EPISENTA SOLUTION FOR INJECTION

Active substance: SODIUM VALPROATE

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MASTER

Format: 175 x 300 mm –  Laetus-Code: 67

PATIENT INFORMATION LEAFLET

Episenta® solution for injection
(Sodium Valproate 100mg/ml)

Read all of this leaflet carefully before you are given 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 nurse.
In this leaflet:
1. What Episenta Injection is and what it is used for
2. Before you are given Episenta Injection
3. How Episenta Injection should be given
4. Possible side effects
5. How to store Episenta Injection
6. Further information
1. WHAT EPISENTA INJECTION IS AND WHAT IT IS USED FOR
Episenta Injection contains sodium valproate, which belongs
to a group of medicines called antiepileptics. These are used
to control epileptic seizures.
Episenta solution for injection is used to treat various types of
epilepsy (seizures) when it is not possible to take sodium
valproate tablets.
2. BEFORE YOU ARE GIVEN EPISENTA INJECTION
You must NOT be given Episenta injection if:
• you are allergic (hypersensitive) to sodium valproate or any
of the other ingredients of the solution (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 are given Episenta injection 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
injection 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

Episenta 10263916-GB MASTER.indd1 1

• 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, carbapenem agents
(antibiotics used to treat bacterial infections).
The combination of valproic acid and carbapenems
should be avoided because it decreases the effect of
sodium valproate.
• 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 be given Episenta injection;
your doctor will advise you on what is suitable for you.
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Take special care with Episenta injection
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.
Pregnancy:
• It is very important that you tell your doctor before you
are given Episenta injection if you are pregnant or are
planning to become pregnant.
• Tell your doctor immediately if you become pregnant
whilst receiving Episenta treatment.
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 injection 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
Continued overleaf…..

26.03.2012 11:16:56 Uhr

MASTER

Format: 175 x 300 mm –  Laetus-Code: 67

Driving and using machines:
You may experience drowsiness when you are first given
Episenta injection, or if you are also taking other medicines,
such as other antiepileptic drugs or benzodiazepines. If
affected you should not drive or operate machinery.
3. HOW EPISENTA INJECTION SHOULD BE GIVEN
Your doctor will decide on the amount of Episenta injection you
will be given. This will depend on your age and weight and will
be adjusted to achieve adequate control of your seizures.
If you have been taking sodium valproate by mouth, the dose
given to you will be the same by injection. If you have been
receiving other medicines for epilepsy the dose of Episenta
injection will be increased gradually over about 2 weeks.
The total daily dose will normally be given by three or four slow
injections, lasting 3 – 5 minutes, into your veins during the day,
or by a continuous infusion (drip).
Dose for adults including the elderly:
The usual starting dose is 400 – 800mg (4 – 8ml) daily
increasing by 150 – 300mg (1.5 – 3.0ml) every 3 days, until
the seizures are controlled. The maximum daily dose you
should receive is 2,500mg (25ml).
Your doctor may decrease 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. This is
usually 20 – 40 mg (0.2 – 0.4ml) for each kg of body weight.
Your treatment with Episenta injection will be changed to oral
therapy (by mouth) as soon as possible.
It is important for you to keep having your Episenta
treatment until your doctor decides to stop. If you stop,
your seizures may return.
If you think you have missed a dose or been given more
Episenta injection than you should:
Episenta injection will be given to you by a doctor, who will
ensure that the correct dose is given for your condition. If you
have any concerns tell your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines Episenta injection 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 white 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 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, diarrhoea or dizziness,
especially when starting the treatment
• weight gain as your appetite may be increased

Episenta 10263916-GB MASTER.indd2 2

• 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 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 treatment with
Episenta is stopped.
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.
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 INJECTION
Keep out of reach and sight of children.
Episenta injection must not be used after the expiry date
printed on the label or if the solution shows signs of
deterioration such as crystallisation or discolouring. Do not
freeze the medicine. Episenta solution for injection may be
diluted with 0.9% saline or 5% dextrose before infusion. Your
hospital pharmacy will ensure that the solution for injection is
diluted and stored in an appropriate manner.
6. FURTHER INFORMATION
What Episenta injection contains:
• The active substance is sodium valproate 100mg per ml
• The other ingredients are disodium edentate and water for
injections.
What does Episenta injection look like and the contents of
the pack
Episenta solution for injection is a clear colourless solution. It is
available in glass ampoules containing either 3 ml or 10ml of
the solution for injection. Each pack contains 5 ampoules.
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
22595326
01/12 10263916-GB

26.03.2012 11:16:57 Uhr

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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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