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SODIUM VALPROATE ZENTIVA 500MG GASTRO-RESISTANT TABLETS

Active substance(s): SODIUM VALPROATE

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Rare side effects (may affect up to 1 in 1,000 people)
• Abnormal behaviour, restlessness/hyperactivity and
learning disorder
• Kidney problems, bedwetting or increased need to pass
urine
• Skin problems such as rashes. These happen rarely, but
more often in people also taking lamotrigine
• Male infertility, polycystic ovaries
Very rare side effects (may affect up to 1 in 10,000
people)
• Increased breast growth in men
• Acne
• Hair growth
Frequency unknown (cannot be estimated from
available data)
• Fainting
These effects usually get better when you stop taking
sodium valproate.
Bone Disorders
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
osteoporoisis, or take steroids.
Sodium valproate may decrease blood sodium. This can
make you feel tired, weak, dizzy or faint. You may also feel
or be sick and have muscle cramps.

Format : 2x170 x 315 mm D.collée
Plant barcode : 889
Colours : 1
- BLACK
Fonts : Helvetica (10pt)
Assembly Card : UHLMANN 1040
Layout of Cutting :
Technical Card :
Technical Constraint :
Reason for change: Regulatory text

The Marketing Authorisation Holder is:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
The Manufacturer is:
Fawdon Manufacturing Centre,
Edgefield Avenue, Fawdon, Newcastle upon Tyne, NE3
3TT, UK.
or
Sanofi Aventis S.A., Ctra. C-35 La Batlloria-Hostalric, Km,
63,09, 17404, Riells i Viabrea (Girona),

‘Zentiva’ is a registered trademark. © 2015 Zentiva
There are two organisations that will also be happy to try
and answer any general questions on epilepsy.
They can be contacted at:
Epilepsy Action, New Anstey House, Gate Way Drive,
Yeadon, Leeds, LS19 7XY
Telephone: 0808 800 5050
Website: www.epilepsy.org.uk
National Society for Epilepsy (NSE), Chesham
Lane, Chalfont St Peter, Bucks, SL9 0RJ
Telephone: 01494 601400
Website: www.epilepsynse.org.uk

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.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it onto others. It may harm them even if their
symptoms are 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.

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.

What is in this leaflet
1. What sodium valproate is and what is it used for
2. What you need to know before you take sodium valproate
3. How to take sodium valproate
4. Possible side effects
5. How to store sodium valproate
6. Contents of the pack and other information

By reporting side effects you can help provide more
information on the safety of this medicine.
HOW TO STORE SODIUM VALPROATE

• Keep out of the sight and reach of children.
• Do not take this medicine after the expiry date shown on
the pack.
• Store this medicine below 30ºC and in a dry place.
• Store this medicine in the original container. It is
important to keep sodium valproate tablets in their foil
pack until you are ready to take them or they may spoil.
• Ask your pharmacist how to dispose of medicines no
longer required. Do not dispose of medicines by flushing
down a toilet or sink or by throwing out with your
normal household rubbish. This will help to protect the
environment.

1.



WHAT SODIUM VALPROATE IS AND WHAT
IT IS USED FOR

The name of your medicine is Sodium Valproate Zentiva
200mg or 500mg Gastro-resistant Tablets (called sodium
valproate throughout this leaflet). This belongs to a group of
medicines called anti-convulsants or anti-epileptic agents. It
works by controlling the activity of the brain which causes
fits or seizures.
It is used to treat epilepsy (fits) in adults and children.
2.

CONTENTS OF THE PACK AND
OTHER INFORMATION



WHAT YOU NEED TO KNOW BEFORE
YOU TAKE SODIUM VALPROATE

Do not take sodium valproate and tell your doctor if:
• You are allergic (hypersensitive) to sodium valproate or
any of the other ingredients of this medicine (listed in
section 6).
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face throat
or tongue.
• You have liver problems or a family history of liver
problems
• You have a rare illness called porphyria which affects
your metabolism
• You have a genetic problem caused by a mitochondrial
disorder (e.g. Alpers-Huttenlocher syndrome)

What Sodium Valproate Tablets contain
Each tablet contains 200mg or 500mg of sodium valproate
as the active substance.
The other ingredients are: Povidone, talc, magnesium
stearate, calcium silicate, polyvinyl acetate phthalate,
citric acid, hypromellose, macrogol 6000, diethyl phthalate,
stearic acid, titanium dioxide (E171), amaranth lake (E123),
indigo carmine lake (E132) and hydroxypropyl cellulose.
What Sodium Valproate Tablets look like and contents
of the pack
Sodium Valproate 200mg and 500mg Tablets are lilac
gastro-resistant tablets. They are available in blister packs
of 100 tablets.
170 x 315 mm
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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.

Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.

Male Fertility
Taking sodium valproate can be a contributing factor in male
infertility.

6.

‚

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.’

Sometimes it can cause changes in the blood. Here you
may notice unusual bleeding or bruising more easily, severe
stomach pains, feeling shaky or problems with balance.



SODIUM VALPROATE ZENTIVA
200MG AND 500MG
GASTRO-RESISTANT TABLETS

This leaflet was last revised in May 2015.

