Skip to Content

UK Edition. Click here for US version.

NALOXONE HYDROCHLORIDE INJECTION 1MG/ML

Active substance(s): NALOXONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
2.
3.
4.
5.
6.

What Naloxone Hydrochloride Injection is and what it is used for
Before Naloxone Hydrochloride Injection is given
How Naloxone Hydrochloride Injection will be given
Possible side effects
Storing Naloxone Hydrochloride Injection
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.

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)

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 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

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.

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.

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

Store in the original box to protect from light.

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.

Do not store above 25°C.

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.

5. Storing Naloxone Hydrochloride Injection
Keep out of the reach and sight of children.

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:
Date of last revision:

PL 12064/0060
03/2009

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.
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.

D00279

You or your child will be closely monitored during treatment.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide