Naloxone 400 micrograms/ml solution for injection in Pre-filled syringe – patient leaflet, side effects, dosage

1. What Naloxone is and what it is used for

Naloxone is a drug used to counter the effects of opioid overdose, for example morphine overdose.

Naloxone is used for reversal of unwanted effects of opioids for countering life-threatening depression of the central nervous system and respiratory system (breathing difficulties).

Naloxone is also used to diagnose an acute opioid overdose or intoxication.

2. What you need to know before Naloxone is administered to you

Naloxone must not be administered:

• if you are allergic (hypersensitive) to naloxone hydrochloride or to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before Naloxone is administered to you:

Special care will be taken:

• If you are physically dependent to opioids (for example morphine) or have received high doses of these drugs (you may get strong withdrawal symptoms after receiving Naloxone because of a too rapid reversal of the opioid effect; these symptoms may be high blood pressure, palpitations, severe difficulties in breathing or cardiac arrest).
• If you have any heart or circulation problems (because side effects like high or low blood pressure, palpitations or severe difficulties in breathing may appear more likely).

Other medicines and Naloxone

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines:

• If you are taking painkilling medication like buprenorphine. The painkilling effect may even become stronger while you are treated with Naloxone. However, the reversal of unwanted effects, like respiratory depression caused by buprenorphine is limited.
• If you are taking sedatives, as Naloxone may possibly have a less rapid effect.
• If you are taking any medication that may affect your heart or circulation (e.g. antihypertensive drugs e.g. clonidine), even those not prescribed.

Naloxone with alcohol

Please inform your doctor if you drank alcohol. In patients with multi-intoxication (with opioids and sedatives or alcohol) Naloxone may have a less rapid effect.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is no adequate information available regarding the use of Naloxone in pregnant women. During pregnancy, your doctor will outweigh the benefit of Naloxone against possible risks to the unborn baby. Naloxone can cause withdrawal symptoms in the newborn baby.

Breast-feeding

It is not known whether Naloxone passes into breast milk and it has not been established whether infants who are breast-fed are affected by Naloxone. Therefore, breast-feeding is not recommended for 24 hours after treatment.

Driving and using machines

After receiving Naloxone for the reversal of the effects of opioids you must not take part in road traffic, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours since the effects of opioids may possibly recur.

Naloxone contains sodium

This medicine contains less than 1mmol sodium (23mg) per 1ml dose, that is to say essentially “sodium-free”.

3. How Naloxone is administered

The recommended doses given to you are:

Naloxone Injection is restricted for use in adults and adolescents aged 16 years or over.

Reversal of the unwanted effects of opioids 0.1 – 0.2mg, if necessary, additional injections of 0.1mg may be given

Diagnosis and treatment of opioid overdose or intoxication:

0.4 – 2mg, if necessary, the injections can be repeated at intervals of 2-3 minutes. The maximum dose of 10mg should not be exceeded.

For reversal of the unwanted effects of opioids, patients are monitored to ensure that the desired effect of Naloxone occurs. Additional doses may be given every 1 – 2 hours if necessary.

In elderly patients with heart or circulation problems or in those receiving medicines that can produce heart or circulation disorders (e.g. cocaine, methamphetamine, cyclic

antidepressants, calcium channel blockers, beta-blockers, digoxin) Naloxone will be used with caution since serious side effects such as fast heart beat (ventricular tachycardia) and fibrillation have occurred.

If you have the impression that the effect of Naloxone is too strong or too weak, talk to your doctor.

Method of administration

This medicine is for administration in a medical or healthcare setting only.

Naloxone will be given to you always by intravenous or intramuscular injection (into a vein or into a muscle). The IM administration of naloxone hydrochloride should only be used in cases where an IV administration is not possible. The most rapid effect is obtained by means of IV administration, which is why this method of administration is recommended in acute cases. Naloxone will be given by your anaesthetist or experienced physician or other qualified healthcare professional.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It may be difficult to know what side effects Naloxone has, because it is always given after other drugs have also been used.

The following side effects may be serious. If any of the following side effects occur, consult a doctor immediately:

Common (may affect up to 1 in 10 people):

• Fast heart beat.

Uncommon (may affect up to 1 in 100 people):

• Changes in the way your heart beats, slow heart rate.

Rare (may affect up to 1 in 1,000 people):

• Seizures.

The following information is intended for healthcare professionals only:

This medicinal product is for single use only.

Please inspect the medicinal product visually prior

to use . Use only clear and colourless solutions practically free from particles.

INP134 10 0000 0 0000000 Very rare (may affect up to 1 in 10,000 people):

• Allergic reactions (nettle rash, nasal catarrh or a cold, difficult breathing, Quincke’s oedema (giant swelling)), allergic shock
• Fibrillation, cardiac arrest
• Fluids on the lungs (pulmonary oedema).

Other side effects include:

Very common (may affect more than 1 in 10 people):

• Nausea.

Common (may affect up to 1 in 10 people):

• Dizziness, headache
• Increased or decreased blood pressure (you may have a headache or feel faint)
• Vomiting
• If a too large dose is given after 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).

Uncommon (may affect up to 1 in 100 people)

• Involuntary trembling or quivering (tremor), sweating
• Diarrhoea, dry mouth
• Over breathing (hyperventilation)
• Irritation of vessel wall has been reported after i.v. administration; local irritation and inflammation have been reported after i.m. administration.

Rare (may affect up to 1 in 1,000 people):

• Tension.

Very rare (may affect up to 1 in 10,000 people):

• Discoloration and lesions of the skin (erythema multiforme).

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 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.

5. How to store Naloxone

Keep this medicine out of the sight and reach of children.

You should not be given Naloxone after the expiry date which is stated on the box (Twist box) and syringe label after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Keep the syringe in the outer box in order to protect from light.

Shelf-life after first opening

After first opening, the medicinal product should be used immediately.

Do not use this medicine if you notice discolouration of solution or visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Naloxone contains

The active substance is naloxone hydrochloride dihydrate. Each 1ml pre-filled syringe contains 0.4mg naloxone hydrochloride (as dihydrate).

The other ingredients are: sodium chloride, hydrochloric acid, concentrated (for pH adjustment) and water for injections.

What Naloxone looks like and contents of the pack

Naloxone is a clear and colourless solution for injection in pre-filled syringe, practically free from foreign particles.

1ml clear glass pre-filled syringe with tip cap, plunger stopper (grey bromobutyl rubber stopper) and plunger rod (polypropylene). Graduations per 0.1ml are present on the barrel of the syringe.

The pre-filled syringe is supplied with needle (23G; 30mm), packaged in an outer box (Twist Box).

Pack sizes: one pre-filled syringe and one needle.

Each Naloxone prefilled syringe delivers a single dose of 1ml injection equal to 400micrograms naloxone hydrochloride

Marketing Authorisation Holder

Accord, Barnstaple, EX32 8NS, UK

Manufacturer

Accord Healthcare Ltd,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF

United Kingdom

Or

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice

Poland

Or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040, Spain

This leaflet was last revised in June 2023.

If you would like a leaflet with larger text, please contact

01271 385257