Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Naloxone hydrochloride dihydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
This medicine contains the active substance naloxone. Naloxone temporarily reverses the effects of opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine and morphine. Nyxoid is a nasal spray used for the emergency treatment of opioid overdose or possible opioid overdose in adults and adolescents over 14 years. Signs of overdose include: breathing problems severe sleepiness not responding to a loud noise or touch. If you are at risk of an opioid overdose you should always carry your Nyxoid with you. Nyxoid works for a short time only to reverse the effects of opioids while you wait for emergency medical attention. It is not a substitute for emergency medical care. Nyxoid is intended for use by appropriately trained individuals. Always tell your friends and family that you carry Nyxoid with you. 2.
e Nyxoid
Do not use Nyxoid If you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Nyxoid will be supplied to you only after you or your carer have been taught how to use it. It is to be given right away and does not take the place of emergency medical care. Emergency services should be called if an opioid overdose is suspected. 1
The signs and symptoms of an opioid overdose can return after this nasal spray is given. If this happens, further doses may be given after 2 to 3 minutes using a new nasal spray. The patient should be monitored closely until emergency help has arrived after being given this medicine. Conditions to look out for If you are physically dependent on opioids or if you have received high doses of opioids (for example heroin, methadone, fentanyl, oxycodone, buprenorphine or morphine). You may get strong withdrawal symptoms with this medicine (see later in section 4 of this leaflet under 'Conditions to look out for') If you take opioids to control pain. The pain may increase when you receive Nyxoid. If you use buprenorphine. Nyxoid may not fully reverse breathing problems. Tell your doctor if you have damage to the inside of your nose as this could affect how Nyxoid works. Children and adolescents Nyxoid is not for use in children or adolescents under 14 years. Receiving Nyxoid close to giving birth Tell your midwife or doctor if you have received Nyxoid close to or during labour. Your baby could suffer from sudden opioid withdrawal syndrome, which could be life-threatening if not treated. Watch out for the following symptoms in your baby during the first 24 hours after the baby is born: seizures (fits) crying more than usual increased reflexes. Other medicines and Nyxoid Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving a supply of this medicine. If you are given Nyxoid while you are pregnant or breast-feeding, your baby should be closely monitored. Driving and using machines After taking this medicine, you must not drive, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours, since the effects of opioids may recur. Nyxoid contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'. 3.
How Nyxoid is to be given
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
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Training will be provided on how to use Nyxoid before it is supplied to you. Below is a step by step guide. Instructions for giving Nyxoid nasal spray 1.
Check for symptoms and response.
2.
Call for an ambulance. Nyxoid is not a substitute for emergency medical care.
3.
Peel off the back of the blister from the corner to remove the nasal spray from the container. Place the nasal spray within easy reach.
4.
Lay the patient on their back. Support the back of the neck and allow the head to tilt back. Clear away anything blocking their nose.
5.
Hold the nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle. Do not prime or test the Nyxoid nasal spray before use as it contains only one dose of naloxone and cannot be reused.
3
6.
Gently insert the device nozzle in one nostril. Press firmly on the plunger until it clicks to give the dose. Remove the nasal spray nozzle from the nostril after giving the dose.
7.
Place the patient into the recovery position on their side with mouth open pointing towards the ground and stay with the patient until the emergency services arrive. Watch for an improvement in the patient's breathing level, alertness and response to noise and touch.
8.
If the patient is no better within 2-3 minutes, a second dose can be given. Be aware – even if they wake up, they may become unconscious again, and stop breathing. If this happens, a second dose can be given immediately. Give Nyxoid in the other nostril using a new Nyxoid nasal spray. This can be done while the patient is in the recovery position.
9.
If the patient does not respond to two doses, further doses may be given (if available). Stay with the patient and continue to watch for an improvement until the emergency services arrive who will give further treatment.
In patients who are unconscious and not breathing normally additional life-saving support should be given if possible. For more information or video, scan the QR code or visit www.nyxoid.com <QR code> + www.nyxoid.com If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects although not everyone gets them. The side effects below may happen with this medicine. Conditions to look out for
4
Nyxoid can cause acute withdrawal symptoms if the patient is dependent on opioid drugs. Symptoms can include: drug withdrawal syndrome include restlessness, irritability, hyperaesthesia (increased skin sensitivity), nausea (feeling sick), vomiting (being sick), gastrointestinal pain (stomach cramps), muscle spasms (a sudden tightening of your muscles, body aches), dysphoria (unpleasant or uncomfortable mood), insomnia (difficulty in sleeping), anxiety, hyperhidrosis (excessive sweating), piloerection (goose bumps, shivering or trembling), tachycardia (fast heart rate), increased blood pressure, yawning, pyrexia (fever). Behavioural changes including violent behaviour, nervousness and excitement may also be observed. Acute withdrawal symptoms occur uncommonly (may affect up to 1 in 100 people). Tell your doctor if you experience any of these symptoms. Very common: may affect more than 1 in 10 people Feeling sick (Nausea) Common: may affect up to 1 in 10 people Dizziness, headache Fast heart rate High blood pressure, low blood pressure Being sick (vomiting) Uncommon: may affect up to 1 in 100 people Tremor Slow heart rate Sweating Irregular heart beat Diarrhoea Dry mouth Rapid breathing Very rare: may affect up to 1 in 10,000 people Allergic reactions such as swelling of the face, mouth, lips or throat, allergic shock Life-threatening irregular heartbeat, heart attack Build-up of fluid in the lungs Skin problems such as itching, rash, redness, swelling, severe flaking or peeling of the skin. Reporting of side effects 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 at: 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. 5.
