SODIUM VALPROATE 500 MG GASTRO-RESISTANT TABLETS

Active substance: SODIUM VALPROATE

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SODIUM VALPROATE 200 mg AND
500 mg GASTRO-RESISTANT TABLETS

BEFORE YOU TAKE SODIUM
VALPROATE

DO NOT take Sodium Valproate if you:
• are allergic (hypersensitive) to Sodium
Valproate or any of the other ingredients
Read all of this leaflet carefully before you
of this medicine
start taking this medicine.
• suffer from, or there is a family history
• Keep this leaflet. You may need to read it
of liver disease
again.
• suffer from porphyria (a deficiency of
• If you have any further questions, ask
specific enzymes within the body,
your doctor or pharmacist.
causing an increase of substances
• This medicine has been prescribed for
known as porphyrins).
you. Do not pass it on to others. It may
harm them, even if their symptoms are
Take special care with Sodium Valproate
the same as yours.
• If any of the side effects get serious, or if A small number of people being treated
you notice any side effects not listed in this with anti-epileptics such as Sodium
Valproate have had thoughts of harming
leaflet, please tell your doctor or
or killing themselves. If at any time you
pharmacist.
have these thoughts, immediately contact
IN THIS LEAFLET:
your doctor.
1. What Sodium Valproate is and what it is
Talk to your doctor before you start to
used for
take this medicine if you:
2. Before you take Sodium Valproate
• have severe fits or suffer from brain
3. How to take Sodium Valproate
disease or a metabolic condition
4. Possible side effects
affecting your brain
5. How to store Sodium Valproate
• suffer from kidney problems
6. Further information
• suffer from systemic lupus
1 WHAT SODIUM VALPROATE IS AND erythematosus (an immune system
WHAT IT IS USED FOR
condition affecting skin, bones and
joints, lungs, or kidneys)
Sodium Valproate Gastro-resistant Tablets
• are diabetic, as Sodium Valproate may
contain the active ingredient Sodium
give an indication that ketones are
Valproate, which belongs to a group of
present in the urine when this is not the
medicines known as anticonvulsants.
case
Sodium Valproate is a medicine for the
• have any metabolic disorders,
treatment of epilepsy and mania. Sodium
particularly hereditary enzyme
Valproate may be taken either on its own as deficiency disorders such as a urea cycle
your only treatment for epilepsy or you may disorder because of the risk of increased
take it together with another epilepsy
ammonia level in the blood
therapy.
• have an increased appetite and are
Sodium Valproate is used in the treatment of
putting on weight. Please regularly
mania, where you may feel very excited,
check your body weight when you are
elated, agitated, enthusiastic or hyperactive. on this medicine.
Mania occurs in an illness called ‘bipolar
disorder’. Sodium Valproate can be used
when lithium can not be used.
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Children and adolescents
Children and adolescents under 18 years
of age:
Sodium Valproate should not be used for
children and adolescents below 18 years
of age for the treatment of mania.
Your doctor may wish to do blood tests
before you start and during the first six
months of your treatment to:
• check your levels of Sodium Valproate
• check for blood or liver problems,
especially in children under 3 years of
age, or patients who suffer from severe
seizures, have brain disease and/or
learning disabilities, or have a history of
liver disease
• your doctor may do regular blood tests
and liver function tests before and
during your treatment with this
medicine.
Taking other medicines
In particular, tell your doctor or nurse if
you are taking any of the following
medicines:
• any other anti-epileptics e.g. phenytoin,
phenobarbital, carbamazepine,
lamotrigine, topiramate, primidone,
felbamate
• any anti-depressant medicines including
monoamine oxidase inhibitors
• anti-psychotic agents - for mental health
problems. Sodium Valproate may
increase the effects of these drugs. In
particular, when taken with the medicine
olanzapine the following effects may
occur: neutropenia (a blood problem
which reduces the chance of fighting
infection), tremor, dry mouth, increased
appetite and weight gain, problems with
speech, sleepiness or extreme tiredness
• benzodiazepines (used as sleeping
tablets and to treat anxiety)
• antibiotics such as erythromycin,
rifampicin,
• chloroquine or mefloquine (for malaria).
Taking these with Sodium Valproate
may increase the chance of a fit. Before








travelling to a malaria area, ask your
doctor or pharmacist about the best
malaria prevention tablets for you
cimetidine (for the treatment of stomach
ulcers) or colestyramine (to treat high
levels of fat in the blood)
carbapenem agents (antibiotic used to
treat bacterial infection). The combination
of valproic acid and carbapenems
should be avoided because it may
decrease the effect of Sodium Valproate
drugs that prevent blood clotting such
as aspirin or warfarin
zidovudine (used to treat HIV and AIDS)
temozolomide (used to treat cancer).

Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Taking Sodium Valproate Tablets with food
and drink
Take Sodium Valproate tablets with or
after food. This will help to stop the
feelings of sickness that may happen after
taking the tablet.
Pregnancy and breast-feeding
Pregnancy
Information for women who are pregnant,
planning to become pregnant, or who
could become pregnant.
Before you start taking Sodium Valproate,
your doctor should discuss with you the
possible problems when it is taken in
pregnancy.
• unplanned pregnancy is not desirable in
women receiving Sodium Valproate
• you should not take this medicine if you
are pregnant or a women 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. Sodium
Valproate has no effect on how well the
oral contraceptive pill works.
Women taking Sodium Valproate during
pregnancy have a higher risk than other 2

women of having a child with an
abnormality. The chance of abnormalities
is increased if you are also taking other
antiepileptic medicines at the same time.
These abnormalities include:
• head and face deformities including cleft
palate, a gap or depression in the lip
• malformations of the arms and legs
• deformities of the bones, including hip
dislocation
• deformities of the tube from the bladder
to the penis where the opening is
formed in a different place
• heart and blood vessels malformations
with heart defects
• abnormalities in the lining of nerve
tubes with holes or protrusions
• spina bifida.
Women who take Sodium Valproate
during pregnancy may be more likely to
have a baby with spina bifida. This is an
abnormality of the spinal cord. Taking
folic acid 5 mg each day 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
birth defects. These other defects can
usually be detected in the first 3 months
of the pregnancy using routine antenatal
screening blood tests and ultrasound
scans.
Pregnant mothers who take Sodium
Valproate may have babies with blood
clotting problems (such as blood not
clotting or not clotting very well).
This may appear as bruising or a bleeding
which takes a long time to stop.
Some babies born to mothers who took
Sodium Valproate during pregnancy may
develop less quickly than normal. These
children may require additional
educational support.
Talk to your doctor before stopping taking
Sodium Valproate if you want to become
pregnant. It is important not to stop your

Sodium Valproate suddenly, as it is likely
that your fits will come back.
Women who are planning to get pregnant
If you become pregnant, think you may be
pregnant or plan to become pregnant
while taking Sodium Valproate, you must
tell your doctor straight away.
• your doctor will give you appropriate
counselling and will suggest changes to
your treatment or dose
• he or she will also want to check your
progress while you are pregnant.
It is very important that you discuss your
treatment with your doctor well before
you become pregnant.
Breast-feeding
Very little Sodium Valproate gets into the
breast milk. However, talk to your doctor
about whether you should breast-feed
your baby. Ask your doctor or pharmacist
for advice before taking any medicine.
Driving and using machines
You may feel sleepy:
• when you first start taking Sodium
Valproate
• if you are taking it with other medicines,
such as other antiepileptic drugs or
benzodiazepines.
If this happens to you, do not drive or use
any tools or machines.

3 HOW TO TAKE SODIUM VALPROATE
Always take Sodium Valproate Gastroresistant Tablets exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
These tablets have been coated with a
substance that will allow them to pass
through the stomach before dissolving.
The tablets should be swallowed
preferably with a drink of water usually
after meals. These tablets should not be
chewed or crushed.
3

The usual dose is:
Taking Sodium Valproate on its own:
• Adults
Initially 600 mg daily, increasing by
200 mg at three-day intervals until
control of fits is achieved. This may be
increased up to a maximum of 2500 mg
per day. This quantity may be given in
one dose or can be divided and taken in
two separate doses e.g. half in the
morning and half in the evening.
• Children over 20 kg
Initially 400 mg daily. The doctor will
adjust the dose of Sodium Valproate for
your child based on the child’s body
weight until control of fits is achieved.
This quantity may be given in one dose
or can be divided and given in two
separate doses e.g. half in the morning
and half in the evening.
• Children under 20 kg
The doctor will calculate the appropriate
dose of Sodium Valproate for your child
based on the child’s body weight.
• The Elderly and patients with
kidney problems
Your doctor will decide a suitable dose
to achieve adequate control of your
epilepsy.

Mean daily dose
• the recommended daily doses usually
range between 1000 mg and 2000 mg.
Taking Sodium Valproate together with
another therapy:
You may be taking other drugs to control
your epilepsy at the same time as Sodium
Valproate. If you are, your doctor may
increase the dose of Sodium Valproate.
If you take more Sodium Valproate than
you should
If you (or someone else) swallow a lot of
the tablets all together, or if you think a
child has swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause nausea,
vomiting, dizziness, and difficulty
breathing.
Please take this leaflet, any remaining
tablets, and the container with you to the
hospital or doctor so that they know
which tablets were consumed.

If you forget to take Sodium Valproate
If you forget to take your tablets, take
them as soon as you remember, unless it
is nearly time to take the next dose. DO
When treatment is first started, you may be NOT take a double dose to make up for a
forgotten dose.
prescribed a lower dose. This is because
some patients need less Sodium Valproate
Stopping treatment with Sodium
than others to control their fits. Your
doctor will increase the dosage until your Valproate
condition is controlled. Because of this, it DO NOT stop taking Sodium Valproate or
change the number of tablets you are
is very important that you follow the
taking without first discussing this with
instructions your doctor has given you
your doctor, as this may lead to a
about how much to take.
recurrence of your symptoms.
Mania
If you have any further questions on the
The daily dosage should be established
and controlled individually by your doctor. use of this product, ask your doctor or
pharmacist.
Initial dose
• the recommended initial daily dose is
750 mg.
4

POSSIBLE SIDE EFFECTS

• blood clotting problems
• spontaneous bruising or bleeding.

