Naloxone hydrochloride Galenica Senese

Patient Information Leaflet: Information for the User

NALOXONE HYDROCHLORIDE GALENICA SENESE for adults 0.4 mg/ml injection solution, for children 0.04 mg/2 ml injection solution

Naloxone Hydrochloride
Equivalent Medicine
Please read all of this leaflet carefully before using this medicine as 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 others, even if their symptoms are the same as yours, as 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 GALENICA SENESE is and what it is used for
2. What you need to know before using NALOXONE HYDROCHLORIDE GALENICA SENESE
3. How to use NALOXONE HYDROCHLORIDE GALENICA SENESE
4. Possible side effects
5. How to store NALOXONE HYDROCHLORIDE GALENICA SENESE
6. Package contents and other information

1. What NALOXONE HYDROCHLORIDE GALENICA SENESE is and what it is used for

NALOXONE HYDROCHLORIDE GALENICA SENESE contains the active substance naloxone hydrochloride dihydrate, which belongs to the class of opioid antagonists. It works by blocking the effects of opioid substances such as morphine and heroin.
NALOXONE HYDROCHLORIDE GALENICA SENESE for adults is used to reverse the effects of acute intoxication due to overdose (overdose) of opioid derivatives (analgesics, narcotics).
NALOXONE HYDROCHLORIDE GALENICA SENESE for children 0.04 mg/2 ml is indicated for respiratory depression in newborns caused by maternal exposure to opioid derivatives before delivery.
This medicine is used only in emergency situations and by specialized medical personnel.

2. What you need to know before using NALOXONE HYDROCHLORIDE GALENICA SENESE

Do not use NALOXONE HYDROCHLORIDE GALENICA SENESE

• 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 GALENICA SENESE.
The symptoms of acute opioid poisoning (overdose) are:

• irregular breathing or periods of no breathing (respiratory depression);
• absence of reflexes (comatose state, precoma, or conscious 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 GALENICA SENESE 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 severe respiratory problems (laryngospasm);
• if you have heart or circulatory problems, or if you are taking other medicines that may be harmful to the heart.

After initial treatment, the patient must be transferred to hospital and closely monitored, as symptoms of poisoning may reappear.
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 do not have spontaneous breathing, but only as an additional 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 GALENICA SENESE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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 may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
There are no available data to determine the effect of this medicine during pregnancy and breastfeeding.
Driving and using machines
There are no available data to determine the effect of this medicine on the ability to drive vehicles or operate machinery.

3. How to use NALOXONE HYDROCHLORIDE GALENICA SENESE

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered to you by a doctor or another healthcare professional, 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.
For intravenous infusion (drip), NALOXONE HYDROCHLORIDE GALENICA SENESE may be diluted in parenteral solvents (for example, 0.9% sodium chloride solution 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 necessary, the medicine may be re-administered.

Use in adults
Treatment of opioid overdose (known or suspected)
The recommended initial dose is 0.4 mg/ml (1 vial).
If no improvement in breathing is observed after intravenous administration, the dose should be repeated 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 symptom improvement is achieved.
Within 1–2 hours after the first dose, repeat administration may be necessary, possibly via intramuscular route.

Excessive doses of naloxone may reduce the analgesic effect of opioids and increase blood pressure.
Too rapid reversal of opioid effects may cause nausea, vomiting, sweating, or rapid heartbeat (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 administration guidelines for adults.

If you use more NALOXONE HYDROCHLORIDE GALENICA SENESE than you should
This medicine will be administered by trained healthcare professionals, so overdose is unlikely.
In case of accidental ingestion/overdose of naloxone hydrochloride, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Following the instructions contained in this leaflet reduces the risk of side effects.
The following side effects may occur:

• nausea;
• tremor;
• sweating;
• increase or decrease in blood pressure;
• seizures, agitation;
• heart problems (fibrillation, cardiac arrest);
• fluid accumulation around the lung (pulmonary edema);
• increase in growth hormone levels;
• altered sensation in limbs (paraesthesiae);
• memory disturbances;
• breathing difficulties (dyspnoea, hypoxia and respiratory depression, hyperventilation);
• difficulty swallowing (dysphagia);
• hot flushes and flushing;
• increased urge to urinate (micturition);
• vomiting;
• rapid heartbeat (ventricular tachycardia);
• 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NALOXONE HYDROCHLORIDE GALENICA SENESE

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.
It is intended for single and uninterrupted administration; any remaining solution must not be used.
After first opening the packaging, the medicine must be used immediately for a single and uninterrupted administration.
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. Contents of the pack and other information

What NALOXONE HYDROCHLORIDE GALENICA SENESE contains
NALOXONE HYDROCHLORIDE GALENICA SENESE adults 0.4 mg/ml injectable solution:

• The active substance is naloxone hydrochloride dihydrate. Each 1 ml vial contains 0.4 mg of naloxone hydrochloride dihydrate.
• The other components are water for injections q.s., hydrochloric acid.

NALOXONE HYDROCHLORIDE GALENICA SENESE children 0.04 mg/2 ml injectable solution:

• The active substance is naloxone hydrochloric acid dihydrate. Each 2 ml vial contains 0.04 mg of naloxone hydrochloride dihydrate.
• The other components are water for injections q.s., hydrochloric acid.

Description of the appearance of NALOXONE HYDROCHLORIDE GALENICA SENESE and contents of the pack
NALOXONE HYDROCHLORIDE GALENICA SENESE adults 0.4 mg/ml injectable solution
Pack of 10 vials containing 1 ml of injectable solution.
NALOXONE HYDROCHLORIDE GALENICA SENESE children 0.04 mg/2 ml injectable solution
Pack of 5 vials containing 2 ml of injectable solution.

Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni d'Arbia (SI)
Italy