PDFLARGE FONT PDF

Sodium Valproate Wockhardt

Sodium Valproate


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Sodium Valproate Wockhardt.

It does not contain all of 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 using Sodium Valproate Wockhardt against the benefits it is expected to 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 Wockhardt is used for

Sodium Valproate Wockhardt is a medicine used to for the treatment of 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.

Sodium Valproate Wockhardt 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 Wockhardt may also be used to control mania, a mental condition with episodes of overactivity, elation or irritability.

Sodium Valproate Wockhardt may be used alone or in combination with other medicines to treat your condition.

Sodium Valproate Wockhardt may be used short-term in place of oral sodium valproate tablets or liquid when the medicine cannot be given by mouth.

Your doctor, however, may have prescribed Sodium Valproate Wockhardt for another reason.

Ask your doctor if you have any questions about why it has been prescribed for you.

There is no evidence that Sodium Valproate Wockhardt is addictive.

This medicine is available only with a doctor's prescription.

Before you are given it

When you must not receive it

You should not receive Sodium Valproate Wockhardt 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 Wockhardt may have adverse effects on the liver and the kidneys.
  • a 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.
  • known or suspected of having a genetic problem causing a mitochondrial disorder.

You should not be given Sodium Valproate Wockhardt if you are allergic to it or any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Before you are given it

Tell your doctor if you have allergies to:

  • any of the ingredients listed at the end of this leaflet
  • any other medicines
  • any other substances, such as foods, preservatives or dyes

If you are a female patient of child- bearing age, make sure that you talk to your doctor about the risks associated with taking Sodium Valproate Wockhardt during pregnancy.

Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines of this kind, Sodium Valproate Wockhardt 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. Also, children born to mothers who take Sodium Valproate Wockhardt throughout their pregnancy may be at risk of impaired cognitive development or withdrawal syndrome.

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 Wockhardt, 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.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • liver problems (hepatic insufficiency, hepatic damage)
  • kidney problems
  • urea cycle disorders
  • ornithine transcarbamylase (OTC) deficiency
  • carnitine palmitoyltransferase (CPT) type II deficiency
  • systemic lupus erythematosus (a disease affecting the skin, joints and kidneys)
  • family history of a genetic problem causing mitochondrial disorder.

Tell your doctor if you plan to have surgery.

If you have not told your doctor about any of the above, tell them before you are given Sodium Valproate Wockhardt.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Some medicines and Sodium Valproate Wockhardt 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, topiramate, diazepam, lorazepam, oxcarbamazepine, rifunamide and ethosuximide
  • medicines used to treat depression e.g. monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants
  • benzodiazepines (medicines used as sedatives or to treat anxiety)
  • oral contraceptives. Sodium Valproate Wockhardt should have little effect on the oral contraceptive pill, however, you should let your doctor know that you are taking it
  • zidovudine or any other anti viral medications
  • antipsychotic medicines including clozapine (a medicine used to treat schizophrenia)
  • quetiapine or olanzapine (a medicine used to treat bipolar disorder and schizophrenia).
  • mefloquine (a medicine used to treat malaria)
  • propofol (a medicine used to help blood flow to the brain)
  • nimodipine (a medicine used to help blood flow to the brain)
  • cimetidine (used to treat stomach ulcers)
  • erythromycin, rifampicin and carbapenem antibiotics such as Invanz and Merrem.
  • cholestyramine (Questran Lite)
  • acetazolamide (Diamox)

These medicines and others may be affected by Sodium Valproate Wockhardt, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

Tell your doctor or pharmacist if your child is taking any other medicines before they are given Sodium Valproate Wockhardt, 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 Sodium Valproate Wockhardt.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given Sodium Valproate Wockhardt.

How it is given

Sodium Valproate Wockhardt will be given to you as an infusion or injection into the veins.

Adults:

If you are currently taking an oral formulation of sodium valproate (tablets, liquid or syrup) and are now changing over to Sodium Valproate Wockhardt, the total daily dose of Sodium Valproate Wockhardt should remain the same. In these circumstances, Sodium Valproate Wockhardt may be given as several separate injections, drips or infusions throughout the day, or as one long continuous drip or infusion lasting 24 hours a day.

