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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _w hameln

Read all of this leaflet carefully before this medicine is administered to you.

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

Naloxone 400 micrograms/ml solution for injection/infusion

- naloxone hydrochloride -

In this leaflet:

1. What Naloxone 400 micrograms/ml solution for injection/infusion is and what it is used for

2.    Before Naloxone 400 micrograms/ml solution for injection/infusion is administered to you

3. How Naloxone 400 micrograms/ml solution for injection/infusion is administered

4.    Possible side effects

5.    How to store Naloxone 400 micrograms/ml solution for injection/infusion

6.    Further information

1.    WHAT NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION/INFUSION IS AND WHAT IT IS USED FOR

Naloxone 400 micrograms/ml solution for injection/ infusion is a drug used to counter the effects of opioid overdose, for example morphine overdose.

Naloxone 400 micrograms/ml solution for injection/ infusion 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 400 micrograms/ml solution for injection/ infusion is also used to diagnose an acute opioid overdose or intoxication.

If a woman has been given analgesic drugs during labour, a newborn child can be treated with Naloxone 400 micrograms/ml solution for injection/infusion for reversal of unwanted effects of opioids, e.g. if he/she suffers from breathing problems or depression of the central nervous system.

2.    BEFORE NALOXONE 400 MICROGRAMS/ ML SOLUTION FOR INJECTION/INFUSION IS ADMINISTERED TO YOU

Naloxone 400 micrograms/ml solution for injection/ infusion must not be administered

-    If you are allergic (hypersensitive) to naloxone hydrochloride or to any of the ingredients of this medicinal product.

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).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken 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

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The following information is intended for medical or healthcare professionals only:

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.

Using Naloxone 400 micrograms/ml solution for injection/infusion with food and drink

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.

Pregnancy and breast-feeding

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/infusion for injection 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. Ask your doctor for advice before taking any medicine.

Driving and using machines

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.

Important information about some of the ingredients of Naloxone 400 micrograms/ml solution for injection/infusion

This medicinal product contains 3.8 mmol (88.5 mg) sodium per maximum daily dose. Please tell your doctor, if you are on a low sodium diet, he/she will take it into account.

3. HOW NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION/INFUSION IS ADMINISTERED

The usual doses given to you are

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 an additional injection of 0.1 mg per kg may be given

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.

w hameln

Naloxone 400 micrograms/ml solution for injection/infusion

Shelf-life after first opening

After first opening the medicinal product should be used immediately.

Shelf-life after dilution

Chemical and physical in-use stability has been demonstrated for 24 hours below 25°C.

From the microbiological point of view, the dilutions 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 in controlled and validated aseptic conditions.

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.

Method of administration

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Naloxone 400 micrograms/ml solution for injection/infusion can cause side effects, although not everybody gets them.

The frequency of side effects is classified into the following categories:

It may be difficult to know what side effects Naloxone 400 micrograms/ml solution for injection/infusion has, because it is always given after other drugs have also been used.

Immune system disorders

Very rare:    Allergic reactions (nettle rash, nasal

catarrh or a cold, difficulty breathing, Quincke’s oedema (facial swelling)), allergic shock.

Nervous system disorders Common:    Dizziness, headache.

Uncommon:    Involuntary trembling or quivering

(tremour), sweating.

Rare:    Seizures, tension.

Cardiac disorders

Common:    Fast heart beat.

Uncommon:    Changes in the way your heart beats,

slow heart rate.

Very rare:    Fibrillation, cardiac arrest.

Vascular disorders

Common:    Increased or decreased blood

pressure (you may have a headache or feel faint).

Respiratory disorders

Very rare:    Fluid on the lungs (pulmonary

oedema).

Gastrointestinal disorders Very common:    Nausea.

Common:    Vomiting.

Uncommon:    Diarrhoea, dry mouth.

Skin and subcutaneous tissue disorders Very rare:    Discolouration and lesions of the skin

(erythema multiforme).

General disorders and administration site conditions Common:    If too large a 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

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For i.v. infusion Naloxone 400 micrograms/ml solution for injection/infusion is diluted only with sodium chloride 0.9% or glucose 5%. 5 ampoules of Naloxone 400 micrograms/ml solution for injection/infusion (2 mg) per 500 ml give 4 pg/ml.

It is recommended that infusions of Naloxone 400 micrograms/ml solution for injection/infusion should not be mixed with preparations containing bisulphite, metabisulphite, long-chain or high-molecular-weight anions, or solutions with an alkaline pH.

well as the effects on your breathing). Uncommon:    Over breathing (hyperventilation),

irritation of the blood vessel wall has been reported after i.v. administration; local irritation and inflammation have been reported after i.m. administration.

Reporting of side effects

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: www.mhra.gov. uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE NALOXONE 400 MICROGRAMS/ ML SOLUTION FOR INJECTION/INFUSION

Keep out of the reach and sight of children.

Naloxone 400 micrograms/ml solution for injection/ infusion must not be administered after the expiry date, which is stated on the ampoule label and the carton. The expiry date refers to the last day of that month.

Keep the ampoules in the outer carton in order to protect from light.

Store below 25°C.

Store diluted solutions below 25°C.

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 400 micrograms/ml solution for injection/infusion contains

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.

What Naloxone 400 micrograms/ml solution for injection/infusion looks like and contents of the pack

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 and manufacturer

Marketing authorisation holder

hameln pharma plus gmbh

Langes Feld 13, 31789 Hameln, Germany

Manufacturer

hameln pharmaceuticals gmbh

Langes Feld 13, 31789 Hameln, Germany

This medicinal product is authorised in the Member

States of the EEA under the following names:

xxxxx/29/14

This medicinal product is for single use only.

Please inspect the medicinal product visually prior to use (also after dilution). Use only clear and colourless solutions practically free from particles.

xxxxx/29/14