NYXOID 1.8 mg NASAL SPRAY SOLUTION SINGLE-DOSE CONTAINER

Introduction

Package Leaflet: Information for the User

Nyxoid 1.8 mg Nasal Spray Solution in Single-Dose Container

naloxone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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.

Contents of the Package Leaflet

1. What is Nyxoid and what is it used for

1. What you need to know before you use Nyxoid
2. How to use Nyxoid

1. Possible side effects
2. Storage of Nyxoid
3. Contents of the pack and further information

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

• breathing problems

• extreme drowsiness

• not responding to a loud noise or touch

If you are at risk of opioid overdose, you should always carry Nyxoid with you.Nyxoid only works temporarily to reverse the effects of opioids while waiting for emergency medical care. It is not a substitute for emergency medical care. Nyxoid should be used by people with the appropriate training.

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

2. What you need to know before you use 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 only be provided after you or your caregiver have received training on how to use it.

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

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

The signs and symptoms of an opioid overdose may return after administering this nasal spray. If this happens, other doses can be administered after 2 to 3 minutes, using a new Nyxoid nasal spray. After receiving this medicine, the patient should remain under close supervision until emergency help arrives.

Medical conditions to be aware of

• 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 section 4 of this leaflet, under “Medical conditions to be aware of”).

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

• If you use buprenorphine. Nyxoid may not completely reverse the breathing problems.

Tell your doctorif you have damage inside your nose, as this could affect the functioning of Nyxoid.

Children and adolescents

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

Administration of Nyxoid to mothers near childbirth

Tell your doctor or midwifeif you have used Nyxoidnear childbirthor during it.

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

During the 24 hours following the birth of your baby, be aware of the following symptoms in your baby:

• seizures (fits)

• more crying than usual

• increased reflexes

Other medicines and Nyxoid

Tell your doctor if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are given Nyxoid while pregnant or breastfeeding, your baby should be kept under close supervision.

Driving and using machines

After taking this medicine, do not drive, use machines, or engage in other activities that require physical or mental effort for at least 24 hours, as the effect of the opioids may return.

Nyxoid contains sodium

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

3. How to use Nyxoid

Follow the instructions for administration of this medicine exactly as told by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse again.

You will be provided with training on how to use Nyxoid before it is supplied. The following is a step-by-step guide.

Instructions for administering Nyxoid nasal spray solution

1. Check for symptoms and response.
   • Check for response to see if the person is conscious.You can shout their name, gently shake their shoulders, speak loudly in their ear, rub their sternum, pinch their ear or the base of a fingernail.

• Check the airway and breathing.Clear the mouth or nose of any blockage. Check breathing for 10 seconds. Is the chest moving? Can you hear breathing sounds? Can you feel breathing on your cheek?

• Check for signs of overdose, such as: no response to touch or sound, slow and irregular breathing or no breathing, snoring, gasping, or rapid breathing, blue-tinged fingers or lips, very small pupils.

• If 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 offthe back of the blister by a corner to remove the nasal sprayfrom the container. Place the nasal spray in an easily accessible location.

1. Turn the patient onto their back. Hold the neck from behind, allowing the head to tilt back. Clear anything that may block the nose.

1. Hold the lower part of the plunger on 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 useas it contains only one dose and cannot be reused.

1. Gently insert the nozzle of the device into one of the nostrils. Firmly pressthe plunger until it clicksto administer the dose. Remove the nozzle of the nasal spray device from the nostril after administering the dose.

1. Place the patient in the recovery positionon their side, with the mouth

open, facing downwards, and stay with the patient until emergency services arrive. Check if there is any improvement in the patient's breathing, level of alertness, and response to noise or touch.

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

1. If the patient does not respond to two doses, other doses can be administered (if available). Stay with the patient and continue to check for any improvement until emergency services arrive, who will administer further treatment.

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

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

+ www.nyxoid.com

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

Medical conditions to be aware of

Nyxoid may cause acute withdrawal symptomsif the patient is dependent on opioids. The symptoms can include: The drug withdrawal syndrome includes restlessness, irritability, hyperesthesia (increased skin sensitivity), nausea (feeling sick), vomiting (being sick), gastrointestinal pain (stomach cramps), muscle spasms (sudden muscle tension), dysphoria (unpleasant or uncomfortable mood), insomnia (difficulty sleeping), anxiety, hyperhidrosis (excessive sweating), piloerection (goosebumps, shivers, or tremors), tachycardia (rapid heart rate), increased blood pressure, yawning, pyrexia (fever). Behavioral changes, such as violent behavior, nervousness, and excitement, may also occur.

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

1. people).

Tell your doctorif 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

• Vomiting

Uncommon: may affect up to 1 in 100 people

• Tremor

• Slow heart rate

• Sweating

• Irregular heart rate

• Diarrhea

• Dry mouth

• Rapid breathing

Rare: may affect up to 1 in 10,000 people

• Allergic reactions, such as swelling of the face, mouth, lips, or throat, anaphylactic shock

• Irregular and potentially life-threatening heartbeats, myocardial infarction

• Fluid accumulation in the lungs

• Skin problems such as itching, rash, redness, swelling, or intense skin peeling

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton, blister, and label after EXP. The expiry date is the last day of the month shown.

Do not freeze.

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

6. Container contents and additional information

Nyxoid composition

• The active ingredient is naloxone. Each nasal spray contains 1.8 mg of naloxone (as dihydrochloride 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).

Appearance of the product and container contents

This medication contains naloxone in 0.1 ml of a clear, colorless to pale yellow solution in a pre-loaded nasal spray, solution in a single-dose container (nasal spray, solution)

Nyxoid is packaged in a cardboard box containing 2 closed nasal sprays in individual 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

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this prospectus:

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