FLUMAZENIL Fresenius Kabi 0.1 mg/ml Injectable

Introduction

Package Leaflet: Information for the User

Flumazenil Fresenius Kabi 0.1 mg/ml injectable EFG

flumazenil

Contents of the pack:

1. What is Flumazenil Fresenius Kabi and what is it used for
2. What you need to know before you use Flumazenil Fresenius Kabi
3. How to use Flumazenil Fresenius Kabi
4. Possible side effects
5. Storage of Flumazenil Fresenius Kabi
6. Contents of the pack and further information

1. What is Flumazenil Fresenius Kabi and what is it used for

Flumazenil is an antidote to completely or partially neutralize the central sedative effect of benzodiazepines (a specific group with sedative, sleep-inducing, muscle-relaxing, and anxiolytic properties).

Therefore, it should be used in anesthesia to wake you up after certain diagnostic tests or in intensive care if you have been kept sedated. Flumazenil can also be used for the diagnosis and treatment of poisoning or overdose with benzodiazepines.

Flumazenil is also used in children (over 1 year of age) to wake them up after they have been given medicines from the group of "benzodiazepines" to put them to sleep during a medical procedure.

2. What you need to know before you use Flumazenil Fresenius Kabi

Do not use Flumazenil Fresenius Kabi

• If you are allergicto the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If benzodiazepines have been administered to control a potentially life-threatening situation(e.g., control of intracranial pressure or a severe epileptic seizure).

potentially life-threatening

epileptic seizure.

• In mixed intoxicationswith benzodiazepines and certain types of antidepressants (the so-called tricyclic and tetracyclic antidepressants such as Imipramine, Clomipramine, Mirtazepine, or Mianserina). The toxicity of these antidepressants may be masked by the protective effects of benzodiazepines. If you present symptoms of a significant overdose of these antidepressants, Flumazenil Fresenius Kabi should not be used to reverse the effect of benzodiazepines.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Flumazenil Fresenius Kabi.

• If you do not wake up after administration of Flumazenil Fresenius Kabi, another cause should be considered because Flumazenil Fresenius Kabi specifically neutralizes the effects of benzodiazepines.
• If Flumazenil Fresenius Kabi is administered to you at the end of your operation to wake you up, it should not be administered until the effects of muscle relaxants have disappeared.
• Generally, the effect of Flumazenil is shorter than that of benzodiazepines, and therefore, sedation may reappear. Therefore, it is necessary for you to remain under observation, possibly in the intensive care unit, until all effects of Flumazenil have disappeared.
• If you have received high doses and/or long-term treatment (chronic) with benzodiazepines at any time within weeks before administration of flumazenil, you should not be given a rapid injection of high doses (above 1 mg) of Flumazenil, as it may cause withdrawal symptoms (see section 4. Possible side effects).
• If you have been treated for long periods with high doses of benzodiazepines, the benefits of using Flumazenil Fresenius Kabi should be weighed against the risk of withdrawal symptoms.
• Children who have been sedated previously with Midazolam. These children should be kept under observation in the intensive care unit for at least 2 hours after administration of Flumazenil Fresenius Kabi, as sedation may reappear or breathing difficulties may occur. In case of sedation by other benzodiazepines, monitoring should be adjusted according to the estimated duration.
• If you are epileptic and have received treatment with benzodiazepines for a long time, administration of flumazenil is not recommended, as it may cause seizures.
• Seizures or other toxic effects may be more severe in cases of overdose with multiple medications (e.g., benzodiazepine and tricyclic antidepressant poisoning).
• If you have a severe brain injury (and/or unstable intracranial pressure), you should be careful, as Flumazenil Fresenius Kabi may cause an increase in intracranial pressure.
• Flumazenil Fresenius Kabi is not recommended for the treatment of benzodiazepine addiction or benzodiazepine withdrawal symptoms.
• If you have had panic attacks before, Flumazenil Fresenius Kabi may cause new attacks.
• If you are dependent on alcohol or drugs, as you have a higher risk of tolerance and dependence.
• If you have liver problems, the elimination of Flumazenil may be delayed.

Pediatric population

• Children should only receive Flumazenil Fresenius Kabi after deliberate sedation. There are not enough data on any other indication. The same applies to children under 1 year of age.

Using Flumazenil Fresenius Kabi with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

When using flumazenil in case of accidental overdose, it should be taken into account that the toxic effects of other psychotropic medications (especially tricyclic antidepressants such as Imipramine) that are taken simultaneously may be increased with the decrease of the benzodiazepine effect.

No interaction has been observed with other central nervous system depressants.

Using Flumazenil Fresenius Kabi with alcohol

No known interactions between flumazenil and ethanol have been observed.

Pregnancy, breastfeeding, and fertility

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

Due to the lack of experience during pregnancy, Flumazenil Fresenius Kabi should only be used if the benefitto you is greater than the potential riskto the unborn child. Administration of Flumazenil during pregnancy is not contraindicated in an emergency situation.

It is not known whether flumazenil passes into breast milk. Therefore, breastfeeding should be avoided for 24 hoursafter administration of flumazenil.

Driving and using machines

For a period of 24 hours after administration of flumazenil to reverse the sedative effects of benzodiazepines, do not drive, do not use any machine, or perform any other activitythat requires mental concentration, as sedation may reappear.