If you are not currently taking any other form of sodium valproate by mouth, your doctor will decide what dose you will receive, depending on your condition and other factors such as your weight.

Children:

The dose for children is usually 20 to 30mg for each kg of body weight every day. If epilepsy is not controlled the dose may be increased up to 40mg for each kg of body weight every day, as long as blood tests are done to check the amount of Sodium Valproate Wockhardt in the blood. If higher doses are needed, further blood tests must be done to check that Sodium Valproate Wockhardt is not causing side effects.

If you take too much (overdose)

Your doctor will decide what dose of Sodium Valproate Wockhardt you need, and this will be given under close supervision, usually in a hospital setting.

The risk of an overdosage in these circumstances is low. In the event of an overdose occurring, your doctor will decide on the treatment necessary.

While you are receiving it

Things to be careful of

Be careful when driving or operating machinery until you know how Sodium Valproate Wockhardt affects you. It may cause drowsiness in some people. Make sure you know how you react to Sodium Valproate Wockhardt before you drive a car, operate machinery or do anything else that could be dangerous if you are drowsy or light headed.

The effects of alcohol could be made worse while you are receiving Sodium Valproate Wockhardt. Combining it and alcohol can make you more sleepy, dizzy or lightheaded. Your doctor may suggest you avoid alcohol while you are treated with Sodium Valproate Wockhardt.

Side effects

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or nurse as soon as possible if you do not feel well while Sodium Valproate Wockhardt is being given to you.

Tell your doctor if you notice any of the following and they worry you:

  • nausea or vomiting
  • bleeding, tender or enlarged gums
  • abdominal cramps or pain
  • changes in appetite
  • changes in your weight
  • irregular menstrual periods
  • diarrhoea
  • loss of bladder control
  • headache
  • unusual movements, including tremor and shaking
  • rapid uncontrollable movements of the eye
  • unsteadiness when walking, dizziness or light-headedness
  • depression
  • hair loss
  • feeling tired or drowsy
  • memory impairment
  • confusion
  • hallucinations
  • disturbance in attention
  • changes in behaviour including aggression and agitation
  • nail and nail bed disorders

These are the more common side effects of Sodium Valproate Wockhardt. 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.

Tell your doctor immediately if you notice any of the following:

  • more frequent or more severe seizures (fits)
  • blood clotting problems
  • spontaneous bruising or bleeding
  • skin rashes
  • 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
  • fainting
  • bizarre behaviour
  • suicidal thoughts
  • suicide attempts
  • severe upper stomach pain, often with nausea, vomiting and/or loss of appetite especially when prolonged

These are serious side effects. You may need urgent medical attention.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also happen in some patients. Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

Ask your doctor to answer any questions you may have.

After receiving it

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

If you need to store Sodium Valproate Wockhardt before taking it to hospital, make sure it is stored in a dry place where the temperature does not exceed 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a windowsill.

Do not leave it in the car. Heat and damp can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one and a half metres above ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Sodium Valproate Wockhardt, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Return any unused medicine to your pharmacist.

Product description

What it looks like

Sodium Valproate Wockhardt comes as a clear colourless solution in glass ampoules.

Each box of Sodium Valproate Wockhardt contains one, five or ten glass ampoules.

Ingredients

Each ampoule contains the active ingredient sodium valproate 100 mg/mL. Each 4 mL ampoule contains 400 mg sodium valproate and each 10 mL ampoule contains 1000 mg sodium valproate.

Sponsor

Wockhardt Bio Pty Limited
Suite 103,
39 East Esplanade,
MANLY NSW 2095, Australia

Distributed in Australia by

InterPharma Pty Ltd
PO Box 115,
MANLY, NSW, 1655
Australia

This document was prepared in October 2018.

Australian Register Numbers:

400 mg/4 mL
AUST R 279248

1000 mg/10 mL
AUST R 279285

Published by MIMS February 2019

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Dr Me Pty Limited, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.