VENTIZOLVE 1.26 MG NASAL SPRAY SOLUTION IN SINGLE-DOSE CONTAINER - patient leaflet, side effects, dosage

Package leaflet: Information for the user

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.

What is in this leaflet

• 1. What Ventizolve is and what it is used for

• 2. What you need to know before you receive Ventizolve

• 3. How to give Ventizolve

• 4. Possible side effects

• 5. How to store Ventizolve

• 6. Contents of the pack and other information

1. what ventizolve is and what it is used for

Ventizolve contains the active ingredient naloxone which is an opioid antidote. This medicine is used to reverse the effect of known or suspected opioid overdose in adults (e.g. morphine, heroin, methadone, fentanyl, oxycodone or buprenorphine).

Ventizolve is a nasal spray used for the emergency treatment of opioid overdose or possible opioid overdose in adults. Signs of overdose include:

• breathing problems
• severe sleepiness
• not responding to a loud noise or touch.

If you are at risk of an opioid overdose you should always carry your Ventizolve with you.

Ventizolve works for a short time only to reverse the effects of opioids while you wait for emergency medical attention. It is not a substitute for emergency medical care.

Always tell your friends and family that you carry Ventizolve with you.

2. what you need to know before you receive ventizolve-     if you are allergic to naloxone or any of the other ingredients of this medicine (listed in section

• 6).

Warnings and precautions

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

Ventizolve is to be given right away and does not take the place of standard emergency medical care. Call for emergency medical help right away, even if the person wakes up. CALL 999 or 112.

• - One nasal spray of Ventizolve contains only one dose of naloxone. It is important that the nasal spray is not primed or tested prior to use, as this will empty the nasal spray and you will not receive the medicine you need. Use a second Ventizolve nasal spray, if additional doses are required. Additional doses can be given after 2 to 3 minutes after the initial dose(s) (see section 3).

• - Symptoms of acute withdrawal syndrome: It is possible that Ventizolve can lead to a too rapid reversal of the opioid effect which may cause an acute withdrawal syndrome in persons who are physically dependent on opioids. Symptoms of acute withdrawal syndrome can be fast heart rate, high blood pressure, body aches and stomach cramps, diarrhoea, nausea, vomiting, sweating, fever, goose bumps, shivering or trembling, changes in behaviour including violent behaviour, nervousness, anxiety, excitement, restlessness or irritability, unpleasant or uncomfortable mood, increased skin sensitivity, difficulty in sleeping. If you are taking opioids for the relief of chronic pain, you may also experience increased pain when you receive Ventizolve.

• - The duration of effect of some opioids may exceed that of Ventizolve. Even if an initial response is observed, it is important that patients are kept under observation, as the signs and symptoms of opioid overdose may come back. In this case additional doses of Ventizolve can be administered (see section 3).

• - If you use buprenorphine , be aware that Ventizolve may not fully reverse breathing problems and an additional dose may be required.

• - Tell your doctor if you have damage to the inside of your nose as this could affect how Ventizolve works.

Children and adolescents

Do not use this medicine in children and adolescents.

Other medicines and Ventizolve

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

If you are using or have used high doses of opioids or long acting opioids, tell your doctor.

Ventizolve with alcohol

The onset of effect of this medicine may be slower in patients with intoxication caused by opioids and alcohol.

Pregnancy and breast-feeding

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 obtaining this medicine. If you are given Ventizolve while you are pregnant or breast-feeding, your baby should be closely monitored.

Driving and using machines

As the effect of opioids may return, do not drive or use machines, or perform physically or mentally challenging tasks for at least 24 hours after treatment with Ventizolve.

Ventizolve contains benzalkonium chloride

This medicine contains 0.02 mg benzalkonium chloride in each nasal spray, which is equivalent to 0.2 mg/ml. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to give Ventizolve

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults:

One spray (1.26 mg naloxone) given intranasally (into the nose).

First aid should be given until healthcare professionals (HCP) are on the site. Place the patient into recovery position. If no significant clinical effect is achieved or the condition worsens following initial treatment, one additional dose may be administered after 2–3 minutes.

