Patient Leaflet Updated 16-Feb-2023 | Neuraxpharm UK Ltd
Sodium oxybate 500 mg/ml oral solution
Sodium oxybate 500 mg/ml oral solution
sodium oxybate
1. What Sodium oxybate oral solution is and what it is used for
2. What you need to know before you take Sodium oxybate oral solution
3. How to take Sodium oxybate oral solution
4. Possible side effects
5. How to store Sodium oxybate oral solution
6. Contents of the pack and other information
The name of this medicinal product is Sodium oxybate 500 mg/ml oral solution, referred to as Sodium oxybate oral solution in this leaflet.
Sodium oxybate oral solution contains the active substance sodium oxybate. Sodium oxybate works by consolidating night-time sleep, though its exact mechanism of action is unknown.
Sodium oxybate oral solution is used to treat narcolepsy with cataplexy in adults, adolescents and children from 7 years of age.
Narcolepsy is a sleep disorder that may include attacks of sleep during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations and poor sleep. Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise.
Talk to your doctor or pharmacist before taking Sodium oxybate oral solution:
If any of these apply to you, tell your doctor before you take Sodium oxybate oral solution.
While you are taking Sodium oxybate oral solution, if you experience bed wetting and incontinence (both urine and faeces), confusion, hallucinations, episodes of sleepwalking or abnormal thinking you should tell your doctor straight away. Whilst these effects are uncommon, if they do occur they are usually mild-to-moderate in nature.
If you are elderly, your doctor will monitor your condition carefully to check whether sodium oxybate is having the desired effects.
Sodium oxybate has a well-known abuse potential. Cases of dependency have occurred after the illicit use of sodium oxybate.
Your doctor will ask if you have ever abused any drugs before you start taking Sodium oxybate oral solution and whilst you are using the medicine.
Sodium oxybate oral solution can be taken by adolescents and children from 7 years of age when they are over 15 kg in weight.
Sodium oxybate oral solution cannot be taken by children below 7 years of age or below 15 kg in weight.
If you are a child or adolescent, your doctor will monitor your body weight regularly.
Whilst the doctor is adjusting the dose which may take a number of weeks, parent/caregivers should carefully monitor the child's breath during the first 2 hours after sodium oxybate intake to assess if there is any abnormality in breathing, for example stoppage of breathing for short periods while sleeping, noisy breathing and bluish colour of the lips and face. If abnormality in breathing is observed medical support should be sought and the doctor should be informed as soon as possible. If any abnormality is noted after the first dose, the second dose should not be administered. If no abnormality is noted the second dose can be administered. The second dose should not be given earlier than 2½ hours or later than 4 hours after the first dose.
If you have had or are having upsetting feelings particularly if you are feeling very sad or have lost interest in life it is important that you tell the doctor or caregiver.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular Sodium oxybate oral solution should not be taken together with sleep inducing medicines and medicines that reduce central nervous system activity (the central nervous system is the part of the body related to the brain and spinal cord).
Also tell your doctor or pharmacist if you are taking any of the following types of medicines:
If you are taking valproate, your daily dose of sodium oxybate will need to be adjusted (see section 3) as it may lead to interactions with valproate.
You must not drink alcohol while taking Sodium oxybate oral solution, as its effects can be increased.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
There have been very few women who have taken sodium oxybate sometime during their pregnancy and a few of them had spontaneous abortions. The risk of taking sodium oxybate during pregnancy is unknown, and, therefore, the use of sodium oxybate in pregnant women or women trying to become pregnant is not recommended.
Patients taking sodium oxybate should not breast-feed since it is known that sodium oxybate passes into breast milk.
Changes in sleep patterns have been observed in breastfed infants from exposed mothers.
Sodium oxybate oral solution will affect you if you drive or operate tools or machines. Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or that requires mental alertness for at least 6 hours after taking Sodium oxybate oral solution. When you first start taking Sodium oxybate oral solution, until you know whether it makes you sleepy the next day, use extreme care while driving a car, operating heavy machinery or doing anything else that could be dangerous or needs you to be fully mentally alert.
