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EPILIM 400MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): SODIUM VALPROATE / SODIUM VALPROATE / SODIUM VALPROATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Epilim® 400mg
Powder and Solvent
for solution for
injection/infusion
Sodium valproate

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

▼ This medicine is subject to additional

GRAFICA - FOTOCOMPOSIZIONE

-

DIMENSIONS mm:
COUNTRY:

UK

2

//
10 pt.

COLOUR 2:

LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:

REFLEX BLUE BLACK

08 GIU 2017

COLOURS N°: COLOUR 1:

89031958
(int. version 1)

420 x 296 (210 x 148)

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

DESCRIPTION:

DIE CUT:

Via G. Tartini, 2 2 0 1 5 8 - M I L A N O
02.375787 • e-mail: crominfoto@tiscali.it
CROMinFOTO s.n.c. Tel.

TYPE OF MATERIAL:

VERSION: OLD CODE:

LEAFLET FOLDED EPILIM 400 MG

CODE:

89031958 1 a 89031140 I027

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
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.
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• 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 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.
What is in this leaflet
1. What Epilim Injection is and what it is
used for
2. What you need to know before you take
Epilim Injection
3. How Epilim Injection is given
4. Possible side effects
5. How to store Epilim Injection
6. Contents of the pack and other
information

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

i

What Epilim Injection is
The name of your medicine is Epilim
400mg Powder and Solvent for solution for
injection/infusion (called Epilim Injection
in this leaflet).
What Epilim Injection contains
Epilim Injection contains a medicine called
sodium valproate. This belongs to a group
of medicines called anti-convulsants or
anti-epileptic agents. It works by helping to
calm the brain down.
What Epilim Injection is used for
Epilim Injection is used to treat epilepsy
(fits) in adults and children. The injection is
given when it is not possible to have your
medicine by mouth.
2. What you need to know before
you take Epilim Injection
Do not have Epilim Injection
and tell your doctor or nurse if:
X You are allergic (hypersensitive) to
sodium valproate or any of the other
ingredients of Epilim Injection (see
Section 6: Contents of the pack and other
information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems,
swelling of your lips, face, throat or tongue
X You have a known metabolic disorder, i.e
a urea cycle disorder
X You have liver problems or you or your
family have a history of liver problems
X You have a genetic problem caused
by a mitochondrial disorder (e.g.
Alpers-Huttenlocher syndrome)
Do not have this medicine if any of the
above apply to you. If you are not sure, talk
to your doctor or pharmacist before having
Epilim Injection.
Warnings and precautions
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.
As with other antiepileptic drugs,
convulsions may become worse or happen
more frequently whilst taking this
medicine. If this happens contact your
doctor immediately.
Talk to your doctor or pharmacist before
taking Epilim Injection:
▲ 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 fits (epilepsy), brain disease or a
metabolic condition affecting your brain
▲ 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.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before having Epilim Injection.
Weight gain
Having Epilim Injection 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 having Epilim Injection
and during your treatment.
Other medicines and Epilim
Injection
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
Injection can affect the way some other
medicines work. Also some medicines can
affect the way Epilim Injection works.
The following medicines can increase
the chance of you getting side effects,
when taken with Epilim Injection:
• Some medicines used for pain and
inflammation (salicylates) such as aspirin.
• Some other medicines used to treat fits
(epilepsy) – see section 3, “Patients taking
other medicines for ‘fits”. This includes
medicines such as phenobarbital,
primidone, phenytoin, carbamazepine
topiramate, lamotrigine and felbamate.
Epilim Injection 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 Injection 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 Injection and carbapenems
should be avoided because it may
decrease the effect of your medicine.
• Colestyramine used to lower blood fat
(cholesterol) levels
Taking Epilim Injection with food and
drink
Alcohol intake is not recommended during
treatment.
Pregnancy, breast feeding and fertility
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.
• 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).
• 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.
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
CONSIDERING TRYING FOR A BABY
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.

Your doctor may decide to change the dose
of valproate or switch you to another
medicine before you start trying for a baby.
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.
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:
• 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.
• Tell your doctor at once when you
know or think you might be pregnant.
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.
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.
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 Injection 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 or having
any medicine.

Driving and using machines:
You may feel sleepy when taking Epilim
Injection. 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 health problems
may increase sleepiness.
3. How Epilim Injection is given

GRAFICA - FOTOCOMPOSIZIONE

-

DIMENSIONS mm:
COUNTRY:

UK

2

//
10 pt.

COLOUR 2:

LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:

REFLEX BLUE BLACK

08 GIU 2017

COLOURS N°: COLOUR 1:

89031958
(int. version 1)

420 x 296 (210 x 148)

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

DESCRIPTION:

DIE CUT:

Via G. Tartini, 2 2 0 1 5 8 - M I L A N O
02.375787 • e-mail: crominfoto@tiscali.it
CROMinFOTO s.n.c. Tel.