Nyxoid
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton, blister pack and the label after EXP. The expiry date refers to the last day of that month. Do not freeze. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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6.
What Nyxoid contains –
The active substance is naloxone. Each nasal spray contains 1.8 mg of naloxone (as hydrochloride dihydrate). The other ingredients are trisodium citrate dihydrate (E331), sodium chloride, hydrochloric acid (E507), sodium hydroxide (E524) and purified water (see "Nyxoid contains sodium" in section 2).
What Nyxoid looks like and contents of the pack This medicine contains naloxone in 0.1 ml of a clear, colourless to pale yellow solution in a pre-filled nasal spray, solution in single dose container (nasal spray, solution). Nyxoid is packed in a carton containing 2 nasal sprays individually sealed in blisters. Each nasal spray contains one single dose of naloxone. Marketing Authorisation Holder Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Manufacturers Bard Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Mundipharma DC B.V. Leusderend 16 3832 RC Leusden Netherlands This leaflet was last revised in July 2025
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Nyxoid 1.8 mg nasal spray, solution in a single-dose container comes as nasal spray containing 1.8mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Nyxoid 1.8 mg nasal spray, solution in a single-dose container is naloxone hydrochloride dihydrate.
This leaflet reproduces the patient information leaflet approved for Nyxoid 1.8 mg nasal spray, solution in a single-dose container, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.
Nyxoid is indicated in adults and adolescents aged 14 years and over.
Nyxoid is not a substitute for emergency medical care.
Posology
Adults and adolescents aged 14 years and over
The recommended dose is 1.8 mg administered into one nostril (one nasal spray).
In some cases, further doses may be necessary. The appropriate maximum dose of Nyxoid is situation specific. If the patient does not respond, the second dose should be administered after 2-3 minutes. If the patient responds to the first administration but then relapses again into respiratory depression, the second dose should be administered immediately. Further doses (if available) should be administered in alternate nostrils and the patient should be monitored whilst awaiting arrival of the emergency services. Emergency services may administer further doses according to local guidelines.
Paediatric population
The safety and efficacy of Nyxoid in children below 14 years has not been established. No data are available.
Method of administration
Nasal use.
Nyxoid should be administered as soon as possible to avoid damage to the central nervous system or death.
Nyxoid contains only one dose and therefore it must not be primed or tested prior to administration.
Detailed instructions on how to use Nyxoid are provided in the Package Leaflet and a Quick Start Guide is printed on the back of each blister. In addition, training is provided via a video and a Patient Information Card.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Instructing patients / users on the proper use of Nyxoid
Nyxoid should only be made available once the suitability and competence of an individual to administer naloxone in the appropriate circumstances has been established. Patients or any other person who might be in a position to administer Nyxoid must be instructed in its proper use and the importance of seeking medical assistance.
Nyxoid is not a substitute for emergency medical care and may be used instead of intravenous injection, when intravenous access is not immediately available.
Nyxoid is intended to be administered as a part of a resuscitation intervention in suspected overdose casualties, where opioid drugs may be involved or suspected, likely in a non-medical setting. Therefore, the prescriber should take appropriate steps to ensure that the patient and/or any other person who might be in a position to administer Nyxoid thoroughly understands the indications and use of Nyxoid.
The prescriber should describe the symptoms which allow presumptive diagnosis of central nervous system (CNS) / respiratory depression, the indication and the instructions for use with the patient and / or person who might be in a position to administer this product to a patient experiencing a known or suspected opioid overdose event. This should be performed in accordance with the educational guidance for Nyxoid.
Monitoring of the patient for a response
Patients who respond satisfactorily to Nyxoid must be closely monitored. The effect of some opioids can be longer than the effect of naloxone, which could lead to reoccurrence of respiratory depression and therefore further doses of naloxone may be required.
Opioid withdrawal syndrome
Receiving Nyxoid can lead to a rapid reversal of the opioid effect which can cause an acute withdrawal syndrome (see section 4.8). Patients who are receiving opioids for the relief of chronic pain may experience pain and opioid withdrawal symptoms when Nyxoid is administered.
Effectiveness of naloxone
Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs, respiration should be mechanically assisted.
Intranasal absorption and efficacy of naloxone can be altered in patients with damaged nasal mucosa and septal defects.
Paediatric population
Opioid withdrawal may be life-threatening in neonates if not recognised and properly treated and may include the following signs and symptoms: convulsions, excessive crying and hyperactive reflexes.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Naloxone elicits a pharmacological response due to the interaction with opioids and opioid agonists. When administered to opioid dependent subjects, naloxone can cause acute withdrawal symptoms in some individuals. Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described, more typically when naloxone is used post-operatively (see sections 4.4 and 4.8).
Administration of Nyxoid may decrease the analgesic effects of opioids used primarily to provide pain relief, due to its antagonist properties (see section 4.4).
When administering naloxone to patients who have received buprenorphine as an analgesic, complete analgesia may be restored. It is thought that this effect is a result of the arch-shaped dose-response curve of buprenorphine with decreasing analgesia in the event of high doses. However, reversal of respiratory depression caused by buprenorphine is limited.
Pregnancy
There are no adequate data from the use of naloxone in pregnant women. Studies in animals have shown reproductive toxicity only at maternally toxic doses (see section 5.3). The potential risk for humans is unknown. Nyxoid should not be used during pregnancy unless the clinical condition of the woman requires treatment with naloxone.
In pregnant women who have been treated with Nyxoid, the fetus should be monitored for signs of distress.
In opioid dependent pregnant women, naloxone administration can cause withdrawal symptoms in newborn infants (see section 4.4).
Breast-feeding
It is unknown whether naloxone is excreted in human breast milk and it has not been established whether infants who are breast-fed are affected by naloxone. However, as naloxone is practically not orally bioavailable its potential to affect a breast-fed infant is negligible. Caution should be exercised when naloxone is administered to a breast-feeding mother but there is no need to discontinue breast-feeding. Breast-fed babies from mothers who have been treated with Nyxoid should be monitored to check for sedation or irritability.
Fertility
No clinical data on effects of naloxone on fertility are available, however data from rat studies (see section 5.3) indicate no effects.
Patients who have received naloxone to reverse the effects of opioids should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the opioids may return.
Summary of the safety profile
The most common adverse reaction (AR) seen with naloxone administration is nausea (frequency very common). Typical opioid withdrawal syndrome is expected with naloxone which may be caused by the abrupt withdrawal of opioid in persons physically dependent on them.
Tabulated list of adverse reactions
The following adverse reactions have been reported with Nyxoid and/or other naloxone-containing medicinal products during clinical studies and post marketing experience. ARs are listed below by system organ class and frequency.
Frequency categories are assigned to those adverse reactions considered to be at least possibly causally related to naloxone and are defined as very common: (≥ 1/10); common: (≥ 1/100, < 1/10); uncommon: (≥ 1/1,000, < 1/100); rare: (≥ 1/10,000, < 1/1,000) very rare: (< 1/10,000); not known (cannot be estimated from the available data).
Immune system disorders
Very rare:
Hypersensitivity, Anaphylactic shock
Nervous system disorders
Common
Uncommon
Dizziness, Headache
Tremor
Cardiac disorders
Common
Uncommon
Very rare
Tachycardia
Arrhythmia, Bradycardia
Cardiac fibrillation, Cardiac arrest
Vascular disorders
Common
Hypotension, Hypertension
Respiratory, thoracic and mediastinal disorders
Uncommon
Very rare
Hyperventilation
Pulmonary oedema
Gastrointestinal disorders
Very common
Common
Uncommon
Nausea
Vomiting
Diarrhoea, Dry mouth
Skin and subcutaneous tissue disorders
Uncommon
Very rare
Hyperhidrosis
Erythema multiforme
General disorders and administration site conditions
Uncommon
Drug withdrawal syndrome (in patients dependent on opioids)
Description of selected adverse reactions
Drug withdrawal syndrome
Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia. Behavioural changes including violent behaviour, nervousness and excitement may also be observed.
Vascular disorders
In reports on intravenous/intramuscular naloxone: hypotension, hypertension, cardiac arrhythmia (including ventricular tachycardia and fibrillation) and pulmonary oedema have occurred with the postoperative use of naloxone. Adverse cardiovascular effects have occurred more frequently in postoperative patients with a pre-existing cardiovascular disease or in those receiving other medicinal products that produce similar adverse cardiovascular effects.
Paediatric population
Nyxoid is intended for use in adolescents 14 years and over. Frequency, type and severity of adverse reactions in adolescents are expected to be the same as in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In view of the indication and the broad therapeutic margin, overdose is not to be expected.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Nyxoid 1.8 mg nasal spray, solution in a single-dose container. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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