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SODIUM VALPROATE TEVA 200 MG GASTRO-RESISTANT TABLETS

Active substance(s): SODIUM VALPROATE

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Package leaflet: Information for the user
Sodium Valproate Teva 200 and 500 mg Gastro-resistant Tablets
▼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.
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.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness seem 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.

What is in this leaflet
1. What Sodium Valproate is and what it is 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
1.
What Sodium Valproate is and what it is used for
Sodium Valproate Teva Gastro-resistant Tablets contain the active ingredient Sodium Valproate, which
belongs to a group of medicines known as anticonvulsants.
Sodium Valproate is a medicine for the treatment of epilepsy and mania. Sodium Valproate may be taken
either on its own as your only treatment for epilepsy or you may take it together with another epilepsy
therapy.
Sodium Valproate is used in the treatment of mania, where you may feel very excited, elated, agitated,
enthusiastic or hyperactive. Mania occurs in an illness called ‘bipolar disorder’. Sodium Valproate can
be used when lithium can not be used.

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You must talk to a doctor if you do not feel better or if you feel worse within a few days of taking this
medicine.
2.

What you need to know before you take Sodium Valproate

Do not take Sodium Valproate:
 if you are allergic to Sodium Valproate or any of the other ingredients of this medicine
 if you suffer from, or there is a family history of liver disease
 if you suffer from porphyria (a deficiency of specific enzymes within the body, causing an increase
of substances known as porphyrins).
 If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
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.
Talk to your doctor or pharmacist before taking Sodium Valproate
 if you have severe fits or suffer from brain disease or a metabolic condition affecting your brain
 if you suffer from kidney problems
 if you suffer from systemic lupus erythematosus (an immune system condition affecting skin, bones
and joints, lungs, or kidneys)
 if you are diabetic, as Sodium Valproate may give an indication that ketones are present in the urine
when this is not the case
 if you have any metabolic disorders, particularly hereditary enzyme deficiency disorders such as a
urea cycle disorder because of the risk of increased ammonia level in the blood
 if you have an increased appetite and are putting on weight. Please regularly check your body weight
when you are on this medicine.
 if you know that there is a genetic problem causing a mitochondrial disorder in your family.
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.
Weight gain
Taking Sodium Valproate may make you put on weight. Talk to your doctor about how this will
affect you.
Blood tests
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.

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Other medicines and Sodium Valproate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
 any other anti-epileptics e.g. phenytoin, phenobarbital, carbamazepine, lamotrigine, topiramate,
primidone, felbamate
 any anti-depressant medicines including monoamine oxidase inhibitors (MAOI) such as
moclobemide, selegiline, linezolid
 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
 Medicines used to calm emotional and mental conditions such as diazepam and olanzapine
 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) such as imipenem, meropenem,
rifampicin and erythromycin. 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).

Sodium Valproate with food, drink and alcohol
Alcohol intake is not recommended during treatment.
Take Sodium Valproate Tablets with or after food. This will help to stop the feelings of sickness that
may happen after taking the tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
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 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. It can cause serious birth defects and can
affect the way in which the child develops as it grows; these abnormalities include:

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 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 (where the bones of the spine are not properly developed).
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 5mg 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.
Important advice for women
• Valproate can be harmful to unborn children when taken by a woman during pregnancy.
• Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the risks but
all doses carry a risk.

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• 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.
• 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 ever 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 is 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

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• 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 it 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/bipolar disorder 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.
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.

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If this happens to you, do not drive or use any tools or machines.

3. How to take Sodium Valproate
Sodium Valproate treatment must be started and supervised by a doctor specialised in the treatment
of epilepsy or bipolar disorders. Always take this medicine exactly as your doctor or pharmacist
has told you. 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.
The recommended dose is:
 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.
 Older people and patients with kidney problems
Your doctor will decide a suitable dose to achieve adequate control of your epilepsy.
When treatment is first started, 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 increase the dosage
until your condition is controlled. Because of this, it is very important that you follow the
instructions your doctor has given you about how much to take.
Mania
The daily dosage should be established and controlled individually by your doctor.
Initial dose
• The recommended initial daily dose is 750 mg.
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.

