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SODIUM VALPROATE IVAX ORAL SOLUTION BP 200MG/5ML
Active substance(s): SODIUM VALPROATE / SODIUM VALPROATE / SODIUM VALPROATE
Sodium Valproate Ivax Oral Solution BP 200mg/5ml
▼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.
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 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.
Sodium Valproate Ivax Oral Solution will be referred to as “Sodium Valproate” throughout this
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
What Sodium Valproate is and what it is used for
Sodium Valproate contains 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 or fits
women of child bearing age suffering from severe epilepsy or those not responding to other
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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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.
You must talk to a doctor if you do not feel better or if you feel worse within a few days of taking
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
(listed in section 6).
if you have a rare illness called porphyria which affects your metabolism
if you have ever had problems with your liver or have a family history of liver problems.
If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher
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 are diabetic, as Sodium Valproate may affect tests on your urine giving an indication that
ketones are present in the urine when this is not the case
if you have any sudden abdominal pain, nausea, vomiting or loss of appetite, as your doctor may
want to do some blood tests
if you are likely to become pregnant
if you are likely to increase your weight, as whilst taking your solution your appetite may be
increased so you must take care to avoid weight gain. Please regularly check your body weight
when you are on this medicine.
if you have kidney problems - you may need a lower dose.
if you have any metabolic disorder, particularly a urea cycle disorder which is passed on in
families there is a risk of increased amounts of ammonia in the blood.
if you have an illness called “lupus” - a disease of the immune system which affects skin, bones,
joints, lungs and kidneys
if you are taking salicylates
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.
Your doctor may want you to have blood tests before you start and during the first six months of your
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
to check your blood cell counts as these may be affected by using sodium valproate.
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Your doctor may do regular blood tests and liver function tests before and during your treatment
with this medicine.
Other medicines and Sodium Valproate
Tell your doctor, pharmacist or nurse if you are taking, if you have recently taken or might take any
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
Drugs for depression, including monoamine oxidase inhibitors.
Benzodiazepines - used as sleeping tablets and for anxiety
Medicines for thinning the blood such as warfarin and aspirin
Other medicines for epilepsy, for example, phenytoin, topiramate, carbamazepine,
Phenobarbital, primidone, felbamate and lamotrigine
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
Colestyramine (for high blood fat levels)
Cimetidine - for stomach ulcers
Erythromycin, rifampicin (antibiotics used for bacterial infections)
Mefloquine 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
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 oral solution.
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.
Information for women who are pregnant, planning to become pregnant, or who could
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.
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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. 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
Heart and blood vessels malformations with heart defects
Abnormalities in the lining of nerve tubes with holes or protrusions
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
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
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
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
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
• 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.
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.
• 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
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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.
• 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 it unlikely that it
will reduce the risk of birth defects associated with valproate use.
• 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
• 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.
• Tell your doctor at once if you know you are pregnant or think you might be pregnant.
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• 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.
If this happens to you, do not drive or use any tools or machines.
Sodium Valproate contains Sorbitol, Sodium propyl hydroxybenzoate (E217) and Sodium
methyl hydroxybenzoate (E219)
This medicine contains a significant amount of Sorbitol. The higher dose of this medicine is not
suitable for people with hereditary fructose intolerance as it can cause stomach upset and
Sodium propyl hydroxybenzoate (E217) and Sodium methyl hydroxybenzoate (E219). These
may cause a rash and other skin reactions such as contact dermatitis, which may not appear at
the beginning of treatment. Rarely there have been reports of a rash appearing straight away,
with wheezing or breathing problems. Talk to a doctor straight away if this happens.
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.
The recommended dose is:
Taking sodium valproate on its own for epilepsy (fits):
Initially, 600mg (three 5ml spoonfuls) in divided doses.
Your doctor will increase this amount by 200mg (one 5ml spoonful) every three days until your
epilepsy is controlled. The maintenance dose is usually between 1000mg and 2000mg (five to
ten 5ml spoonfuls) a day taken in divided doses, but it can sometimes be as high as 2500mg.
Your dosage will be determined by your doctor, according to the control of your epilepsy.
Children over 20 kg
The initial dose is 400mg (two 5ml spoonfuls) a day. Your doctor will then increase and adjust
the dose for your child based on the child’s body weight until your child’s epilepsy is controlled.
Children under 20 kg
Your doctor will calculate the appropriate dose according to your child’s body weight.
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The daily dosage should be established and controlled individually by your doctor.
• 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 give you a different dose of sodium valproate.
