Flumazenil Fresenius Kabi 0.1 mg/ml injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Flumazenil Fresenius Kabi 0.1 mg/ml solution for injection EFG

flumazenil

Contents of the leaflet:

1. What Flumazenil Fresenius Kabi is and what it is used for
2. What you need to know before using 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 other information

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

Flumazenil is an antidote used to reverse, either completely or partially, the central sedative effects of benzodiazepines (a specific group of drugs with sedative, sleep-inducing, muscle-relaxant, and anxiolytic properties).

Therefore, it should be used in anesthesia to awaken patients after certain diagnostic procedures or in intensive care settings when sedation has been administered. Flumazenil may also be used for the diagnosis and treatment of benzodiazepine intoxication or overdose.

Flumazenil is also used in children (over 1 year of age) to awaken them after administration of medicines from the "benzodiazepine" group to induce sleep during a medical procedure.

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

Do not use Flumazenil Fresenius Kabi

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

• If benzodiazepines have been administered to control a potentially life-threatening condition (e.g., control of intracranial pressure or a severe epileptic seizure).

• In cases of mixed intoxication involving benzodiazepines and certain types of antidepressants (so-called tricyclic and tetracyclic antidepressants such as Imipramine, Clomipramine, Mirtazepine or Mianserine). The toxicity of these antidepressants may be masked by the protective effects of benzodiazepines. If you show symptoms of significant overdose with these antidepressants, Flumazenil Fresenius Kabi must not be used to reverse the effects of benzodiazepines.

Warnings and precautions

Talk to your doctor or pharmacist before using Flumazenil Fresenius Kabi.

• If you do not wake up after administration of Flumazenil Fresenius Kabi, another cause should be considered, as Flumazenil Fresenius Kabi specifically counteracts the effects of benzodiazepines.
• If you are given Flumazenil Fresenius Kabi at the end of your surgery to wake you up, it should not be administered until the effects of muscle relaxants have worn off.
• Generally, the effect of Flumazenil is shorter than that of benzodiazepines, and therefore sedation may recur. Therefore, you must remain under observation, possibly in an intensive care unit, until all effects of Flumazenil have completely disappeared.
• If you have received high doses and/or long-term (chronic) treatment with benzodiazepines at any time within the weeks prior to flumazenil administration, a rapid injection of high doses (greater than 1 mg) of Flumazenil must not be given, as it may cause withdrawal symptoms (see section 4. Possible side effects).
• If you have been treated for prolonged periods with high doses of benzodiazepines, the benefits of using Flumazenil Fresenius Kabi should be weighed against the risk of withdrawal symptoms.
• Children previously sedated with Midazolam. These children must remain under observation in an intensive care unit for at least 2 hours after administration of Flumazenil Fresenius Kabi, as sedation or difficulty breathing may recur. In cases of sedation due to other benzodiazepines, monitoring should be adjusted according to the estimated duration of action.
• If you have epilepsy and have received long-term treatment with benzodiazepines, administration of flumazenil is not recommended, as it may trigger seizures.
• Seizures or other toxic effects may be more severe in cases of overdose involving multiple drugs (e.g., intoxication with benzodiazepines and tricyclic antidepressants).
• If you have a severe brain injury (and/or unstable intracranial pressure), caution is required, as Flumazenil Fresenius Kabi may cause an increase in intracranial pressure.
• Flumazenil Fresenius Kabi is not recommended for the treatment of benzodiazepine dependence or benzodiazepine withdrawal symptoms.
• If you have previously experienced panic attacks, Flumazenil Fresenius Kabi may trigger new attacks.
• If you are dependent on alcohol or medications, as you have an increased risk of tolerance and dependence.
• If you have liver problems, elimination of Flumazenil may be delayed.

Paediatric population

• Children should only receive Flumazenil Fresenius Kabi after deliberate sedation. There is insufficient 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 need to take any other medicines.

When using flumazenil in cases of accidental overdose, it should be considered that toxic effects of other psychotropic drugs (especially tricyclic antidepressants such as Imipramine) taken simultaneously may be increased as the effect of benzodiazepines decreases.

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

Use of Flumazenil Fresenius Kabi with alcohol

There are no known interactions between flumazenil and ethanol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Due to lack of experience during pregnancy, Flumazenil Fresenius Kabi should only be used if the benefit to you outweighs the potential risk to the unborn child. Administration of Flumazenil during pregnancy is not contraindicated in emergency situations.

