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EPISENTA SOLUTION FOR INJECTION

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

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Format: 175 x 480 mm – Laetus-Code: ..... – Schrift: 9 EN-PL-UK,
p
Desitin Arzneimittel
04/2017

MOCKUP

1

Package leaflet: Information for the user
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.
• 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 Episenta Injection is and what it is used for
2. What you need to know before you use Episenta
Injection
3. How to use Episenta Injection
4. Possible side effects
5. How to store Episenta Injection
6. Contents of the pack and other information
1. What 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 epileptic seisures (fits) when it is not possible to
take sodium valproate tablets.
2. What you need to know before you take Episenta
Injection
Do not use Episenta Injection
• if you are allergic to sodium valproate or any of the
other ingredients of this medicine (listed in Section 6)
• if you, or a member of your family, have or have had
severe liver problems
• if you suffer from a disease called porphyria (a rare
condition that affects the breakdown of components
of red blood cells).
• if you have a genetic problem causing a mitochondrial
disorder (e.g. Alpers-Huttenlocher syndrome)
• if you suffer from urea cycle disorder (a certain metabolic disorder)
Warnings and precautions
Talk to your doctor before taking Episenta Injection
• if 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 have any metabolic disorders, particularly inherited enzyme deficiency disorders. If urea cycle disorder
is suspected, metabolic investigations should be performed before you take Episenta Injection because of
a risk of an increased ammonia level in your blood.
• if 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
• if you are pregnant, think you might be, or are planning to become pregnant (see section ‘Pregnancy and
breast- feeding’)
• if you are a woman of childbearing age. You should
be informed of the risks and benefits of treatment with
Episenta in pregnancy (see section ‘Important advice
for women’)
• if you are breast feeding
• if you are being tested for diabetes, as Episenta may
affect the results of urine tests
• if you know that there is a genetic problem causing a
mitochondrial disorder in your family
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.
As with other antiepileptic drugs, convulsions may
become worse or happen more frequently whilst taking
this medicine. If this happens contact your doctor immediately.
Weight gain
Having Episenta 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 Episenta Injection and during your treatment.
Other medicines and Episenta Injection
Tell your doctor, pharmacist or nurse if you are taking,
have recently taken or might take any other medicines.
The following medicines may affect the way Episenta
Injection works or they may be affected by Episenta
Injection:
• 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 such as moclobemide,
selegiline, linezolid
• 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 such as diazepam
• zidovudine – used to treat HIV and AIDS
• temozolomide – used to treat cancer
• rifampicin – used to treat tuberculosis and other infections
• quetiapine – medicine for treatment of psychiatric disorders (increased risk of low white blood cell numbers)
It may still be possible for you to be given Episenta
Injection; your doctor will advise you on what is suitable
for you.
Taking Episenta with food and drink
Alcohol intake is not recommended during treatment.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
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.
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.

Episenta IV-GB MOCKUP_042017.indd 1

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Episenta solution for injection

Format: 175 x 480 mm – Laetus-Code: ..... – Schrift: 9 EN-PL-UK,
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Desitin Arzneimittel
04/2017

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
A small amount of sodium valproate, the active substance of Episenta, gets into the breast milk. Talk to your
doctor about whether you should breast-feed your baby.
Fertility
Episenta may decrease your fertility. However, single
reports have shown that this effect is reversible after
discontinuation of the medicine.
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.
Episenta Injection contains sodium
One 3 mL ampoule Episenta Injection contains 1.81 mmol
(41.6 mg) sodium.
One 10 mL ampoule Episenta Injection contains
6.0 mmol (138.8 mg) sodium.
Take this into consideration if you are on a controlled
sodium diet.
3. How to use Episenta Injection
Episenta injection treatment must be started and supervised by a doctor specialised in the treatment of epilepsy.
Dosage
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).
Adults, including the elderly:
The recommended starting dose is 400 – 800 mg (4 –
8 ml) daily increasing by 150 – 300 mg (1.5 – 3.0 ml)
every 3 days, until the seizures are controlled. The maximum daily dose you should receive is 2,500mg (25 ml).
Your doctor may decrease your dose if you are taking
other antiepileptic drugs, have poor kidney function or
you are an elderly patient.
Children and adolescents
The dose for children will depend on their weight. This
is usually 20 – 40 mg (0.2 – 0.4 ml) for each kg of body
weight.
Your treatment with Episenta injection will be changed to
oral therapy (by mouth) as soon as possible.
Patients with kidney problems
Your doctor may decide to adjust your or your child’s
dose.
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.
If you stop using Episenta Injection
It is important for you to keep having your Episenta treatment until your doctor decides to stop. If you stop, your
seizures may return.
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. Episenta
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 Episenta Injection.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines this medicine can cause side effects
although not everybody gets them.
Tell your doctor IMMEDIATELY if you notice any of
the following serious side effects. You may require
urgent medical attention:
• 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 Episenta 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 Episenta
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 ‘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).
• Severe pain in abdomen and back, nausea and vomiting. You may have a serious, rare problem with your
pancreas

