Introduction

Package Insert: Information for the User

Flumazenil B. Braun 0.1 mg/mL Injectable Solution EFG

Read this package insert carefully before you start taking this medicine 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, pharmacist, or nurse.
This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.

1. What is Flumazenil B. Braun and what is it used for

Flumazenil B. Braun is an antagonist agent (antidote) for a specific group of medications known as benzodiazepines. Benzodiazepines have sedative, sleep-inducing, and muscle-relaxing properties. They are used to induce sleep and calm anxiety. Flumazenil can completely or partially reverse these effects.

Flumazenil can be used

in anesthesia to wake a patient after surgery or certain diagnostic tests
if a patient has been kept under sedation in intensive care

Flumazenil can also be used for the diagnosis and treatment of benzodiazepine intoxications or overdoses.

Flumazenil is used in children over 1 year old to wake them up after receiving benzodiazepines to induce sleep during a medical procedure.

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

No use Flumazenil B. Braun

Si esalérgicoal flumazenil o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).
Si le han administrado benzodiazepinas para el controlde una situación de riesgo vital(por ejemplo control de la presión en el cerebro o un ataque epiléptico grave)

Advertencias y precauciones

Consulte a su médico, farmacéutico o enfermero antes de empezar a usar Flumazenil B. Braun.

Se debe tener especial cuidado

Si usted es epiléptico y ha recibido tratamiento con benzodiazepinas durante un largo periodo de tiempo, en este caso, la administración de flumazenil puede producir convulsiones.
Si tiene daño cerebral grave (y/o presión inestable en su cerebro), puesto que el Flumazenil B. Braun puede ocasionar un aumento de presión en su cerebro.
Si sufre alguna enfermedad hepática. Su médico ajustará cuidadosamente la administración de Flumazenil B. Braun.
Si ha tenido crisis de angustia en el pasado, puesto que el Flumazenil B. Braun puede provocar nuevos ataques.
Si está muy nervioso debido a su operación o si tiene un historial de ansiedad. Su médico ajustará cuidadosamente la administración de Flumazenil B. Braun.
Si se le ha tratado durante periodos largos con elevadas dosis de benzodiazepinas, puesto que se corre el riesgo de síntomas de abstinencia (los síntomas de abstinencia se detallan en la sección 4. “Posibles efectos adversos”).
Si es adicto al alcohol o los medicamentos. En este caso usted tiene un riesgo mayor de tolerancia a la benzodiacepina y a la dependencia.
Si tiene una enfermedad coronaria. Se debe informar a su médico para poder tenerle más tiempo bajo sedación.

Su estado de alerta y las constantes vitales (como la presión arterial, frecuencia cardíaca y la respiración) se controlarán durante un periodo de tiempo adecuado después de haber recibido flumazenil. Como la acción del flumazenil suele ser más corta que la de las benzodiazepinas,puede volver a presentarse sedación.Usted será vigilado atentamente, posiblemente en la unidad de cuidados intensivos, hasta que los efectos de Flumazenil hayan desaparecido por completo.

Si se le administra flumazenil al final de su operación para despertarle, no se le debe administrar hasta que los efectos de los relajantes musculares hayan desaparecido.

Su médico considerará que puede producirse dolor postoperatorio después de una cirugía mayor antes de darle Flumazenil B. Braun.

Si no se despiertadespués de la administración de de flumazenil, debe considerarse otra razón para ello, puesto que el flumazenil revierte específicamente los efectos de las benzodiazepinas.

Su médico evitará la inyección rápida de Flumazenil B. Braun.Si usted ha recibido un tratamiento prolongado (crónico) con benzodiazepinas, lainyección rápidade elevadas dosis de Flumazenil B. Braun (más de 1 mg) puede producirsíntomas de abstinencia.

Flumazenil B. Braun no se recomienda para el tratamiento de ladependencia a benzodiazepinaso de lossíntomas de abstinencia de benzodiazepinas.

Su médico le administrará Flumazenil B. Braun sólo con especial precaución en caso de intoxicaciones mixtas con benzodiazepinas y ciertos tipos de antidepresivos (los llamados antidepresivos cíclicos como imipramina, clomipramina, mirtazapina o mianserina). La toxicidad de estos antidepresivos se puede enmascarar por los efectos protectores de la benzodiazepina (ver también la sección 2 “Uso de Flumazenil con otros medicamentos”). Los signos de una sobredosis significativa con antidepresivos cíclicos incluyen:

dilatación de las pupilas, incapacidad para orinar, boca seca,
condiciones graves o potencialmente mortales como agitación, problemas respiratorios, convulsiones, problemas cardíacos y coma.

Niños

Los niños que han sido previamente sedados con midazolám deben ser estrechamente observados en las unidades de cuidados intensivos durante al menos 2 horas después de la administración de Flumazenil B. Braun. Puede darse una sedación repetida o dificultades respiratorias.

En caso de sedación mediante otras diazepinas, la monitorización se debe ajustar de acuerdo con su duración esperada.

Los niños de 1 año o menores solamente deben recibir el flumazenil si los riesgos se han sopesado cuidadosamente frente a las ventajas del tratamiento.