If two doses of 1.26 mg naloxone do not result in a significant improvement in symptoms, it should be considered that the symptoms may be caused completely or partially by other factors or substances than opioids.

Instructions for Use

- Check for a response, to see if the person is conscious. You can shout their name, gently shake their shoulders, talk loudly into their ears, rub their breastbone (sternum), pinch their ear or the bed of their fingernail.

• - Check airways and breathing. Clear the mouth and nose of any blockages. For 10 seconds check for breathing – is the chest moving? Can you hear breathing sounds? Can you feel breath on the cheek?

• - Check for signs of overdose , such as: no response to touch or sounds, slow uneven breathing or no breathing, snoring, gasping or gulping, blue or purple fingernails or lips.

• - If an overdose is suspected Ventizolve should be given.

• 2. Call emergency medical services. CALL national rescue number 999 or 112.

• 3. Place the patient on his/her back. Ensure free airways. It is recommended to inspect and clear the nasal airway before giving the nasal spray.

• 4. Open the inner packaging by first removing the rubber band, then pressing at the centre of both flat sides of the plastic pebble to open.

Do not prime or test the nasal spray prior to use. One nasal spray of Ventizolve contains only one dose of naloxone.

• 5. Support the back of the neck to allow the head to tilt back. Insert the spray nozzle into one nostril. Press firmly on the plunger until it clicks to give the dose, then remove the nasal spray from the nostril.

• 6. Place the patient into recovery position. Stay with the patient until the emergency services arrive. Watch for an improvement in the patient’s breathing level, alertness and response to noise and touch.

• 7. If there is no improvement, a second dose should be given after 2–3 minutes in the other nostril.

4. 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 use of Ventizolve as it is always given after use of opioids.

Possible side effects include

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

• – feeling sick

Common (may affect up to 1 in 10 people):

• – dizziness, headache

• – fast heart beat

• – increased or lowered blood pressure (you may experience headache or a sensation of fainting)

• – being sick (vomiting)

Uncommon (may affect up to 1 in 100 people):

• – tremor, sweating

• – irregular heart beat, slow heart beat

• – diarrhoea, dry mouth

• – rapid breathing

• – withdrawal symptoms such as restlessness or irritability, increase of skin sensitivity, feeling sick, vomiting, stomach cramps, muscle cramps, unpleasant or uncomfortable mood, difficulty in sleeping, anxiety, sweating, goose bumps, fast heartbeat rate, 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

• – build-up of fluid in the lungs

• – skin problems such as itching, rash, redness, swelling, severe flaking or peeling of the skin

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store ventizolve

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, plastic cover and carton after EXP. The expiry date refers to the last day of that month.

Do not freeze. Keep the single-dose containers in the plastic cover in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

– The active substance is naloxone. Each nasal spray container delivers 1.26 mg of naloxone (as

hydrochloride dihydrate)

• – The other excipients are povidone, glycerol, disodium edetate, benzalkonium chloride, citric

What Ventizolve looks like and contents of the pack

Ventizolve is a clear, colourless solution packed in a glass vial with a rubber stopper inside a spray device comprised of polypropylene and stainless steel. No further device assembly is required.

Each pack contains 2 single-dose nasal spray containers.

Marketing Authorisation Holder

dne pharma as

Karihaugveien 22

NO-1086 OSLO

NORWAY

Manufacturer

Pharma Production AS

Karihaugveien 22

NO-1086 OSLO

NORWAY

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

Accord-UK Ltd

Tel: +44 (0)1271 385257

This leaflet was last revised in August 2021.

The following information is intended for bystanders only:

Place the patient on his/ her back. Clear nose and mouth.

Do not prime or test the nasal spray.

Support the back of the neck. Insert the spray nozzle into one nostril. Press the plunger firmly until it clicks.

Place the patient into recovery position. Stay with the patient until the emergency services arrive. After 2–3 minutes, if the patient does not improve, give a second nasal spray in the other nostril.