Nyxoid 1.8 mg nasal spray, solution in a single-dose container

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Nyxoid is and what it is used for
2. What you need to know before you receive Nyxoid
3. How Nyxoid is to be given
4. Possible side effects
5. How to store Nyxoid
6. Contents of the pack and other information

If you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6).

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.

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.

• 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.

Nyxoid is not for use in children or adolescents under 14 years.

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

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.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

1. Check for symptoms and response.

• Check for a response, to see if the person is conscious. You can shout their name, gently shake their shoulders, talk loudly into their ears, rub their breastbone (sternum), pinch their ear or the bed of their fingernail.
• Check airways and breathing. Clear the mouth and nose of any blockages. For 10 seconds check for breathing – is the chest moving? Can you hear breathing sounds? Can you feel breath on the cheek?
• Check for signs of overdose, such as: no response to touch or sounds, slow uneven breathing or no breathing, snoring, gasping or gulping, blue or purple fingernails or lips.
• If an overdose is suspected Nyxoid should be given.

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.

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.

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.

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.

• 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).

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.