Naloxone hydrochloride Molteni

Package leaflet: Information for the user

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

Read this entire 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Naloxone Hydrochloride Molteni is and what it is used for

Naloxone Hydrochloride Molteni contains the active substance naloxone, which belongs to the class of opioid antagonists. It works by blocking the effects of opioid substances such as morphine and heroin.
Naloxone Hydrochloride Molteni adults 0.4 mg/ml is used as an antidote in acute poisoning due to overdose of opioid-derived medicines (narcotic analgesics).
Naloxone Hydrochloride Molteni children 0.04 mg/2 ml is used in newborns in case of irregular breathing or episodes of absent breathing (respiratory depression) caused by maternal use of opioid substances before delivery.

2. What you need to know before using Naloxone Hydrochloride Molteni

Do not use Naloxone Hydrochloride Molteni

• if you are allergic to naloxone or to 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 poisoning (overdose) include:

• irregular breathing or periods of no breathing (respiratory depression);
• absence of reflexes (comatose state, pre-coma, or wakeful coma, and in more severe cases, deep coma);
• constricted pupils (miosis). For the treatment of these symptoms, in addition to naloxone, resuscitation techniques will be necessary, such as cardiac massage, artificial respiration, and administration of medicines that increase blood pressure (vasopressors).

Naloxone Hydrochloride Molteni is not effective against respiratory depression caused by non-opioid medicines.
This medicine should be administered with caution:

• if you have recently (within the hours prior to administration) experienced serious respiratory problems (laryngospasm);
• if you have heart or circulatory problems, or if you are taking other medicines that are harmful to the heart.

After initial treatment, the patient must be transferred to hospital and carefully monitored, as symptoms of poisoning may recur.
Children and newborns
Naloxone may be used in newborns of mothers who have taken an opioid substance within 4 hours before delivery, and in newborns who lack independent breathing, but only as an adjunctive therapy.
In newborns of opioid-dependent mothers, the use of naloxone is not recommended, as it may worsen withdrawal symptoms and seizures.
Other medicines and Naloxone Hydrochloride Molteni
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and consult your doctor if you are taking clonidine, a medicine used to treat high blood pressure.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
There are insufficient data available to determine the effects of this medicine on the ability to drive vehicles or operate machinery.

3. How to use Naloxone Hydrochloride Molteni

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

This medicine will be administered to you intravenously (into a vein), subcutaneously (under the skin), or intramuscularly (into a muscle), depending on your needs.

In emergency situations, the intravenous route is recommended because it produces a faster effect.

If necessary, Naloxone Hydrochloride Molteni can be diluted in 0.9% sodium chloride solution (physiological saline) or 5% glucose solution.

After treatment, the patient must be continuously monitored and transferred to hospital as soon as possible, because symptoms may recur. If needed, the administration of the medicine can be repeated.

Use in adults

Treatment of opioid overdose (known or suspected)
The recommended initial dose, whether administered intravenously, subcutaneously, or intramuscularly, is 0.4 mg/mL (1 vial).
If no improvement in respiration is observed after intravenous administration, it is advisable to repeat the dose at intervals of 2–3 minutes.

Treatment of post-operative opioid-induced depression
The recommended dose ranges from 0.1 to 0.2 mg administered intravenously in incremental doses at intervals of 2–3 minutes, until adequate improvement of symptoms is achieved.
Within 1–2 hours after the first administration, the dose may need to be repeated, even via intramuscular route.

Excessive doses of naloxone may reduce the analgesic effect of opioids and increase blood pressure. A too-rapid action of naloxone may cause nausea, vomiting, sweating, or palpitations (tachycardia).

Use in children and adolescents
For the treatment of opioid overdose (known or suspected), the recommended initial dose is 0.01 mg/kg body weight, administered intravenously, intramuscularly, or subcutaneously.
The dose may be repeated according to the recommendations for administration in adults.

If you use more Naloxone Hydrochloride Molteni than you should
In case of accidental ingestion/overdose of this medicine, inform your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur, at an unknown frequency (frequency cannot be determined from the available data):

• nausea;
• increased heart rate (tachycardia);
• increase or decrease in blood pressure;
• vomiting;
• tremor;
• seizures, agitation;
• heart disorders (fibrillation, cardiac arrest);
• fluid accumulation around the lung (pulmonary edema);
• increased levels of growth hormone;
• altered sensation in limbs (paraesthesiae);
• memory disturbances;
• breathing difficulties (dyspnoea, hypoxia and respiratory depression, hyperventilation);
• difficulty swallowing (dysphagia);
• hot flushes, sweating and flushing;
• increased urge to urinate (micturition);
• hallucinations.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Naloxone Hydrochloride Molteni

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store this medicine in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Naloxone Hydrochloride Molteni contains
Naloxone Hydrochloride Molteni adults 0.4 mg/ml injectable solution

• The active substance is naloxone hydrochloride. Each 1 ml vial contains 0.4 mg of naloxone hydrochloride.
• The other component is water for injections.

Naloxone Hydrochloride Molteni children 0.04 mg/2 ml injectable solution

• The active substance is naloxone hydrochloride. Each 2 ml vial contains 0.04 mg of naloxone hydrochloride.
• The other component is water for injections.

Description of the appearance of Naloxone Hydrochloride Molteni and contents of the pack
Naloxone Hydrochloride Molteni adults 0.4 mg/ml injectable solution
Pack containing 1 vial with 1 ml of injectable solution.
Naloxone Hydrochloride Molteni children 0.04 mg/2 ml injectable solution
Pack containing 1 vial with 2 ml of injectable solution.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Strada Statale 67 – Fraz. Granatieri
Scandicci (Florence)
Italy