Nyxoid

Package leaflet: Information for the user

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

naloxone
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 belongs to a group of medicines
that cause a temporary neutralization of the effects of opioids such as heroin, methadone, fentanyl,
oxycodone, buprenorphine and morphine.
Nyxoid is a nasal spray used for emergency treatment of opioid overdose or suspected opioid
overdose in adults and adolescents from 14 years of age. Signs of overdose include:

• breathing problems
• severe drowsiness
• unresponsiveness to loud noise or physical stimulation.

If you are at risk of opioid overdose, you must always carry Nyxoid with you. Nyxoid works for a short period of time to temporarily reverse the effects of opioids while emergency medical assistance is being sought. It is not a substitute for emergency medical care. Nyxoid is intended for use by appropriately trained individuals.
Always inform your friends and family members that you carry Nyxoid with you.

2. What you need to know before receiving Nyxoid

Do not use Nyxoid
If you are allergic to naloxone or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Nyxoid will only be provided to you after you or the person caring for you has received instructions
on how to use it.
It must be administered immediately and does not replace emergency medical care.

• Call emergency services immediately if opioid overdose is suspected.

Signs and symptoms of opioid overdose may reappear after administration of
this nasal spray. If this occurs, additional doses may be given every 2–
3 minutes using a new nasal spray. After administering this medicine, the patient
must be closely monitored until emergency assistance arrives.
Conditions to be aware of:

• If you have physical dependence on opioids or have received high doses of opioids (e.g. heroin, methadone, fentanyl, oxycodone, buprenorphine, and morphine). You may experience severe withdrawal symptoms with this medicine (see section 4 of this leaflet, “Conditions to be aware of”).
• If you are taking opioids for chronic pain management. Pain may increase when you receive Nyxoid.
• If you are using buprenorphine. Nyxoid may not fully reverse breathing problems.

Tell your doctor if you have nasal septum damage, as this may affect
the effectiveness of Nyxoid.
Children and adolescents
Nyxoid is not indicated for use in children or adolescents under 14 years of age.
Receiving Nyxoid close to childbirth
Inform your midwife or doctor if you have received Nyxoid close to or during labor.
The baby may experience acute opioid withdrawal syndrome, which could
be potentially life-threatening if not treated.
Watch carefully for the following symptoms in your baby during the first 24 hours after
birth:

• seizures (fits)
• excessive crying
• increased reflexes.

Other medicines and Nyxoid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before receiving a supply of this medicine.
If you are given Nyxoid during pregnancy or while breastfeeding, the baby must
be closely monitored.
Driving and using machines
After receiving this medicine, do not drive, operate machinery, or perform any
other activity requiring physical or mental effort for at least 24 hours, as the effects of
opioids may reappear.
Nyxoid contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How Nyxoid should be administered

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Before using Nyxoid, you will be given instructions on how to use it. Detailed instructions are provided below.

Instructions for administering Nyxoid nasal spray

1. Check for symptoms and responsiveness.
   • Check responsiveness to see if the person is conscious. Call their name, gently shake their shoulders, speak loudly into their ears, rub their chest (sternum), pinch their ears or fingernails.
   • Check the airway and breathing. Clear the mouth and nose of any obstructions. Check breathing for 10 seconds; does the chest move? Can you hear breathing sounds? Can you feel breath on your cheek?
   • Check for signs of overdose, such as: no response to touch or sound, slow or irregular breathing, snoring, gasping, swallowing motions, or blue-tinged nails or lips.
   • If an overdose is suspected, administer Nyxoid immediately.
2. Call an ambulance. Nyxoid is not a substitute for emergency medical care.

3. Peel back the back of the blister pack from one corner to remove the nasal spray from its container. Keep the nasal spray within reach.

4. Lay the patient on their back (supine position). Support the back of their head and allow the head to tilt backward. It is best to check that the nose is clear before administering Nyxoid.

5. Hold the nasal spray with your thumb on the bottom of the plunger and your index and middle fingers on either side of the nozzle. Do not prime or test the nasal spray before use, as it contains a single dose of naloxone and cannot be reused.

6. Gently insert the device nozzle into one nostril of the patient. Firmly press the plunger until you feel a click to deliver the dose. Remove the nasal spray nozzle from the nostril after administering the dose.

7. Place the patient in the recovery position on their side, with their mouth open and facing downward. Stay with the patient until help arrives. Observe whether the patient shows signs of improvement in breathing, alertness, and response to sound and touch.

8. If the patient does not improve within 2–3 minutes, a second dose may be administered. Be cautious, as even if the patient wakes up, they may lose consciousness again and stop breathing. In this case, a second dose can be given immediately. Spray Nyxoid into the other nostril using a new Nyxoid nasal spray device. This can be done while the patient is in the recovery position.
9. If the patient does not respond to two doses, additional doses may be administered (if available). Stay with the patient and monitor for any signs of improvement until emergency medical services arrive and provide further treatment.