Flumazenil Fresenius Kabi contains sodium

This medicine contains less than 1 mmol (or 23 mg) of sodium per 5 ml ampoule, so it is essentially "sodium-free".

This medicine contains 37 mg of sodium (main component of table salt) per 10 ml ampoule, equivalent to 1.9% of the maximum daily intake of 2 g of sodium recommended for an adult.

3. How to use Flumazenil Fresenius Kabi

Flumazenil is administered by intravenous injection(into a vein) or diluted as an intravenous infusion(over a longer period).

Flumazenil should be administered by an anesthesiologist or a doctor with experience. Flumazenil can be used simultaneously with other measures for recovery of consciousness.

This medicine is for single use only. Any remaining solution should be discarded. The solution should be inspected visually before use. It should only be used if the solution is clear, colorless, and practically free of particles.

The recommended dose is as follows:

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

In patients with impaired liver function, the elimination of flumazenil may be slower, and therefore, careful dose assessmentis recommended.

No dose adjustment is requiredin patients with impaired renal function.

Use in children

Children under 1 year of age:

There are not enough data on the use of flumazenil in children under 1 year of age. Therefore, flumazenil should only be administered in children under 1 year of age if the potential benefitsto the patient outweigh the possible risk.

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

For information for healthcare professionals, see the relevant section below.

4. Possible side effects

Like all medicines, Flumazenil Fresenius Kabi can cause side effects, although not everybody gets them.

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

Nausea

Common (may affect up to 1 in 10 people)

Hypersensitivity reactions (allergic reactions), anxiety (after rapid injection, does not require treatment), emotional lability, insomnia, somnolence, dizziness, headache, nervousness (after rapid injection, does not require treatment), tremor or shivering (chills), dry mouth, hyperventilation, speech disorders, subjective skin sensations (e.g., cold, heat, tingling, pressure, etc.) in the absence of stimulation (paresthesia), double vision, strabismus (squinting), increased tearing, palpitations (after rapid injection, does not require treatment), flushing, orthostatic hypotension, transient increase in blood pressure (upon awakening), sweating, fatigue, pain at the injection site.

Uncommon (may affect up to 1 in 100 people)

Fear (after rapid administration; does not require treatment), seizures (in patients with epilepsy or severe hepatic impairment, mainly after long-term treatment with benzodiazepines or multiple drug abuse), abnormal hearing, increased or decreased heart rate, premature heartbeat (extrasystole), breathing difficulties, cough, nasal congestion, chest pain, tremors (after rapid injection, does not require treatment).

Frequency not known (cannot be estimated from the available data)

Withdrawal symptoms (see below); panic attacks (in patients with a history of panic attacks), abnormal crying, nervousness, aggressive reactions, severe allergic reactions (anaphylaxis).

If you have been treated for long periods with benzodiazepines, flumazenil may induce withdrawal symptoms. The symptomsare: tension, nervousness, anxiety, emotional lability, confusion, hallucinations, tremor or shivering (chills), and seizures.

In general, the side effectsin childrendo not differ much from those in adults. When Flumazenil Fresenius Kabi is used to reverse sedation in children, abnormal crying, nervousness, and aggressive reactions have been observed.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flumazenil Fresenius Kabi

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 and carton. The expiry date is the last day of the month stated.

Do not store above 25°C.

This medicine is for single use only.

Shelf life after opening: the medicine should be used immediately.

Shelf life after dilution: 24 hours.

Chemical and physical stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage time and conditions are the responsibility of the user and should not exceed 24 hours at 2-8°C, unless the dilution has been made in aseptic controlled and validated conditions.

Do not use this medicine if the solution is not clear and free of particles.

Any remaining solution should be disposed of according to local requirements.

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

6. Container Content and Additional Information

Composition of Flumazenil Fresenius Kabi

The active ingredientis flumazenil.

Each milliliter contains 0.1 mg of flumazenil.

Each 5 ml ampoule contains 0.5 mg of flumazenil.

Each 10 ml ampoule contains 1.0 mg of flumazenil.

The other componentsare disodium edetate, glacial acetic acid, sodium chloride,

4% sodium hydroxide solution, water for injection.

Appearance of the Product and Container Content

Flumazenil Fresenius Kabi is a clear and colorless solution for injection or concentrate for solution for perfusion, packaged in clear glass ampoules.

It is available in the following formats:

Cardboard boxes with 5 or 10 ampoules containing 5 ml of solution.

Cardboard boxes with 5 or 10 ampoules containing 10 ml of solution.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Fresenius Kabi España S.A.U.

Marina 16-18,

E-08005 Barcelona

Manufacturer: Fresenius Kabi Austria GmbH

Hafnerstraße 36

A – 8055 Graz

Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:March 2021

This information is intended only for healthcare professionals:

Details on storage conditions can be found in section 5.

Storage of Flumazenil Fresenius Kabi

When Flumazenil Fresenius Kabi is used by perfusion, it must be diluted before use. Flumazenil should only be diluted with sodium chloride 9 mg/ml (0.9% p/v) solution, glucose 50 mg/ml (5% p/v) solution, or sodium chloride 4.5 mg/ml (0.45% p/v) + glucose 25 mg/ml (2.5% p/v) solution. The compatibility between flumazenil and other solutions for injection has not been established.

This medicinal product should not be mixed with other medicinal products except those mentioned in this section.

For more information on dosing instructions, see section 3 of the leaflet.