Nyxoid 1.8 mg solution for nasal spray in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nyxoid 1.8 mg solution for nasal spray in single-dose container

naloxone

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Nyxoid is and what it is used for

2. What you need to know before using Nyxoid

3. How to use Nyxoid

4. Possible side effects

5. How to store Nyxoid

6. Contents of the pack and other information

1. What Nyxoid is and what it is used 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 spray solution used for the emergency treatment of opioid overdose, or suspected opioid overdose, in adults and adolescents aged 14 years and older. Signs of overdose include:

• difficulty breathing

• extreme sleepiness

• unresponsiveness to loud noise or physical stimulation

If you are at risk of opioid overdose, you should always carry Nyxoid with you. Nyxoid works only temporarily to reverse the effects of opioids while emergency medical care is being sought. It is not a substitute for emergency medical care. Nyxoid should be used by individuals who are appropriately trained.

Always inform your friends and family that you carry Nyxoid with you.

2. What you need to know before using Nyxoid

Do not use Nyxoid

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

Warnings and precautions

Nyxoid will only be provided to you after you or your caregiver has received training on how to use it.

It must be administered immediately and does not replace emergency medical care.

• You must call emergency services if an opioid overdose is suspected.

Signs and symptoms of an opioid overdose may return after administering this nasal spray. If this happens, additional doses may be given after 2 to 3 minutes, using a new nasal spray device. After receiving this medicine, the patient must remain under close supervision until emergency help arrives.

Medical conditions requiring attention

• If you are physically dependent on opioids or have received high doses of opioids (e.g., heroin, methadone, fentanyl, oxycodone, buprenorphine, or morphine). You may experience severe withdrawal symptoms with this medicine (see further in section 4 of this leaflet under “Medical conditions requiring attention”).

• If you take opioids to control pain. Pain may increase when you receive Nyxoid.

• If you use buprenorphine. Nyxoid may not fully reverse respiratory problems.

Tell your doctor if you have damage inside the nose, as this could affect how Nyxoid works.

Children and adolescents

Nyxoid must not be used in children or adolescents under 14 years of age.

Administration of Nyxoid in mothers close to delivery

Tell your doctor or midwife if you have used Nyxoid close to delivery or during childbirth.

Your baby may experience a sudden opioid withdrawal syndrome, which could be life-threatening if not treated.

During the 24 hours after your baby is born, watch for the following symptoms in your baby:

• seizures (fits)

• excessive crying

• increased reflexes

Other medicines and Nyxoid

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before receiving this medicine. If you are given Nyxoid while pregnant or breastfeeding, your baby must remain under close supervision.

Driving and using machines

After taking this medicine, you must not drive, operate machinery, or engage in other activities requiring physical or mental effort for at least 24 hours, as the effects of opioids may return.

Nyxoid contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially “sodium-free”.

3. How to use Nyxoid

Follow exactly the instructions for administering this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Training on how to use Nyxoid will be provided before you are given the medicine. Below is a step-by-step guide.

Instructions for administering Nyxoid nasal spray solution

1. Check symptoms and response.

• Check for responsiveness to see if the person is conscious. You may shout their name, gently shake their shoulders, speak loudly into their ear, rub their sternum, pinch their earlobe, or pinch the base of a fingernail.
• Check the airway and breathing. Clear any blockage from the mouth or nose. Check breathing for 10 seconds. Is the chest moving? Can you hear breathing sounds? Can you feel breathing against your cheek?
• Check for signs of overdose, such as: unresponsiveness to touch or sound, slow or irregular breathing or no breathing, snoring, gasping or rapid breaths, blue or purple lips or fingernails, very small pupils.
• If an overdose is suspected, Nyxoid should be administered as soon as possible.

1. Call an ambulance. Nyxoid is not a substitute for emergency medical care.

1. Peel back the blister backing at one corner to remove the nasal spray device from its packaging. Place the nasal spray device within easy reach.

1. Lay the patient on their back. Support the neck at the back, allowing the head to tilt backwards. Clear anything that might block the nose.

1. Hold the base of the plunger of the nasal spray device with your thumb, and place your index and middle fingers on either side of the nozzle. Do not prime or test the device before use, as it contains only one dose and cannot be reused.

1. Gently insert the nozzle of the device into one of the nostrils. Press firmly on the plunger until it clicks to deliver the dose. Remove the nasal spray nozzle from the nostril after administering the dose.

1. Place the patient in the recovery position on their side, with the mouth open and facing downward. Stay with the patient until emergency services arrive. Watch for any improvement in the patient’s breathing, level of alertness, and response to sound or touch.

1. If the patient does not improve within 2–3 minutes, a second dose may be given. Note that even if the patient wakes up, they may become unconscious again and stop breathing. If this happens, a second dose can be administered immediately. Administer Nyxoid into the other nostril using a new Nyxoid nasal spray device. This can be done while the patient is in the recovery position.

2. If the patient does not respond to two doses, additional doses may be given (if available). Stay with the patient and continue to monitor for any improvement until emergency services arrive and provide further treatment.

In patients who are unconscious and not breathing normally, life-saving supportive measures should be applied when possible.

For more information or videos, scan the QR code or visit www.nyxoid.com

+ www.nyxoid.com

If you have further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine.

Medical problems that require attention

Nyxoid may cause acute withdrawal symptoms if the patient is opioid-dependent. Symptoms may include: drug withdrawal syndrome comprising restlessness, irritability, hyperesthesia (increased skin sensitivity), nausea (feeling unwell), vomiting (being sick), gastrointestinal pain (stomach cramps), muscle spasms (sudden muscle tension, body aches), dysphoria (unpleasant or uncomfortable mood), insomnia (difficulty sleeping), anxiety, hyperhidrosis (excessive sweating), piloerection (goosebumps, chills or shivering), tachycardia (rapid heartbeat), increased blood pressure, yawning, pyrexia (fever). Changes in behaviour may also occur, such as aggressive behaviour, nervousness and agitation.

Acute withdrawal symptoms occur uncommonly (may affect up to 1 in

1. people).

Tell your doctor if you experience any of these symptoms.

Very common: may affect more than 1 in 10 people

• Feeling unwell (nausea)

Common: may affect up to 1 in 10 people

• Dizziness, headache

• Fast heart rate

• High blood pressure, low blood pressure

• Vomiting

Uncommon: may affect up to 1 in 100 people

• Tremor

• Slow heart rate

• Sweating

• Irregular heart rate

• 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

• Irregular and potentially life-threatening heartbeats, myocardial infarction

• Fluid accumulation in the lungs

• Skin problems such as itching, rash, redness, severe skin peeling or scaling

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nyxoid

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister, and label after EXP. The expiry date is the last day of the month indicated.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Nyxoid

• The active substance is naloxone. Each nasal spray contains 1.8 mg of naloxone (as dihydrochloride dihydrate).
• The other components are trisodium citrate dihydrate (E331), sodium chloride, hydrochloric acid (E507), sodium hydroxide (E524) and purified water. (See “Nyxoid contains sodium” in section 2.)

Presentation of the product 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 a single-dose container (nasal spray, solution).

Nyxoid is packaged in a cardboard box containing 2 nasal sprays individually sealed in blisters. Each nasal spray contains a single dose of naloxone.

Marketing Authorization Holder

Mundipharma Corporation (Ireland) Limited
United Drug House Magna Drive
Magna Business Park
Citywest Road
Dublin 24
Ireland

Manufacturer

Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden
The Netherlands

For more information about this medicine, you can contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu