Prenoxad 1mg/ml Solution for Injection in a pre-filled syringe

• If you have any further questions, please ask your doctor, pharmacist or nurse
• 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.

1. What Prenoxad Injection is and what it is used for
2. What you need to know before Prenoxad Injection is administered to you
3. How Prenoxad Injection will be given
4. Possible side effects
5. How to store Prenoxad Injection
6. Contents of the Pack and other information

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

Before giving you Prenoxad Injection your prescribing doctor as per local clinical guidance and the trained individual will have undergone training to use Prenoxad Injection and may have considered whether special care needs to be taken if:

• you have taken or been given a large dose of opioid drugs or if you have a drug-dependence (drug addiction) problem
• you have kidney or liver problems
• you have heart or circulation problems
• Prenoxad is not effective in product overdoses other than opioids
• you suffer from high blood pressure, irregular heart beat or difficulty in breathing suffer from high blood pressure, irregular heart beat or difficulty in breathing.

If you have any of these problems you should make your doctor or trained individual aware.

If you are able, you must tell your doctor or the trained individual administering Prenoxad Injection if you are taking or have recently taken any medicines, including those obtained without a prescription.

A number of medicines can interact with Naloxone Injection which can significantly alter their effects. In particular, tell your doctor if you are taking

• Strong pain killer medicines like buprenorphine and pentazocine.
• Sleeping pills
• Medicines that may affect your heart or blood circulation (e.g. antihypertensive drugs, cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, betablockers, digoxin and clonidine) even those not prescribed

Prenoxad Injection should not be used if you are pregnant or breast-feeding unless it is absolutely essential.

The potential risk for humans is unknown.

IF THE PATIENT IS BREATHING NORMALLY BUT IS UNROUSABLE OR UNCONSCIOUS:

1 Move the patient into the recovery position, lying on their side, mouth open and pointing towards the ground.

2 Give one dose (0.4 ml) of Prenoxad (to first black line) into the outer thigh or upper arm muscle (through clothing if necessary). Leave the needle attached to the syringe and place on the retaining cradle in box.

3 Call 999 and ask for an ambulance.

4 Give further intramuscular injections of 0.4ml Prenoxad Injection (to next black line) into the outer thigh or upper arm muscle (through clothing if necessary) every 2–3 minutes using the same needle until the ambulance arrives or the patient regains consciousness.

IF THE PATIENT DOES NOT APPEAR TO BE BREATHING NORMALLY:

1 Call 999 immediately and ask for an ambulance.

2 Give basic life support by giving the patient 30 chest compressions and 2 rescue breaths if possible.

3 Give one dose (0.4 ml) of Prenoxad (to first or next black line) into the outer thigh or upper arm muscle (through clothing if necessary) if the patient is still not breathing. Leave the needle attached to the syringe and place on the retaining cradle in box

4 Give 3 cycles of 30 chest compressions and 2 rescue breaths if the patient is still not breathing.

5 Repeat steps 3 and 4 until the ambulance arrives or the patient is breathing normally.

When the patient is breathing normally or has gained consciousness move them to the recovery position (lying on their side, mouth open and pointing towards the ground). Watch continuously.

Breast-feeding should be avoided in the first 24 hours after treatment with Prenoxad Injection.

Naloxone Hydrochloride Injection must be used with caution in breast feeding mothers.

This medicine can affect your ability to drive and operate machinery. Do not drive, operate machinery or engage in other activities demanding physical or mental exertion for at least 24 hours if you feel drowsy or cannot think clearly.

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium- free’.

Known or suspected opioid overdose:

Prenoxad Injection should only be given where it is known or suspected that an opioid overdose has occurred.

The following procedure should be followed:

See overleaf for diagrams to help the person give the injections.

If medical assistance has not arrived after you have used up the contents of one syringe and you have a second syringe available then this may be used using the same procedure as with the first. Use of the second syringe in the same way as the first does not present a safety hazard.

Prenoxad Injection is for single patient use only and any unused injection solution should be discarded as instructed in section 5.

This product must not be used by children under the age of 16 years and neonates in the home or non-medical setting.

If your child is given or has taken an opioid overdose, you should call an ambulance straight away and start giving chest compressions with rescue breaths if necessary.

If you think you have been given too much or too little tell your doctor or the ambulance crew at the scene of the overdose. The following symptoms have been observed if too much Prenoxad has been given:

Seizure, decrease or increase blood pressure, decrease heart rate and memory impairment.

Very common (may affect more than 1 in 10 people): feeling sick.

Common (may affect up to 1 in 10 people): dizziness, headache, faster beating of the heart, decreased or increased blood pressure, vomiting or pain.

Uncommon (may affect up to 1 in 100 people): tremor, sweating, over breathing (hyperventilation), irregular heartbeat, decreased heart rate, diarrhoea, dry mouth, local irritation, inflammation, faster or deeper breathing.

Rare (may affect up to 1 in 1,000 people): fits (seizure), tension.

Very rare (may affect up to 1 in 10,000 people): Severe problems with the heart (Fibrillation and cardiac arrest),fluid in the lungs,discolouration and lesions of the skin,allergic reactions (urticaria, rhinitis, dyspnoea, Quincke’s oedema), anaphylactic shock.

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 www.mhra.gov.uk/yellowcard 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.

The active substance is Naloxone Hydrochloride 1mg per ml.

The other ingredients are Sodium Chloride, Water for Injection and Dilute Hydrochloric Acid.

The injection is supplied in a 2ml prefilled syringe containing 2ml of a clear, colourless solution together with two needles. The syringe and needles are contained in a yellow box.