NALOXONE HCL MULTIPLE DOSES*F 0.4MG 1ML

NALOXONE HYDROCHLORIDE MOLTENI adults 0.4 mg/ml injectable solution
NALOXONE HYDROCHLORIDE MOLTENI children 0.04 mg/2 ml injectable solution

What it is and what it is used for
Naloxone Hydrochloride Molteni contains the active ingredient naloxone, belonging to the class of opioid antagonists. It works by blocking the activity of opioid derivatives, such as morphine and heroin.

Naloxone Hydrochloride Molteni adults 0.4 mg/ml is used as an antidote in acute intoxications due to overdose of opioid-derived medications (narcotic analgesics).

Naloxone Hydrochloride Molteni children 0.04 mg/2 ml is used in newborns in cases of irregular and intermittently absent breathing (respiratory depression) caused by the mother's use of opioid substances before delivery.

What you need to know before taking the medicine
Do not use Naloxone Hydrochloride Molteni
- if you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Naloxone Hydrochloride Molteni.

Symptoms of acute opioid intoxication (overdose) are:
- irregular and intermittently absent breathing (respiratory depression);
- absence of reflexes (comatose state, pre-coma or vigilant coma, and in the most severe cases, deep coma);
- narrowing of the eye's pupil (miosis).
For the treatment of these symptoms, in addition to naloxone, resuscitation techniques such as cardiac massage, artificial respiration, and the administration of blood pressure-increasing medications (vasopressors) will be necessary.

Naloxone Hydrochloride Molteni is not effective against respiratory depression caused by the use of non-opioid medications.

This medicine should be administered with caution:
- if, in the hours preceding the administration of this medicine, you have experienced severe respiratory problems (laryngospasm);
- if you suffer from heart or circulatory problems or are taking other drugs harmful to the heart.

After the first intervention, the patient must be transferred to the hospital and carefully monitored, as symptoms of intoxication may reappear.

Children and newborns
Naloxone can be used in newborns of mothers who have taken an opioid substance within 4 hours before delivery and in newborns who do not have independent breathing, but only as an additional therapy.

In newborns of drug-addicted mothers, the use of naloxone is not recommended, as it can worsen withdrawal symptoms and seizures.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur, with unknown frequency (frequency cannot be estimated from the available data):
- nausea.
- accelerated heartbeat (tachycardia);
- increased or decreased blood pressure;
- vomiting;
- tremor;
- seizures, agitation;
- heart problems (fibrillation, cardiac arrest);
- fluid accumulation around the lung (pulmonary edema);
- increased growth hormone levels;
- altered sensation in the limbs (paresthesias);
- memory disturbances;
- breathing difficulties (dyspnea, hypoxia and respiratory depression, hyperventilation);
- difficulty swallowing (dysphagia);
- hot flashes, sweating and redness;
- urge to urinate (micturition);
- hallucinations.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.