Naloxone Accord

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Naloxone Accord 0.4 mg/ml solution for injection/infusion in pre-filled syringe

naloxone hydrochloride
Please read this leaflet carefully before this medicine is administered to you,
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist.

Contents of this leaflet:

1. What Naloxone Accord is and what it is used for
2. What you need to know before you are given Naloxone Accord
3. How Naloxone Accord is administered
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 counteract the effects of opioid overdose,
for example, morphine overdose.
Naloxone Accord is used to reverse the adverse effects of opioids in order to counteract depression of the central nervous system and respiratory system (breathing difficulties), which may be life-threatening.
Naloxone Accord is also used for the diagnosis of opioid intoxication or acute opioid overdose.
If a woman has taken analgesics during labour, the newborn will be treated with Naloxone Accord
to reverse the adverse effects of opioids, e.g. if the newborn experiences breathing problems or
depression of the central nervous system.

2. WHAT YOU SHOULD KNOW BEFORE NALOXONE IS ADMINISTERED TO YOU

ACCORD
You must not be given Naloxone Accord
if you are allergic (hypersensitive) to naloxone hydrochloride or to any of the excipients of
this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before you are given Naloxone Accord.
Take particular care if:
You are physically dependent on opioids (e.g. morphine), or have taken high doses of
these substances (you may experience severe withdrawal symptoms after receiving Naloxone Accord due to too rapid reversal of opioid effects; such symptoms may include high blood pressure, palpitations, severe breathing difficulties, or cardiac arrest).
You have heart or circulatory problems (because side effects such as high or low blood pressure, palpitations, or severe breathing difficulties may be more likely to occur).

Other medicines and Naloxone Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
If you are taking painkillers such as buprenorphine, whose pain-relieving effect may
increase during treatment with Naloxone Accord. However, the reversal of undesirable effects,
such as respiratory depression caused by buprenorphine, is limited.
If you are taking sedatives, as they may delay the effect of Naloxone Accord.
If you are taking medicines that may affect your heart or circulation (e.g. antihypertensive drugs such as clonidine), including those without a prescription.

Naloxone Accord and alcohol
Inform your doctor if you have consumed alcohol. Naloxone Accord may act less rapidly in patients
with multiple intoxication (from opioids and sedatives or alcohol).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.

Pregnancy
There is insufficient information available on the use of Naloxone Accord in pregnant women. During pregnancy, your doctor must weigh the benefits of Naloxone Accord against the potential risks to the fetus. 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 breastfed infants are affected. Therefore, breastfeeding is not recommended for 24 hours after treatment.

Driving and using machines
After receiving Naloxone Accord to reverse the effects of opioids, do not drive vehicles or operate machinery, or engage in any other activities requiring physical or mental effort for at least 24 hours, as the effects of opioids may reappear.

Naloxone Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml dose, i.e. it is essentially "sodium-free".

3. HOW NALOXONE ACCORD IS ADMINISTERED TO YOU

The recommended doses to be administered to you are as follows:
Reversal of undesirable effects of opioids
Adults: 0.1 – 0.2 mg; if necessary, additional injections of 0.1 mg may be given
Children: 0.01 – 0.02 mg per kg of body weight; if necessary, additional injections of the same dosage may be given
Diagnosis of opioid intoxication or overdose
Adults: 0.4 – 2 mg; if necessary, injections may be repeated at 2-3 minute intervals. It is recommended not to exceed the maximum dose of 10 mg.
Children: 0.01 mg per kg of body weight; if necessary, additional injections of 0.1 mg per kg may be given.
Reversal of opioid-induced effects in the newborn whose mother has taken opioids:
0.01 mg per kg of body weight; if necessary, additional injections may be given.
To reverse the undesirable effects of opioids (in adults, children, and also newborns), patients are monitored to ensure the desired effect of Naloxone Accord occurs. If necessary, additional doses may be administered every 1–2 hours.
In elderly patients with heart or circulatory problems, or in patients who have taken medicines that may cause cardiac or circulatory disturbances (e.g. cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin), Naloxone Accord will be used with caution, as serious adverse effects such as increased heart rate (ventricular tachycardia) and fibrillation have been reported.
The pre-filled syringe of Naloxone Accord must not be used in newborns weighing 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 will always be administered to you by intravenous or intramuscular injection (into a vein or into a muscle), or, after dilution, by intravenous infusion (over a longer period than injection). Naloxone Accord will be administered by an anaesthetist or experienced doctor.
If you have any doubts about the use of Naloxone Accord, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
It may be difficult to recognize the side effects of Naloxone Accord, as it is always administered after other medications have been used.