Like all medicines, Sodium Valproate can
cause side effects, although not everybody If you experience any of the following
gets them.
effects, you need not worry, but you should
discuss with your doctor any that become
Stop taking the tablets and tell your
troublesome; these effects usually reverse
doctor immediately or go to the casualty on stopping the tablets:
department at your nearest hospital if the • feeling unwell (nausea) or being sick,
following happens:
stomach ache, or diarrhoea - especially
• an allergic reaction causing swelling of
for the first few days after starting the
the lips, face, or neck leading to severe
treatment
difficulty in breathing, or severe skin
• changes in the amount of ammonia in
rash or hives
the blood; symptoms of this may include
• a sudden illness, especially if it is within
drowsiness, being sick, or difficulties
the first six months of treatment,
with balance and co-ordination such as
particularly if it includes repeated
unsteadiness when walking
vomiting, extreme tiredness, abdominal • tiredness, confusion, hallucinations,
pain, drowsiness, weakness, loss of
change in mood, loss of consciousness
appetite, severe upper stomach pains,
• neurological problems including
nausea, jaundice (yellowing of the skin
reversible dementia
or whites of the eyes), swelling of the
• extrapyramidal disorders, the symptoms
legs, worsening of your condition or a
may include feeling shaky (tremor),
general feeling of being unwell. If you
sleepy (sedation) or unsteady when
have some of these symptoms, they
walking or jerky muscle movements
may be signs of problems with your
• skin reactions such as rashes occur
liver or pancreas
rarely, but patients who are also taking
• a serious illness with blistering of the
lamotrigine may be more at risk
skin (toxic epidermal necrolysis).
• acne
• vasculitis (inflammation of the blood
These are very serious but rare side effects.
vessels) - you may notice pain, redness
You may need urgent medical attention or
or itching
hospitalisation.
• loss of hair; this is usually temporary
but when it grows back it may be more
Tell your doctor as soon as possible if you
curly than before
experience any of the following effects or • increased hair growth in women
if you get any unusual symptoms, as you • increased breast growth in men
may have to stop taking the tablets:
• changes in periods in women
• suicidal thoughts or other changes in your • hearing problems
behaviour including feeling very alert
• swelling of the feet and legs (oedema)
may occur, sometimes with aggression, • weight gain, as your appetite may be
hyperactivity, and behavioural
increased
deterioration. This can be associated with • immune disorders
more frequent or severe fits, loss of drive, • kidney problems, bedwetting or
particularly if phenobarbital is taken at the
increased need to pass urine
same time, or if your Sodium Valproate
• liver problems
dose has been suddenly increased
• inflammation of the pancreas.
5

These effects usually get better when you
stop taking Sodium Valproate tablets.

6 FURTHER INFORMATION

What Sodium Valproate Gastro-resistant
Sodium Valproate may also rarely cause a Tablets contain:
• Sodium Valproate Gastro-resistant
deficiency or decrease in blood sodium,
Tablets contain either 200 mg or 500 mg
which may be identified by the following
of Sodium Valproate.
common symptoms: dehydration
• The other ingredients are povidone
including fatigue, weakness, cramp,
(E1201), talc, magnesium stearate (E572),
nausea, vomiting, bloating, swelling, and
calcium silicate, polyvinyl acetate,
tightness of the hands and feet, dizziness,
polyvinyl acetate phthalate, citric acid
confusion, fainting or seizures.
anhydrous, hypromellose, macrogol
Less commonly you may be bloated with
6000, violet lake solids, diethyl phthalate,
swelling and tightness of the hands and
and stearic acid.
feet, feel confused and have fits.
Sometimes it can cause changes in the
What Sodium Valproate Gastro-resistant
blood. Here you may notice unusual
Tablets look like and contents of the pack:
bleeding or bruising more easily, severe
stomach pains, feeling shaky or problems • Sodium Valproate 200 mg
Gastro-resistant Tablets are round lilac
with balance.
biconvex gastro-resistant tablets.
• Sodium Valproate 500 mg
There have been reports of bone
Gastro-resistant Tablets are round lilac
disorders including osetopenia and
biconvex gastro-resistant tablets.
osteoporosis (thinning of the bone) and
• Sodium Valproate Gastro-resistant
fractures. Check with your doctor or
Tablets are available in packs of 100 and
pharmacist if you are on long-term
112 tablets.
antiepileptic medication, have a history of
Not all pack sizes may be marketed.
oseoporosis, or take steroids.
If any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

5 HOW TO STORE SODIUM
VALPROATE

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
The company responsible for manufacture
is: Sterwin Medicines, Fawdon
Manufacturing Centre, Fawdon, Newcastle
Upon Tyne, England.

Keep out of the reach and sight of children.
Do not store above 30°C. Store in the
This leaflet was last revised:
original package.
January 2012.
Do not use Sodium Valproate after the
expiry date that is stated on the outer
PL 00289/0324-0325
packaging. The expiry date refers to the
last day of that month.
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.

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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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