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EPISENTA 1000 MG PROLONGED-RELEASE GRANULES

Active substance: SODIUM VALPROATE

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Desitin Arzneimittel GmbH mm – Laetus-Code: ohne – Schrift: 9 p 500/1000 mg PL, 03/15
Format: 190 x 420

1.3.2.EN-PL-UK page 1 of 2
MOCKUP

PATIENT INFORMATION LEAFLET
b  his medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by
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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 granules)

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.
•  eep this leaflet. You may need to read it again.
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• f you have any further questions, ask your doctor or pharmacist.
I
• 
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.
•  you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
If
See section 4.
In this leaflet:
1. What Episenta Granules are and what they are used for
2. Before you take Episenta Granules
3. How to take Episenta Granules
4. Possible side effects
5. How to store Episenta Granules
6. Further information
1.  hat Episenta Granules are and what they are used for
W
Episenta granules contain the active ingredient sodium val­
proate, which belongs to a group of medicines called antiepi­
leptics, 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 can­
not be used.
2.  efore you take Episenta Granules
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Do NOT take Episenta granules if:
• 
you are allergic (hypersensitive) to sodium valproate or any
of the other ingredients of the granules (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 dis­
order (e.g. Alpers-Huttenlocher syndrome).
Before you take Episenta granules 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
•  are being tested for diabetes, as Episenta may affect the
you
results of urine tests
• 
you know that there is a genetic problem causing a mito­
chondrial 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
granules work 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, fel­
bamate
• 
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 mono­
amine 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.
I
t may still be possible for you to take Episenta granules; 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 Granules
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.

Episenta
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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.
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•  ell your doctor immediately if you become pregnant
whilst taking Episenta.
Important advice for women
•  alproate can be harmful to unborn children when taken by
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a woman during pregnancy.
•  alproate carries a risk if taken during pregnancy. The higher
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the dose, the higher the risks but all doses carry a risk.
• t can cause serious birth defects and can affect the way in
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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.
• f you take valproate during pregnancy you have a higher
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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 val­
proate 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.
• t is estimated that up to 30 – 40% of preschool children
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whose mothers took valproate during pregnancy may have
problems with early childhood development. Children affect­
ed can be slow to walk and talk, intellectually less able than
other children, and have difficulty with language and memory.
•  utistic spectrum disorders are more often diagnosed in
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children exposed to valproate and there is some evidence
children may be more likely to develop symptoms of
Attention Deficit Hyperactivity Disorder (ADHD).
• f you are a woman capable of becoming pregnant your
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doctor should only prescribe valproate for you if nothing else
works for you.
•  efore prescribing this medicine to you, your doctor will have
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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.
•  sk your doctor about taking folic acid when trying for a
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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 associat­
ed 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 contracep­
tion throughout your treatment. Talk to your doctor or family
planning clinic if you need advice on contraception.
Key messages:
•  ake sure you are using an effective method of contracep­
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tion.
•  ell your doctor at once if you are pregnant or think you
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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:
•  ake sure you are using an effective method of contracep­
M
tion.
•  ell your doctor at once if you are pregnant or think you
T
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.

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Episenta 150/300/500/1000 mg

Desitin Arzneimittel GmbH mm – Laetus-Code: ohne – Schrift: 9 p 500/1000 mg PL, 03/15
Format: 190 x 420

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:
•  o not stop using your contraception before you have talked
D
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.
•  ell your doctor at once when you know or think you might
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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:
•  ell your doctor at once if you know you are pregnant or
T
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 granules, or if you are taking it with other medicines,
such as other antiepileptic drugs or benzodiazepines. If affect­
ed you should not drive or operate machinery.
3. How to take Episenta Granules
Always take Episenta granules 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 doc­
tor specialised in the treatment of epilepsy or bipolar disorders.
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 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 antie­
pileptic 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 granules without consulting your doctor. If you stop, your seizures may return. You
should continue to take Episenta granules for as long as your
doctor tells you to.
Mania
The daily dosage should be established and controlled individ­
ually 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:
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 chew­
ing or crushing the granules.
• 
The food or drink should be cold or at room temperature.
•  not store a mixture of the granules with liquid or soft food
Do
for future use.
•  the granules are taken in a drink, some may stick to the
If
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 granules 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 a dose of Episenta granules:
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.

1.3.2.EN-PL-UK page 2 of 2
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4. Possible side effects
Like all medicines Episenta granules 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 treat­
ment, which may include:
– epeated vomiting, stomach pain, nausea, dislike of usual
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food, loss of appetite
–  xtreme tiredness, drowsiness, weakness
e
– aundice (yellowing of the skin or white of the eyes)
j
–  welling of the feet, legs or eyelids, bruising, nosebleed
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–  orsening of your epilepsy.
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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 the abdomen and back, nausea and vomit­
ing. You may have a serious, rare problem with your pancre­
as
• 
Blistering of the skin, mouth, eyes and genitals
If you experience any of the side effects 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 hallu­
cinations and loss of consciousness
• 
headache, convulsions, delirium and coma have been
reported rarely
• 
increased alertness, and occasionally aggression, hyperac­
tivity and worsening behaviour
• 
loss of co-ordination, vomiting and reduced levels of con­
sciousness 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
• 
see your doctor if you develop bruising or bleeding
Many of these effects will normally reverse when you stop
taking Episenta granules.
There have been reports of bone disorders including osteo­
penia 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 Granules
Keep out of reach and sight of children.
Store the sachets in the original packaging below 30 °C.
Keep the container tightly closed.
Do not use after the expiry date printed on the sachet and
carton.
6. Further information
What Episenta granules contain:
• 
The active substance is sodium valproate
• 
The other ingredients are calcium stearate, colloidal anhy­
drous silicon dioxide (methylated), ammonium methacrylate
copolymer Type B, sorbic acid, sodium hydroxide, ethyl
cellulose, dibutyl sebacate and oleic acid.
What Episenta granules look like and the 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:
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: March 2015

03/2015  Episenta 500_1000 Signal

Episenta
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03/2015

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S-00-0021

16.03.15 14:13
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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