NALOXONE CHLOR MOLT ADULTS 0.4 MG/ML INJECTABLE SOLUTION 1 VIAL OF 1 ML

Name
NALOXONE HYDROCHLORIDE MOLTENI adults 0.4 mg/ml solution for injection
NALOXONE HYDROCHLORIDE MOLTENI children 0.04 mg/2 ml solution for injection


What it is and what it is used for
Naloxone Cloridrato Molteni contains the active ingredient naloxone, belonging to the class of opioid antagonists. It works by blocking the activity of opium 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 opium-derived drugs (narcotic analgesics).

Naloxone Hydrochloride Molteni children 0.04 mg/2 ml is used in newborns in case of irregular and at times absent breathing (respiratory depression) caused by the mother's intake of opioid substances before giving birth.


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 sometimes absent breathing (respiratory depression);
- absence of reflexes (comatose state, precoma or conscious coma and in the most serious cases deep coma);
- constriction of the pupil of the eye (miosis).
To treat these symptoms, in addition to naloxone, resuscitation techniques will be necessary, such as cardiac massage, artificial respiration and the administration of drugs that increase blood pressure (vasopressors).

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 you have had severe breathing problems (laryngospasm) in the hours before taking this medicine;
- if you suffer from heart or circulation problems or are taking other medicines that are harmful to the heart.

After the first intervention, the patient must be transferred to hospital and must be carefully monitored, as it is possible that the 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 adjunctive therapy.

In newborns of drug-addicted mothers, the use of naloxone is not recommended, because 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 an unknown frequency (frequency cannot be estimated from the available data):
- nausea.
- acceleration of the heartbeat (tachycardia);
- increase or decrease in blood pressure;
- vomit;
- tremor;
- convulsions, agitation;
- heart problems (fibrillation, cardiac arrest);
- accumulation of fluid around the lung (pulmonary edema);
- increased growth hormone levels;
- alteration of sensitivity in the limbs (paraesthesia);
- memory disorders;
- respiratory difficulties (dyspnea, hypoxia and respiratory depression, hyperventilation);
- difficulty swallowing (dysphagia);
- hot flashes, sweating and redness;
- urge to urinate (urination);
- hallucinations.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.