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SODIUM VALPROATE TABLETS BP 200MG (E/C)

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Sodium Valproate Tablets 200mg

Please read this leaflet carefully before you start to take your medicine.
It tells you some of the more important things you should know.
If you want to know more, or you are not sure about anything, ask your doctor or
pharmacist.

WHAT'S IN YOUR MEDICINE
Sodium Valproate tablets come in one strength, containing 200mg of the active ingredient
Sodium valproate. They are identified by the following markings:
Violet enteric-coated tablets

COX

SU

They also contain: colloidal silica, hypromellose phthalate, macrogol, magnesium stearate,
maize starch, polysorbate, povidone, sodium sulphate, stearic acid, triacetin, E131, E132,
E171, E464, E553.
Sodium content: 1.214mmol/tablet
Sodium Valproate Tablets are available in pack sizes of 50s, 100s, 250s, 500s, 1000s.
Sodium valproate is one of a group of medicines called anticonvulsants or anti-epileptic
agents. These tablets are specially coated so that they do not dissolve in the stomach
MA holder/Manufacturer: Actavis, Barnstaple, EX32 8NS, UK

ABOUT YOUR MEDICINE
The name of your medicine is Sodium valproate, which is the generic (common) name. Your
doctor may have given you this medicine before from another company and it may have
looked slightly different. Either brand will have the same effect.
Sodium Valproate Tablets are used for:
the treatment of epilepsy.
BEFORE TAKING YOUR MEDICINE 4.3 – 4.6
Make sure you have told your doctor if you:
are pregnant, plan to, or become pregnant or are breast feeding. It is essential that you
discuss your epilepsy treatment with your doctor well before you intend to become
pregnant. Women who take sodium valproate during the first month of pregnancy to
control their epilepsy have a small risk (1-2%) of having a baby with spina bifida, an
abnormality of the spinal cord. There is also an increased risk of other congenital
abnormalities. These can usually be detected in the first part of pregnancy by normally
used screening tests. Taking folic acid 5mg daily as soon as you stop contraception may
lower the risk of having a baby with spina bifida. Rarely, there may also be clotting
problems in the new born if the mother has taken sodium valproate during pregnancy.
Infants born to mothers who took sodium valproate during pregnancy may develop less
quickly than normal. This may also be because of the mother’s epilepsy but the exact
cause is not known. It is important not to stop your sodium valproate suddenly as this
may result in fits, which may harm you or your unborn baby.
are sensitive to sodium valproate, valproic acid or any other ingredients in the
formulation.

have liver disease, or a family history of liver disease.
are taking other medicines such as orlistat (used for weight loss), anticoagulants (eg
warfarin and salicylates such as aspirin), antibiotics such as ertapenem and meropenem,
antidepressants, cholestyramine, cimetidine, mono-amine oxidase inhibitors (MAOIs),
antipsychotics/neuroleptics (eg chlorpromazine, flupenthixol, haloperidol, thioridazine,
pimozide, prochlorperazine, sulpiride), other anticonvulsants (eg carbamazepine,
lamotrigine, phenobarbitone, phenytoin), and including any that you can buy without
prescription.
If you need a urine test for diabetes, tell your doctor, as Sodium valproate may affect the
results.
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.
If you see another doctor or go into hospital, let them know what medicines you are taking.
TAKING YOUR MEDICINE
Your doctor has decided the dose which is best for you. Always follow your doctor's
instructions exactly, and those on the pharmacy label. If you do not understand anything, ask
your doctor or pharmacist.
Sodium Valproate Tablets may be taken twice daily. The daily dosage of this medicine will
be different for different patients. Age and bodyweight are considered, and the dosage will be
adjusted according to your response to the medicine. The average dosages are given below:
Age group
Dosage
Adults
600mg daily initially. The dose is then normally
increased at
3 day intervals until control is achieved. This is usually
within the dosage range 1000-2000mg daily.
(with other anticonvulsants)
Dosage may need to be increased.
Children over 20kg
400mg daily initially. The dose is then gradually
increased
from the starting dose.
Children under 20kg
A different presentation of this medicine (eg syrup) is
normally given to this age group.
These tablets should be taken as instructed - swallowed whole and not crushed, followed by a
glass of water, usually after food. Continue to take them for as long as your doctor tells you
to, it may be dangerous to stop without their advice.
If you forget to take a dose, take another as soon as you remember and then your next dose at
the usual time. NEVER take two doses at the same time.
Make sure you keep your regular check up appointments. They are very important as your
dosage may need to be changed. Your doctor will monitor your liver function with blood
tests before giving you Sodium Valproate and during the first six months of treatment.
If you are elderly, it is particularly important to take this medicine exactly as directed by the
doctor.

If you see another doctor or go into hospital, let them know what medicines you are taking.
If you accidentally take more than your prescribed dose, contact your nearest hospital casualty
department, or tell your doctor, immediately. Take any remaining tablets and the container
with you.

AFTER TAKING YOUR MEDICINE
Like many medicines, Sodium Valproate may cause side effects, particularly when you first
start taking it. These may include drowsiness (especially when Sodium valproate is taken with
other medicines), minor stomach upsets, and nausea (feeling sick). Sodium valproate often
causes an increased appetite so you must take care to avoid weight gain. Your doctor will
monitor your weight during treatment.
Tell your doctor immediately if you suffer from any of the following:
Abnormal bleeding or an increased tendency to bruising and nosebleeds, sore throats,
feverishness or infections.
Extreme tiredness or weakness, loss of appetite, vomiting (being sick), drowsiness,
confusion or hallucinations (seeing, hearing or feeling things that are not there).
Jaundice (yellowing of the skin and whites of the eyes).
Severe stomach pain and feeling or being sick.
Disease of the brain (encephalopathy).
Fits, worsening of your fits.
Shakiness of the arms and legs or general unsteadiness.
Other side effects that may occur include
Increased alertness, aggression and hyperactivity or other behavioural changes.
Hair loss - this is usually temporary but the hair may become curlier than before.
Enlarged breasts in men.
Rashes, severe rashes such as Toxic Epidermal Necrolysis and Stevens-Johnson
syndrome, acne or excessive hairiness.
Irregular or absent menstrual periods.
Swelling of the lower legs.
Kidney problems such as Fanconi’s syndrome, kidney inflammation or failure.
You should tell your doctor if you notice these or any other unusual symptoms.
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.
Sodium valproate may affect the liver. If you develop a sudden illness at any time, especially
during the first 6 months of treatment, and particularly if it includes extreme tiredness, loss of
appetite, vomiting, stomach pain, water retention, jaundice (yellowing of the skin) or
worsening of your epilepsy, tell your doctor immediately and seek advice.
Your medicine may alter the numbers and types of your blood cells. If you notice a tendency
to bruise more easily, nosebleeds, sore throats or infections, you should tell your doctor who
may want to give you a blood test.

You should also tell your doctor if you experience abnormal bleeding or severe stomach
pains, shakiness of the arms or legs, general unsteadiness, a skin rash, vomiting, irregular and
jerky movements, and increased clouding of consciousness, or anything else which is unusual.
STORING YOUR MEDICINE
Do not use the tablets after the expiry date shown. Keep the tablets below 25°C in a dry
place and in the original packaging. KEEP THEM IN A SECURE PLACE WHERE
CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for
YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the
same as yours. Unless your doctor tells you to, do not keep medicines that you no longer
need - give them back to your pharmacist for safe disposal.
Date of last revision: April 2012

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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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