PACKAGE LEAFLET: INFORMATION FOR THE USER

NALOXONE 400 microgram/ml solution for injection or infusion naloxone hydrochloride

Read all of this leaflet carefully before you start using this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What NALOXONE is and what it is used for

2.    Before you use NALOXONE

3.    How to use NALOXONE

4.    Possible side effects

5.    How to store NALOXONE

6.    Further information

1. WHAT NALOXONE IS AND WHAT IT IS USED FOR

NALOXONE is a drug used to counter the effects of opioid overdose, for example morphine overdose. NALOXONE is used for reversal of unwanted effects of opioids for countering life-threatening depression of the central nervous system and respiratory system (breathing difficulties).

NALOXONE is also used to diagnose an acute opioid overdose or intoxication.

2. BEFORE YOU USE NALOXONE

Do not use NALOXONE

if you are allergic (hypersensitive) to naloxone hydrochloride or any of the other ingredients of

NALOXONE.

Take special care with NALOXONE

-    if you are physically dependent to morphine or similar drugs or when you have received high doses of these drugs, you may develop withdrawal symptoms like high blood pressure, rapid heartbeat, serious respiratory problems or stop of the heartbeat.

-    if NALOXONE must be administered to your newborn baby, as acute withdrawal symptoms can occur.

-    if you have cardiovascular complaints (because side effects like high and low blood pressure, rapid heartbeat or serious respiratory problems probably can occur sooner).

-    if you take the analgesic drug buprenorphine. In that case naloxone is effective to a limited extend (see also the paragraph ‘’Taking other medicines”).

Please consult your doctor even if these statements were applicable to you at any time in the past.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines

obtained without a prescription.

Please note that these statements may also apply to products used some time ago or at some time in the

future.

-    If you use analgesics, such as buprenorphine, the analgesic effects can be increased when you are treated with NALOXONE.

-    An administration of NALOXONE in coma as a consequence of clonidine-overdose, serious high blood pressure has been reported. Clonidine is a medicine used in withdrawal symptoms occurring after stopping opioides. It is also administered in high blood pressure, migraine and menopausal flushes.

Using NALOXONE with food and drink

Please inform your doctor if you drank alcohol. In patients with multiple intoxication (with opioids and sedatives or alcohol) NALOXONE onset of effect can be less rapid.

Pregnancy

There are no adequate data available on the use of NALOXONE in pregnant women. During pregnancy, your doctor will outweigh the benefits of the use of NALOXONE against the possible risks for the unborn baby. NALOXONE can cause withdrawal symptoms in the baby (see paragraph Take special care with...).

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

It is not known whether NALOXONE passes into breast milk and it has not been established whether infants who are breast-fed are affected by NALOXONE. Therefore, breast-feeding is not recommended for 24 hours after treatment.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

After receiving NALOXONE for the reversal of the effects of opioids you must not take part in road traffic, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours since the effects of opioids may possibly recur.

Important information about some of the ingredients of NALOXONE

This medicinal product contains 17.7 mg sodium per 2 mg dose (5 ml) of naloxone hydrochloride. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO USE NALOXONE Dose

Your doctor will determine the right dose.

Adults

•    Overdose of opioides: 400 microgram. If needed, the dose can be repeated at 2-3 minute intervals.

•    Reducing the effect of opioides used in anaesthesia for an operation: 100-200 microgram at 2-3 minute intervals.

Children and adolescents

•    Overdose of opioides: 10-20 microgram/kg body weight. If needed, the dose can be repeated at 2-3 minute intervals.

Neonates

•    Decreased respiration caused by opioides: 10 microgram/kg body weight. If needed, the dose can be repeated at 2-3 minute intervals.

Elderly

In elderly patients with heart diseases NALOXONE must be used with caution.

Method of administration

NALOXONE is administered as an injection. It is injected into a vein (=intravenous) or into a muscle (=intramuscular) by a doctor or a nurse.

It also can be given as intravenous infusion after dilution with sodium chloride 0.9% or glucose 5%. Duration of treatment

Your doctor will determine the duration of treatment.

If you have the impression that the effect of NALOXONE is too strong or too weak, talk to your doctor or pharmacist.

If you use more NALOXONE than you should

If you may have received more NALOXONE than you should, talk to your doctor or nurse immediately. He/she will take further measures, if necessary.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

The possible side effects are ranked according to their frequency:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

The following side effects may appear:

Very common: sickness, feeling of being sick

Common: dizziness, headache, rapid heartbeat, low blood pressure, high blood pressure, vomiting, postoperative pain

Uncommon: shiver, sweating, heart rhythm disturbance, slow heartbeat, diarrhoea, dry mouth, rapid and deep breathing (hyperventilation), irritation of vessel wall (after intravenous administration)

Rare: fits, tension

Very rare: rapid and irregular heartbeat, stop of heartbeat, fluid accumulation in the lungs, allergic reactions (urticaria, rhinitis, respiratory difficulties, anaphylactic shock)

When NALOXONE is administered to persons addicted to morphine or similar drugs, acute withdrawal symptoms can occur (for example high blood pressure and heart symptoms). This can also occur in babies of opioid-dependent mothers.

If a too large dose is given after an operation, you may become excited and feel pain (because the painkilling effects of the medicines you were given will have been counteracted as well as the effects on your breathing).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE NALOXONE

Keep out of reach and sight of children.

Do not use NALOXONE after the expiry date which is stated on the carton and ampoule after “exp”. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the ampoules in the outer carton in order to protect from light.

After first opening the medicinal product must be used immediately.

After dilution, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place under controlled and validated aseptic conditions.

This medicinal product is for single use only. Discard any unused solution.

Do not use NALOXONE if you notice a discolouration, cloudiness or particles in the solution.

For i.v. infusion, NALOXONE 0.4 mg/ml is diluted with sodium chloride 0.9% w/v or glucose 5% w/v.

5 ampoules of NALOXONE 0.4 mg/ml (2 mg) diluted to 500 ml give a final concentration of 4 microgram/ml.

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.

6. FURTHER INFORMATION What NALOXONE contains

The active substance is naloxone hydrochloride.

Each ampoule of 1 ml of solution for injection or solution contains 400 microgram/ml naloxone hydrochloride (as naloxone hydrochloride dihydrate).

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

What NALOXONE looks like and contents of the pack

NALOXONE is a clear and colourless solution for injection or solution.

NALOXONE is available in packs with 10 ampoules of 1 ml solution of injection or solution.

Marketing Authorisation Holder Orpha-Devel Handels und Vertriebs GmbH 3002 Purkersdorf, Austria

Manufacturer

Hikma Italia S.p.A.

27100 Pavia, Italy

G.L. Pharma GmbH A-1160 Vienna, Austria

Amomed Pharma GmbH A-1050 Vienna, Austria

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

Bulgaria, NEXODAL 0,4 mg/ml HH^e^HOHeH pa3TBop hot HH$y3HH

Czechia, NEXODAL 0,4 mg/ml injekcni roztok nebo infuzniho roztoku

Denmark, NEXODAL 0,4 mg/ml injektions-/infusionsv$ske, oplosning

Estonia, NEXODAL 0,4 mg/ml suste-/infusioonilahus

France, ANOPIDAL 0,4 mg/ml solution injectable ou pour perfusion

Finland, NEXODAL 0,4 mg/ml injektioneste, liuos tai infuusio

Germany, NEXODAL 0,4 mg/ml Injektionslosung oder Infusionslosung

Greece, Naloxon Orpha 0,4 mg/ml svsorpo Sra^upa ^ sy%uan

Hungary, NEXODAL 0,4 mg/ml oldatos injekcio vagy infuzio

Ireland, NALOXONE 400 microgram/ml solution for injection or infusion

Italy, NEXODAL 0,4 mg/ml soluzione iniettabile o per infusione

Latvia, NEXODAL 0,4 mg/ml injekcinis tirpalas vai infuzijam

Lithuania, NEXODAL 0,4 mg/ml injekcinis/infuzinis tirpalas

Luxembourg, NEXODAL 0,4 mg/ml Injektionslosung oder Infusionslosung

Netherlands, Naloxon Orpha 0,4 mg/ml oplossing voor injectie of infusie

Norway, NEXODAL 0,4 mg/ml injeksjons-/infusjonsv$ske, opplosning

Poland, NEXODAL 0,4 mg/ml roztwor do wstrzykiwan lub infuzji

Romania, NEXODAL 0,4 mg/ml solufie injectabila sau perfuzabila

Slovenia, NEXODAL 0,4 mg/ml raztopina za injiciranje ali infundiranje

Sweden, NEXODAL 0,4 mg/ml injektionsvatska, losning eller infusion

United Kingdom, NALOXONE 400 microgram/ml solution for injection or infusion

This leaflet was last approved in 06/2014

6