Skip to Content

UK Edition. Click here for US version.

EPISENTA 1000 MG PROLONGED-RELEASE GRANULES

Active substance(s): SODIUM VALPROATE / SODIUM VALPROATE

View full screen / Print PDF » Download PDF ⇩
Transcript
MOCKUP

Format: 190 x 594 mm – Laetus-Code: .... – Schrift: 9 p

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® 500 mg prolonged-release granules
Episenta® 1000 mg prolonged-release granules
(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 breastfeeding’)
• 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. 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

Episenta 500_1000-GB MOCKUP_112016.indd 1

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 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 500 mg contains 3 mmol (69.0 mg) sodium per
dose.
Episenta 1000 mg contains 6 mmol (137.9 mg) sodium per
dose.
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.

07.03.17 13:26

Format: 190 x 594 mm – Laetus-Code: .... – Schrift: 9 p

Dosage
Epilepsy
Your doctor will decide the number of sachets 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) before,
with or after meals.
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.
Patients with kidney problems
Your doctor may decide to adjust your or your child’s dose.
Method of administration
Episenta granules should be swallowed without chewing with
plenty of liquid, e.g. a full glass of water. Tear open the sachet
and sprinkle or stir the contents into soft food or a drink
and swallow immediately without chewing or crushing the
granules. The food or drink should be cold or at room temperature. Do not store a mixture of the granules with liquid or
soft food 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 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 sachets 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
achingmuscles. 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
If you experience any of the side effects listed below tell your
doctor if they become troublesome or you are worried:

Episenta 500_1000-GB MOCKUP_112016.indd 2

MOCKUP

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)
• gingival disorder (mainly gingival hyperplasia), inflammation
of the gums
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 sachets 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 sachet 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 and oleic acid.
What Episenta looks like and contents of the pack
Episenta prolonged-release granules are white to off-white
granules packed in sachets. The sachets are available in
packs of 50, 100 and 200 for both the 500mg and the
1000mg strengths. 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 view ⇕

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.

Hide