Skip to Content

UK Edition. Click here for US version.

EPILIM CHRONOSPHERE 100MG PROLONGED-RELEASE GRANULES

Active substance(s): SODIUM VALPROATE / VALPROIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Epilim® Chronosphere® 100mg Prolonged
Release Granules
Sodium valproate and Valproic acid

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

Take special care with Epilim Chronosphere
A small number of people being treated with antiepileptics such as sodium valproate have had
thoughts of harming or killing themselves. If at any time you
have these thoughts, immediately contact your doctor.
Check with your doctor or pharmacist before taking
your medicine if:
 You have diabetes. This medicine may affect the results of
urine tests
 You have kidney problems. Your doctor may give you a
lower dose
 You have a „urea cycle disorder‟ - where too much
ammonia builds up in the body.
 You have an illness called “systemic lupus erythematosus
(SLE)” a disease of the immune system which affects
skin, bones, joints and internal organs.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Epilim
Chronosphere
Weight gain
Taking Epilim Chronosphere may make you put on weight.
Talk to your doctor about how this will affect you.
Blood tests
Your doctor may wish to do blood tests before you start
taking Epilim Chronosphere and during your treatment.

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
What Epilim Chronosphere is
Chronosphere can affect the way some other medicines
The name of your medicine is Epilim Chronosphere 100mg
Prolonged Release Granules (called Epilim Chronosphere in work. Also some medicines can affect the way Epilim
Chronosphere works.
this leaflet). “Prolonged release” means that the active
ingredients (sodium valproate and valproic acid) are slowly
The following medicines can increase the chance of you
released from the granules over a long period of time.
getting side effects, when taken with Epilim
Epilim Chronosphere Prolonged Release Granules are also Chronosphere:
 Some medicines used for pain and inflammation
available in strengths 250mg, 500mg, 750mg and 1000mg.
(salicylates) such as aspirin
What Epilim Chronosphere contains
 Some other medicines used to treat fits (epilepsy) – see
page 2, section 3, “Patients taking other medicines for
Epilim Chronosphere contains two medicines called sodium
„fits‟. This includes medicines such as phenobarbital,
valproate and valproic acid. Both belong to a group of
primidone, phenytoin, carbamazepine, topiramate,
medicines called anti-convulsants or anti-epileptic agents.
lamotrigine and felbamate
They work by helping to calm the brain down.
What Epilim Chronosphere is used for
Epilim Chronosphere is used to treat epilepsy (fits) in adults
and children.

Do not take Epilim Chronosphere and tell your
doctor if:
 You are allergic (hypersensitive) to sodium
valproate, valproic acid or any of the other ingredients of
Epilim Chronosphere (listed in Section 6 below).
 You have liver problems or you and your family have a
history of liver problems
 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.

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.

