Medication Guide App

EPISENTA 1000 MG PROLONGED-RELEASE GRANULES

Active substance: SODIUM VALPROATE

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Format: 190 x 420 mm – Laetus-Code: 6492

PATIENT INFORMATION LEAFLET

Episenta® 500mg prolonged-release granules
Episenta® 1000mg prolonged-release granules
(sodium valproate)

(Referred to in this leaflet as Episenta granules)
Read all of this leaflet carefully before you start taking this medicine.
– Keep this leaflet in case you need to refer to it again.
– If you want to know more about your medicine or have any questions, you should ask your doctor or pharmacist.
– This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
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. WHAT EPISENTA GRANULES ARE AND WHAT THEY ARE USED FOR
Episenta granules contain 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 GRANULES
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).
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
• you are being tested for diabetes, as Episenta may affect
the results of urine tests.
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,
felbamate
• mefloquine and chloroquine – used to prevent and treat
malaria
• cimetidine – used to treat ulcers
• antipsychotics – used to treat psychological disorders e.g.
olanzapine
• antidepressants – 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

Episenta 10264316-GB_PROOF.indd 1

• temozolomide – used to treat cancer
• rifampicin – used to treat tuberculosis and other infections.
It may still be possible for you to be 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.
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.
Your doctor should discuss with you the problems that may
arise if Episenta is used in pregnancy because of the
potential risk to the foetus.
Women who are receiving treatment for epilepsy are 2 to 3
times more likely to have babies with deformities than in the
general population. The deformities most frequently seen are
cleft palate and heart or blood vessel defects. Developmental
delay has also been reported in children born to mothers with
epilepsy.
Women who take sodium valproate during the first months of
pregnancy to control their epilepsy have a small risk (1 to
2%) of having a baby with spina bifida, an abnormality of the
spinal cord. Taking folic acid 5 mg daily as soon as you stop
contraception may lower the risk of having a baby with spina
bifida.
There is also an increased risk of other deformities in your
baby. These can usually be detected in the first part of
pregnancy by the routine antenatal screening tests.
Some babies may develop less quickly than normal and
rarely, some may have clotting problems if the mother has
taken sodium valproate during pregnancy.
If treatment with Episenta granules is considered necessary,
the lowest effective dose will be used, which may be given in
several small doses during the day. During pregnancy,
specialised prenatal monitoring should be given to detect any
deformities.
It is important, however, not to stop taking Episenta granules
suddenly as this may result in seizures, which may harm you
or your unborn baby.
Manic episodes in bipolar episodes
You should not take this medicine if you are pregnant or a
woman of child-bearing age unless explicitly advised by your
doctor. If you are a woman of child-bearing age, you have to
use effective contraception during treatment.
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 affected you should not drive or operate
machinery.

Continued overleaf…

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Format: 190 x 420 mm

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.
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
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 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
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:
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 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.
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
treatment, which may include:
o repeated vomiting, stomach pain, nausea, dislike of
usual food, loss of appetite
o extreme tiredness, drowsiness, weakness
o jaundice (yellowing of the skin or whites of the eyes)
o swelling of the feet, legs or eyelids, bruising, nosebleed
o worsening of your epilepsy.

These symptoms may indicate a serious effect on your liver.
Your blood may be taken before or during treatment to check
for any effects on the liver, particularly in very young children
and those at risk
• Severe pain in the abdomen and back, nausea and
vomiting. You may have a serious, rare problem with you
pancreas
• 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
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
• see your doctor if you develop bruising or bleeding
Many of these effects normally reverse when you stop taking
Episenta granules.
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.
5. HOW TO STORE EPISENTA GRANULES
Keep out of reach and sight of children.
Store the sachets in their 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, silicon dioxide
(methylated)
ammonio methacrylate copolymer type B, sodium lauryl
sulphate, polysorbate 80, ethylcellulose, dibutylsebacate
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: April 2012

01/12 10264316-GB

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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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