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NALOXONE HYDROCHLORIDE MINIJET 400 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): NALOXONE HYDROCHLORIDE ANHYDROUS

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Patient Information Leaflet: Naloxone Hydrochloride Injection Minijet,
400 micrograms/ml solution for injection naloxone hydrochloride

Patient Information Leaflet: Naloxone
Hydrochloride Minijet,
400 micrograms/ml solution for injection
naloxone hydrochloride
Read all of this leaflet carefully before you
are given this medicine.
• Keep this leaflet. You may need to read it
again
• If you have any fur ther questions, ask your
doctor or nurse
In this leaflet, Naloxone Hydrochloride Minijet 400 micrograms/ml solution for injection
will be called Naloxone.
In this leaflet:
1. What Naloxone is for
2. Before you are given Naloxone
3. How Naloxone will be given to you
4. Possible side effects
5. How to store Naloxone
6. Further information.

1. What Naloxone is for
Naloxone belongs to a group of medicines
called “opioid antagonists.” It counteracts strong
painkillers (opiates).
Naloxone is used to restore the body’s
breathing if it has been affected by strong
painkillers (usually opioids such as morphine,
heroin, methadone etc.) which may have been
given during an operation for example.
It is also used for the same reason af ter an
overdose of these drugs has been taken, or
when an overdose of opioids is suspected.
As Naloxone is only used in medical emergencies,
the injection will be given by a doctor or nurse
in a hospital.
2. Before you are given Naloxone
Do not use Naloxone if:
• You are allergic to Naloxone
• You are allergic to any of the other
ingredients in Naloxone (see section 6)
If this applies to you talk to your doctor or
nurse.
Check with your doctor before you are
given
Naloxone if:
• You are addicted to heroin or similar drugs
• You have heart or circulation problems
• You are pregnant, planning pregnancy or
breast-feeding
• You have just had an operation

Tell your doctor if you are taking any of the
following medicines:
• Medicines that may affect your hear t
• Any other medicine, including medicines
obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, tr ying to
become pregnant or breastfeeding.
Naloxone will only be given to you if your doctor
considers the benefit of treatment outweighs the
risk to the developing or new born baby.
3. How Naloxone will be given to you
Important:
• Naloxone will be given to you by a
doctor or nurse. Your doctor will choose
the dose that is right for you
• The dose depends on how much you need to
reverse the effects on your breathing. The
following is a guide.
• Naloxone is always given by injection by a
doctor or health professional, usually into a
blood vessel. It may be given slowly through a
drip. It can be given into a muscle or under the
skin.
Adults and the elderly
• To treat an overdose or suspected overdose
of opioids, between 400 and 2000 micrograms
may be given ever y 2-3 minutes.
• After an operation 100-200 micrograms
may be given ever y 2-3 minutes.

Children
• The usual dose is 10 micrograms for ever y
kg they weigh increased to 100 micrograms
per kg if there is not a good enough
response.
Patients are monitored to make sure the effect
of the Naloxone lasts as long as the drugs it is
counteracting. Additional doses may be given
ever y 1-2 hours if necessar y.
If you think you have been given more
Naloxone than you should
As this medicine will be given to you by a
doctor or nurse, it is unlikely that you will
be given too little or too much. However, if
you think you have been given too much of this
medicine, please tell your doctor.
If you have any further questions about the use of
this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines Naloxone can cause side
effects, although not ever ybody gets them.
It may be difficult to know what side effects
Naloxone has because it is always given af ter
other drugs have also been used.
Side effects include:
• Feeling sick or being sick
• Tremor, sweating
• Over breathing (associated with an abrupt
return to consciousness)
• Fast heart beat or disturbed heart rhythm
• Increased or decreased blood pressure (you
may have a headache or feel faint)
• Fluid on the lungs
• Fits
• If Naloxone is given to people addicted to
heroin or similar drugs, it can cause an acute

withdrawal syndrome. This can also happen
to babies born to opioid-dependent mothers.
The sudden reversal of narcotic depression
when naloxone is taken may cause violent
behaviour
• If too large a dose is given af ter
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).
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via:
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
United Kingdom
Yellow Card Scheme
Website: 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
Keep out of the reach and sight of children.
Do not use this medicine after the expir y date
on the car ton and vial label. The expir y date
refers to the last day of that month.
Store below 25°C.
Keep the glass syringe in the outer car ton to
protect from light.

Single use only. Discard and unused contents.
Your doctor or nurse will make sure your
medicine is correctly stored and disposed of.
6. Further information
What Naloxone contains
The active substance is naloxone hydrochloride
(as the dihydrate). There are 400 micrograms
per ml.
The other ingredients are: sodium chloride,
hydrochloric acid (for pH adjustment) and
‘water for injections’.
What Naloxone looks like
Naloxone is a sterile solution. It comes in 3
different pack sizes as follows:
1 ml clear glass syringe with a luer-lock
2 ml clear glass syringe with an integral 1.25 inch
needle
5 ml clear glass vial with a separate injector. Not all
pack sizes may be marketed.
Marketing Authorisation Holder
International Medications Systems (UK) Limited,
208 Bath Road, Slough, Berkshire, SL1 3WE, UK.
Manufacturer
UCB Pharma Limited, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK
This leaflet was last updated May 2015.

If this leaflet is difficult to see or read
or you would like it in a different
format, please contact: International
Medications Systems (UK) Limited, 208
Bath Road, Slough, Berkshire
SL1 3WE, UK.
143840-XX

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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.

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