Patient Leaflet Updated 29-Nov-2023 | ADVANZ Pharma
Naloxone Hydrochloride Injection 400 micrograms/1ml
Naloxone Hydrochloride 400micrograms/ml Solution for Injection/Infusion
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Naloxone Hydrochloride 400 micrograms/ml Solution for Injection/Infusion. It will be referred to as Naloxone Injection/Infusion for ease hereafter.
1. What Naloxone Injection/Infusion is and what it is given for
2. What you need to know 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. Contents of the pack and other information
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:
Talk to your doctor or pharmacist before you are given Naloxone Injection/Infusion. Your doctor will take special care if:
Remember that naloxone rapidly reverses the effects of opioid drugs. If you are receiving large doses of opioids, or if you have a drug addiction problem, naloxone might cause acute opioid withdrawal symptoms.
Tell your doctor if you are taking or have recently taken or might take any other medicines.
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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
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.
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.
This medicine contains 88.2 mg sodium (main component of cooking/table salt) in maximum daily dose of 10mg naloxone hydrochloride. This is equivalent to 4.4% of the recommended maximum daily dietary intake of sodium for an adult.
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.
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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can 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: (may affect more than 1 in 10 people)
Common: (may affect up to 1 in 10 people)
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: (may affect up to 1 in 100 people)
Rare: (may affect up to 1 in 1,000 people)
Very Rare: (may affect up to 1 in 10,000 people)
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.
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
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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.
Do not throw away any medicines via wastewater . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is naloxone hydrochloride dihydrate. The other ingredients are sodium chloride, dilute hydrochloric acid (for pH adjustment) in water for injections.
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.
This leaflet was last revised in November 2023.
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