It is not known whether flumazenil passes into breast milk. Therefore, breastfeeding is not recommended for 24 hours after administration of flumazenil.

Driving and use of 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 machinery, or perform any other physical activity or tasks requiring mental concentration, as sedation may recur.

Flumazenil Fresenius Kabi contains sodium

This medicine contains less than 1 mmol (or 23 mg) of sodium per 5 ml vial and is therefore considered essentially “sodium-free”.

This medicine contains 37 mg of sodium (the main component of table/cooking salt) per 10 ml vial, 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 the vein) or diluted as an intravenous infusion (over a longer period).

Flumazenil must be administered by an anaesthetist or a doctor with experience. Flumazenil may be used simultaneously with other measures to promote recovery of consciousness.

This medicine is for single use only. Any remaining solution must be discarded. The solution should be inspected visually before use. It should only be used if the

solution is clear, colourless, and practically free from 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 assessment is recommended.

Dose adjustments are not required in patients with altered kidney function.

Use in children

Children under 1 year of age:

There is insufficient data on the use of flumazenil Kai in children under 1 year of age. Therefore, flumazenil should only be administered to children under 1 year of age if the potential benefits to the patient outweigh the possible risks.

If you have any further questions about the use of this medicinal product, ask your doctor or

pharmacist.

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

4. Possible adverse effects

Like all medicines, Flumazenil Fresenius Kabi can have adverse effects, although not everyone will experience 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, difficulty falling asleep and staying asleep (insomnia), drowsiness (somnolence), dizziness, headache, nervousness (after rapid injection, does not require treatment), involuntary tremor or shivering (chills), dry mouth, abnormally rapid and deep breathing (hyperventilation), speech disorders, subjective skin sensations (e.g. cold, heat, tingling, pressure, etc.) in the absence of stimulation (paresthesia), double vision, strabismus (squinting), increased lacrimation (tear production), palpitations (after rapid injection, does not require treatment), skin redness (flushing), drop in blood pressure upon changing position from lying down to standing up, transient increase in blood pressure (upon waking), sweating, fatigue, pain at 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 benzodiazepine treatment or multiple drug abuse), abnormal hearing, increased or decreased heart rate, premature heartbeat (extrasystoles), difficulty breathing, cough, nasal congestion, chest pain, tremors (after rapid injection, does not require treatment).

Frequency not known (cannot be estimated from available data)
Withdrawal symptoms (see below); panic attacks (in patients with history of panic reactions), abnormal crying, nervousness, aggressive reactions, severe allergic reactions (anaphylaxis).

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

In general, adverse effects in children do not differ greatly 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 adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the label and on the carton. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

This medicine is for single use only.

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

Shelf life after dilution: 24 hours.

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

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage duration and conditions prior to use are the responsibility of the user and should not exceed 24 hours at 2–8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.

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

Any unused solution should be discarded according to local requirements.

Medicines should not be disposed of via wastewater or household waste. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Flumazenil Fresenius Kabi

The active substance is flumazenil.

Each millilitre 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 components are disodium edetate, glacial acetic acid, sodium chloride,
4% solution of sodium hydroxide, water for injections.

Appearance of the product and contents of the container

Flumazenil Fresenius Kabi is a clear, colourless solution for injection or
concentrate for solution for infusion, packaged in colourless glass ampoules.

It is available in the following pack sizes:

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi España S.A.U.

Marina 16-18,

E-08005 Barcelona, Spain

Manufacturer: Fresenius Kabi Austria GmbH

Hafnerstraβe 36

A – 8055 Graz, Austria

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

Date of the most recent review of this leaflet: March 2021

This information is intended for healthcare professionals only:

Details on storage conditions can be found in section 5.

Storage of Flumazenil Fresenius Kabi

When Flumazenil Fresenius Kabi is administered by infusion, it must be diluted prior to use. Flumazenil should only be diluted with sodium chloride 9 mg/ml (0.9% w/v) solution, glucose 50 mg/ml (5% w/v) solution, or sodium chloride 4.5 mg/ml (0.45% w/v) + glucose 25 mg/ml (2.5% w/v) solution. Compatibility of flumazenil with other injectable solutions has not been established.

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

For further information on dosage instructions, see section 3 of the package leaflet.