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

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
How much to take
product, ask your doctor or pharmacist.
Adults
 The starting dose is 600mg daily. Your doctor will
gradually increase this dose by 200mg every 3 days
Like all medicines, Epilim Chronosphere can cause side
depending on your condition
effects, although not everybody gets them.
 The usual dose is generally between 1000mg and 2000mg
(20-30mg per kilogram of body weight) each day
Tell your doctor straight away if you notice any
 This may be increased to 2500mg each day depending on
of the following serious side effects - you may
your illness
need urgent medical treatment:
 You have an allergic reaction. The signs may include: a
Children over 20 kilograms
rash, joint pain, fever (systemic lupus erythematosus),
 The starting dose should be 400mg daily. Your doctor
swallowing or breathing problems, swelling of your lips,
should increase this dose depending on your child‟s illness
face, throat or tongue. Hands, feet or genitals may also be
 The usual dose is usually between 20 and 30mg for each
affected. More severe allergic reactions can lead to lymph
kilogram of body weight
node enlargement and possible impairment of other
 This may be increased to 35mg for each kilogram of body
organs.
weight each day depending on your child‟s illness
 Liver problems and problems of the pancreas may show
as a sudden illness which may happen in the first six
Children under 20 kilograms
months of treatment. This happens in a very small
 The usual dose is 20mg for each kilogram of body weight
number of people taking Epilim Chronosphere. It includes
 Depending on the child‟s condition your child‟s doctor may
feeling and being sick many times, being very tired, sleepy
decide to increase this dose
and weak, stomach pain including very bad upper
stomach pain, jaundice (yellowing of the skin or whites of
Patients with kidney problems
the eyes), loss of appetite, swelling (especially of the legs
 Your doctor may decide to adjust your or your child‟s dose
and feet but may include other parts of the body),
Patients taking other medicines for ‘fits’ (epilepsy)
worsening of your fits or a general feeling of being unwell
 You or your child may be taking other medicines for
Your doctor may tell you to stop taking Epilim
epilepsy at the same time as Epilim Chronosphere. If so,
Chronosphere immediately if you have these symptoms
your doctor should gradually initiate treatment depending
 You have a skin rash or skin lesions with a pink/red ring
on you or your child‟s condition
and a pale centre which may be itchy, scaly or filled with
 Your doctor may increase the dose of Epilim
fluid. The rash may appear especially on the palms or
Chronosphere by 5 to 10mg for each kilogram of body
soles of your feet. These could be signs of a serious
weight each day depending on which other medicines you
allergy to the medicine called „erythema multiforme‟
are taking
 Blistering or bleeding of the skin around the lips, eyes,
mouth, nose and genitals. Also flu-like symptoms and
If you take more Epilim Chronosphere than you should
fever. This may be something called „Stevens-Johnson
If you take more Epilim Chronosphere than you should, tell
syndrome‟
a doctor or go to a hospital casualty department straight
 Severe blistering rash where layers of the skin may peel
away. Take the medicine pack with you. This is so the
off to leave large areas of raw exposed skin over the body.
doctor knows what you have taken. The following effects
Also a feeling of being generally unwell, fever, chills and
may happen: feeling sick or being sick, pupils of the eye
aching muscles. This may be something called „Toxic
become smaller, dizziness, loss of consciousness, weak
epidermal necrolysis‟
muscles, breathing problems, headaches, memory loss and  Bruising more easily and getting more infections than
unusual or inappropriate behaviour.
usual. This could be a blood problem called
„thrombocytopenia‟. It can also be due to a fall in the
If you forget to take Epilim Chronosphere
number of white blood cells, bone marrow depression or
If you forget to take a dose, take it as soon as you
another condition that affects red blood cells, white blood
remember. However, if it is nearly time for the next dose,
cells and platelets (pancytopenia) or how the blood clots
skip the missed dose.
 Blood clotting problems (bleeding for longer than normal),
Do not take a double dose to make up for a forgotten dose.
bruising or bleeding for no reason
 Changes in mood, loss of memory, lack of concentration
If you stop taking Epilim Chronosphere
and deep loss of consciousness (coma)
Keep taking until your doctor tells to stop. Do not stop taking
 Underactive thyroid gland, which may cause tiredness or
Epilim Chronosphere just because you feel better. If you
weight gain (hypothyroidism)
stop your fits may come back.
 Breathing difficulty and pain due to inflammation of the
lungs (pleural effusion)
Tests
Make sure you or your child keep your regular appointments
for a check up. They are very important as your or your

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
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
 Agression, agitation, disturbance in attention, abnormal
behaviour, restlessness/hyperactivity and learning
disorder
 Tingling or numbness in the hands and feet

Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the
sachet and the pack after EXP. The expiry date refers to the
last day of that month.
Do not store above 25°C. Store in the original packaging.
Do not refrigerate or freeze.
Medicines should not be disposed of via household
wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help protect the environment.

What Epilim Chronosphere contains
 Each sachet of 303mg prolonged 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 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 prolonged release granules are supplied in cartons
of 30 sachets.
Product Licence Holder and Manufacturer
This product is procured from within the EU by the Product
Licence Holder: IMED Healthcare Ltd, New Road,
Buncrana, Co. Donegal, Ireland.
Manufacturer: Sanofi Winthrop Industrie, 196, avenue du
Maréchal Juin, 45200 Amilly, France
This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
PL: 40854/0027

POM

This leaflet was last revised on 26/04/2013
There are two organisations that will also be happy to try
and answer any general questions on epilepsy. They can be
contacted at:

Bone Disorders
There have been reports of bone disorders including
osteopenia and osteoporosis (thinning of the bone) and
Epilepsy Action, New Anstey House, Gate Way Drive,
fractures. Check with your doctor or pharmacist if you are on Yeadon, Leeds, LS19 7XY
long-term antiepileptic medication, have a history of
Telephone: 0808 800 5050. Website: www.epilepsy.org.uk
osteoporosis, or take steroids.
National Society for Epilepsy (NSE), Chesham Lane,
Blood tests
Chalfont St Peter, Bucks, SL9 0RJ
Epilim Chronosphere can change levels of liver enzymes,
Telephone: 01494 601400.
salts or sugars shown up on blood and urine tests.
Website: www.epilepsynse.org.uk
Male Fertility
Taking Epilim Chronosphere can be a contributing factor in
male infertility. Talk to your doctor or pharmacist if any of the
side effects gets serious or lasts longer than a few days, or
if you notice any side effects not listed in this leaflet.

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.

Hide