Sodium Valproate Juno
| Consumer Medicine Information (CMI) summary |
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
| 1. Why am I using Sodium Valproate Juno? |
Sodium Valproate Juno contains the active ingredient sodium valproate. Sodium Valproate Juno is used for the treatment of epilepsy in adults and children
For more information, see Section 1. Why am I using Sodium Valproate Juno? in the full CMI.
| 2. What should I know before I use Sodium Valproate Juno? |
Do not use if you have ever had an allergic reaction to Sodium Valproate Juno or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Sodium Valproate Juno? in the full CMI.
| 3. What if I am taking other medicines? |
Some medicines may interfere with Sodium Valproate Juno and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
| 4. How do I use Sodium Valproate Juno? |
- If you are not currently taking Sodium Valproate Juno or 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. Sodium Valproate Juno will be given to you as an infusion or injection into the veins.
More instructions can be found in Section 4. How do I use Sodium Valproate Juno? in the full CMI.
| 5. What should I know while using Sodium Valproate Juno? |
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Drinking alcohol |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using Sodium Valproate Juno? in the full CMI.
| 6. Are there any side effects? |
All medicines have some unwanted side effects. Mostly these are mild and short-lived. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Sodium Valproate Juno.
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. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Sodium Valproate Juno
Active ingredient: sodium valproate
| Consumer Medicine Information (CMI) |
This leaflet provides important information about using Sodium Valproate Juno. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Sodium Valproate Juno.
Where to find information in this leaflet:
1. Why am I using Sodium Valproate Juno?
2. What should I know before I use Sodium Valproate Juno?
3. What if I am taking other medicines?
4. How do I use Sodium Valproate Juno?
5. What should I know while using Sodium Valproate Juno?
6. Are there any side effects?
7. Product details
| 1. Why am I using Sodium Valproate Juno? |
Sodium Valproate Juno contains the active ingredient sodium valproate. Sodium Valproate Juno belongs to a group of medicines called anticonvulsants.
Sodium Valproate Juno is used 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. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.
Sodium Valproate Juno may also be used to control mania, a mental condition with episodes of overactivity, elation or irritability.
Sodium Valproate Juno may be used alone or in combination with other medicines to treat your condition. Sodium Valproate Juno 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 Juno 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 Juno is addictive.
This medicine is available only with a doctor's prescription.
| 2. What should I know before I use Sodium Valproate Juno? |
Warnings
Do not use Sodium Valproate Juno if:
- you are allergic to sodium valproate, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
- 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 Juno 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 are pregnant, unless your doctor has determined no alternative treatment works for you.
Check with your doctor if you:
- have any other medical conditions have or have had any other 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.
- an inborn deficiency in carnitine and are taking carnitine
- have impaired dietary intake in carnitine especially in children less than 10 years old
- systemic lupus erythematosus (SLE) (a disease affecting the skin, joints and kidneys)
- family history of a genetic problem causing mitochondrial disorder - take any medicines for any other condition
If you have not told your doctor about any of the above, tell them before you take Sodium Valproate Juno.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or intend to become pregnant.
If you are a girl or woman of childbearing age, make sure that you talk to your doctor about the risks associated with taking Sodium Valproate Juno during pregnancy.
You must not take Sodium Valproate Juno unless you use an effective method of birth control (contraception) at all times during your treatment with Sodium Valproate Juno. Do not stop taking Sodium Valproate Juno or your contraception until you have discussed this with your doctor.
Your doctor will advise you further.
If you are a parent or carer, tell your doctor when your child using Sodium Valproate Juno experiences her first period.
Sodium Valproate Juno can be harmful to unborn children when taken by a woman during pregnancy. It can cause serious birth defects and can affect the way in which the child develops as it grows. Also, children born to mothers who take Sodium Valproate Juno throughout their pregnancy may be at risk of impaired cognitive development or withdrawal syndrome. However, do not stop taking Sodium Valproate Juno 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.
What do I need to consider about contraception?
Use an effective method of contraception and consult your doctor before planning pregnancy.
Sodium Valproate Juno can seriously harm an unborn child when taken during pregnancy. If you are a girl or woman of childbearing age, you must use at least one effective method of birth control (contraception) without interruption during your entire treatment with Sodium Valproate Juno. Your doctor should discuss with you the most appropriate method of contraception for you.
