Active ingredient
- naloxone hydrochloride dihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 02848/0135.
Naloxone Hydrochloride Injection USP 20 micrograms/1ml and 400 micrograms/1ml
PATIENT INFORMATION LEAFLET
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 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:
2. Before you are given Naloxone Injection/Infusion
Speak to your doctor if this applies to you before you are given this medicine.
Your doctor will take special care if:
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
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 .
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.
For adults:
For children:
For new born babies:
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 occurring in more than 1 in 10 people)
Common: (probably occurring in less than 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: (probably occurring in less than 1 in 100 people)
Rare: (probably occurring in less than 1 in 1000 people)
Very Rare: (probably less than 1 in 10000 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.
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 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:
Manufacturer:
This leaflet was last revised in April 2022
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+44 (0)208 588 9131
+44 (0)208 588 9131
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