Leaflet: information for the patient

Fomed 0.4 mg/ml injectable solution and for infusion EFG

Naloxone hydrochloride

Read this leaflet carefully before starting to use this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Fomed is and for what it is used

2. What you need to know before starting to use Fomed

3. How to use Fomed

4. Possible side effects

5. Storage of Fomed

6. Contents of the pack and additional information

Fomedis a medication used to counteract the effects of opioid overdose, for example, morphine overdose.

Fomedis used to reverse the unwanted effects of opioids, counteract central nervous system depression and respiratory apparatus (breathing difficulties), which put the patient's life at risk.

Fomedis also used to diagnose acute opioid overdose or poisoning. If a woman has received analgesic medications during childbirth, the newborn can be treated with Fomedto reverse the unwanted effects of opioids, for example, if the newborn experiences respiratory problems or central nervous system depression.

No use Fomed:

• if you areallergicto hydrochloride naloxone or to any of the other ingredients ofthis medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fomed.

You should take special care

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

• If you have anyheart or circulatory problems(because it is more likely that side effects such as high or low blood pressure, palpitations, or severe breathing difficulties will occur).

Use of Fomedwithother medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication.

• If you are takingpain medicationsuch as buprenorphine.The analgesic effect may be even more intense while you receive treatment with Fomed. However, the reversal of unwanted effects, such as respiratory depression caused by buprenorphine is limited.
• If you are takingsedativessince Fomedmay have a less rapid effect.
• If you are taking any medication that may affect yourheart or circulation(for example, blood pressure medications such as clonidine), even non-prescription ones.

Use ofFomedwith food, drinks, and alcohol

Inform your doctor if you have consumed alcohol. In patients with multiple intoxication (with opioids and sedatives or alcohol), Fomedmay have a less rapid effect.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consultyour doctor or pharmacist before using this medication.

Pregnancy

No adequate information is available regarding the use of naloxone in pregnant women. During pregnancy, your doctor will weigh the benefits of naloxone against the possible risks to the fetus. Naloxone may cause withdrawal syndrome in the newborn.

Lactation

The passage of naloxone into breast milk is unknown, and it has not been determined whether infants who consume breast milk are affected by naloxone. Therefore, breastfeeding is not recommended for 24 hours after treatment.

Driving and operating machinery

After receiving naloxone to reverse the effects of opioids, you should not drive, operate machinery, or perform any other activity that requires physical or mental effort for a minimum period of 24 hours, as it is possible that the effects of opioids may recur.

Fomedcontainssodium.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medicationin case of doubt, consult your doctor or pharmacist again.

The recommended doses that will be administered to you are

For reversing the undesired 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 kilogram of body weight, if necessary, additional injections of the same dose may be administered.

Diagnosis of opioid overdose or intoxication

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

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

Reversal of undesired effects of opioids in newborns whose mothers have received opioids

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

To reverse the undesired effects of opioids (in adults, children, and also in newborns), patients are monitored to check that the desired effect of naloxone hydrochloride is produced. If necessary, additional doses may be administered every 2 hours.

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

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

Administration form

Naloxone hydrochloride will be administered to you always by intravenous or intramuscular injection (in a vein or in a muscle) or, after dilution, as an intravenous infusion (for a long period of time).Naloxone hydrochloride will be administered by your anesthesiologist or by an experienced doctor. For more information, see below in the section “This information is intended only for healthcare professionals”.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It may be difficult to know which side effects hydrochloride naloxone has, because it is always administered after other medicines have been used.

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

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

• Fast 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.
• Lung fluid (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 (may have a headache or feel dizzy).
• Vomiting.
• If a very high dose is administered after surgery, you may feel agitated and experience pain (because the analgesic effects of the received medicines will have been counteracted, as well as the effects on your breathing).

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

• Involuntary tremors, sweating.
• Diarrhea, dry mouth.
• Overbreathing (hyperventilation).
• Irritation of the walls of the blood vessels (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):

• Decoloration and skin lesions (erythema multiforme).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe labelafter CAD. The expiration date is the last day of the month indicated.

This medication does not requireany special temperatureof conservation. Store the ampoules in the outer packaging to protect them from light.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacisthow to dispose ofthepackaging and of themedicines that you no longerneed. This way, you will help protect the environment.

Composition of Fomed

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

Appearance of the product and contents of the package

Fomed is a transparent and colorless or almost colorless solution.

Glass ampoules in PVC molded 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Responsible for manufacturing

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., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

Last review date of this leaflet: October 2021

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This information is intended solely for healthcare professionals:

Dosage

Complete or partial reversal of central nervous system depression and especially respiratory depression caused by natural or synthetic opioids

Adults

The dose is determined for each patient to obtain 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 can be administered at 2-minute intervals until satisfactory breathing and consciousness are achieved. Another additional injection may be necessary within 1 to 2 hours, depending on the type of active substance to be antagonized (short-term effect or slow release), the amount administered, and the time and method of administration. Naloxone can also be administered as an intravenous infusion.

Infusion:

Since the effect of some opioids is more prolonged than the intravenous bolus of naloxone hydrochloride, in cases where it has been confirmed that the depression was induced by these substances or if there is any reason to suspect it, naloxone hydrochloride should be administered as a continuous intravenous 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. Carefully consider the use of continuous intravenous infusion and, if necessary, use respiratory assistance.

Pediatric population

Initially, 0.01 to 0.02 mg of naloxone hydrochloride per kg IV, at 2- to 3-minute intervals, until satisfactory breathing 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 opioid administered.

Diagnosis of suspected overdose or acute intoxication by opioids

Adults

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

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

Pediatric population

The usual initial dose is 0.01 mg of naloxone hydrochloride per kg IV. If satisfactory clinical response is not obtained, 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 central nervous system depression in the newborn whose mother has received opioids

The usual dose is 0.01 mg of naloxone hydrochloride per kg 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).

Geriatric patients

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

Administration form

This medication can be administered intravenously (IV), intramuscularly (IM), or as an intravenous infusion.

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

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

If naloxone is administered IM, it is essential to remember that the onset of action is slower than after IV injection; however, IM administration has a longer-lasting effect. The duration of action depends on the dose and route of administration of naloxone hydrochloride, ranging from 45 minutes to 4 hours.

Additionally, it should be noted that IM doses are generally higher than IV doses, and should be adapted to each individual patient.

It is also possible that the duration of effect of some opioids (e.g., dextropropoxyphene, dihydrocodeine, methadone) may be longer than that of naloxone hydrochloride, so patients should be continuously monitored, and additional doses administered as necessary.

Expiration date after the first opening of the package

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

Expiration date after dilution

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

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

Naloxone hydrochloride can be diluted only with sodium chloride 0.9% or glucose 5%. Five 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 anions, or high molecular weight anions, or solutions with alkaline pH.

This medication is for single use.

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