Naloxone 400 micrograms/ml solution for Injection/Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Naloxone 400 micrograms/ml solution for injection/infusion is and what it is used for
2. What you need to know before Naloxone 400 micrograms/ml solution for injection/infusion is administered to you
3. How to administer Naloxone 400 micrograms/ml solution for injection/infusion
4. Possible side effects
5. How to store Naloxone 400 micrograms/ml solution for injection/infusion
6. Contents of the pack and other information

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

Talk to your doctor or pharmacist before Naloxone 400 micrograms/ml solution for injection/infusion is administered to you.

Take special care with Naloxone 400 micrograms/ml solution for injection/infusion and tell your doctor

• If you are physically dependent on opioids (for example morphine) or have received high doses of these drugs (you may get strong withdrawal symptoms after receiving Naloxone 400 micrograms/ml solution for injection/infusion because of a rapid reversal of the opioid effect; these symptoms may be high blood pressure, palpitations, severe difficulties in breathing or cardiac arrest).
• If you have any heart or circulation problems (because side effects like high or low blood pressure, palpitations or severe difficulties in breathing may appear more likely).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

• If you are taking painkilling medication like buprenorphine. The painkilling effect may even become stronger while you are treated with Naloxone 400 micrograms/ml solution for injection/infusion. However, the reversal of unwanted effects, like respiratory depression caused by buprenorphine is limited.
• If you are taking sedatives, as Naloxone 400 micrograms/ml solution for injection/infusion may possibly have a less rapid effect.
• If you are taking any medication that may affect your heart or circulation (e.g. antihypertensive drugs e.g. clonidine), even those not prescribed.

Please inform your doctor if you drank alcohol. In patients with multi-intoxication (with opioids and sedatives or alcohol) Naloxone 400 micrograms/ml solution for injection/infusion may have a less rapid effect.

There is no sufficient information available regarding the use of Naloxone 400 micrograms/ml solution for injection/infusion in pregnant women. During pregnancy, your doctor will assess the benefit of Naloxone 400 micrograms/ml solution for injection/infusion against possible risks to the embryo or to the foetus.

It is not known whether Naloxone 400 micrograms/ml solution for injection/infusion passes into breast milk and it has not been established whether infants who are breast-fed are affected by Naloxone 400 micrograms/ml solution for injection/infusion. Therefore, breast-feeding should be avoided for 24 hours after treatment.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

After receiving Naloxone 400 micrograms/ml solution for injection/infusion for the reversal of the effects of opioids you must not drive a vehicle, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours as the effects of opioids may possibly recur.

This medicine contains 3.54 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.2% of the recommended maximum daily dietary intake of sodium for an adult.

Reversal of the unwanted effects of opioids

Adults: 0.1 - 0.2 mg, if necessary additional injections of 0.1 mg may be given

Children: 0.01 - 0.02 mg per kg body weight, if necessary additional injections of the same dose may be given

Diagnosis of opioid overdose or intoxication

Adults: 0.4 - 2 mg, if necessary the injections can be repeated at intervals of 2 - 3 minutes. The maximum dose of 10 mg should not be exceeded.

Children: 0.01 mg per kg body weight, if necessary the dose can be increased in the next injection to 0.1 mg per kg.

Reversal of the unwanted effects of opioids in neonates whose mothers have received opioids

0.01 mg per kg body weight, if necessary additional injections may be given.

For reversal of the unwanted effects of opioids (in adults, children and also in neonates) patients are monitored to ensure that the desired effect of Naloxone 400 micrograms/ml solution for injection/infusion occurs.

Additional doses may be given every 1-2 hours if necessary.

In elderly patients with heart or circulation problems or in those receiving medicines that can produce heart or circulation disorders (e.g. cocaine, methamphetamine, tricyclic antidepressants, calcium channel blockers, beta-blockers, digoxin) Naloxone 400 micrograms/ml solution for injection/infusion will be used with caution since serious side effects such as fast heart beats (ventricular tachycardia and fibrillation) have occurred.

If you have the impression that the effect of Naloxone 400 micrograms/ml solution for injection/infusion is too strong or too weak, talk to your doctor.

Naloxone 400 micrograms/ml solution for injection/infusion will be given to you always by intravenous or intramuscular injection (into a vein or into a muscle) or, after dilution, as an intravenous infusion (over a longer period). Naloxone 400 micrograms/ml solution for injection/infusion will be given by your anaesthetist or an experienced physician.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at Website: 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.

Each 1 ml ampoule contains 0.4 mg naloxone hydrochloride (as naloxone hydrochloride dihydrate).

The other ingredients are sodium chloride, hydrochloric acid diluted (for pH adjustment) and water for injections.

Naloxone 400 micrograms/ml solution for injection/infusion is a clear and colourless solution in colourless glass ampoules containing 1 ml solution for injection/infusion.

Pack sizes: 5 and 10 ampoules

Not all pack sizes may be marketed.

Marketing authorisation holder:

Manufacturer:

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark Naloxon Hameln 0,4 mg/ml injektions-/infusionsvæske, opløsning

Germany Naloxon-hameln 0,4 mg/ml Injektions-/Infusionslösung

Norway Naloxon Hameln 0,4 mg/ml injeksjons-/infusjonsvæske, oppløsning

Sweden Naloxon Hameln 0,4 mg/ml injektions-/infusionsvätska, lösning

The Netherlands Naloxon HCl-hameln 0,4 mg/ml, oplossing voor injectie/infusie

United Kingdom Naloxone 400 micrograms/ml solution for injection/infusion