Sodium Valproate Juno should have little effect on the oral contraceptive pill, however, you should let your doctor know that you are taking it.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Medicines used in the treatment of epilepsy, including Sodium Valproate Juno, pass into breast milk. Your doctor will discuss the risks and benefits of taking Sodium Valproate Juno if you are breastfeeding or planning to breastfeed.
| 3. What if I am taking other medicines? |
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Sodium Valproate Juno and affect how it works. These include:
- aspirin (and other salicylates)
- medicines used to prevent clots (anticoagulants) e.g. warfarin.
- other medicines used to treat epilepsy e.g. phenobarbital (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 Juno 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
- cannabidiol (used to treat epilepsy and other conditions)
- antipsychotic medicines including clozapine (a medicine used to treat schizophrenia)
- quetiapine or olanzapine (medicines used to treat bipolar disorder and schizophrenia)
- mefloquine (a medicine used to treat malaria)
- propofol (a medicine used before and during general anaesthesia)
- 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
- colestyramine (Questran Lite)
- acetazolamide (Diamox)
- metamizole (a medicine used to treat pain and fever)
- methotrexate (a medicine used to treat cancer and some inflammatory diseases)
- some anti-infectives that contain pivalate (e.g pivampicillin, adefovir and dipivoxil)
These medicines and others may be affected by Sodium Valproate Juno, 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 Juno, 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 Juno.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sodium Valproate Juno.
| 4. How do I use Sodium Valproate Juno? |
How is it given
Sodium Valproate Juno 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 Juno, the total daily dose of Sodium Valproate Juno should remain the same. In these circumstances, Sodium Valproate Juno 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 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 40 mg for each kg of body weight every day, as long as blood tests are done to check the amount of Sodium Valproate Juno in the blood. If higher doses are needed, further blood tests must be done to check that Sodium Valproate Juno is not causing side effects.
If you use too much Sodium Valproate Juno
Your doctor will decide what dose of Sodium Valproate Juno 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.
| 5. What should I know while using Sodium Valproate Juno? |
Things you should do
- Remind any doctor, dentist or pharmacist you visit that you are using Sodium Valproate Juno.
- If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.
- Call your doctor or nurse straight away if you do not feel well while Sodium Valproate Juno is being given to you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Sodium Valproate Juno affects you.
Sodium Valproate Juno may cause drowsiness or light-headedness in some people. Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy or light-headed.
Drinking alcohol
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.
The effects of alcohol could be made worse while you are receiving Sodium Valproate Juno.
Combining Sodium Valproate Juno and alcohol can make you more sleepy, dizzy or lightheaded. Your doctor may suggest you avoid alcohol while you are being treated with Sodium Valproate Juno.
Looking after your medicine
- If you need to store Sodium Valproate Juno before taking it to hospital, make sure it is stored in a dry place where the temperature does not exceed 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
| 6. Are there any side effects? |
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
| Less serious side effects | What to do |
Gastrointestinal related:
| Speak to your doctor if you have any of these less serious side effects and they worry you. These are the more common side effects of Sodium Valproate Juno. Mostly these are mild and short-lived. |
Serious side effects
| Serious side effects | What to do |
Gastrointestinal related:
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects or if you have any thoughts of harming yourself or committing suicide. You may need urgent medical attention or hospitalisation. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
| 7. Product details |
This medicine is only available with a doctor's prescription.
What Sodium Valproate Juno contains
| Active ingredient (main ingredient) | Each ampoule contains the active ingredient sodium valproate 400mg. |
| Other ingredients (inactive ingredients) | Water for injections |
| Potential allergens | None |
Do not take this medicine if you are allergic to any of these ingredients.
What Sodium Valproate Juno looks like
Sodium Valproate Juno (Aust R 281241) comes as a clear colourless liquid in a glass ampoule.
Who distributes Sodium Valproate Juno
Juno Pharmaceuticals Pty Ltd
42 Kelso Street,
Cremorne,
VIC 3121
www.junopharm.com.au
This leaflet was prepared in November 2022.
Published by MIMS January 2023