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EPILIM CHRONOSPHERE 1000MG MODIFIED RELEASE GRANULES

Active substance(s): SODIUM VALPROATE / VALPROIC ACID

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S1680 LEAFLET Epilim 20150408

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

5. How to store Epilim Chronosphere

S1680 LEAFLET Epilim 20150408



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
sachet and the pack after EXP. The expiry date refers to the
last day of that month.

The name of your medicine is Epilim Chronosphere 1000mg
modified release granules but will be referred to as Epilim
Chronosphere throughout the following leaflet.

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

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.

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.

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.

Talk to your doctor or pharmacist before taking Epilim
Chronosphere if:



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

6. Contents of the pack and other information



Blisters with the skin flaking away



Rapid, uncontrollable movement of the eyes



Feeling sick, stomach ache or diarrhoea, especially when
starting treatment. Feeling sick may be made better by taking
the granules with food

If you have a genetic problem caused by a mitochondrial
disorder (e.g. Alpers-Huttenlocher syndrome)

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

High levels of ammonia in the blood. Symptoms of this
condition are being sick, problems with balance and coordination, feeling lethargic or less alert



You have a rare illness called porphyria



Keep out of the sight and reach of children.





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:



PACKAGE LEAFLET: INFORMATION FOR THE USER



What Epilim Chronosphere contains



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.

What Epilim Chronosphere looks like and contents of the pack
Epilim Chronosphere are small off -white to slightly yellow, waxy
microgranules.

®

®

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.

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



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.



Fainting



Hearing loss

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



Skin problems such as rashes. These happen rarely, but more
often in people also taking Lamotrigine



Keep this leaflet. You may need to read it again.

Product Licence holder



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.

Taking Epilim Chronosphere may make you put on weight. Talk to
your doctor about how this will affect you.



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.

Blood tests



Acne



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

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



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

Manufacturer



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

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



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.

POM

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Epilim and Chronosphere are registered trademarks of SanofiAventis.

Other medicines and Epilim Chronosphere

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

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.

2. What you need to know 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 20150408

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 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.

Reporting of side effects

Your doctor may wish to do blood tests before you start taking
Epilim Chronosphere and during your treatment.

What is in this leaflet

Epilim Chronosphere can change levels of liver enzymes, salts or
sugars shown up on blood and urine tests.

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

Weight gain

PL No: 19488/1680

Leaflet revision date: 08 April 2015

Blood tests

Male Fertility

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Epilim Chronosphere

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

What Epilim Chronosphere is used for



Medicines for depression

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



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



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

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

2. What you need to know before you take Epilim
Chronosphere

By reporting side effects you can help provide more information on
the safety of this medicine.



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

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

CONTINUING TREATMENT AND CONSIDERING TRYING FOR A
BABY



The granules should not be given in babies bottles. This is
because they can block the nipple

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.



If you feel the effect of your medicine is too weak or too strong,
do not change the dose yourself but ask your doctor

Alcohol intake is not recommended during treatment.

Your doctor may decide to change the dose of valproate or switch
you to another medicine before you start trying for a baby.

Pregnancy, breast feeding and fertility

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.

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.



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:

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.
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.



Tell your doctor at once when you know or think you might be
pregnant.

If you or your child go into hospital or visit another doctor or a
dentist, tell them you are taking Epilim Chronosphere.



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

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



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

4. Possible side effects



The mixture of granules with food or drink should be swallowed
immediately

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.

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

How much to take

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.

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 (2030mg per kilogram of body weight) each day



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.

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

Children over 20 kilograms

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.



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



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

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



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)

Children under 20 kilograms


Depending on the child’s condition your child’s doctor may
decide to increase this dose
Patients with kidney problems


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 may decide to adjust your or your child’s dose

Patients taking other medicines for ‘fits’ (epilepsy)


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.

The usual dose is 20mg for each kilogram of body weight



Driving and using machines:


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.

S1680 LEAFLET Epilim 20150408



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

If you forget to take Epilim Chronosphere



Take this medicine by mouth



Do not crush or chew the granules

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 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

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.

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.

Adults

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).





How to take this medicine

Tests

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.

Expand view ⇕

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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