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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 not take a double dose to make up for a forgotten dose.
If you stop taking Sodium Valproate
DO NOT stop taking Sodium Valproate or change the number of tablets you are taking without
first discussing this with your doctor, as this may lead to a recurrence of your symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking the tablets and tell your doctor immediately or go to the casualty department at
your nearest hospital if any of the following happens:
 an allergic reaction causing swelling of the lips, face, throat, neck or tongue leading to severe
difficulty in swallowing or breathing. Hands, feet or genitals may also be affected.Severe skin
rash or hives joint pain, fever (systemic lupus erythematosus). More severe allergic reactions
can lead to lymph node enlargement and possible impairment of other organs.
 Liver problems and problems of the pancreas (e.g inflammation of the pancreas) may show as
a sudden illness, especially if it is within the first six months of treatment, particularly if it
includes repeated vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, loss of
appetite, severe upper stomach pains, nausea, jaundice (yellowing of the skin or whites of the
eyes), swelling of the legs, worsening of your condition or a general feeling of being unwell.
If you have some of these symptoms, they may be signs of problems with your liver or
pancreas
 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 may 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 (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.) depression or another condition that affects red blood cells,
white blood cells and platelets (pancytopenia) or how the blood clots

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Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no reason
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)
Breathing difficulty and pain due to inflammation of the lungs (pleural effusion)
Birth defects

These are very serious but rare side effects. You may need urgent medical attention or
hospitalisation.
Other side effects
Tell your doctor as soon as possible if you experience any of the following effects or if you get
any unusual symptoms, as you may have to stop taking the tablets:
Very common: may affect more than 1 in 10 people
 tremor
 feeling unwell (nausea)
Common: may affect up to 1 in 10 people












decrease in blood sodium, which may be identified by the following common symptoms:
dehydration including fatigue, weakness, cramp, nausea, vomiting, bloating, swelling,
and tightness of the hands and feet, dizziness, confusion, fainting or seizures. Less
commonly you may be bloated with swelling and tightness of the hands and feet, feel
confused and have fits. 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.
tiredness, confusion, disturbance in attention, hallucinations, change in mood, loss of
consciousness, aggression, agitation.
extrapyramidal disorders, the symptoms may include feeling shaky (tremor), or unsteady
when walking or jerky muscle movements
hearing problems or hearing loss
stomach ache, or diarrhoea - especially for the first few days after starting the treatment
nail and nail bed disorders
loss of hair; this is usually temporary but when it grows back it may be more curly than
before
painful periods in women
weight gain, as your appetite may be increased

Uncommon: may affect up to 1 in 100 people





neurological problems including reversible parkinsonism (feeling shaky)
changes in periods in women (irregular)
swelling of the feet and legs (oedema)

Rare: may affect up to 1 in 1,000 people

 suicidal thoughts or other changes in your behaviour including feeling very alert may occur,
sometimes with aggression, hyperactivity, and behavioural deterioration. This can be associated
with more frequent or severe fits, loss of drive, particularly if phenobarbital is taken at the same
time, or if your Sodium Valproate dose has been suddenly increased
 Obesity
 changes in the amount of ammonia in the blood; symptoms of this may include drowsiness,
being sick, or difficulties with balance and co-ordination such as unsteadiness when walking

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abnormal behaviour, restlessness/hyperactivity and learning disorder
neurological problems including reversible dementia
sleepy (sedation)
kidney problems, bedwetting or increased need to pass urine
skin reactions such as rashes occur rarely, but patients who are also taking lamotrigine may
be more at risk


Very rare: may affect up to 1 in 10,000 people





acne
increased hair growth in women; hair, including body or facial hair grows more than normal
increased breast growth in men

Not known: frequency cannot be estimated from the available data




vasculitis (inflammation of the blood vessels) - you may notice pain, redness or itching
being sick

These effects usually get better when you stop taking Sodium Valproate tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sodium Valproate
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help to protect the
environment.
6.

Contents of the pack and other information

What Sodium Valproate Teva Gastro-resistant Tablets contain
 Sodium Valproate Gastro-resistant Tablets contain either 200 mg or 500 mg of Sodium
Valproate.
 The other ingredients are povidone (E1201), talc, magnesium stearate (E572), calcium
silicate, polyvinyl acetate, polyvinyl acetate phthalate, citric acid anhydrous, hypromellose,
macrogol 6000, violet lake solids, diethyl phthalate, and stearic acid.
What Sodium Valproate Gastro-resistant Tablets look like and contents of the pack
 Sodium Valproate Teva 200 mg Gastro-resistant Tablets are round lilac biconvex gastroresistant tablets.
 Sodium Valproate Teva 500 mg Gastro-resistant Tablets are round lilac biconvex gastroresistant tablets.
 Sodium Valproate Teva Gastro-resistant Tablets are available in packs of 100 and 112
tablets.
Not all pack sizes may be marketed.

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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.
This leaflet was last revised in April 2016
PL 00289/0324-0325

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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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