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EPISENTA 300MG PROLONGED RELEASE CAPSULES

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

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Episenta®300mg Prolonged Release Capsules
(sodium valporate)
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.
Your medicine is available using the above name but will be referred to as
Episenta throughout this leaflet.
Patient Information Leaflet
WARNING FOR WOMEN AND GIRLS
This medicine can seriously harm an unborn baby.
Always use effective contraception during treatment.
If you are thinking about becoming pregnant, or you become pregnant,
talk to your doctor straight away.
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. AlpersHuttenlocher 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.
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.

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 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 out of sight and reach of children.
• Do not use Episenta capsules after the expiry date printed on the
container label and carton.
• Do not store above 30˚C.
• Store in the original container. Keep the container tightly closed.
• If the capsules become discoloured or show signs of any deterioration,
you should seek the advice of your pharmacist who will advise you what
to do.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6) Further information
What Episenta contains
The active substance is sodium valproate.
Each prolonged release capsule contains 300mg of sodium valproate

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.

The other ingredients are calcium stearate, silicon dioxide (methylated)
ammonio methacrylate copolymer type B, sodium lauryl sulphate,
polysorbate 80, ethylcellulose, dibutylsebacate, oleic acid, gelatine, E132
(indigo carmine) and quinoline yellow (E104).

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.

What Episenta looks like and contents of the pack
Episenta capsules are green/transparent hard gelatine capsules containing
white granules.

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

Episenta capsules are available in containers of 50 capsules.
PL 10383/2169

Episenta 300mg Prolonged Release Capsules

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Desitin Arzneimittel GmbH Weg beim
Jäger 214, D-22335 Hamburg, Germany. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd., 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 08.08.2016
Episenta is a registered trademark of Desitin Arzneimittel GmbH, Germany.

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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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