2

If you experience any of the side effects listed below
tell your doctor if they become troublesome or you are
worried:
Very common(may affect more than 1 in 10 people):
• nausea
• tremor
Common (may affect up to 1 in 10 people)
• mild stomach ache or diarrhoea, especially when starting the treatment
• loss of co-ordination, vomiting and reduced levels of
consciousness may indicate changes in the amount of
ammonia in the blood
• reduced sodium in the blood
• restlessness*, confusional state, aggression*, agitation*, disturbance in attention*
• memory disorder, involuntary eye movements (nystagmus), headache
• temporary hair loss, which may be more curly on
re-growth
• nail and nail bed disorders
• women experience painful period cramps
• weight gain – as your appetite may be increased
(should be monitored as this could be a sign of polycystic ovaries)
Uncommon (may affect up to 1 in 100 people)
• shakiness (tremor), drowsiness, unsteadiness when
walking
• immune disorders e.g. vasculitis (inflammation of the
blood vessels often with skin rash)
• increased male hormone (androgen), which can lead
to masculinisation and increased male pattern hair
growth in women (hirsutism), acne or hair loss with the
typical male appearance (such as receding hairline)
• inadequate release of a hormone called ADH (anti –
diuretic hormone)
• Parkinson like symptoms( reversible)
• tingling or numbness in the hands and feet
• abnormal stoppage in women’s periods
• swelling of the feet and legs (oedema)
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.
Rare (may affect up to 1 in 1,000 people)
• decreased number and quality of blood-forming cells
in the spinal cord (myelodysplastic syndrome)
• enlarged red blood cells in normal (macrocytosis) or
decreased number (macrocytic anaemia)
• loss of hearing
• obesity
• tiredness and confusion which may progress to hallucinations, convulsions and loss of consciousness
• learning disorder*, increased alertness, and occasionally aggression, (psychomotor) hyperactivity and
worsening behaviour
• impaired understanding, memory and thinking (cognitive disorder)
• underactive thyroid
• reduced level of blood clotting proteins (coagulation
factors) and changes in coagulation tests (see section “Warnings and precautions” and “Pregnancy,
breast-feeding and fertility”)
• biotin (B-vitamin) deficiency
• changes in the amount of ammonia in the blood.
• reduced male fertility
• polycystic ovaries in women
• kidney problems, bedwetting or increased need to
pass urine
Very rare (may affect up to 1 in 10,000 people)
• skin reactions such as acne or rashes
• bedwetting
• increased hair growth in women
• breast enlargement in men
• headache, delirium and coma
Not known (frequency cannot be estimated from the
available data)
• allergic reactions
• kidney problems which will be detected by testing your
urine or an increased need to pass urine
• severe reduction in number of white blood cells which
makes infections more likely
• see your doctor if you develop bruising or bleeding
Many of these effects will normally reverse when you
stop taking Episenta.
* These side effects have been particularly observed in
children.
You may notice the remains of the white shells of the
granules in your stools (faeces). This is normal and
the active part of the medicine will already have been
released from the granule.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Episenta Injection
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label after “Exp.:”. The expiry date refers to
the last day of that month.
Do not use this medicine if you notice 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. Contents of the pack and other information
What Episenta Injection contains:
• The active substance is sodium valproate 100 mg
per ml
• The other ingredients are disodium edentate and water
for injections.
What Episenta Injection looks like and contents of
the pack
Episenta solution for injection is a clear colourless
solution. It is available in glass (type I) ampoules with
silicone coating on the inside containing either 3 ml or
10 ml of the solution for injection. Each pack contains
5 ampoules.
Marketing Authorisation Holder and Manufacturer
Desitin Arzneimittel GmbH
Weg beim Jäger 214
D-22335 Hamburg, Germany
e-mail: medinfo@desitin.co.uk
This leaflet was last revised in 04/2017

Episenta IV-GB MOCKUP_042017.indd 2

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Episenta solution for injection

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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