Less commonly you may be bloated with swelling and
tightness of the hands and feet, feel confused and have fits.

5.

PATIENT INFORMATION LEAFLET

Talk to your doctor or pharmacist before taking sodium
valproate if:
• You have diabetes. This medicine may affect the results
of urine tests
• You have kidney problems – you may need a lower dose

• You have a ‘urea cycle disorder’ - where too much
ammonia builds up in the body
• You have an illness called “lupus” – a disease of the
immune system which affects the skin, bones, joints,
lungs and kidneys
• You know that there is a genetic problem caused by a
mitochondrial disorder in your family
Talk to your doctor or pharmacist before taking sodium
valproate if you have these conditions. Do this even if you no
longer have them, but have had them in the past.
Sodium valproate can increase your appetite and may make
you put on weight. Talk to your doctor about how this will
affect you.
Your doctor may wish to do blood tests before you start
taking sodium valproate and during the first six months of
treatment.
Warnings and precautions
A small number of people being treated with anti-epileptics
such as sodium valproate have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.
Other medicines and sodium valproate
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. This includes herbal
medicines. This is because sodium valproate can affect the
way some other medicines work. Also some medicines can
affect the way sodium valproate works.
In particular, check with your doctor or pharmacist if you are
taking any of the following medicines:
• 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 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.
• Medicines for depression – including monoamine
oxidase inhibitors (MAOI) such as moclobemide.
• Benzodiazepines (such as Diazepam) – used as sleeping
tablets and for anxiety.
• Some medicines for epilepsy such as phenytoin,
carbamazepine, topiramate, phenobarbital, lamotrigine,
primidone, felbamate.
• Medicines for thinning the blood such as warfarin.
• Salicylates such as aspirin
• Cholestyramine – for high blood lipid (fat) levels.
• Cimetidine - for stomach ulcers.
• Carbapenem agents (antibiotics used to treat bacterial
infections) such as imipenem, meropenem, rifampicin
and erythromycin. The combination of sodium valproate
and carbapenems should be avoided because it may
decrease the effect of your medicine
• Mefloquine and chloroquine – used to prevent and
treat 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.
• Zidovudine – for HIV and AIDS.
• Temozolomide – for cancer.
Taking sodium valproate with food and drink
Take sodium valproate with or after food. This will help to
stop the feelings of sickness that may happen after taking
the tablets.
Alcohol intake is not recommended during treatment.
Pregnancy, breast feeding and fertility
Important advice for women
• Valproate can be harmful to unborn children when taken
by a woman during pregnancy.
• Whether taken on its own or with another epilepsy
medicine, valproate seems to carry a higher risk if taken
during pregnancy than other epilepsy medicines. 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.

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Code :
678963
Update : V4- 22/05/2015
Vista folder : 1400763
Current item code: 678913
Product/Item type : VALPROATE 250/500MG
Country : GB
Artwork by : M.Pacho
Plant : Riells
Plant code : 190708/190714

Technical Data

For sanofi use only

sanofi
Riells Packaging Team

• If you take valproate during pregnancy you have a higher
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 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 it 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 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
Very little sodium valproate gets into the breast milk.
However, talk to your doctor about whether you should
breastfeed 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.
Important information about some the ingredients of
sodium valproate tablets
These tablets contain:
• The colouring agent amaranth lake (E123), which may
cause an allergic reaction in some people.
• 27.6mg sodium per 200mg dose and 69mg sodium per
500mg dose. To be taken into consideration by patients
on a controlled sodium diet.
3.

HOW TO TAKE SODIUM VALPROATE

Always take sodium valproate exactly as your doctor has
told you. You should check with your doctor or pharmacist
if you are not sure.
Sodium valproate treatment must be started and supervised
by a doctor specialised in the treatment of epilepsy.
Taking this medicine
• Swallow the tablets whole with a drink of water
• Do not crush or chew
• Take with or just after a meal. This will help reduce the
chances of getting certain side effects such as nausea or
upset stomach.
How much to take

Adults

• The usual dose of sodium valproate is


between 1000mg and 2000mg each day.

• This may be increased to 2500mg each day.

• Take this in 2 separate doses – half in the

morning and half in the evening.

Children over 20kg:

• The dose of sodium valproate is based on

the child’s weight.

• The usual dose is between 20 and 30mg for


each kg of body weight.

• This may be increased to 35mg for each kg

of body weight each day.

• Take this in 2 separate doses – half in the

morning and half in the evening.

Children under 20kg:

• The usual dose of sodium valproate is based


on the child’s weight.

• The usual dose is 20mg for each kg of body

weight.

• Give in 2 separate doses – half in the


morning and half in the evening.

