PACKAGE LEAFLET: INFORMATION FOR THE USER    D00279

Naloxone Hydrochloride Injection 1mg/ml

Naloxone Hydrochloride

Because of your condition it may not be possible for you to read this leaflet before you are given Naloxone Hydrochloride Injection. The leaflet has been provided to you to give some information that you should have. You may wish to read it later.

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

•    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse

In this leaflet:

1.    What Naloxone Hydrochloride Injection is and what it is used for

2.    Before Naloxone Hydrochloride Injection is given

3.    How Naloxone Hydrochloride Injection will be given

4.    Possible side effects

5.    Storing Naloxone Hydrochloride Injection

6.    Further information

1.    What Naloxone Hydrochloride Injection is and what it is used for.

Naloxone belongs to a group of medicines that reverse the action of opioid drugs e.g. morphine.

This medicine is used to:

•    reverse the action of opioid drugs e.g. if you have been given or taken an overdose of these drugs.

•    reverse the action of opioids given during surgery.

•    allow a newborn baby to breathe following birth if opioids have been given to the mother during childbirth.

2.    Before Naloxone Hydrochloride Injection is given

This medicine is often used in circumstances where the doctor may need to act very rapidly. You will not be given this medicine unless your doctor feels it is absolutely necessary.

You should not be given Naloxone Hydrochloride Injection if:

•    you know you are allergic (hypersensitive) to Naloxone Hydrochloride or to any other ingredients in this medicine, listed in section 6 of this leaflet.

Your doctor will take special care with Naloxone Hydrochloride Injection if:

•    you have taken or been given a large dose of opioid drugs

•    you have kidney or liver problems

•    you have heart problems

If you have taken or been given a dose of opioid drugs and have just given birth, your doctor will take special care in giving naloxone to your baby.

Your doctor will be able to advise you on your particular situation. Taking other medicines

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

Pregnancy and breast-feeding

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

Driving or using machines

Please speak to your doctor before driving or using machines.

3.    How Naloxone Hydrochloride Injection will be given

The doctor or nurse will administer the injection slowly into a vein (intravenously by injection or as a drip), into a muscle (intramuscularly), or under the skin (subcutaneously). The dose depends on individual needs and responses to the treatment.

Adults

Known or suspected opioid overdose:

An initial dose of Naloxone Hydrochloride Injection will be given intravenously. If there is no improvement in your condition you may receive further doses at 2 to 3 minute intervals. If the injection cannot be given into a vein, then it may be given in the muscle or under the skin.

Following surgery:

The dose will be adjusted to your individual needs to ensure you can breathe comfortably while maintaining adequate pain relief. Usually the initial dose will be given intravenously followed by further injections into the muscle if required.

Children and newborns

The dose will be adjusted to the child or baby's needs. The injection may be given into a vein, muscle or under the skin. Additional doses may be given at different intervals.

You or your child will be closely monitored during treatment.

If you are given more or less Naloxone Hydrochloride Injection than you should have

This medicine will be given to you in hospital and it is unlikely that you will be given too little or too much. However, tell your doctor if you have any concerns.

4.    Possible side effects

Like all medicines Naloxone Hydrochloride Injection can cause side effects, although not everybody gets them.

Possible side effects include:

•    feeling or being sick

•    sweating

•    a change in heart rate or irregular heartbeat (fibrillation)

•    increased blood pressure

•    shaking

•    fits

•    fluid collecting in the lungs

•    heart attack

When used after an operation Naloxone Hydrochloride Injection could cause:

•    low or high blood pressure

•    a change in heart rate or irregular heartbeat (fibrillation)

•    difficulty in breathing

•    fluid collecting in the lungs

•    heart attack

•    agitation

If you have an opioid addiction when given Naloxone Hydrochloride Injection you could experience symptoms of withdrawal which include:

•    body aches

•    fever

•    sweating

•    runny nose and sneezing

•    goose-bumps

•    yawning

•    weakness

•    shivering or shaking

•    feeling nervous, irritable or restless

•    feeling or being sick

•    diarrhoea

•    stomach cramps

•    high blood pressure and rapid heartbeat

In some circumstances, the baby of a mother who is dependent on opioids may also be opioid dependent. In newborn babies with opioid dependence Naloxone Hydrochloride Injection may cause:

•    fits

•    crying

•    jerking or twitching movements (hyperactive reflexes)

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

5.    Storing Naloxone Hydrochloride Injection

Keep out of the reach and sight of children.

You should not be given Naloxone Hydrochloride Injection after the expiry date which is printed on the box. The doctor or nurse will check the expiry date on the label before administering the injection to you.

Store in the original box to protect from light.

Do not store above 25°C.

6.    Further Information

What Naloxone Hydrochloride Injection contains.

The active ingredient is Naloxone Hydrochloride 1mg per ml.

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

What Naloxone Hydrochloride Injection looks like and contents of the pack.

The injection is supplied in a 2ml prefilled syringe containing 1ml of a clear, colourless solution. The syringe is contained in a box.

Marketing Authorisation Holder:

Aurum Pharmaceutical Ltd Bampton Road Harold Hill Romford, RM3 8UG United Kingdom

Manufacturer:

Martindale Pharmaceuticals Ltd.

Bampton Road Romford, RM3 8UG United Kingdom

Product Licence Number:    PL 12064/0060

Date of last revision:    03/2009

Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom

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