1.8 mg nasal spray, solution in a single-dose
naloxone container
What Nyxoid is and what it is used for
This medicine contains the active substance naloxone. Naloxone temporarily cancels the effects of opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine, and morphine.
Nyxoid is a nasal spray used for the acute treatment of opioid overdose or suspected opioid overdose in adults and adolescents over 14 years of age. Signs of overdose include:
• breathing problems
• severe drowsiness
• no reaction to loud noises or touch.
If you are at risk for an opioid overdose, always carry your Nyxoid with you. Nyxoid only works for a short time to eliminate the effects of opioids while you wait for emergency medical attention. It is not a substitute for emergency medical care. Nyxoid is intended for use by suitably trained persons.
Always tell friends and family that you are taking Nyxoid with you.
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 cautions
You will only be given Nyxoid after you or the person giving the medicine have been shown how to use it.
It should be given immediately and does not replace emergency medical care.
• Call an ambulance in case of suspected opioid overdose.
Signs and symptoms of opioid overdose may recur after this nasal spray is given. If this happens, an additional dose may be given to you after 2 to 3 minutes with a new nasal spray. The patient should be closely monitored after receiving this medicine until the emergency personnel arrives.
Conditions you should watch out for
• If you are physically addicted to opioids or if you have been given high doses of opioids (eg heroin, methadone, fentanyl, oxycodone, buprenorphine, or morphine). You may experience severe withdrawal symptoms with this medicine (see section 4 below in this leaflet under “Conditions you should be careful of”).
• If you are taking opioids to relieve pain. The pain may increase when you receive Nyxoid.
• If you are using buprenorphine. Nyxoid may not completely relieve breathing problems.
Tell your doctor if you have nose injuries as this may affect the way Nyxoid works.
Children and young people
Nyxoid must not be used in children and adolescents under 14 years of age.
Getting Nyxoid near a delivery
Tell your midwife or doctor if you have received Nyxoid near or during childbirth. Your child may suffer from sudden opioid withdrawal syndrome which can be life-threatening if left untreated.
Look for the following symptoms in your baby for the first 24 hours after the baby is born:
• seizures (epileptic seizures)
• cries more than usual
• increased reflexes.
Other medicines and Nyxoid
Tell 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 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 you are pregnant or breastfeeding, your baby should be closely monitored.
Driving and using machines
Once you have taken this medicine, you must not drive, use machines or engage in any other physically or mentally demanding activity for at least 24 hours, as the effects of opioids may recur.
How to use Nyxoid
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
You will be shown how to use Nyxoid before accessing the medicine. Below is a step-by-step guide.
Instructions for how to give Nyxoid nasal spray:
1. Check consciousness and breathing.
– Check if the person can be awakened to see if the person is conscious.
You can shout the person’s name, gently shake your shoulders, speak in a loud voice in your ear, rub the sternum, pinch their ear, or nail bed one on one finger.
– Check airway and respiration. Make sure your mouth and nose are free of obstructions. Check to breathe for 10 seconds – is your chest moving? Can you hear breathing sounds? Can you feel the breath on your cheek?
– Check for signs of overdose, eg: no reaction to touch or sound, slow uneven breathing or no breathing, snoring, wheezing, blue or purple fingernails or lips.
– Give Nyxoid if an overdose is suspected.
2. Call for an ambulance. Nyxoid does not replace emergency medical care.
3. Remove the back of the blister pack from the corner to remove the nasal spray from the container. Place the nasal spray within easy reach.
4. Place the patient on his back. Support your neck and tilt your head back. Clear everything that blocks the nose.
5. Hold the nasal spray with your thumb on the underside of the plunger and your index and middle fingers on each side of the nozzle. Do not test the spray before using it as it contains only one dose of naloxone and cannot be reused.
Carefully insert the device nozzle into one of the patient’s nostrils. Press firmly on the plunger until it clicks to give a dose. Remove the device nozzle from the nostril after giving one dose.
7. Place the patient on his side in a stable side position with his mouth open diagonally downwards and stay with the patient until the ambulance arrives. Look for an improvement in the patient’s breathing level, alertness, and response to sound and touch.
8. If the patient does not get better within 2-3 minutes, a second dose may be given. Be careful – even if the patient wakes up, he/she may lose consciousness again and stop breathing. If this happens, a second dose can be given immediately. Repeat steps 3-6 in the other nostril with a new Nyxoid nasal spray. This can be done while the patient is in a stable lateral position.
9. If the patient does not respond to two doses, additional doses may be given (if available). Stay with the patient and look for an improvement until ambulance personnel arrive and can provide further treatment.
In patients who are unconscious and do not breathe normally, additional life-saving treatment should be given if possible.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
Permission to watch out for
Nyxoid can cause acute withdrawal symptoms if the patient is addicted to opioid drugs. Symptoms may include:
• fast heart rate, high blood pressure
• body aches and stomach cramps
• nausea, vomiting, diarrhea
• sweating, fever, goosebumps, tremors or tremors
• changes in behavior, including violent behavior, nervousness, anxiety, agitation, restlessness or irritability
• discomfort or discomfort
• increase in skin sensitivity
• hard to sleep.
Acute withdrawal symptoms occur less frequently (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
• Nausea
Common: may affect up to 1 in 10 people
• Dizziness, headache
• Fast pulse
• High blood pressure, low blood pressure
• Nausea (vomiting)
Uncommon: may affect up to 1 in 100 people
• Shaking
• Slow pulse
• Sweating
• Irregular heartbeat
• Diarrhea
• 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
Accumulation of fluid in the lungs
• Skin problems such as itching, rash, redness, swelling, severe flaky or scaly skin
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 “EXP”. The expiration date is the last day of the specified month.
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. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substance is naloxone. Each nasal spray contains 1.8 mg of naloxone (as
hydrochloride dihydrate).
The other ingredients are trisodium citrate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, and purified water.
What the medicine looks like and contents of the pack
This medicine contains 0.1 ml of naloxone in a clear, colorless to pale yellow solution in a pre-filled nasal spray, solution in single-dose containers.
Nyxoid is packaged in a carton containing 2 nasal sprays, individually packaged in blisters. Each nasal spray contains a single dose of naloxone.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Mundipharma Corporation (Ireland) Limited
Millbank House
Arkle Road
Sandyford Industrial Estate
Dublin 18
Ireland
Manufacturer:
Mundipharma DC BV
Listening 16
3832 RC Leusden
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
Mundipharma AB
Tel: + 46 (0) 31 773 75 30
info@mundipharma.se