Los niños solo deben recibir el flumazenil después de unasedación intencionada. No se dispone de datos suficientes para cualquier otra indicación. Lo mismo aplica para los niños menores de 1 año.

Uso de Flumazenil B. Braun con otros medicamentos

Informe a su médico o farmacéutico si está utilizando o ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento.

El flumazenil contrarresta el efecto de todos los medicamentos que actúan a través del receptor de las benzodiacepinas. Esto incluye a los medicamentos que no pertenecen al grupo de las benzodiacepinas pero que tienen su mismo principio activo, como la zopiclona (como el Zimovane), triazolopiridazina y otros.

Las benzodiazepinas pueden enmascarar los efectos tóxicos de ciertos medicamentos psicotrópicos (especialmente antidepresivos tricíclicos como la imipramina, ver también la sección 2 “Advertencias y precauciones”. Cuando se utiliza el flumazenil en casos de una sobredosis accidental debe tenerse en cuenta que los efectos tóxicos de dichos medicamentos tomados de forma concomitante, pueden incrementar con la desaparición del efecto benzodiazepínico.

No se ha observado interacción con alcohol u otros depresores del sistema nervioso central.

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.

Debido a la insuficiente experiencia durante el embarazo sólo debe utilizarse Flumazenil B. Braun con precaución y solo si elbeneficiopara usted es superior al potencialriesgopara el feto. La administración de Flumazenil durante el embarazo no está contraindicada en una situación de emergencia.

No se conoce si Flumazenil se excreta en leche materna.No debe amamantar durante 24 horasdespués de la administración de Flumazenil B. Braun. La administración de Flumazenil B. Braun durante la lactancia no está contraindicada en una situación de urgencia.

Conducción y uso de máquinas

Después de recibir Flumazenil B. Braun para corregir los efectos sedantes de las benzodiazepinas, no puedeconducir, manejarmaquinariao iniciar cualquier otraactividadque requiera esfuerzo físico o mental durante al menos 24 horas ya que puede volver a aparecer sedación.

Flumazenil B. Braun contiene sodio

Este medicamento contiene menos de 23 mg (1 mmol) de sodio por ml (solución inyectable), por lo que se considera esencialmente "exento de sodio".

3. How to use Flumazenil B. Braun

Flumazenil should be administered by your anesthesiologist or experienced doctor. Flumazenil B. Braun is administered asinjectionintravenously (into a vein) or diluted asinfusionintravenously (over a prolonged period)

Flumazenil may be used at the same time as other resuscitation measures.

The recommended dose is as follows:

Adults
Anesthesia	Intensive Care
Dosage level:
Initial dose: 0.2 mg administered intravenously over a period of 15 seconds	Initial dose: 0.3 mg administered intravenously
If necessary, an additional dose of 0.1 mg may be injected and repeated at intervals of 60 seconds, if the level of consciousness is not obtained at 60 seconds, up to a maximum dose of 1.0 mg.	If necessary, an additional dose of 0.1 mg may be injected and repeated at intervals of 60 seconds, if the level of consciousness is not obtained at 60 seconds, up to a maximum dose of 2.0 mg
The usual required dose ranges from 0.3 to 0.6 mg, but may vary depending on the patient's characteristics and the benzodiazepine used.	If somnolence is repeated, a second rapid injection may be administered. A useful intravenous infusion of 0.1-0.4 mg/h may be helpful. The infusion rate should be adjusted individually to achieve the desired level of consciousness.

The infusion should be interrupted every 6 hours to check if sedation is repeated.

Newborns, infants, and adolescents (1 to 17 years)

Correction of deliberate sedation

Dosage level:

Injection of 0.01 mg/kg of body weight (up to 0.2 mg) administered intravenously over a period of 15 seconds. If, after a waiting period of 45 seconds, the required level of consciousness is not obtained, a subsequent injection of 0.01 mg/kg (up to 0.2 mg) may be administered.

If necessary, repeated injections may be administered at intervals of 60 seconds (up to a maximum of 4 times) until a maximum dose of 0.05 mg/kg or 1 mg, whichever is the lesser dose.

Newborns, infants less than 1 year

There are not enough data on the use of flumazenil in children under 1 year.

Therefore, flumazenil should only be administered in children under 1 year if the potential benefits for the patient outweigh the possiblerisks(see also the section 2 “Warnings and precautions”).

Patients with renal (kidney) or hepatic (liver) dysfunction

In patients with liver dysfunction, flumazenil elimination may be delayed, and therefore acareful dose adjustmentis recommended.

In patients with kidney dysfunctionno dose adjustments are required.

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

For information for healthcare professionals, please see the corresponding section below.

4. Possible Adverse Effects

Like all medicines, Flumazenil B. Braun may cause side effects, although not everyone will experience them.

