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EPISENTA 150 MG PROLONGED-RELEASE CAPSULE

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

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Format: 145 x 594 mm – Laetus-Code: .... – Schrift: 9 p

MOCKUP

Package leaflet: Information for the patient
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.
What is in this leaflet:
1. What Episenta is and what it is used for
2. What you need to know before you take Episenta
3. How to take Episenta
4. Possible side effects
5. How to store Episenta
6. Contents of the pack and other information
1. What Episenta is and what it is used for
Episenta contains the active substance 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. 
What you need to know before you take
Episenta
Do not take Episenta
• 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
• 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
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
Taking Episenta 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 Episenta and during your treatment.
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.
Other medicines and Episenta
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 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, rufinamide
• 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 may decrease 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 take Episenta; 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.

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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.
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 first start

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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.
Important information about some of the ingredients of Episenta
Episenta 300 mg contains 1.8 mmol (41.4 mg) sodium per capsule.
Take this into consideration if you are on a controlled
sodium diet.
3. How to take Episenta
Always take this medicine exactly as your doctor has
told you. 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.
Dosage
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 recommended 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 and adolescents
The dose for children will depend on their weight:
For children over 20kg the recommended starting
dose is 300mg daily. This can be increased up to a
maximum of 35mg for each kg of bodyweight daily 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.
Manic episodes in bipolar disorder
Adults
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.
Method of administration
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.
Patients with kidney problems
Your doctor may decide to adjust your or your child’s
dose.
If you take more Episenta than you should
If you take more Episenta 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 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. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Episenta
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.
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 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.
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 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. 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
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).

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• 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.
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
Keep this medicine out of the sight and reach of
children.
Store the capsules in the original package.
Store below 30 °C.
Keep the container tightly closed.
Do not use this medicine after the expiry date which is
stated on the container label and carton after “Expiry
date:”. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater. Ask
your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Episenta contains
• The active substance is sodium valproate
• The other ingredients are calcium stearate, colloidal
anhydrous silicon dioxide (methylated), ammonio
methacrylate copolymer type B, sorbic acid, sodium
hydroxide, ethyl cellulose, dibutyl sebacate, oleic
acid, gelatin, sodium lauryl sulfate, indigo carmine
(E 132) and (for 300 mg capsules only) quinoline
yellow (E104).
What Episenta looks 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 and Manufacturer
Desitin Arzneimittel GmbH
Weg beim Jäger 214
22335 Hamburg
Germany
e-mail: medinfo@desitin.co.uk
This leaflet was last revised in 02/2017

07.03.17 13:26

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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