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EPISENTA SOLUTION FOR INJECTION

Active substance(s): SODIUM VALPROATE

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Format: 175 x 480 mm  –  Laetus-Code: 67  –  Schrift: 9 EN-PL-UK,
p
Desitin Arzneimittel
11/2015

MOCKUP

1

PATIENT INFORMATION LEAFLET
b 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.

Episenta®

Solution for injection

(Sodium Valproate 100mg/ml)
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 any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
symptoms seem 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.
In this leaflet:
1. What Episenta Injection is and what it is used for
2. Before you are given Episenta Injection
3. How Episenta Injection should be given
4. Possible side effects
5. How to store Episenta Injection
6. Further information
1. W
 HAT EPISENTA INJECTION IS AND
WHAT IT IS USED FOR
Episenta Injection contains sodium valproate, which
belongs to a group of medicines called antiepileptics.
These are used to control epileptic seizures.
Episenta solution for injection is used to treat various
types of epilepsy (seizures) when it is not possible to
take sodium valproate tablets.
2. BEFORE YOU ARE GIVEN EPISENTA INJECTION
You must NOT be given Episenta injection if:
• you are allergic (hypersensitive) to sodium valproate
or any of the other ingredients of the solution (listed in
Section 6 Further Information)
• you, or a member of your family, have or have had
severe liver problems
• you suffer from a disease called porphyria (a rare
condition that affects the breakdown of components
of red blood cells)
• you have a genetic problem causing a mitochondrial
disorder (e.g. Alpers-Huttenlocher syndrome).
Before you are given Episenta injection tell your
doctor if:
• you have systemic lupus erythematous (an allergic
condition which causes joint pain, skin rashes and
fever)
• you have any metabolic disorders, particularly inherited enzyme deficiency disorders such as urea cycle
disorder because of a risk of an increased ammonia
level in your blood
• you have reduced kidney function. Your doctor may
want to monitor the levels of sodium valproate in your
blood and change your dose as necessary
• you are pregnant, think you might be, or are planning
to become pregnant
• you are a woman of childbearing age. You should be
informed of the risks and benefits of treatment with
Episenta in pregnancy
• you are breast feeding
• you are being tested for diabetes, as Episenta may
affect the results of urine tests
• you know that there is a genetic problem causing a
mitochondrial disorder in your family.
Taking/using other medicines
Tell your doctor if you are taking or have recently taken
any of the following medicines as they may affect the
way Episenta injection works or they may be affected
by Episenta:
• colestyramine – used to reduce the level of blood
lipids (fats)
• other antiepileptic medicines e.g. phenytoin, primidone, carbamazepine, phenobarbital, lamotrigine,
topiramate, felbamate
• mefloquine and chloroquine – used to prevent and
treat malaria
• cimetidine – used to treat ulcers
• antipsychotics – used to treat psychological disorders
e.g.olanzapine
• antidepressant – used to treat depression including
monoamine oxidase inhibitors
• anticoagulation therapy – used to thin the blood e.g.
warfarin
• salicylates e.g. aspirin
• antibiotics e.g. erythromycin, carbapenem agents
(antibiotics used to treat bacterial infections).The
combination of valproic acid and carbapenems
should be avoided because it decreases the effect of
sodium valproate.
• benzodiazepines – used as sleeping tablets and to
treat anxiety
• zidovudine – used to treat HIV and AIDS
• temozolomide – used to treat cancer
• rifampicin – used to treat tuberculosis and other infections.
It may still be possible for you to be given Episenta
injection; your doctor will advise you on what is suitable
for you.
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Take special care with Episenta injection
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.
Pregnancy:
• It is very important that you tell your doctor
before you are given Episenta injection if you are
pregnant or are planning to become pregnant.
• Tell your doctor immediately if you become pregnant whilst receiving Episenta treatment.

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/bipolar disorder is controlled and the risks to your baby are reduced.
• Tell your doctor at once when you know or think you
might be pregnant.

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Format: 175 x 480 mm  –  Laetus-Code: 67  –  Schrift: 9 EN-PL-UK,
p
Desitin Arzneimittel
11/2015

