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NALOXONE HYDROCHLORIDE 20 MICROGRAMS/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): NALOXONE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Naloxone Hydrochloride 20micrograms/ml
Solution for Injection/Infusion
Naloxone Hydrochloride 400micrograms/ml
Solution for Injection/Infusion
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.
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.
The name of your medicine is Naloxone Hydrochloride
20micrograms/ml Solution for Injection/Infusion, Naloxone
Hydrochloride 400 micrograms/ml Solution for Injection/Infusion. It
will be referred to as Naloxone Injection/Infusion for ease hereafter.
In this leaflet:
1. What Naloxone Injection/Infusion is and what it is used for
2. Before you are given Naloxone Injection/Infusion
3. How Naloxone Injection/Infusion is given to you
4. Possible side effects
5. How to store Naloxone Injection/Infusion
6. Further information
1. WHAT NALOXONE INJECTION/INFUSION IS AND
WHAT IT IS USED FOR
Naloxone belongs to a group of medicines known as opioid
antagonists. Opioid medicines are strong painkillers such as
morphine and codeine. In high doses these painkillers can result in
side effects which cause difficulty in breathing and drowsiness.
These effects can be reversed by an opioid antagonist (blocks the
effects of opioids).
Naloxone Injection/Infusion may be used:
• to treat the breathing problems caused by these opioid painkillers
• to help determine whether a patient has taken or received an
overdose of opioid drugs
• to reverse the depressant effects on breathing and on other parts
of the brain and spinal cord in newborn infants (resulting from the
use of opioid painkillers in the mother during childbirth).
2. BEFORE YOU ARE GIVEN NALOXONE INJECTION/INFUSION
You should not be given this medicine if you know that you are
allergic to naloxone, or to any of the other ingredients (listed in
Section 6 at the end of this leaflet).
Speak to your doctor if this applies to you before you are given this
medicine.
Your doctor will take special care if:
• you have received large doses of opioid drugs or if you have a
drug-dependence (drug addiction) problem
• you suffer from any heart or circulatory problems
• you suffer from high blood pressure, irregular heart beat or
difficulty in breathing
• you have a newborn baby who requires this injection/infusion; tell
the doctor beforehand if you received large doses of opioid drugs
before you gave birth or if you have a drug-dependence problem
• you are suffering from diseases of the kidney, liver or lung.
Speak to your doctor if one of these applies to you before you are
given this medicine.
Taking other medicines:
Tell your doctor before you are given this medicine if you are taking
or have recently taken any other medicines, including medicines
obtained without a prescription.
A number of medicines can interact with Naloxone Injection/Infusion
which can significantly alter their effects. In particular, tell your
doctor if you are taking
• Strong pain killer medicines like buprenorphine and pentazocine.
• Sleeping pills
• Medicines that may affect your heart or blood circulation (e.g.
antihypertensive drugs, cocaine, methamphetamine, cyclic
antidepressants, calcium channel blockers, beta-blockers, digoxin
and clonidine) even those not prescribed.
Pregnancy and breast-feeding
Tell your doctor before you are given this medicine if you are
pregnant, think you may be pregnant or are planning to become
pregnant, or are breast-feeding.
The potential risk for humans is unknown. Naloxone
injection/infusion should not be used during pregnancy unless
clearly necessary.
Naloxone Injection/Infusion must be used with caution in breast feeding
mothers. Breast-feeding should be avoided for 24 hours after treatment.
Driving and using machines:
After receiving Naloxone Injection/Infusion, 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 effect of
opioids may possibly recur.
Important information about some of the ingredients of
Naloxone Injection/Infusion
Naloxone Hydrochloride 400micrograms/ml Solution for
Injection/Infusion contains 3.8 mmol (88.2 mg) sodium per maximum
daily dose of 10mg naloxone hydrochloride and Naloxone
Hydrochloride 20micrograms/ml Solution for Injection/Infusion
contains 77.2 mmol(1.78 g) sodium per maximum daily dose of 10mg
naloxone hydrochloride. Ask your doctor about this if you are on a
strict sodium controlled diet.
3. HOW NALOXONE INJECTION/INFUSION IS GIVEN TO YOU
Naloxone Injection/Infusion is always given by a doctor or nurse.