People with kidney problems
If you or your child have kidney problems, your doctor may
prescribe a lower dose.
Do not change the dose you have been prescribed without
first discussing with your doctor.
When treatment is first started
At first you may be prescribed a lower dose. This is because
some patients need less sodium valproate than others to
control their fits. Your doctor will then increase the dosage
until your condition is controlled.
• Because of this it is very important that you follow your
doctor’s instructions about how much to take.
• Blood tests may be needed to check how well the
medicine is working.
• You may be taking other medicines for epilepsy at the
same time as sodium valproate. If so, your doctor may
increase the dose of sodium valproate by 5 to 10mg for
each kg of body weight each day.
Appointments
Make sure you keep your regular appointments for a checkup. They are very important as your dose may need to be
changed. If you go into hospital or visit another doctor or a
dentist, tell them you are taking sodium valproate.
If you take more sodium valproate than you should
An overdose of this medicine may be dangerous. If you
think you may have taken more sodium valproate tablets
than you should (or someone else has taken some), talk to
a doctor, pharmacist or go to the nearest hospital casualty
department straight away. Take the carton and any sodium
valproate tablets left with you so that the doctors know what
you have taken.
The following effects may happen: feeling sick or being
sick, pupils of the eye become smaller, dizziness, loss of
consciousness, weak muscles and poor reflexes, breathing
problems, headaches, fits (seizures), confusion, memory
loss and unusual or inappropriate behaviour.
If you forget to take sodium valproate
If you forget to take a dose at the right time, take it as soon
as you remember, unless it is nearly time for your next dose.
If you stop taking sodium valproate
Do not stop taking sodium valproate without first discussing
this with your doctor, even if you feel better. This is because
stopping suddenly may lead to your fits coming back.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, sodium valproate can cause side effects,
although not everybody gets them. Usually they are not
serious, and may stop if you change to another medicine.
Stop taking sodium valproate and see a doctor or go to
a hospital straight away if:
• You get swelling of the face, lips or throat which may
cause difficulty in swallowing or breathing. Hands, feet
or genitals may also be affected. More severe allergic
reactions can lead to lymph node enlargement and
possible impairment of other organs.You could also
notice an itchy, lumpy rash (hives), nettle rash (urticaria),
joint pain or fever (systemic lupus erythematosus).
This may mean you are having an allergic reaction to
sodium valproate.
Tell your doctor straight away if you notice any of the
following serious side effects – you may need urgent
medical treatment.
• Liver problems and problems of the pancreas may show
as a sudden illness which may happen in the first six
months of treatment. This is a common side effect in
people taking sodium valproate.
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), leg swelling, worsening of your
epilepsy or a general feeling of being unwell. Your doctor
may tell you to stop taking sodium valproate if you have
these symptoms.
Uncommon side effects (may affect up to 1 in 100
people)
• Breathing difficulty and pain due to inflammation of
lungs (pleural effusion)

Rare side effects (may affect up to 1 in 1,000 people)
• 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 peel off to
leave large areas of raw exposed skin over the body.
Also a feeling of being generally unwell, fever, chills and
aching muscles. 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 (pantocytopenia)
• Blood problems such as blood clotting problems
(bleeding for longer than normal), bruising or bleeding for
no reason or getting infections more easily than usual.
These blood problems could include bone marrow
depression or how the blood clots.
• 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)
Tell your doctor as soon as possible if you have any of
the following side effects:
• Very unusual behaviour including being very alert, and
sometimes also aggressive, hyper-active and showing
bad behaviour. This can be associated with more
frequent or severe fits, and loss of drive. This is more
likely if phenobarbital and topiramate is taken at the
same time or if the sodium valproate dose has been
suddenly increased.
• Sleepy or unsteady when walking or jerky muscle
movements. This is a common side effect (may affect up
to 1 in 10 people)
• Feeling tired, confused, with loss of consciousness
(coma) sometimes accompanied by hallucinations or fits.
This is a common side effect (may affect up to 1 in 10
people)
• Rapid, uncontrollable movement of the eyes. This is a
common side effect (may affect up to 1 in 10 people)
• Blisters with the skin flaking away. This is a rare side
effect (may affect up to 1 in 10,000 people)
• Changes in the amount of ammonia in the blood.
Symptoms of this condition are being sick, problems with
balance and co-ordination, feeling lethargic or less alert.
This is a rare side effect (may affect up to 1 in 10,000
people)
Tell your doctor or pharmacist if any of the following
side effects get serious or lasts longer than a few days,
or if you notice any side effects not listed in this leaflet:
Very common side effects (may affect more than 1 in
10 people)
• Feeling or being sick especially when starting treatment.
Feeling sick may be made better by taking the tablet with
or after food
• Feeling shaky (tremor)
Common (may affect up to 1 in 10 people)
• Stomach ache or diarrhoea, especially when starting
treatment
• Hearing problems
• Loss of hair which is usually temporary. When it grows
back it may be more curly than before
• Weight gain – as your appetite may be increased
• Headache
• Aggression, agitation and disturbance in attention
• Painful periods
Uncommon side effects (may affect up to 1 in 100
people)
• Feeling tired, confused, having hallucinations or changes
in mood and loss of consciousness (coma)
• Inflamed blood vessels (vasculitis) – you may notice pain,
redness or itching
• Changes in women’s periods absence of periods
• Swelling of the feet and legs (oedema)
• Severe stomach pain which may reach through to your
back. This could be a sign of pancreatitis.
• Tingling or numbness in the hands and feet
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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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