FOMED 0.4 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

2. What you need to know before you use Fomed

Do not use Fomed:

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

Warnings and precautions

Talk to your doctor or pharmacist before you start using Fomed.

You should be especially careful

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

• if you have any heart or circulation problems(as it is more likely that side effects such as high or low blood pressure, palpitations or severe breathing difficulties will occur).

Using Fomed with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

• if you are taking painkillers like buprenorphine. The analgesic effect may be even more intense while you are being treated with Fomed. However, the reversal of unwanted effects, such as respiratory depression caused by buprenorphine, is limited.
• if you are taking sedatives as Fomed may have a less rapid effect.
• if you are taking any medicine that may affect your heart or circulation (e.g. high blood pressure medicines like clonidine), even if they are not prescribed.

Using Fomed with food, drinks and alcohol

Tell your doctor if you have drunk alcohol. In patients with multiple intoxication (with opioids and sedatives or alcohol), Fomed may have a less rapid effect.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

There is limited information on the use of naloxone in pregnant women. During pregnancy, your doctor will weigh the benefits of naloxone against the possible risks for the unborn child. Naloxone may cause withdrawal syndrome in the newborn.

Breast-feeding

It is not known whether naloxone passes into breast milk and it has not been established whether breast-fed infants are affected by naloxone. Therefore, breast-feeding is not recommended for 24 hours after treatment.

Driving and using machines

After you have received naloxone to reverse the effects of opioids, do not drive, use machinery, or perform any other activity that requires physical or mental effort for at least 24 hours, as the effects of the opioids may recur.

Fomed contains sodium.

This medicine contains less than 1 mmol (23 mg) per 1 ml; i.e. it is essentially ‘sodium-free’.

3. How to use Fomed

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended doses that will be administered to you are

To reverse the unwanted effects of opioids

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

Children: 0.01 to 0.02 mg per kg 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 2 to 3 minute intervals. The maximum dose should not exceed 10 mg.

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

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

0.01 mg per kg 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 check that the desired effect of naloxone hydrochloride is achieved. If necessary, additional doses may be administered every 1 to 2 hours.

In elderly patients with heart or circulation problems or in those who are taking medicines that may cause circulation or heart disorders (e.g. cocaine, methamphetamine, tricyclic antidepressants, calcium channel blockers, beta-blockers, digoxin), naloxone hydrochloride will be used with caution as serious side effects such as rapid heart rate (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 intravenous infusion (over a long period of time).

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It may be difficult to know which side effects are caused by naloxone hydrochloride, as it is always administered after other medicines have been used.

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

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

• Rapid heart rate.

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

• Changes in the way your heart beats, 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 (hives, runny nose or cold, difficulty breathing, Quincke's edema (severe swelling)), anaphylactic shock.
• Fibrillation, cardiac arrest.
• Fluid in the lungs (pulmonary edema).

Other side effects include:

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

• Nausea.

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

• Dizziness, headache.
• Increased or decreased blood pressure (you may have a headache or feel dizzy).
• Vomiting.
• If a very high dose is administered after an operation, you may feel agitated and have pain (because the analgesic effects of the medicines you received will have been counteracted, as well as the effects on your breathing).

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

• Involuntary tremors, sweating.
• Diarrhoea, dry mouth.
• Over-breathing (hyperventilation).
• Irritation of the 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):

• Discoloration and skin lesions (erythema multiforme).

Chills, agitation and anxiety have also been reported.

Reporting of side effects

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

5. Storage of Fomed

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 label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions. Keep 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 no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Fomed Composition

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

Product Appearance and Container Contents

Fomed is a clear and colorless or almost colorless solution.

Transparent glass ampoules in molded PVC trays, sealed with a PE sheet and packaged in a cardboard box.

Packaging of 5 or 10 ampoules of 1 ml.

Only some package 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

You can request more information about this medication by contacting 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 last revision of this prospectus: March 2025

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This information is intended only for healthcare professionals:

Dosage

Total or partial reversal of CNS depression and especially respiratory depression caused by natural or synthetic opioids

Adults

The dose is determined for each patient to achieve an optimal respiratory response while maintaining adequate analgesia. Generally, an 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. Another additional injection may be necessary within 1 to 2 hours, depending on the type of active substance being antagonized (short-acting or slow-release), the amount administered, and the time and mode of administration. Naloxone can also be administered as an intravenous infusion.

Infusion:

The duration of the effect of some opioids is longer than that of the intravenous bolus of naloxone hydrochloride. Therefore, in cases where it has been proven that depression has been induced by such substances or if there is any reason to suspect it, naloxone hydrochloride should be administered as a continuous infusion. The infusion rate is determined individually for each patient, depending on the patient's response to the intravenous bolus and the patient's reaction to the intravenous infusion. The use of continuous intravenous infusion should be carefully considered, and if necessary, respiratory assistance should be employed.

Pediatric population

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

Diagnosis of suspected overdose or acute intoxication by opioids

Adults

The initial dose is generally 0.4 to 2 mg of naloxone hydrochloride by IV. If no improvement in respiratory depression is observed immediately after IV administration, injections can be repeated at 2 to 3 minute intervals.

Naloxone hydrochloride can also be injected intramuscularly (initial dose, generally 0.4 to 2 mg) if intravenous administration is not possible. If 10 mg of naloxone hydrochloride do not produce significant improvement, this suggests that the depression is caused completely or partially by other conditions or active substances distinct from opioids.

Pediatric population

The initial dose is usually 0.01 mg of naloxone hydrochloride per kg by IV. If no satisfactory clinical response is observed, an additional injection of 0.1 mg/kg can be administered. Depending on the individual patient, an IV infusion may also be necessary. If IV administration is not possible, naloxone hydrochloride can also be administered intramuscularly (initial dose of 0.01 mg/kg), divided into several doses.

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

The usual dose is 0.01 mg of naloxone hydrochloride per kg by IV. If respiratory function does not reverse to a satisfactory degree with this dose, the injection can be repeated at 2 to 3 minute intervals. If IV administration is not possible, naloxone hydrochloride can also be administered IM (initial dose of 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 occurred in postoperative patients after the administration of naloxone hydrochloride.

Method of administration

This medication can be injected intravenously (IV) or intramuscularly (IM) or subcutaneously (s.c.) or can be administered as an intravenous infusion.

The IM administration of naloxone hydrochloride should only be used in cases where IV administration is not possible.

The fastest effect is achieved through IV administration, so this method of administration is recommended in acute cases.

If naloxone is administered IM or s.c., it should be remembered that the onset of action is slower than after IV injection. However, IM or s.c. administration has a more prolonged effect than IV administration.

The onset of action varies from half to two minutes after IV administration to three minutes after IM or s.c. administration.

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

It should be noted that IM doses are generally higher than IV doses and should be adapted to each patient individually.

As the duration of the effect of some opioids (e.g., dextropropoxyphene, dihydrocodeine, methadone) may be longer than that of naloxone hydrochloride, patients should be kept under continuous surveillance, administering repeated doses if necessary.

Expiry after first opening of the container

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

Expiry after dilution

The physical-chemical stability of the diluted product has been demonstrated for 30 hours below 25 ºC.

From a microbiological point of view, the dilutions should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and would not normally be longer than 24 hours at a temperature of 2 to 8 ºC, unless the dilution has been made in controlled and validated aseptic conditions.

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

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

This medication is for single use.

Please inspect the medication visually before use (also after dilution). Use only clear and colorless solutions, practically free of particles.