It may be injected into a vein, a muscle, or the tissue just under the
skin. It may also be given by a drip into a vein.
The dose of the injection/infusion will be calculated by your doctor.
This will depend upon your weight and the circumstances that
require treatment.
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For adults:
• To treat an overdose or suspected overdose of opioids, between
400 and 2000 micrograms may be given every 2-3 minutes.
• After an operation 100-200 micrograms may be given every 2-3
minutes.
For children:
• The usual dose is 10 micrograms for each kilogram they weigh
increased to 100 micrograms per kg to achieve the desired response.
For new born babies:
• The usual starting dose is 10 micrograms per kg body weight
every 2-3 minutes. Or a single dose of 200 micrograms may be
given at birth.
If you think you have been given more Naloxone
Injection/Infusion than you should have
This is unlikely as your injection/infusion will be administered by a
doctor or nurse. If you are concerned about the dose, discuss it with
your doctor.
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 Injection/Infusion can sometimes cause
side-effects, although not everybody gets them.
All medicines can cause allergic reactions although serious
allergic reactions are rare. Any sudden wheeziness, difficulty in
breathing, swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body) should be reported to a
doctor immediately.
Other side effects may include:
Very common: (probably occuring in more than 1 in 10 people)
• Feeling sick
Common: (probably occurring in less than 1 in 10 people)
• Dizziness
• Headache
• Fast Heart beat
• Increased or decreased blood pressure
• Vomiting
• Post-operative pain
If too large a dose is given after an operation, you may become
excited and feel pain (because the pain killing effects of medicines
you were given will have been counteracted as well as the effects on
your breathing).
Uncommon: (probably occurring in less than 1 in 100 people)
• Tremors
• Sweating
• Changes in the way your heart beats
• Slow heart rate
• Over breathing (hyperventilation)
• Diarrhoea
• Dry mouth
• Irritation of the walls of the veins has been reported after intravenous administration.
• Local irritation, burning and redness have been reported after the
intra-muscular administration.
Rare: (probably occurring in less than 1 in 1000 people)
• Fits (seizures)
• Tension
Very Rare: (probably less than 1 in 10000 people)
• Severe problems with the heart (Fibrillation and cardiac arrest)
• Fluid in the lungs
• Discolouration and lesions of the skin.
• Allergic reactions (urticaria, rhinitis, dyspnoea, Quincke's
oedema), anaphylactic shock
If any of the side-effects become serious, or if you notice any
side-effects not listed in the leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE NALOXONE INJECTION/INFUSION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and ampoule label after ‘Exp’. The expiry date refers to the
last day of that month.
Do not store above 25°C.
Keep the ampoules (small bottles) in the outer carton in order to
protect from light.
If only part used, discard the remaining solution.
Do not use the ampoule if the contents are discoloured in any way.
For single use only.
6. FURTHER INFORMATION
The active substance is naloxone hydrochloride dihydrate.
The other ingredients are sodium chloride, dilute hydrochloric acid
in water for injections.
What Naloxone Hydrochloride Injection/Infusion looks like and
contents of pack
Naloxone Hydrochloride 20micrograms/ml Solution for
Injection/Infusion (0.02 mg/ml) is a clear, colourless, sterile solution
containing 40 micrograms (0.04 mg) naloxone hydrochloride
present as naloxone hydrochloride dihydrate in 2ml clear glass
ampoules (small bottles).
Naloxone Hydrochloride 400micrograms/ml Solution for
Injection/Infusion (0.4 mg/ml) is a clear, colourless, sterile solution
containing 400 micrograms (0.4mg) naloxone hydrochloride
present as naloxone hydrochloride dihydrate in 1ml clear glass
ampoules (small bottles).
Pack size: 3, 5 or 10 ampoules may be packaged together in
cardboard cartons. All pack sizes may not be marketed.
Marketing authorisation holder: Mercury Pharma International Ltd,
4045, Kingswood Road, City West Business Park, Co Dublin,
Ireland.
Manufacturer: Delpharm Tours, La Baraudiere, 37170, ChambrayLes-Tours, France.
This leaflet was last revised in April 2012
100117/LF/2, 100488/LF/2
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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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