Nyxoid 1,8 mg solucion para pulverizacion nasal en envase unidosis

Product Information for the User

Nyxoid 1.8 mg Nasal Spray in Single-Dose Container

Naloxone

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

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

1. Possible adverse effects
2. Storage of Nyxoid
3. Contents of the container and additional information

This medication contains the active ingredient naloxone. Naloxone temporarily reverses the effects of opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine, and morphine.

Nyxoid is a nasal spray used for emergency treatment of overdose, or possible overdose, by opioids in adults and adolescents 14 years of age and older. Signs of overdose include:

• breathing difficulties

• 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.Nyxoidonly temporarily reverses the effects of opioids while waiting for emergency medical attention. It is not a substitute for emergency medical attention. Nyxoid should be used by people with proper preparation.

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

No use Nyxoid

If you are allergic to naloxone or any of the other ingredients in this medication (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 must be administered immediately and does not replace emergency medical care.

• You should call emergency services if you suspect an opioid overdose.

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

Medical conditions to be aware of

• If you have physical dependence on opioids or have received high doses of opioids (such as heroin, methadone, fentanyl, oxycodone, buprenorphine, or morphine). You may experience severe withdrawal symptoms with this medication (see more in section 4 of this prospectus, 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 respiratory problems.

Inform your doctorif you have damage inside your nose, as this could affect thefunctioning of Nyxoid.

Children and adolescents

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

Nyxoid administration in mothers close to delivery

Inform your doctor or midwifeif you haveused Nyxoidclose todeliveryor during the same.

Your baby may suffer from arapid opioid withdrawal syndrome, which could put their life at risk if not treated.

Be vigilant for the following symptoms in your baby during the 24 hours following birth:

• convulsions (seizures)

• excessive crying

• increased reflexes

Other medications and Nyxoid

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before receiving a supply of this medication. If you are given Nyxoid while pregnant or breastfeeding, your baby should remain under close supervision.

Driving and operating machinery

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

Nyxoid contains sodium

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

Follow the exact administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

You will receive training on how to use Nyxoid before it is supplied. Below is a step-by-step guide.

Instructions for administering Nyxoid nasal spray:

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

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

1. Removethe back of the blister pack by one corner toextract the nasal sprayfrom thecontainer. Place the nasal spray in an easily accessible location.

1. Turn the patient onto their back. Hold the back of the neck, allowing the head to tilt backward. Clear any blockage from the nose.

1. Hold the lower end of the plunger of the nasal spray with your thumb and place your index and middle fingers on either side of the nozzle.Do not squeeze or test the device before usesince it contains only one dose and cannot be reused.

1. Insert the nozzle of the device gently intoone of the nasal passages.Press firmlythe plungeruntil it clicksto administer the dose. Remove the nozzle from the nasal spray after administering the dose.

1. Place the patient inrecovery positionon their side, with their mouth

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

1. If the patientdoes not improvein2-3 minutes,another dose can be administered.Be aware that even if they wake up, they may become unconscious again and stop breathing. If this happens, another dose can be administered immediately. Administer Nyxoid in the other nasal passage using a new Nyxoid nasal spray. This can be donewhilethe patient is in the recovery position.

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

In unconscious patients who are not breathing normally, additional life-saving measures should be applied whenever possible.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. This medicine may cause the following side effects.

Medical conditions to be aware of

Nyxoid may causeacute withdrawal symptomsif the patient is dependent on opioids. The symptoms may include: The withdrawal syndrome includes 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, excessive sweating, piloerection (goosebumps, chills, or tremors), tachycardia (rapid heart rate), increased blood pressure, yawning, pyrexia (fever). Behavioral changes, such as violent behavior, nervousness, and excitement, may also be observed.

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

1. people).

Inform your doctorif you experience any of these symptoms.

Very common: may affect more than 1 in 10 people

• Sensation of illness (nausea)

Common: may affect up to 1 in 10 people

• Dizziness, headache

• Fast heart rate

• High blood pressure, low blood pressure

• Vomiting

Infrequent: may affect up to 1 in 100 people

• Tremor

• Slow heart rate

• Sweating

• Irregular heart rate

• Diarrhea

• Dry mouth

• Fast breathing

Very rare: may affect up to 1 in 10,000 people

• Allergic reactions, such as facial swelling, mouth, lip, or throat swelling, anaphylactic shock

• Irregular and potentially fatal heartbeats, myocardial infarction

• Pulmonary edema

• Dermatological problems such as itching, urticaria, redness, swelling, or intense skin peeling

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, blister pack, and label after EXP. The expiration date is the last day of the month indicated.

Do not freeze.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the medication that is no longer needed. This will help protect the environment.

Composition of Nyxoid

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

Appearance of the product and contents of the container

This medicine contains naloxone in 0.1 ml of a transparent, colourless to pale yellow solution in a preloaded nasal spray, solution in a single-dose container.

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

Responsible for manufacturing:

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:February 2023.

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