In patients who are unconscious and have abnormal breathing, additional life-saving measures should be performed if possible.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur with this medicine:
Conditions to pay attention to
Nyxoid may cause acute withdrawal symptoms if the patient is dependent on opioid medicines. Symptoms may include: substance abuse withdrawal syndrome, including restlessness, irritability, hyperesthesia (increased skin sensitivity), nausea (feeling unwell), vomiting (feeling sick), gastrointestinal pain (stomach cramps), muscle spasms (sudden muscle stiffness, body aches), dysphoria (bad mood or feeling of discomfort), insomnia (difficulty sleeping), anxiety, hyperhidrosis (excessive sweating), piloerection (goosebumps, tremors or shaking), tachycardia (increased heart rate), increased blood pressure, yawning, pyrexia (fever). Behavioural changes may also be observed, including aggressive behaviour, nervousness and agitation.
Acute withdrawal symptoms are not common (may affect 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 unwell (nausea)

Common: may affect up to 1 in 10 people

• Dizziness, headache
• Fast heartbeat
• High blood pressure, low blood pressure
• Vomiting

Uncommon: may affect up to 1 in 100 people

• Tremor
• Slow heart rate
• Sweating
• Irregular heartbeat
• 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, anaphylactic shock
• Potentially life-threatening irregular heartbeat, heart attack
• Fluid accumulation in the lungs
• Skin problems such as itching, rash, redness, swelling, severe peeling or cracking of the skin

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 Scad./EXP. The expiry date refers to the last day of that month.
Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Nyxoid contains

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

Description of the appearance of Nyxoid and contents of the pack
This medicine contains naloxone in 0.1 mL of a clear, colourless to pale yellow solution and is supplied in a pre-filled single-dose nasal spray container (nasal spray, solution).
Nyxoid is packaged in a cardboard box containing 2 individually sealed nasal sprays in blisters. Each nasal spray contains a single dose of naloxone.

Marketing Authorisation 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Mundipharma BV Mundipharma Corporation (Ireland) Limited
+32 2 358 54 68 Airija
[email protected] Tel +353 1 206 3800

България Luxembourg/Luxemburg
ТП„Мундифарма медикъл ООД“ Mundipharma BV
Тел.: + 359 2 962 13 56 +32 2 358 54 68
e-mail: [email protected] [email protected]

Česká republika Magyarország
Mundipharma Gesellschaft m.b.H., Medis Hungary Kft
organizační složka Tel: +36 23 801 028
Tel: + 420 222 318 221 [email protected]
E-Mail: [email protected]

Danmark Malta
Mundipharma A/S Mundipharma Corporation (Ireland) Limited
Tlf. 45 17 48 00 L-Irlanda
[email protected] Tel +353 1 206 3800

Deutschland Nederland
Mundipharma GmbH Mundipharma Pharmaceuticals B.V.
Gebührenfreie Info-Line: +49 69 506029-000 Tel: + 31 (0)33 450 82 70
[email protected] [email protected]

Eesti Norge
Mundipharma Corporation (Ireland) Limited Mundipharma AS
L-Irlanda Tlf: + 47 67 51 89 00
Tel +353 1 206 3800 [email protected]

Ελλάδα Österreich
Mundipharma Corporation (Ireland) Limited Mundipharma Gesellschaft m.b.H.
Ιρλανδία Tel: +43 (0)1 523 25 05-0
Tel +353 1 206 3800 [email protected]

España Polska
Mundipharma Pharmaceuticals, S.L. Mundipharma Polska Sp. z o.o.
Tel: +34 91 3821870 Tel: + (48 22) 866 87 12
[email protected] [email protected]

France Portugal
MUNDIPHARMA SAS Mundipharma Farmacêutica Lda
+33 1 40 65 29 29 Tel: +351 21 901 31 62
[email protected] [email protected]

Hrvatska România
Medis Adria d.o.o. Mundipharma Gesellschaft m.b.H., Austria
Tel: + 385 (0) 1 230 34 46 Tel: +40751 121 222
[email protected] [email protected]

Ireland Slovenija
Mundipharma Pharmaceuticals Limited Medis, d.o.o.
Tel +353 1 206 3800 Tel: +386 158969 00
[email protected]

Ísland Slovenská republika
Icepharma hf. Mundipharma Ges.m.b.H.-o.z.
Tlf: + 354 540 8000 Tel: + 4212 6381 1611
[email protected] [email protected]

Italia Suomi/Finland
Mundipharma Pharmaceuticals Srl Mundipharma Oy
Tel: +39 02 3182881 Puh/Tel: + 358 (0)9 8520 2065
[email protected] [email protected]

Κύπρος Sverige
Mundipharma Pharmaceuticals Ltd Mundipharma AB
Τηλ.: +357 22 815656 Tel: + 46 (0)31 773 75 30
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
SIA Inovatīvo biomedicīnas tehnoloģiju institūts Mundipharma Pharmaceuticals Limited
Tel: + 37167800810 Tel: +353 1 206 3800
[email protected]

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