients are hard paraffin, glycerol dibehenate and colloidal
hydrated silica.
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.
Manufacturer and Licence Holder
This medicine is manufactured by Sanofi Winthrop Industrie, 196, avenue du
Maréchal Juin, 45200 Amilly, France and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.


PL 15184/1346

Epilim and Chronosphere are registered trademarks of Sanofi-Aventis
Leaflet revision date: 26/09/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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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.