Fomed 0.4 mg/ml solution for injection and infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fomed 0.4 mg/ml solution for injection and infusion EFG

Naloxone hydrochloride

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fomed is and what it is used for

Fomed is a medicine used to counteract the effects of opioid overdose, for example, morphine overdose.

Fomed is used to reverse the unwanted effects of opioids, counteracting central nervous system and respiratory depression (difficulty breathing), which can be life-threatening.

Fomed is also used to diagnose acute opioid overdose or poisoning. If a woman has received analgesic medications during childbirth, the newborn may be treated with Fomed to reverse the unwanted effects of opioids, for example, if experiencing breathing difficulties or central nervous system depression.

2. What you need to know before using Fomed

Do not use Fomed:

• if you are allergic to naloxone hydrochloride or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Fomed.

Special caution is needed:

• If you have physical dependence on opioids (e.g., morphine), or if you have received high doses of these drugs (you may experience severe withdrawal symptoms after receiving Fomed due to too rapid reversal of opioid effects; these symptoms may include high blood pressure, palpitations, severe breathing difficulties, or cardiac arrest).

• If you have any heart or circulatory problems (because side effects such as high or low blood pressure, palpitations, or severe breathing difficulties are more likely to occur).

Use of Fomed with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• If you are taking pain medication such as buprenorphine. The pain-relieving effect may be even stronger while receiving Fomed treatment. However, reversal of unwanted effects, such as respiratory depression caused by buprenorphine, is limited.
• If you are taking sedatives, as Fomed may act more slowly.
• If you are taking any medication that may affect your heart or circulation (e.g., antihypertensives such as clonidine), including non-prescription medicines.

Use of Fomed with food, drinks, and alcohol

Inform your doctor if you have consumed alcohol. In patients with multiple intoxication (opioids and sedatives or alcohol), Fomed may act more slowly.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is insufficient information regarding the use of naloxone in pregnant women. During pregnancy, your doctor will weigh the benefits of naloxone against the potential risks to the unborn child. Naloxone may cause withdrawal syndrome in the newborn.

Breastfeeding

It is unknown whether naloxone passes into breast milk, and it has not been established whether breastfed infants are affected by naloxone. Therefore, breastfeeding is not recommended for 24 hours after treatment.

Driving and using machines

After receiving naloxone to reverse the effects of opioids, you must not drive, operate machinery, or perform any other activity requiring physical or mental effort for at least 24 hours, as the effects of opioids may recur.

Fomed contains sodium.

This medicine contains less than 1 mmol (23 mg) per 1 ml; therefore, it is essentially “sodium-free”.

3. How to use Fomed

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended doses to be administered

To reverse the unwanted effects of opioids

Adults: 0.1 to 0.2 mg; if necessary, additional injections of 0.1 mg may be given.

Children: 0.01 to 0.02 mg per kg of body weight; if necessary, additional injections of the same dose may be administered.

Diagnosis of opioid overdose or poisoning

Adults: 0.4 mg to 2 mg; if necessary, injections may be repeated at intervals of 2 to 3 minutes. The maximum dose of 10 mg must not be exceeded.

Children: 0.01 mg per kg of body weight; if necessary, an additional injection of 0.1 mg per kg may be administered.

Reversal of unwanted opioid effects in newborns whose mothers have received opioids

0.01 mg per kg of body weight; if necessary, additional injections may be administered.

To reverse the unwanted effects of opioids (in adults, children, and also in newborns), patients are monitored to ensure the desired effect of naloxone hydrochloride is achieved. If necessary, additional doses may be administered every one to two hours.

In elderly patients with heart or circulation problems, or in those receiving medications that may cause circulatory or cardiac disorders (e.g., cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin), naloxone hydrochloride should be used with caution, as serious adverse effects such as rapid heartbeat (ventricular tachycardia) and fibrillation have occurred.