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.
Driving and using machines:
You may experience drowsiness when you are first
given Episenta injection, or if you are also taking other
medicines, such as other antiepileptic drugs or benzodiazepines. If affected you should not drive or operate
machinery.
3. HOW EPISENTA INJECTION SHOULD BE GIVEN
Episenta injection treatment must be started and
supervised by a doctor specialised in the treatment of
epilepsy.
Your doctor will decide on the amount of Episenta
injection you will be given. This will depend on your age
and weight and will be adjusted to achieve adequate
control of your seizures.If you have been taking sodium
valproate by mouth, the dose given to you will be the
same by injection. If you have been receiving other
medicines for epilepsy the dose of Episenta injection will
be increased gradually over about 2  weeks. The total
daily dose will normally be given by three or four slow
injections, lasting 3 – 5 minutes, into your veins during
the day, or by a continuous infusion (drip).
In accordance with best practice and national guidelines, a filter device with a pore size of not more than
5  µm is recommended when drawing up from an
ampoule before the administration of IV products,
including Episenta solution for injection.
Dose for adults including the elderly:
The usual starting dose is 400 – 800mg (4 – 8ml) daily
increasing by 150 – 300mg (1.5 – 3.0ml) every 3 days,
until the seizures are controlled. The maximum daily
dose you should receive is 2,500mg (25ml).
Your doctor may decrease your dose if you are taking
other antiepileptic drugs, have poor kidney function or
you are an elderly patient.
Dose for children:
The dose for children will depend on their weight. This
is usually 20 – 40mg (0.2 – 0.4ml) for each kg of body
weight.
Your treatment with Episenta injection will be changed
to oral therapy (by mouth) as soon as possible.
It is important for you to keep having your Episenta
treatment until your doctor decides to stop. If you stop,
your seizures may return.
If you think you have missed a dose or been given
more Episenta injection than you should:
Episenta injection will be given to you by a doctor, who
will ensure that the correct dose is given for your condition. If you have any concerns tell your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines Episenta injection can cause side
effects although not everyone will get them.
Tell your doctor IMMEDIATELY if you notice any of
the following serious side effects. You may require
urgent medical attention:
• you suddenly feel ill, particularly in the first 6 months
of treatment, which may include:
• repeated vomiting, stomach pain, nausea, dislike of
usual food, loss of appetite
• extreme tiredness, drowsiness, weakness
• jaundice (yellowing of the skin or white of the eyes)
• swelling of the feet, legs or eyelids, bruising, nosebleed
• worsening of your epilepsy

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If you experience any of the side effects listed below
tell your doctor if they become troublesome or you are
worried:
• nausea, mild stomach ache, diarrhoea or dizziness,
especially when starting the treatment
• weight gain as your appetite may be increased
• shakiness (tremor), drowsiness, unsteadiness when
walking
• tiredness and confusion which may rarely progress to
hallucinations and loss of consciousness
• headache, convulsions, delirium and coma have been
reported rarely
• increased alertness, and occasionally aggression,
hyperactivity and worsening behaviour
• loss of co-ordination, vomiting and reduced levels of
consciousness may indicate changes in the amount
of ammonia in the blood
• allergic reactions
• skin reactions such acne or rashes
• kidney problems which will be detected by testing
your urine, bedwetting or an increased need to pass
urine
• change in women’s periods
• increased hair growth in women
• temporary hair loss, which may be more curly on
re-growth
• breast enlargement in men
• loss of hearing
• immune disorders e.g. vasculitus (inflammation of the
blood vessels often with skin rash)
• severe reduction in number of white blood cells which
makes infections more likely
• nail and nail bed disorders (common)
• obesity (rare)
• see your doctor if you develop bruising or bleeding
Many of these effects normally reverse when treatment
with Episenta is stopped.
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.
If you, or your carer, notice any side effects not listed
in this leaflet, please inform your doctor or pharmacist.
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. You can also report side effects
directly via the national reporting system (see details
below). By reporting side effects you can help provide
more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE EPISENTA INJECTION
Keep out of reach and sight of children.
Episenta injection must not be used after the expiry
date printed on the label or if the solution shows signs
of deterioration such as crystallisation or discolouring.
Do not freeze the medicine. Episenta solution for injection may be diluted with 0.9% saline or 5% dextrose
before infusion. Your hospital pharmacy will ensure
that the solution for injection is diluted and stored in an
appropriate manner.
6. FURTHER INFORMATION
What Episenta injection contains:
• The active substance is sodium valproate 100mg
per ml
• The other ingredients are disodium edentate and
water for injections.
What does Episenta injection look like and the
contents of the pack
Episenta solution for injection is a clear colourless solution. It is available in glass ampoules containing either
3ml or 10ml of the solution for injection. Each pack
contains 5 ampoules.
Marketing Authorisation Holder:
Desitin Arzneimittel GmbH
Weg beim Jäger 214
D-22335 Hamburg, Germany
Manufacturer:
Desitin Arzneimittel GmbH
Weg beim Jäger 214
D-22335 Hamburg, Germany
Date of revision: November 2015

These symptoms may indicate a serious effect on your
liver. Your blood may be taken before or during treatment to check for any effects on the liver, particularly in
very young children and those at risk
• severe pain in abdomen and back, nausea and vomiting. You may have a serious, rare problem with your
pancreas
• blistering of the skin, mouth, eyes and genitals

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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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