For paediatric patients, physicians, parents or caregivers are advised that the waiting time for performing activities that require mental alertness, motor co-ordination or any activities that may have a physical risk may have to be longer than 6 hours, depending on individual sensitivity.
You need to monitor the amount of salt you take as Sodium oxybate oral solution contains sodium which may affect you if you have had high blood pressure, heart or kidney problems in the past.
The maximum recommended daily dose of this medicinal product for an adult contains 1.68 g sodium (found in table salt). This is equivalent to 84.2% of the adult recommended maximum daily dietary intake for sodium.
For every 2.25 g dose of sodium oxybate, this medicine contains 420.8 mg of sodium.
Talk to your pharmacist or doctor if you need Sodium oxybate oral solution on a nightly basis for a prolonged period of time, especially if you have been advised to have a low salt diet.
This medicine contains 0.23 mg benzalkonium chloride per 2.25 g sodium oxybate dose.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you have kidney problems you should consider a dietary recommendation to reduce sodium (salt) intake.
If you have liver problems, the starting dose should be halved. Your doctor may gradually increase your dose.
The following instructions explain how to prepare Sodium oxybate oral solution. Please read the instructions carefully and follow them step by step. Do not allow children to prepare this medicine.
To help you, the Sodium oxybate oral solution carton contains 1 bottle of medicine, a measuring syringe and bottle-adaptor, and two dosing cups with child-resistant caps.
Step 1
Step 2
Step 3
Step 4
Then:
If you have the impression that the effect of Sodium oxybate oral solution is too strong or too weak, talk to your doctor or pharmacist.
Symptoms of sodium oxybate overdose may include agitation, confusion, impaired movement, impaired breathing, blurred vision, profuse sweating, headache, vomiting, decreased consciousness leading to coma and seizures, excessive thirst, muscle cramps and weakness. If you take more Sodium oxybate oral solution than you were told to take, or take it by accident, get emergency medical help right away. You should take the labelled medicine bottle with you, even if it is empty.
If you forget to take the first dose, take it as soon as you remember and then continue as before. If you miss the second dose, skip that dose and do not take Sodium oxybate oral solution again until the next night. Do not take a double dose to make up for a forgotten dose.
You should continue to take Sodium oxybate oral solution for as long as instructed by your doctor. You may find that your cataplexy attacks return if your medicine is stopped and you may experience insomnia, headache, anxiety, dizziness, sleeping problems, sleepiness, hallucination and abnormal thinking.
If you stop taking Sodium oxybate oral solution for more than 14 consecutive days you should consult your doctor as you should restart taking Sodium oxybate oral solution at a reduced dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. These are usually mild to moderate.
Adults - most common side effects observed in clinical studies (occurring in 10% to 20% of patients):
If you experience any of these side effects, tell your doctor straight away.
Children and adolescents - most common side effects observed in a clinical study:
If you experience any of these side effects, tell your doctor straight away.
The side effects in adults and children are the same. If you experience any of the side effects listed below, tell your doctor straight away:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known(cannot be estimated from the available data):
If you experience any of the side effects listed above, tell your doctor straight away.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton box and bottle after ‘EXP’. The expiry date refers to the last day of that month.
After dilution in the dosing cups, the preparation should be used within 24 hours.
Once you open a bottle of Sodium oxybate oral solution, any contents that you have not used within 7 weeks of opening should be disposed of.
This medicine does not require any special storage conditions.
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.
Sodium oxybate oral solution is supplied in a 200 ml amber glass bottle containing 180 ml of oral solution and closed with a polypropylene/polyethylene child-resistant cap. Each pack contains one glass bottle, a LDPE press-in-bottle-adaptor (PIBA) and polypropylene/polyethylene measuring syringe, and two glass dosing cups with polypropylene/polyethylene child-resistant caps.
The oral solution is a clear, colourless to slightly yellow solution.
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This leaflet was last revised in April 2022.
Neuraxpharm UK Ltd, Suite 2, Arlington Flex, Third Floor, Building 1420, Arlington Business Park, Theale, Reading, Berkshire, RG7 4SA, UK