The following adverse reactions could be serious. If you experience any of the following, seek medical
attention immediately:
Common (may affect up to 1 in 10 people):
Rapid heartbeat

Uncommon (may affect up to 1 in 100 people):
Changes in heart rhythm, slowing of heart rate

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

Very rare (may affect up to 1 in 10,000 people):
Allergic reactions (rash, nasal congestion or cold-like symptoms, difficulty breathing, Quincke's edema [giant edema])
Anaphylactic shock
Fibrillation, cardiac arrest
Fluid in the lungs (pulmonary edema)

Other adverse reactions include:
Very common (may affect more than 1 in 10 people):
Nausea

Common (may affect up to 1 in 10 people):
Dizziness, headache
Increase or decrease in blood pressure (may cause headache or feeling faint)
Vomiting
If an excessive dose is administered after surgery, you may feel agitated and experience pain (because the effect of the painkillers you were given, as well as their effects on your breathing, will have been reversed).

Uncommon (may affect up to 1 in 100 people):
Involuntary tremors, sweating
Diarrhea, dry mouth
Shortness of breath (hyperventilation)
After intravenous administration, irritation of the blood vessel walls has been reported; after intramuscular administration, local inflammation and irritation have been reported.

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

Very rare (may affect up to 1 in 10,000 people):
Changes in skin coloration and skin lesions (erythema multiforme)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NALOXONE ACCORD

Keep this medicine out of the sight and reach of children.
Naloxone Accord must not be administered after the expiry date stated on the carton (Twist carton) and on the syringe label after EXP. The expiry date refers to the last day of the month.
This medicine does not require special storage conditions under controlled temperature.
Keep the syringe in the outer carton to protect it from light.

Shelf-life after first opening
After first opening, the medicine must be used immediately.

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

Do not use this medicine if discoloration of the solution or any 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. These measures help protect the environment.

6. Package contents and other information

What Naloxone Accord contains
The active substance is naloxone hydrochloride.
Each 1 ml pre-filled syringe contains 0.4 mg of naloxone hydrochloride (as dihydrate).
The other ingredients are: sodium chloride, concentrated hydrochloric acid (for pH adjustment) and water for injections.

Appearance of Naloxone Accord and contents of the pack
Naloxone Accord is a clear, colourless solution for injection/infusion in a pre-filled syringe, practically free from foreign particles.
The 1 ml pre-filled syringe is made of clear glass with a cap, plunger stopper (grey bromobutyl rubber stopper) and plunger rod (polypropylene). Graduations for 0.1 ml are marked on the syringe barrel.
The pre-filled syringe is supplied with a needle (23 G; 30 mm), packaged in an outer box (Twist Box).
Pack sizes: one pre-filled syringe and one needle.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Accord Healthcare S.L.U.,
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50,
95-200 Pabianice
Poland
Or
Accord Healthcare B.V.
Winthontlaan 200, 3526KV Utrecht
The Netherlands
Or
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040, Spain

This medicinal product is authorised in the European Economic Area countries under the following names:

The following information is intended for healthcare professionals only:
Shelf life after first opening and after dilution: see section 5.
For intravenous infusion, Naloxone Accord should be diluted with sodium chloride solution 9 mg/ml (0.9%) or glucose solution 50 mg/ml (5%).
Five pre-filled syringes of Naloxone Accord (2 mg) in 500 ml give a concentration of 4 micrograms/ml.
It is recommended not to mix infusions of Naloxone Accord with preparations containing bisulphite, metabisulphite, long-chain or high molecular weight anions, or alkaline pH solutions.
This medicinal product is for single use only.
Before use, visually inspect the medicinal product (including after dilution). Use only clear, colourless solutions practically free from particles.