The following side effects may be serious. If you consider that any of the side effects you experience are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

abnormal rapid and deep breathing (hyperventilation)
speech disorders

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

slow or rapid heart rate, premature heartbeat (extrasystole)
difficulty breathing
chest pain

Frequency unknown(cannot be estimated from available data):

convulsions (in patients with epilepsy or severe liver failure, especially after long-term treatment with benzodiazepines or multiple drug abuse)
may cause allergic reactions, including severe allergic reactions related to anaphylaxis

Other side effects include:

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

agitation (after a rapid injection, no treatment required)
problems with falling asleep and staying asleep (insomnia), feeling sleepy (somnolence),
dizziness, headache,
involuntary trembling or shaking movements,
dry mouth,
subjective skin sensations (e.g., cold, heat, tingling, pressure, etc.) in the absence of stimulation (paresthesia),
double vision, strabismus (squint), increased tear production (excessive lacrimation),
sweating,
low blood pressure, orthostatic hypotension (low blood pressure when changing from a supine to an erect position),
uncomfortable feeling: vomiting (after surgery), hiccups,
fatigue,
pain at the injection site.

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

anxiety and fear (after a rapid injection, no treatment required),
awareness of heart rhythm (palpitations, which occur after a rapid injection, no treatment required),
abnormal hearing,
cough, nasal congestion
skin redness
chills

Frequency unknown(cannot be estimated from available data):

panic attacks in patients who have already shown anxiety reactions,
transient increase in blood pressure (on waking),
emotional lability
abnormal crying, agitation, and aggressive reactions.

If you are treated for prolonged periods with benzodiazepines, Flumazenil may inducewithdrawal symptoms (unknown frequency). Thesymptomsinclude: agitation, anxiety, emotional weakness, confusion, and abnormal sensory perception.

In general, theundesirable effectsinchildrenare generally similar to those in adults. When Flumazenil B. Braun is used to wake your child from sedation, abnormal crying, agitation, and aggressive reactions may occur.

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 not mentioned in this leaflet. You can also report them directly through the Spanish System for 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.

5. Conservation of Flumazenil B. Braun

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

Do not use Flumazenil B.Braun after the expiration date that appears on the label and on the box. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

This medication is for single use only.

Shelf life after the first opening of the container: the medication must be used immediately.

Shelf life after dilution: 24 hours.

Chemical and physical stability has been demonstrated during use for 24 hours at 25 ºC.

From a microbiological point of view, the product must be administered immediately. If it is not administered immediately, the storage times in use and the conditions before use are the responsibility of the user and, normally, would not be extended beyond 24 hours at a temperature of 2 to 8 ºC, unless the dilution was performed in controlled and validated aseptic conditions.

The solution must be visually inspected before use. Do not use Flumazenil B. Braun if the solution is not transparent, colorless, and free of particles.

Any unused solution must be disposed of in accordance with local requirements.

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

6. Contents of the packaging and additional information

Composition of Flumazenil B. Braun

Theactive ingredientis flumazenil.

Each milliliter contains 0.1 mg of flumazenil.

Each ampoule with 5 ml contains 0.5 mg of flumazenil.

Each ampoule with 10 ml contains 1.0 mg of flumazenil.

Theother componentsare: edetate disodium, glacial acetic acid, sodium chloride, 4% sodium hydroxide solution, and injection water.

Appearance of the product and contents of the package

Flumazenil B. Braun is a clear and colorless infusion solution in colorless glass ampoules.

The following package sizes are available:

Boxes with 5 or 10 ampoules containing 5 ml of solution.

Boxes with 5 or 10 ampoules containing 10 ml of solution.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen, Germany

Postal address:

34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

This medicinal product is authorized in the Member States of the EEA with the following names:

By the applicant B. Braun

Austria	Flumazenil B. Braun 0.1 mg/ml Injection Solution and Concentrate for the Preparation of an Infusion Solution
Belgium	Flumazenil B. Braun 0.1 mg/ml injection solution
Germany	Flumazenil B. Braun 0.1 mg/ml Injection Solution and Concentrate for the Preparation of an Infusion Solution
Spain	Flumazenil B. Braun 0.1 mg/ml injectable solution EFG
Finland	Flumazenil B. Braun 0.1 mg/ml injection solution, liquid
Iceland	Flumazenil B.Braun 0.1 mg/ml injection solution
Italy	Flumazenil B. Braun 0.1 mg/ml injectable solution
Luxembourg	Flumazenil B. Braun 0.1 mg/ml Injection Solution and Concentrate for the Preparation of an Infusion Solution
Netherlands	Flumazenil B. Braun 0.1 mg/ml, injection solution
Poland	Flumazenil B. Braun 0.1 mg/ml injection solution
Portugal	Flumazenil B. Braun 0.1 mg/ml injectable solution
Sweden	Flumazenil B. Braun 0.1 mg/ml injection solution, solution

Date of the last review of this leaflet: 02/2018

The detailed information on this medicinal product 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 doctors or healthcare professionals:

If Flumazenil B. Braun is to be used for infusion, it must be diluted before the same. The Flumazenil must be diluted only with sodium chloride 9 mg/ml (0.9%) solution, 50 mg/ml (5%) glucose solution, or 4.5 mg/ml (0.45%) sodium chloride + 25 mg/ml (2.5%) glucose solution. The compatibility of Flumazenil with other injectable solutions has not been determined.

This medicinal product must not be mixed with other medicinal products other than those mentioned in this section.