If you take more sodium valproate than you should
If you (or someone else) swallow a lot of the solution all together, or if you think a child has
swallowed any of the solution, contact your nearest hospital casualty department or your doctor
immediately. An overdose is likely to cause nausea, vomiting, dizziness, breathing difficulties or
Please take this leaflet, any remaining solution, and the container with you to the hospital or doctor
so that they know which solution was consumed.
If you forget to take sodium valproate
If you forget to take your medicine, take it 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 your medicine without talking to your doctor first even if you feel better, 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking the solution and tell your doctor immediately or go to the casualty department at
your nearest hospital if the following happens:
an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing;
skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Other side effects
Tell your doctor immediately if the following happens, as you may have to stop taking the
Very common: may affect more than 1 in 10 people
Weight gain - as your appetite may be increased
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Nausea (Feeling unwell) this usually disappears after a few days without your stopping
treatment. You may not get this side effect if you take Sodium Valproate with or after your food
or by taking enteric coated Sodium Valproate.
Stomach pain, this usually disappears after a few days without stopping your treatment. You
may not get this side effect if you take Sodium Valproate with or after your food or by taking
enteric coated Sodium Valproate.
Loose stool, this usually disappears after a few days without stopping your treatment. You may
not get this side effect if you take Sodium Valproate with or after your food or by taking enteric
coated Sodium Valproate.
Common: may affect up to 1 in 10 people
Liver problems- abnormal result of liver enzyme test. It happens particularly early in treatment,
and may be a temporary liver problem which disappears after reduction in dosage of sodium
Nail and nail bed disorders
Rare: may affect up to 1 in 1,000 people
Decreased blood cell count (This can be identified from a blood test). But blood cell counts
return to normal on discontinuation of this medicine
Allergic reactions (signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue)
Sedation (Feeling sleepy) - it is a temporary problem that occurs early in treatment.
Extrapyramidal disorders. The symptoms you may feel are like feeling shaky (tremor), or
unsteady when walking or jerky muscle movements, restlessness
Feeling tired, confused, having hallucinations (feeling things that are not real) or changes in
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 is taken at the same time or if the Sodium Valproate
dose has been suddenly increased
Abnormal liver function
Rash, acne. These happen rarely, but more often in people also taking lamotrigine.
Drug Rash with Eosinophilia and systemic symptoms (DRESS) syndrome
Swelling of the feet and legs (oedema)
Swelling of tissues, usually in the lower limbs, due to the accumulation of fluids
Very rare: may affect up to 1 in 10,000 people
Abnormally low level of sodium in the blood (this can be identified from a blood test). This
can make you feel tired, weak, dizzy or faint
Prolonged unconsciousness (coma)
Shaking and rigidity of muscles
Temporary loss of mental abilities such as thinking, remembering, and reasoning (Dementia)
associated with muscle weakness impairment of speech and vision (cerebral atrophy).
Pancreatitis. Symptoms you may feel are like intense abdominal pain which aggravates after
eating, swollen and tender abdomen, feeling unwell, vomiting, fever and increased pulse rate.
Inability to control the flow of urine
Skin disorder characterized by blistering and peeling of the top layer of skin.
Changes in women's periods
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Increased breast growth in men.
Not known: frequency cannot be estimated from the available data
Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no reason.
Changes in the amount of ammonia in the blood (this can be identified from blood test)
Inflamed blood vessels (vasculitis) - you may notice pain, redness or itching.
Death due to severe liver damage
Loss of hair which is usually temporary. When it grows back it may be more curly than before.
Disorder in muscle movement
Bone marrow failure
Uncontrolled bleeding in new born babies whose mothers have taken Valproate during
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.
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:
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Sodium Valproate
Keep this medicine out of the sight and reach of children.
You should keep your solution in a dry place below 25°C. Keep it in the bottle it came in. Do not
put it into another bottle.
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 protect the environment.
6. Contents of the pack and other information
What Sodium Valproate Ivax Oral Solution contains
The active ingredient in each 5ml of solution is sodium valproate 200mg
The other ingredients are sodium methyl p-hydroxy benzoate, sodium propyl p-hydroxy
benzoate, glycerol, cherry flavour, erythrosine (E127) and sorbitol solution (inactive ingredients).
What Sodium Valproate Ivax Oral Solution looks like and contents of the pack
Sodium Valproate Oral Solution is a pink clear liquid with a cherry smell.
It comes in bottles of 300 ml and 1 litre
Not all pack sizes may be marketed.
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Marketing Authorisation Holder
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive,
Castleford, West Yorkshire, WF10 5HX
Company responsible for manufacture
TEVA UK Limited, Eastbourne BN22 9AG
This leaflet was last revised in March 2016
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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
Meaning of Signature
Regulatory Affairs Approval
30-Mar-2016 03:03:12 PM
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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.