TYPE OF MATERIAL:

VERSION: OLD CODE:

LEAFLET FOLDED EPILIM 400 MG

CODE:

89031958 1 a 89031140 I027

Epilim Injection is always given to you by a
doctor or nurse. This is because it needs to
be given as a slow injection or infusion into
the vein.
If you are not sure why you are being given
Epilim Injection or have any questions
about how much Epilim Injection is being
given to you, speak to your doctor or nurse.
Your doctor will stop giving you Epilim
Injection and change you to Epilim tablets,
granules, syrup or liquid as soon as
possible.
Epilim Injection treatment must be started
and supervised by a doctor specialised in
the treatment of epilepsy.
How much will be given to you
• Your doctor will decide how much to give
you depending on your illness. The
amount of Epilim Injection given to you
or your child will depend on you or your
child’s age or body weight
• If you have been taking Epilim by mouth
your doctor may decide to give you the
same amount of Epilim Injection by
continuous or repeated infusion.
If you have not had Epilim Injection before,
the doctor will use the following doses:
Adults (including the elderly)
• The starting dose is usually between
400mg and 800mg (up to 10mg per
kilogram of body weight)
• This is given as a slow intravenous
injection over 3-5 minutes
• This is followed by a continuous or
repeated infusion, up to a maximum
of 2500mg each day

Patients taking other medicines for
‘fits’ (epilepsy)
• You or your child may be taking other
medicines for epilepsy at the same
time as Epilim Injection. If so, your
doctor should gradually initiate
treatment depending on you or your
child’s condition
• Your doctor may increase the dose of
Epilim Injection by 5 to 10mg for each
kilogram of body weight each day
depending on which other medicines
you are taking
If you have more Epilim Injection than
you should
It is unlikely that your doctor or nurse will
give you too much medicine. Your doctor
will be checking your progress and
checking the medicine that you are given.
Always ask if you are not sure why you are
getting a dose of medicine.
Using too much Epilim Injection can lead
to the following symptoms: feeling sick or
being sick, pupils of the eye become
smaller, dizziness, loss of consciousness,
weak muscles and poor reflexes, breathing
problems, headaches, fits (seizures),
confusion, memory loss and unusual or
inappropriate behaviour.
If you forget to have Epilim Injection
Your doctor or nurse will have instructions
on when to give you this medicine. It is
unlikely that you will not be given the
medicine as it has been prescribed.
However, if you think you may have
missed a dose, then talk to your doctor or
nurse.
If you stop using Epilim Injection
It is important for you to keep having
Epilim injection until your doctor decides
to stop them. If you stop, your fits may
come back.

Children
• The usual dose is between 20mg and
30mg for each kilogram of body weight
each day
• This may be increased to 40mg for
each kilogram of body weight each day
depending on your child’s illness

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
Injection 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 Injection.

Patients with kidney problems
• Your doctor may decide to adjust your
or your child’s dose

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 Injection 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
Injection. 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 Injection 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 ‘StevensJohnson 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
Injection starting dose is high or has
been suddenly increased
• Changes in the amount 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
• An increase in the number and severity
of convulsions
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.
• 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 of the hands or
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 Injection can change levels of liver
enzymes, salts or sugars shown up on blood
and urine tests.
Male Fertility
Epilim Injection can be a contributing
factor in male infertility.
Talk to your doctor or pharmacist if any of
the side effects get serious or lasts longer
than a few days, or if you notice any side
effects not listed in this leaflet.
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
You can also report side effects directly via
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store Epilim Injection
This medicine will be kept by your doctor or
pharmacist in a safe place where children
cannot see or reach it
Do not use this medicine after the expiry
date shown on the vial and the carton after
EXP. The expiry date refers to the last day of
that month.
Only clear solutions free of particles should
be used.
Store below 25°C.
Once diluted, Epilim Injection should be
stored in a refrigerator between 2 - 8°C and
used within 24 hours. Any solution remaining
after 24 hours should be discarded.

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. Contents of the pack and other
information
What Epilim Injection contains
Each vial contains 400mg of the active
substance, sodium valproate
What Epilim Injection looks like and
contents of the pack
Epilim is a freeze-dried powder in a
colourless glass vial with an aluminium
cap. The vial is supplied packed in a carton
along with one ampoule containing 4ml of
water for injection.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer :
SANOFI S.P.A., Via Valcanello 4,
03012 Anagni (FR), ITALY
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 May 2017.
© Sanofi, 1993 - 2017
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

89031958

Expand Transcript

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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