Package Insert: Information for the Patient

Naloxone B. Braun 0.4 mg/mL Injectable Solution and for Infusion

Naloxone Hydrochloride

Read the entire package insert carefully before starting to use the medication because it contains important information for you.

• Keep this package insert as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Naloxone B. Braun and how is it used

2. What you need to know before starting to use Naloxone B. Braun

3. How to use Naloxone B. Braun

4. Possible adverse effects

5. Storage of Naloxone B. Braun

6. Contents of the package and additional information

Naloxona B. Braun is a medication used to counteract the effects of opioid overdose, for example, morphine overdose.

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

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

No use Naloxona B. Braun

• Si esalérgico (hipersensible)al hidrocloruro de naloxona o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de tomar Naloxona B. Braun.

Se deberá tener especial cuidado

• Si tiene dependencia física a los opioides (por ejemplo morfina), o si ha recibido dosis altas de estas drogas (puede padecer síntomas de abstinencia intensos después de recibir Naloxona B. Braun a causa de una reversión demasiado rápida del efecto opiáceo; estos síntomas pueden ser una presión arterial demasiado alta, palpitaciones, dificultad grave para respirar o parada cardíaca).
• Si tiene algúnproblema cardíaco o circulatorio(porque es más probable que aparezcan efectos secundarios como tensión arterial alta o baja, palpitaciones o dificultades graves para respirar).

Uso de Naloxona B. Braun con otros medicamentos

Informe a su médico o farmacéutico si está utilizando o ha utilizado recientemente otros medicamentos.

• Si usted está tomandomedicación analgésicacomo labuprenorfina.El efecto analgésico puede ser incluso más intenso mientras recibe tratamiento con Naloxona B. Braun. Sin embargo, la reversión de los efectos no deseados, como la depresión respiratoria causada por buprenorfina es limitada.
• Si usted está tomandosedantesya que Naloxona B. Braun puede tener un efecto menos rápido.
• Si usted está tomando cualquier medicamento que pueda afectar a sucorazón o circulación(por ejemplo, medicamentos para la hipertensión como la clonidina), incluso los no recetados.

Uso de Naloxona B. Braun con alcohol

Informe a su médico si ha bebido alcohol. En los pacientes con intoxicación múltiple (con opiáceos y sedantes o alcohol), Naloxona B. Braun puede tener un efecto menos rápido.

Embarazo y lactancia

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Embarazo

No se dispone de información adecuada con respecto al uso de Naloxona B. Braun en las mujeres embarazadas. Durante el embarazo, su médico sopesará el beneficio de Naloxona B. Braun contra los posibles riesgos para el nonato. Naloxona B. Braun puede ocasionar síndrome de abstinencia en el recién nacido.

Lactancia

Se desconoce si Naloxona B. Braun pasa a la leche materna y no se ha determinado si los niños que toman leche materna se ven afectados por Naloxona B. Braun. Por lo tanto, no se recomienda la lactancia durante 24 h después del tratamiento.

Conducción y uso de máquinas

Después de haber recibido Naloxona B. Braun para revertir los efectos de los opiáceos, no debe conducir, utilizar maquinaria, ni realizar ninguna otra actividad que requiera esfuerzo físico o mental durante un plazo mínimo de 24 horas, puesto que es posible que los efectos de los opiáceos recurran.

Los pacientes con dietas pobres en sodio deben tener en cuenta que este medicamento contiene88.5 mg (3.8 mmol) de sodiopor dosis diaria máxima.

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 kg of body weight, if necessary, additional injections of the same dose may be administered.

Diagnosisand treatmentof 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 kg of body weight,if an additional dose is necessary, the dose may be increased in the next injection to 0.1 mg per kg

Reversal of undesired effects of opioids 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 undesired effects of opioids (in adults, children, and also in newborns), patients are monitored to ensure that the desired effect of Naloxona B. Braun is produced. If necessary, additional doses may be administered every 2 hours.

In elderly patients with heart problems or circulation issues or those receiving medications that may cause circulation or heart disorders (e.g. cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin) Naloxona B. Braun will be used with caution as severe adverse effects such as rapid heart rate (ventricular tachycardia) and fibrillation have been reported.

If you feel that the effect of Naloxona B. Braun is too intense or too weak, tell your doctor.

Administration form

Naloxona B. Braun 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). Naloxona B. Braun will be administered by your anesthesiologist or an experienced doctor.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

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

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

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

• Fast heart rate

Not frequent (can affect up to 1 in 100 people):

• Changes in the way your heart beats, slow heart rate

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

• Seizures

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

• Nausea

Frequent (can 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)

Not frequent (can affect up to 1 in 100 people):

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

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

• Tension

Very rare (can 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the ampule label and the packaging. The expiration date is the last day of the month indicated.

Store the ampules in the outer packaging to protect them from light.

Store below 25 °C.

Store diluted solutions below 25 °C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Naloxona B. Braun

The active ingredient is hydrochloride of naloxone.

Each ampoule with 1 ml contains 0.4 mg of hydrochloride of naloxone (as naloxone hydrochloride dihydrate).

The other components are sodium chloride, diluted hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Naloxona B. Braunis a transparent and colorless solution, in colorless glass ampoules containing 1 ml of injectable or infusion solution.

Package sizes: 5 and 10 ampoules

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212- Melsungen

Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

Manufacturer responsible:

Hameln Pharmaceuticals GmBH

Langes Feld 13

31789 - Hameln

Germany

or

B BRAUN MEDICAL S.A.
Ronda de los Olivares, Parcela 11, Industrial Estate Los Olivares
23009 - Jaén (Jaén)

Spain

For more information about this medicine, please contact the local representative of the marketing authorization holder:

B. BRAUN MEDICAL, S.A.

Ctra. de Terrassa, 121.

08191 – Rubi (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:March 2018.

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices. http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Expiry date after first opening of the package

After the first opening of the package, the medicine must be used immediately.

Expiry date after dilution

The physical-chemical stability of the diluted product has been demonstrated for 24 hours below 25°C.

From a microbiological point of view, the dilutions must be used immediately. If they are not used immediately, the storage times in use and the conditions before use are the responsibility of the user and are normally not extended beyond 24 hours at a temperature of 2 to 8°C, unless the dilution was made in controlled and validated aseptic conditions.

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

It is recommended not to mix the infusions of Naloxona B. Braun with preparations containing bisulfite, metabisulfite, long-chain anions or high molecular weight anions, or solutions with alkaline pH.

This medicine is for single use.

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