Sodium Valproate Sandoz®
sodium valproate tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Sodium Valproate Sandoz.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Sodium Valproate Sandoz is used for
This medicine is used to treat epilepsy in adults and children.
Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe.
It contains the active ingredient sodium valproate.
Sodium valproate belongs to a group of medicines called anticonvulsants.
These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.
Sodium Valproate Sandoz may also be used to control mania, a mental condition with episodes of overactivity, elation or irritability.
It may be used alone or in combination with other medicines to treat your condition.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor’s prescription.
Before you take Sodium Valproate Sandoz
When you must not take it
Do not take this medicine if you have an allergy to:
sodium valproate, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product description.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine if you have or have had any of the following medical conditions:
liver disease (hepatic dysfunction) or severe hepatitis
a family history of hepatitis, especially when caused by medicines. Medicines used in the treatment of epilepsy, including Sodium Valproate Sandoz may have adverse effects on the liver and the kidneys.
an urea cycle disorder or a family history of urea cycle disorders
a family history of unexplained infant deaths
porphyria which is a rare blood disease of blood pigments
known ornithine transcarbamylase deficiency or a family history of ornithine transcarbamylase deficiency.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
liver problems (hepatic insufficiency, hepatic damage)
urea cycle disorders
ornithine transcarbamylase (OTC) deficiency.
Tell your doctor if you plan to have surgery.
If you are a female patient of child-bearing age, make sure that you talk to your doctor about the risks associated with taking this medicine during pregnancy.
Tell your doctor if you are pregnant or plan to become pregnant. Like most medicines of this kind, Sodium Valproate Sandoz may affect your developing baby if taken in the first trimester of pregnancy, as it is suspected of causing an increased risk of malformations in the exposed foetus. However, do not stop taking this medicine unless your doctor says so, as there are risks to the mother and child from uncontrolled epilepsy or uncontrolled mania episodes.
Your doctor may want to adapt your treatment and/or prescribe dietary supplements of folate.
Your doctor will discuss the risks and benefits of taking it if you are pregnant.
Tell your doctor if you are breastfeeding or planning to breastfeed. Medicines used in the treatment of epilepsy, including Sodium Valproate Sandoz, pass into breast milk. Your doctor will discuss the risks and benefits of taking it if you are breastfeeding or planning to breastfeed.
Tell your doctor if you drink alcohol. If you have more than 2 drinks per day, you may be putting yourself at risk of a seizure or fit.
If you have not told your doctor about any of the above, tell him/her before you start taking Sodium Valproate Sandoz.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Sodium Valproate Sandoz may interfere with each other. These include:
aspirin (and other salicylates)
medicines used to prevent clots (anticoagulants) e.g. warfarin
other medicines used to treat epilepsy e.g. phenobarbitone, methylphenobarbitone, primidone, phenytoin, carbamazepine, clonazepam, felbamate, lamotrigine, diazepam, lorazepam, oxcarbamazepine and ethosuximide
medicines used to treat depression e.g. monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants
oral contraceptives. Sodium Valproate Sandoz should have little effect on the oral contraceptive pill. However, you should let your doctor know that you are taking it.
zidovudine (a medicine used to treat viral infections)
neuroleptic agents including clozapine (a medicine used to treat schizophrenia)
mefloquine (a medicine used to treat malaria)
cimetidine (used to treat stomach ulcers)
erythromycin and carbapenem antibiotics such as Invanz and Merram.
These medicines may be affected by Sodium Valproate Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Tell your doctor or pharmacist if your child is taking any other medicines before you start giving them Sodium Valproate Sandoz, for example, aspirin or any other drugs used to treat epilepsy.
Children, especially young children, can be more sensitive to some of the side effects of this medicine.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take Sodium Valproate Sandoz
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how much to take. This may depend on your age, your condition and whether or not you are taking any other medicines.
Your doctor may recommend that you start with a low dose of Sodium Valproate Sandoz and slowly increase the dose to the lowest amount needed to control your condition.
Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.
Follow the instructions they give you. If you take the wrong dose, Sodium Valproate Sandoz may not work as well and your problem may not improve.
How to take it
Swallow the tablets whole with a full glass of water or other liquid.
Do not crush or chew the tablets. These tablets have a special coating to stop them dissolving until they have gone through the stomach and into the intestines. If you chew them, the coating is destroyed.
When to take Sodium Valproate Sandoz
Your doctor will advise you when to take Sodium Valproate Sandoz.
Always follow your doctor's instructions.
Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
If you are not sure when to take it, ask your doctor.
How long to take Sodium Valproate Sandoz
Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
If you forget to take it
Always remember to take your prescribed dose otherwise you may find that either your seizures or manic symptoms may return.
If you forget a dose, take your next dose as usual. Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Sodium Valproate Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include dizziness, drowsiness or cramps in the abdomen.
While you are taking Sodium Valproate Sandoz
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Sodium Valproate Sandoz.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Things you must not do
Do not take Sodium Valproate Sandoz to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how Sodium Valproate Sandoz affects you. This medicine may cause drowsiness or light-headedness in some people, especially at the beginning of treatment. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling drowsy or sleepy. Sodium Valproate Sandoz may cause drowsiness, dizziness or sleepiness in some people and affect alertness.
Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, sleepiness, dizziness or light-headedness may be worse. Your doctor may suggest to avoid alcohol while treated with Sodium Valproate Sandoz.
What do you need to consider about contraception?
Unplanned pregnancy may not be desirable in patients receiving medicines for epilepsy or mania. You should use an effective method of contraception and consult your doctor before planning pregnancy; for example, your doctor may want you to start taking folate tablets.
Sodium Valproate Sandoz should have little effect on the oral contraceptive pill. However, you should let your doctor know that you are taking it.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Sodium Valproate Sandoz.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
nausea or vomiting
changes in appetite
changes in your weight
unsteadiness when walking, dizziness or light-headedness
feeling tired or drowsy.
These are common side effects of Sodium Valproate Sandoz. Mostly these are mild and short-lived.
Tell your doctor immediately or go to the Accident and Emergency department of your nearest hospital if you have any thoughts of harming yourself or committing suicide.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
more frequent or more severe seizures (fits)
blood clotting problems
spontaneous bruising or bleeding
signs of liver problems such as vomiting, loss of appetite, generally feeling unwell, tiredness, yellowing of the skin and/or eyes, dark urine or blood in urine, pain in the abdomen
swelling of the feet and legs, weight increase due to fluid build up
severe upper stomach pain, often with nausea and vomiting.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
Some of these side effects can only be found when your doctor does tests from time to time to check your progress.
After taking Sodium Valproate Sandoz
Keep your medicine in the original container. If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 30°C.
Do not store Sodium Valproate Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Sodium Valproate Sandoz comes in 2 strengths:
Sodium Valproate Sandoz 200mg - lilac, round, enteric-coated tablets.
Sodium Valproate Sandoz 500mg - lilac, round, enteric-coated tablets.
Available in blisters of 100 tablets.
Sodium Valproate Sandoz 200mg - 200mg sodium valproate
Sodium Valproate Sandoz 500mg - 500mg sodium valproate.
polyvinyl acetate phthalate
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Sodium Valproate Sandoz is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500 1800 634 500
This leaflet was revised in April 2009.
Australian Register Numbers
200mg tablets: AUST R 134367 (blisters)
500mg tablets: AUST R 134368 (blisters)
Published by MIMS/myDr July 2009
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