If you feel that the effect of naloxone hydrochloride is too strong or too weak, tell your doctor.

Method of administration

Naloxone hydrochloride will always be administered by intravenous or intramuscular injection (into a vein or into a muscle), or, after dilution, as an intravenous infusion (over a prolonged period).

Naloxone hydrochloride will be administered by your anesthesiologist or by a doctor with experience. For more information, see below in the section “This information is intended exclusively for healthcare professionals”.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

It may be difficult to determine which adverse effects are due to naloxone hydrochloride, as it is always administered after other medicines have been used.

The following adverse effects may be serious. If you experience any of the following, consult a doctor immediately:

Frequent (may affect up to 1 in 10 people):

• Rapid heartbeat.

Uncommon (may affect up to 1 in 100 people):

• Changes in heart rhythm, slow 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, hives, runny nose or cold-like symptoms, difficulty breathing, angioedema (severe swelling)), anaphylactic shock.
• Fibrillation, cardiac arrest.
• Fluid in the lungs (pulmonary edema).

Other adverse effects include:

Very frequent (may affect more than 1 in 10 people):

• Nausea.

Frequent (may affect up to 1 in 10 people):

• Dizziness, headache.
• Increased or decreased blood pressure (may cause headache or dizziness).
• Vomiting.
• If a very high dose is administered after surgery, you may feel agitated and experience pain (due to reversal of the analgesic effects of previously administered medicines, as well as reversal of their effects on respiration).

Uncommon (may affect up to 1 in 100 people):

• Involuntary tremors, sweating.
• Diarrhea, dry mouth.
• Overbreathing (hyperventilation).
• Irritation of blood vessel walls (after IV administration); local irritation and inflammation (after IM administration).

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

• Tension.

Very rare (may affect up to 1 in 10,000 people):

• Skin discoloration and lesions (erythema multiforme).

Chills, restlessness, and anxiety have occasionally been reported.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Fomed Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store the ampoules in the outer packaging to protect them from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fomed

• The active substance is naloxone hydrochloride. Each 1 ml ampoule contains 0.4 mg of naloxone hydrochloride (as naloxone hydrochloride dihydrate).
• The other components are sodium chloride, edetate disodium, hydrochloric acid, and water for injections.

Appearance of the product and contents of the pack

Fomed is a clear, colourless or almost colourless solution.

Clear glass ampoules in thermoformed PVC trays, sealed with a PE foil and packaged in a cardboard box.

Pack sizes of 5 or 10 ampoules of 1 ml.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer

Medochemie Ltd,

Ampoule Injectable Facility

48 Iapetou Street,

Agios Athanassios Industrial Area,

4101 Agios Athanassios, Limassol

Cyprus

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Date of the most recent review of this leaflet: March 2025

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This information is intended for healthcare professionals only:

Dosage

Reversal of total or partial CNS depression, particularly respiratory depression caused by natural or synthetic opioids

Adults

The dose should be individualized for each patient to achieve optimal respiratory response while maintaining adequate analgesia. Generally, an intravenous (IV) injection of 0.1 to 0.2 mg of naloxone hydrochloride (approximately 1.5 to 3 μg/kg) is sufficient. If necessary, additional IV injections of 0.1 mg may be administered at 2-minute intervals until satisfactory respiration and consciousness are achieved. An additional dose may be required within 1 to 2 hours, depending on the type of opioid involved (short-acting or slow-release), the amount administered, and the timing and route of administration. Naloxone may also be administered as an intravenous infusion.

Infusion:

The duration of action of some opioids exceeds that of a single IV bolus of naloxone hydrochloride. Therefore, in cases where opioid-induced depression is confirmed or suspected, naloxone hydrochloride should be administered as a continuous intravenous infusion. The infusion rate must be individually adjusted based on the patient's response to the IV bolus and to the IV infusion. Continuous IV infusion should be used with caution, and respiratory support should be considered if necessary.

