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EPISENTA 150 MG PROLONGED-RELEASE CAPSULE

Active substance(s): SODIUM VALPROATE

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Desitin Arzneimittel
GmbH
150/300
mg 9
PL,
Format: 145
x 420 mm  –  Laetus-Code: 318 
–  Schrift:
p 11/15

1.3.2.EN-PL-UK
MOCKUPpage 1 of 2

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® 150 mg prolonged-release capsule
Episenta® 300 mg prolonged-release capsule
(sodium valproate)
(Referred to in this leaflet as Episenta)
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 is and what it is used for
2. Before you take Episenta
3. How to take Episenta
4. Possible side effects
5. How to store Episenta
6. Further information
1. What Episenta is and what it is used for
Episenta contains the active ingredient sodium valproate, which belongs to a group of medicines called
antiepileptics which are used to control epileptic
seizures and mania.
Episenta is used in the treatment of
• various types of epilepsy (seizures)
• mania, where you may feel very excited, elated,
agitated, enthusiastic or hyperactive. Mania occurs
in an illness called „bipolar disorder“. Episenta can
be used when lithium cannot be used.
2. Before you take Episenta
Do NOT take Episenta capsules if:
• you are allergic (hypersensitive) to sodium valproate
or any of the other ingredients of the capsules (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 take Episenta 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 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, imipenem, meropenem
• 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 take Episenta; your
doctor will advise you on what is suitable for you.
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Take special care with Episenta Capsules
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.
Children and adolescents
Children and adolescents under 18 years of age:
Episenta should not be used in children and adolescents under 18 years of age for the treatment of mania.

Pregnancy:
• It is very important that you tell your doctor
before you take Episenta if you are pregnant
or are planning to become pregnant.
• Tell your doctor immediately if you become
pregnant whilst taking Episenta.
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.

Episenta150_300-GB MOCKUP_121115.indd 1

Confidential 11/2015

17.11.15 11:28

S-00-0027

Episenta 150/300/500/1000 mg

Desitin Arzneimittel
GmbH
150/300
mg 9
PL,
Format: 145
x 420 mm  –  Laetus-Code: 318 
–  Schrift:
p 11/15

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.
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 first start
taking Episenta, or if you are taking it with other
medicines, such as other antiepileptic drugs or benzodiazepines. If affected you should not drive or operate
machinery.
3. How to take Episenta
Always take Episenta capsules exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Episenta treatment must be started and supervised
by a doctor specialised in the treatment of epilepsy or
bipolar disorders.
Epilepsy:
Your doctor will decide the number of capsules you
should take. This will depend on your age and weight
and will be adjusted to achieve adequate control of
your seizures.
The daily dosage may be taken as one single or two
divided doses (half in the morning and half in the
evening).
Dose for adults including the elderly:
The usual starting dose is 600mg daily increasing by
150 – 300mg every three days until the seizures are
controlled.
This dose is usually within the range of 1,000mg to
2,000mg daily, but can be increased to a maximum of
2,500mg daily if necessary.
Your doctor may alter 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:
For children over 20kg the usual starting dose is
300mg daily. This can be increased up to a maximum
of 35mg for each kg of bodyweight to control the
seizures.
For children under 20kg the usual dose is 20mg for
each kg of bodyweight, which can be increased up to
a maximum of 40mg for each kg of bodyweight daily.
Do not stop taking Episenta without consulting your
doctor. If you stop, your seizures may return. You
should continue to take Episenta for as long as your
doctor tells you to.
Mania
The daily dosage should be established and controlled
individually by your doctor. Initial dose: The recommended initial daily dose is 750mg. Mean daily dose:
The recommended daily doses usually range between
1,000 and 2,000mg.
How to take Episenta:
The capsules should be swallowed whole without
chewing with plenty of liquid, e.g. a full glass of water.
If you have difficulty in swallowing, the contents of the
capsule may be sprinkled or stirred into soft food or
drinks and swallowed immediately without chewing or
crushing the granules.
The food or drink should be cold or at room temperature. A mixture of the granules with liquid or soft food
should not be stored for future use. If the granules are
taken in a drink, some may stick to the glass after the
drink has been finished, you should rinse the glass
with a small amount of water and drink this as well.
The granules should not be given in babies’ bottles as
they can block the teat.
If you take more Episenta capsules than you
should or if someone else accidentally takes your
medicine contact your nearest casualty department or
tell your doctor or pharmacist immediately. Remember
to take the pack, this leaflet and any remaining capsules with you.
If you forget to take a dose of Episenta:
Take it as soon as you remember. If your next dose is
due within 2 hours, take a single dose now and do not
take the next dose. Never double up the next dose to
make up for the one missed.

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4. Possible side effects
Like all medicines Episenta 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
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
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 or diarrhoea, 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 as 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 will normally reverse when you
stop taking Episenta capsules.
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.
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 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
Keep out of reach and sight of children.
Store the capsules in the original packaging below
30 °C.
Keep the container tightly closed.
Do not use Episenta capsules after the expiry date
printed on the container label and carton.
6. Further information
What Episenta capsules contain:
• The active substance is sodium valproate
• The other ingredients are calcium stearate, colloidal
anhydrous silicon dioxide (methy­lated), ammonium
methacrylate copolymer Type B, sorbic acid, sodium
hydroxide, ethyl cellulose, dibutyl sebacate, oleic
acid, gelatin, sodium lauryl sulfate, indigo carmine
(E132) and (for 300mg capsules only) quinoline
yellow (E104).
What Episenta capsules look like and contents
of the pack:
Episenta 150mg capsules are blue/transparent hard
gelatine capsules containing white granules.
Episenta 300mg capsules are green/transparent hard
gelatine capsules containing white granules.
Each pack contains 50, 100 or 200 capsules.
Not all pack sizes may be marketed.
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

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Episenta 150/300/500/1000 mg

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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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