Respinal contains the active substance naloxone which is an antidote to opioids. This medicine is used to eliminate the effect of known or suspected opioid overdose in adults (eg morphine, heroin, methadone, fentanyl, oxycodone, or buprenorphine).

Respinal is a nasal spray used for the acute treatment of opioid overdose or suspected opioid overdose in adults. 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 Respinal with you. Respinal 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.

Always tell friends and family that you are carrying Respinal.

Naloxone contained in Respinal may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.

What you need to know before you receive Respinal

Do not use Respinal

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

Warnings and cautions

This medicine is used for acute treatment of opioid overdose and must be given by someone other than yourself.

Respinal should be given immediately and does not replace emergency medical care.

A Respinal nasal spray contains only one dose of naloxone. The nasal spray mustn’t be charged or tested before use as this will empty the nasal spray and you will not get the medicine you need. Use a new Respinal nasal spray if the additional dose is needed. Additional doses may be given 2-3 minutes after the first dose ( s) (see section 3).
Symptoms of Acute Withdrawal Syndrome: Respinal may cause excessive opioid withdrawal, which may give rise to an acute withdrawal syndrome in people who are physically dependent on opioids. Symptoms of acute withdrawal syndrome may include rapid heartbeat, high blood pressure, body aches, and stomach cramps, diarrhea, nausea, vomiting, sweating, fever, goosebumps, tremors or tremors, behavioral changes, including violent behavior, nervousness, anxiety, arousal or anxiety, restlessness irritability, discomfort or discomfort, increase in skin sensitivity, difficulty sleeping. If you are taking opioids for chronic relief pain, you may also experience increased pain when you receive Respinal.
The effect of some opioids may be longer than the effect of Respinal. Although the patient initially responds to treatment, the patient must be monitored as signs and symptoms of opioid overdose may recur. In such cases, additional doses of Respinal may be given (see section 3).
If you are taking buprenorphine, be aware that Respinal may not eliminate your breathing problems and that an additional dose may be necessary.
Tell your doctor if you have nose injuries as this may affect the way Respinal works.

Children and young people

Do not use this medicine in children and adolescents.

Other medicines and Respinal

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

If you are taking or have been taking high-dose opioids or long-acting opioids, tell your doctor.

Respinal with alcohol

The effect of this medicine may be slower in patients with opioid and alcohol intoxication.

Pregnancy and breastfeeding

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 Respinal while you are pregnant or breastfeeding, your baby should be closely monitored.

Driving and using machines

As the effect of opioids may recur, you must not drive, use machines or engage in any other physically or mentally demanding activity for at least 24 hours after treatment with Respinal.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Respinal contains benzalkonium chloride

This medicine contains 0.02 mg benzalkonium chloride per nasal spray, equivalent to 0.2 mg/ml. Benzalkonium chloride may irritate and swell inside the nose, especially with prolonged use of the medicine.

How Respinal should be given

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults:

One spray (1.26 mg naloxone) intranasally (in the nose).
First aid should be given until medical personnel is in place. Place the patient in a stable lateral position. If no marked improvement is seen or if the condition worsens after the first treatment, an additional dose may be administered after 2-3 minutes.

If two doses of 1.26 mg naloxone do not significantly improve symptoms, it should be considered whether the symptoms may be due in whole or in part to factors or substances other than opioids.

Instructions for use

Check for symptoms and reactions.
- Check reactions to see if the person is conscious. You can shout the person’s name, shake your shoulders gently, speak loudly in your ear, rub your 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, e.g. no reaction to touch or sound, slow uneven breathing or no breathing, snoring, gasping for breath, or swallowing blue or purple fingernails or lips.
- Give Respinal if an overdose is suspected.
Place the patient on his back. Make sure the airways are clear. It is recommended to check and clear everything that blocks the nose before giving the nasal spray.
Open the inner package by first removing the rubber band and then pressing in the middle on the two flat sides of the plastic package to open it.

Do not charge or test the nasal spray before use. A Respinal nasal spray contains only one dose of naloxone.
Support your neck and tilt your head back. Insert the nozzle into one nostril. Press firmly on the plunger until it clicks to give a dose. Then remove the nozzle from the nostril.
Place the patient in a stable lateral position. 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.
If the patient does not get better, a second dose should be given in the second nostril after 2-3 minutes.

If you take more Respinal than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It can be difficult to know if a side effect is due to Respinal as it is always given after using opioids.

Possible side effects include

Very common (may affect more than 1 in 10 people)

nausea.

Common (may affect up to 1 in 10 people)

dizziness, headache
fast heartbeat
high or low blood pressure (you may have a headache or fainting)
vomiting.

Uncommon (may affect up to 1 in 100 people)

trembling, sweating
irregular heartbeats, slow heartbeats
diarrhea, dry mouth
rapid breathing
withdrawal symptoms such as restlessness or irritability, increased skin sensitivity, nausea, vomiting, stomach cramps, muscle cramps, discomfort or discomfort, difficulty sleeping, anxiety, sweating, goosebumps, rapid heartbeat, high blood pressure, yawning, and fever.

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, and severe flaky or scaly skin.

How to store Respinal

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 single-dose container, the protective plastic container, and the carton after EXP. The expiration date is the last day of the specified month.

Do not freeze. Store the single-dose containers in plastic protective packaging. Sensitive to light.

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 container contains 1.26 mg of naloxone (as hydrochloride dihydrate).
The other ingredients are povidone, glycerol, disodium edetate, benzalkonium chloride, citric acid monohydrate, sodium citrate, sodium hydroxide (for pH adjustment ), hydrochloric acid (for pH adjustment ), and water for injections.

What the medicine looks like and the contents of the pack

Respinal is a clear, colorless solution packaged in a glass bottle with a rubber stopper inside a polypropylene and stainless steel spray container. No further assembly of the unit is necessary.

Each pack contains 2 single-dose containers of nasal spray.

Marketing Authorisation Holder

DNE Pharma AS
Karihaugveien 22

1086 Oslo

Norway

Manufacturer

Pharma Production AS

Karihaugveien 22