Paediatric population

Initially, 0.01 to 0.02 mg of naloxone hydrochloride per kg administered intravenously, repeated at 2- to 3-minute intervals until satisfactory respiration and consciousness are achieved. Additional doses may be required at 1- to 2-hour intervals, depending on the patient's response and the dose and duration of action of the opioid administered.

Diagnosis of suspected opioid overdose or acute opioid intoxication

Adults

The initial dose is generally 0.4 to 2 mg of naloxone hydrochloride administered intravenously. If the desired improvement in respiratory depression is not achieved immediately after IV administration, the injection may be repeated at 2- to 3-minute intervals.

Naloxone hydrochloride may also be administered intramuscularly (initial dose generally 0.4 to 2 mg) if IV administration is not feasible. If 10 mg of naloxone hydrochloride does not produce significant improvement, this suggests that the depression is entirely or partially due to conditions or substances other than opioids.

Paediatric population

The usual initial dose is 0.01 mg of naloxone hydrochloride per kg administered intravenously. If a satisfactory clinical response is not obtained, an additional injection of 0.1 mg/kg may be given. Depending on the individual patient, an IV infusion may also be required. If IV administration is not possible, naloxone hydrochloride may be administered intramuscularly (initial dose 0.01 mg/kg), divided into multiple doses.

Reversal of respiratory and CNS depression in the newborn whose mother has received opioids

The usual dose is 0.01 mg of naloxone hydrochloride per kg administered intravenously. If respiratory function does not improve to a satisfactory level with this dose, the injection may be repeated at 2- to 3-minute intervals. If IV administration is not possible, naloxone hydrochloride may also be administered intramuscularly (initial dose 0.01 mg/kg).

Elderly patients

In elderly patients with pre-existing cardiovascular disease or those receiving potentially cardiotoxic medications, naloxone hydrochloride should be used with caution, as serious cardiovascular adverse effects such as ventricular tachycardia and fibrillation have been reported in postoperative patients following administration of naloxone hydrochloride.

Method of administration

This medicinal product may be administered by intravenous (IV) or intramuscular (IM) injection, subcutaneously (s.c.), or as an intravenous infusion.

IM administration of naloxone hydrochloride should only be used when IV administration is not feasible.

The fastest onset of action is achieved with IV administration; therefore, this route is recommended in acute situations.

If naloxone is administered IM or s.c., it should be noted that the onset of action is slower than after IV injection. However, IM or s.c. administration results in a longer duration of effect compared to IV administration.

The onset of action ranges from 0.5 to 2 minutes after IV administration, and up to 3 minutes after IM or s.c. administration.

The duration of action is approximately 20 to 30 minutes after IV administration, and 2 hours 30 minutes to 3 hours after IM or s.c. administration.

It should be noted that IM doses are generally higher than IV doses and must be individually adjusted.

Since the duration of action of some opioids (e.g., dextropropoxyphene, dihydrocodeine, methadone) may exceed that of naloxone hydrochloride, patients must be continuously monitored and repeated doses administered if necessary.

Expiry after first opening of the container

After first opening of the container, the medicinal product should be used immediately.

Expiry after dilution

The physico-chemical stability of the diluted product has been demonstrated for 30 hours at temperatures below 25 °C.

From a microbiological standpoint, dilutions should be used immediately. If not used immediately, storage in use and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution was carried out under controlled and validated aseptic conditions.

For IV infusion, naloxone hydrochloride should be diluted only with 0.9% sodium chloride or 5% glucose. Five ampoules of naloxone hydrochloride (2 mg) in 500 ml correspond to 4 μg/ml.

It is recommended not to mix naloxone hydrochloride infusions with preparations containing bisulphite, metabisulphite, long-chain or high molecular weight anions, or alkaline pH solutions.

This medicinal product is for single use only.

Please inspect the medicinal product visually before use (including after dilution). Use only clear, colourless solutions that are practically free from particles.