Naloxone accord

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Package leaflet: Information for the patient

Naloxone Accord, 400 micrograms/mL, solution for injection / infusion in pre-filled syringe
Naloxoni hydrochloridum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not give it to others.
It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Contents of the leaflet

1. What Naloxone Accord is and what it is used for
2. What you need to know before you use Naloxone Accord
3. How to use Naloxone Accord
4. Possible side effects
5. How to store Naloxone Accord
6. Contents of the pack and other information

1. What Naloxone Accord is and what it is used for

Naloxone Accord is a medicine used to reverse the effects of opioid overdose, for example, overdose of morphine.
Naloxone Accord is used to reverse the unwanted effects of opioids and to counteract life-threatening depression of the central nervous system and respiratory system (difficulty breathing).
Naloxone Accord is also used to diagnose acute opioid overdose or poisoning.
If a woman has received pain-relieving medicines during childbirth, the newborn may be treated with Naloxone Accord to reverse the unwanted effects of opioids, for example, if the baby has breathing problems or depression of the central nervous system.
Naloxone Accord in pre-filled syringe must not be used in infants with body weight less than 4 kg.

2. Important information before using Naloxone Accord

When not to use Naloxone Accord:

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

Naloxone Accord in pre-filled syringe must not be used in infants with body weight less than 4 kg.
Warnings and precautions
Before starting treatment with Naloxone Accord, discuss this with your doctor or pharmacist.
Special caution is required:
In case of physical opioid dependence (e.g. morphine) or when receiving high doses of opioids, because after administration of Naloxone Accord severe withdrawal symptoms may occur due to too rapid reversal of opioid effects, such as high blood pressure, rapid heartbeat, serious breathing difficulties or cardiac arrest.
In case of cardiovascular disorders, due to increased risk of adverse reactions such as high or low blood pressure, rapid heartbeat or serious breathing difficulties.
Naloxone Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken:
When using painkillers, such as buprenorphine, their pain-relieving effect may be intensified during treatment with Naloxone Accord, and reversal of undesirable effects such as respiratory depression caused by buprenorphine is limited.
When using sedatives, because Naloxone Accord may act more slowly.
When using any medicines that may affect the heart or circulatory system (medicines used to treat high blood pressure, e.g. clonidine), even those available without prescription.
Naloxone Accord and alcohol
The patient should inform the doctor if they have consumed alcohol. Naloxone Accord may act more slowly in patients with multiple intoxication (opioids and sedatives or alcohol).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There are insufficient data on the use of Naloxone Accord in pregnant women. Naloxone Accord may be used during pregnancy only if the doctor considers the benefit of treatment to outweigh the risk to the unborn child. Naloxone Accord may cause withdrawal symptoms in the newborn.
Breastfeeding
It is not known whether Naloxone Accord passes into breast milk and it has not been established whether it affects breastfed infants. Therefore, breastfeeding should be discontinued for 24 hours after treatment.
Driving and operating machinery
After receiving Naloxone Accord to reverse the effects of opioids, do not drive, operate machinery, or perform any activities requiring physical or mental alertness for at least 24 hours, because there is a possibility that opioid effects may recur.
Naloxone Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL of solution, meaning the medicine is considered "sodium-free".

3. How to use Naloxone Accord

Recommended dose for the patient:
Reversal of opioid adverse effects:
Adults: 0.1 – 0.2 mg; additional injections of 0.1 mg may be administered if necessary.
Children: 0.01 – 0.02 mg/kg body weight; additional injections of the same dose may be administered if necessary.
Diagnosis and treatment of opioid overdose or poisoning:
Adults: 0.4 – 2 mg; injections may be repeated every 2–3 minutes if necessary. The maximum total dose should not exceed 10 mg.
Children: 0.01 mg/kg body weight; if an additional dose is required, the dose may be increased in the next injection to 0.1 mg/kg.
Reversal of opioid adverse effects in newborns whose mothers received opioids:
0.01 mg/kg body weight; additional injections may be administered if necessary.
To reverse opioid adverse effects (in adults, children, and newborns), patients should be monitored to ensure the desired effect of Naloxone Accord is achieved. If necessary, additional doses may be administered every 1–2 hours.
Naloxone Accord should be used with caution in elderly patients with heart or circulatory problems, or in patients taking medications that may cause cardiac or circulatory disturbances (e.g. cocaine, methamphetamine, tricyclic antidepressants, calcium channel blockers, beta-blockers, digoxin), as serious adverse reactions such as rapid heartbeat (ventricular tachycardia) and ventricular fibrillation have been reported.
Naloxone Accord in prefilled syringe should not be used in infants with body weight less than 4 kg.
If you feel that the effect of Naloxone Accord is too strong or too weak, consult your doctor.
Method of administration
Naloxone Accord is always administered by intravenous or intramuscular injection (into a vein or muscle), or diluted for intravenous infusion (prolonged administration). Naloxone Accord is administered by an anaesthesiologist or experienced physician.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Determining which side effects are caused by Naloxone Accord may be difficult, as it is always administered following the use of other medicines.
The following side effects may be serious. If any of the following side effects occur, consult a doctor immediately:
Side effects occurring frequently (may occur in fewer than 1 in 10 patients):

• Rapid heartbeat.

