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EPILIM CHRONOSPHERE 1000MG MODIFIED RELEASE GRANULES

Active substance: VALPROIC ACID

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S1680 LEAFLET Epilim 20130118

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:

S1680 LEAFLET Epilim 20130118

PACKAGE LEAFLET: INFORMATION FOR THE USER

What Epilim Chronosphere contains

EPILIM CHRONOSPHERE 1000mg MODIFIED
RELEASE GRANULES
(sodium valproate and valproic acid)

®



Each sachet of 3030mg modified release granules contains a
mixture of 666.60mg sodium valproate and 290.27mg valproic
acid, equivalent to 1000mg of sodium valproate.



The other ingredients are hard paraffin, glycerol dibehenate
and colloidal hydrated silica.



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



Epilim Chronosphere are small off -white to slightly yellow, waxy
microgranules.

Hair loss which is usually temporary. When it grows back it may
be more curly than before



These modified release granules are supplied in cartons of 30
sachets.

Hair, including body or facial hair grows more than normal in
women



Skin rash caused by narrow or blocked blood vessels
(vasculitis)

What Epilim Chronosphere looks like and contents of the pack

The name of your medicine is Epilim Chronosphere 1000mg
modified release granules but will be referred to as Epilim
Chronosphere throughout the following leaflet.
Please note that information regarding other strengths 50, 100,
250, 500 and 750mg of Epilim Chronosphere granules may also be
present in the below leaflet.
Read all of this leaflet carefully before you start taking this
medicine.
Keep this leaflet. You may need to read it again.

Product Licence holder



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

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.

Changes in women’s periods and increased hair growth in
women



Breast enlargement in men



Manufacturer

Swelling of the feet and legs (oedema)



Weight gain - as your appetite may be increased

This product is manufactured by Sanofi Winthrop Industrie, 196,
avenue du Maréchal Juin, 45200 Amilly, France.



Kidney problems, bedwetting or increased need to pass urine



Headache

Leaflet revision date: 18 January 2013



Aggression, agitation, disturbance in attention, abnormal
behaviour, restlessness/ hyperactivity, and learning disorder

Epilim and Chronosphere are registered trademarks of SanofiAventis.



Tingling or numbness in the hands and feet

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.

®





Bone Disorders

Take special care with Epilim Chronosphere

6. Further Information

POM



PL No: 19488/1680

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:

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.

1. What Epilim Chronosphere is and what it is used for
2. Before you take Epilim Chronosphere
3. How to take Epilim Chronosphere

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
S1680 LEAFLET Epilim 20130118

4. Possible side effects
5. How to store Epilim Chronosphere
6. Further information

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.

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

The following medicines can increase the chance of you
getting side effects, when taken with Epilim Chronosphere:

What Epilim Chronosphere is



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

The name of your medicine is Epilim Chronosphere 1000mg
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.

Male Fertility

What Epilim Chronosphere contains

Taking Epilim Chronosphere can be a contributing factor in male
infertility.

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.

Epilim Chronosphere may increase the effect of the following
medicines:

5. How to store Epilim Chronosphere



Medicines used for thinning the blood (such as warfarin)



Zidovudine used to treat HIV infection



Temozolomide used to treat cancer

What Epilim Chronosphere is used for

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.



Medicines for depression

Epilim Chronosphere is used to treat epilepsy (fits) in adults and
children.



Monoamine oxidase inhibitors (MAOI) such as moclobemide,
selegiline, linezolid



Keep out of the sight and reach of children.



Do not store above 25°C. Store in the original package. Store
in a dry place.

2. Before you take Epilim Chronosphere



Do not refrigerate or freeze.

Do not take Epilim Chronosphere and tell your doctor if:



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.



You are allergic (hypersensitive) to sodium valproate, valproic
acid or any of the other ingredients of Epilim Chronosphere
(listed in Section 6 below).



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



You have liver problems or you and your family have a history
of liver problems





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

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.

Taking Epilim Chronosphere with food and drink

Women who are planning to get Pregnant

How much to take

Alcohol intake is not recommended during treatment.

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.

Adults

4. Possible side effects



Like all medicines, Epilim Chronosphere can cause side effects,
although not everybody gets them.

Your doctor will give you appropriate counselling and will
suggest changes to your treatment or dose

The starting dose is 600mg daily. Your doctor will gradually
increase this dose by 200mg every 3 days depending on your
condition



He or she will also want to check your progress while you are
pregnant

The usual dose is generally between 1000mg and 2000mg (2030mg per kilogram of body weight) each day



This may be increased to 2500mg each day depending on your
illness

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



Deformities of the tube from the bladder to the penis, where the
opening is formed in a different place



It is very important that you discuss your treatment with your doctor
well before you become pregnant.

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

Children over 20 kilograms

Breast-feeding



Very little Epilim Chronosphere gets into the breast milk. However,
talk to your doctor about whether you should breast-feed your
baby.

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

Ask your doctor or pharmacist for advice before taking any
medicine.



This may be increased to 35mg for each kilogram of body
weight each day depending on your child’s illness

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

Heart and blood vessel malformations, including heart defects





Malformations of the arms and legs





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

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)

Your doctor may tell you to stop taking Epilim Chronosphere
immediately if you have these symptoms

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

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’

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 will decide how much Epilim Chronosphere to give
you or your child depending on your or your child’s body weight

Defects of the lining of the spinal cord



Take this medicine by mouth



An abnormality of the spinal cord called ‘Spina bifida’



If you take more Epilim Chronosphere than you should

Do not crush or chew the granules



Malformations of the urethra



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

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.



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

If you forget to take Epilim Chronosphere



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)

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.



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

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.

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.

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 coordination, 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

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

S1680 LEAFLET Epilim 20130118

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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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