EPILIM CHRONOSPHERE MR 100MG MODIFIED RELEASE GRANULES

Active substance: VALPROIC ACID

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(1,1) -1- 540933 - NPI EPILIM GB-J.indd 09/12/13 13:17

RAD001 (10 pistes) / SCHMUCKER /
RAD002 (1 piste)

540933
V2 - 09/12/2013
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Product type:
Product name:

FOLDED LEAFLET
NPI EPILIM GB-J

Country:

GB

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Plant:

For Sanofi-Aventis use only

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Version and Date:
Previous ID number:

V.P.
AMILLY PHARMA

Technical Data

Format: 180 x 504 mm - Folded 60 x 84mm
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Native file: In Design CS5
Layout of cutting: AY_NPI_180 x 504_B_1
V1 - 09/12/2013 - New regulatory text.
V2 - 09/12/2013 - September -> December.

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Epilim® Chronosphere® 50mg Modified Release Granules
Epilim® Chronosphere® 100mg Modified Release Granules
Epilim® Chronosphere® 250mg Modified Release Granules
Epilim® Chronosphere® 500mg Modified Release Granules
Epilim® Chronosphere® 750mg Modified Release Granules
Epilim® Chronosphere® 1000mg Modified Release Granules
Sodium valproate and Valproic acid

Is this leaflet hard to see or read?
Phone 0845 372 7101 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. See section 4.
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

1. What Epilim Chronosphere is and what it is used for

i

What Epilim Chronosphere is
The name of your medicine is Epilim Chronosphere 50, 100, 250, 500, 750 or 1000mg Modified
Release Granules (called Epilim Chronosphere in this leaflet). “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. 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

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PACKAGING TEAM

• 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 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 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 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 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 stop.
• 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.
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.
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

(1,1) -2- 540933 - NPI EPILIM GB-J.indd 09/12/13 13:17

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.
United Kingdom
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
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 reach and sight 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.

6. Further information
What Epilim Chronosphere contains

• Each sachet of 152mg modified release granules contains a mixture of 33.33mg Sodium
Valproate and 14.51mg Valproic Acid, equivalent to 50mg of the active substance Sodium
Valproate
• 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
• Each sachet of 758mg modified release granules contains a mixture of 166.76mg Sodium
Valproate and 72.61mg Valproic Acid, equivalent to 250mg of the active substance Sodium
Valproate
• Each sachet of 1515mg modified release granules contains a mixture of 333.30mg Sodium
Valproate and 145.14mg Valproic Acid, equivalent to 500mg of the active substance Sodium
Valproate
• Each sachet of 2273mg modified release granules contains a mixture of 500.06mg Sodium
Valproate and 217.75mg Valproic Acid, equivalent to 750mg of the active substance Sodium
Valproate
• Each sachet of 3030mg modified release granules contains a mixture of 666.60mg Sodium
Valproate and 290.27mg Valproic Acid, equivalent to 1000mg 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 or 50 sachets.
Not all packs/strengths may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie,
196, rue 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.
This leaflet was last revised in December 2013.
© Sanofi, 2006-2013
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

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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.

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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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