Side effects occurring not very frequently (may occur in fewer than 1 in 100 patients):

• Heart rhythm disorders, slowed heartbeat.

Side effects occurring rarely (may occur in fewer than 1 in 1,000 patients):

• Seizures.

Side effects occurring very rarely (may occur in fewer than 1 in 10,000 patients):

• Allergic reactions (urticaria, rhinitis or cold-like symptoms, breathing difficulties, Quincke's edema (severe swelling)).
• Ventricular fibrillation, cardiac arrest.
• Fluid in the lungs (pulmonary edema).

Other side effects include:
Side effects occurring very frequently (may occur in fewer than 1 in 10 patients):

• Nausea.

Side effects occurring frequently (may occur in fewer than 1 in 10 patients):

• Dizziness, headache.
• Increased or decreased blood pressure (may cause headache or feeling faint).
• Vomiting.
• If too high a dose is administered post-surgery, the patient may become agitated and experience pain (because the analgesic effect of previously administered medicines, as well as their effect on respiration, is reversed).

Side effects occurring not very frequently (may occur in fewer than 1 in 100 patients):

• Involuntary trembling or shaking, sweating.
• Diarrhea, dry mouth.
• Excessive breathing (hyperventilation).
• Vessel wall irritation reported after intravenous administration; local irritation and inflammation reported after intramuscular administration.

Side effects occurring rarely (may occur in fewer than 1 in 1,000 patients):

• Tension.

Side effects occurring very rarely (may occur in fewer than 1 in 10,000 patients):

• Skin discoloration and skin changes (erythema multiforme).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting of side effects enables the collection of further information on the safety of the medicine.

5. How to store Naloxone Accord

Keep this medicine out of the sight and reach of children.
Do not use Naloxone Accord after the expiry date stated on the carton (carton with Twist cap closure) and on the syringe label after EXP. The expiry date refers to the last day of the stated month.
There are no special requirements regarding storage temperature.
Store the pre-filled syringe in the outer packaging to protect it from light.

Shelf-life after first opening
After first opening, the medicinal product should be used immediately.

Shelf-life after dilution
Chemical and physical in-use stability has been demonstrated for 36 hours at temperatures from 2 to 8°C and at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user – under normal conditions, storage should not exceed 24 hours at 2 to 8°C, unless the dilution is carried out under controlled and validated aseptic conditions.

Do not use this medicine if a change in colour of the solution or visible signs of deterioration are observed.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Naloxone Accord contains
The active substance is naloxone hydrochloride. Each 1 mL pre-filled syringe contains 400 micrograms of naloxone hydrochloride (as naloxone hydrochloride dihydrate).
The other ingredients are: sodium chloride, hydrochloric acid concentrated (for pH adjustment), water for injections.

What Naloxone Accord looks like and contents of the pack
Naloxone Accord is a clear, colourless solution for injection/infusion in a prefilled syringe, practically free from extraneous matter.
The 1 mL prefilled syringe is made of colourless glass with a cap, rubber plunger (grey bromobutyl rubber stopper) and barrel (polypropylene). The syringe barrel is graduated in 0.1 mL increments.
The prefilled syringe is supplied with a needle (23 G; 30 mm), packed in an outer carton (carton with Twist closure).
Pack sizes: one prefilled syringe and one needle.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw, Poland
Tel: +48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice, Poland
or
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca
Barcelona, 08040
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Information intended exclusively for healthcare professionals:

Shelf life after first opening and after dilution: see section 5.
For intravenous infusion, Naloxone Accord must be diluted with sodium chloride 9 mg/mL (0,9%) or glucose 50 mg/mL (5%) solution. By diluting the contents of five Naloxone Accord vial-syringes (2 mg) in 500 mL, a concentration of 4 micrograms/mL is obtained.
It is recommended that Naloxone Accord not be administered in the same infusion with products containing bisulfite, pyrosulfite, long-chain anions or high molecular weight anions, or with alkaline pH solutions.
This medicinal product is intended for single use only.
The medicinal product should be visually inspected before use (including after dilution). Only clear, colourless solutions, practically free from particles, should be used.