Flumazenil B.braun 0,1 mg/ml roztvur do vstzhikivani

Patient Leaflet: User Information

Flumazenil B. Braun, 0.1 mg/ml, solution for injection

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you need advice or more information.
• This medicine has been prescribed specifically for you, do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get worse, or if you notice any not listed in the leaflet, tell your doctor or pharmacist.

Table of Contents of the Leaflet

• 1. What is Flumazenil B. Braun and what is it used for
• 2. Important information before using Flumazenil B. Braun
• 3. How to use Flumazenil B. Braun
• 4. Possible side effects
• 5. How to store Flumazenil B. Braun
• 6. Contents of the pack and other information

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

Flumazenil B. Braun is an antidote for a specific group of medicines called benzodiazepines. Benzodiazepines have a calming, sleep-inducing, and muscle-relaxing effect. They are used for sedation and calming in case of anxiety. Flumazenil B. Braun can completely or partially reverse these effects.

• in anesthesiology, to wake up after surgery or certain diagnostic tests.
• or in intensive care for patients who have been given sedatives.

Flumazenil B. Braun can also be used for diagnosis and treatment of benzodiazepine poisoning or overdose. Flumazenil B. Braun is used in children over 1 year of age to wake them up after benzodiazepines have been used to sedate them for a medical procedure.

2. Important information before using Flumazenil B. Braun

When not to use Flumazenil B. Braun

• In cases where benzodiazepines have been given in a life-threatening situation (e.g., control of intracranial pressure or severe seizure).

Warnings and precautions

Special caution is needed

• in patients with epilepsy, who have been treated with benzodiazepines for a long time. In this case, administration of Flumazenil B. Braun may cause a seizure.
• in cases of severe brain injury (and/or unstable intracranial pressure) because Flumazenil B. Braun may cause an increase in intracranial pressure.
• in cases of liver disease. In this case, the doctor will carefully adjust the dose of Flumazenil B. Braun.
• in cases of a history of panic attacks, as Flumazenil B. Braun may cause new attacks.
• in cases of preoperative stress or a history of anxiety. In this case, the doctor will carefully adjust the dose of Flumazenil B. Braun.
• in cases of long-term treatment with high doses of benzodiazepines due to the risk of withdrawal symptoms (withdrawal symptoms are listed in section 4 "Possible side effects").
• in cases of alcohol or drug dependence. In this case, the risk of benzodiazepine tolerance and dependence may be higher.
• in cases of ischemic heart disease. In this case, you should inform your doctor, as he may decide to extend the sedation.

After administration of Flumazenil B. Braun, the patient's consciousness and vital functions (i.e., blood pressure, heart rate, breathing rate) will be monitored for a suitable period. Since the effect of Flumazenil B. Braun is usually shorter than that of benzodiazepines, a return of sedation is possible. The patient will be closely monitored, possibly in an intensive care unit, until the effect of Flumazenil B. Braun has worn off.

Children

Children who have been given midazolam should be under close observation in an intensive care unit for at least 2 hours after administration of Flumazenil B. Braun. Sedation or respiratory difficulties may recur. In cases of sedation caused by other benzodiazepines, the observation phase for the patient should be adjusted according to the expected duration of action of the medicine. Flumazenil B. Braun can be given to children under 1 year of age only if the potential benefit outweighs the risk (see also section 2 "Warnings and precautions, Children").

• 1. year of age.

Other medicines and Flumazenil B. Braun

Tell your doctor about all the medicines you have taken recently, even those that are available without a prescription. Flumazenil B. Braun reverses the effects of all medicines that act on the benzodiazepine receptor. This includes medicines that are not benzodiazepines but have the same mechanism of action, such as zopiclone (e.g., zimovane), triazolopyridazine, and others. Benzodiazepines may mask the toxic effects of certain psychotropic medicines (especially tricyclic antidepressants, e.g., imipramine, see also section 2 "Warnings and precautions"). When using Flumazenil B. Braun in case of overdose, it should be taken into account that the toxic effects of such medicines taken at the same time may increase as the effect of benzodiazepines wears off.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Due to the lack of sufficient experience, Flumazenil B. Braun should be used during pregnancy with caution and only when the benefit to the patient outweighs the potential risk to the unborn child. There are no contraindications to the use of Flumazenil B. Braun during pregnancy in emergency situations. It is not known whether Flumazenil B. Braun passes into breast milk. Therefore, breastfeeding should be discontinued for 24 hours after administration of Flumazenil B. Braun. There are no contraindications to the use of Flumazenil B. Braun during breastfeeding in emergency situations.

Driving and using machines

After receiving Flumazenil B. Braun to reverse the effects of benzodiazepines, you should not drive vehicles, operate machinery, or engage in other activities that require physical or mental activity for at least 24 hours, as the sedative effect of benzodiazepines may return.

Flumazenil B. Braun contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ml of solution for injection, which means that the medicine is essentially sodium-free.

3. How to use Flumazenil B. Braun

Flumazenil B. Braun is administered by an anesthesiologist or an experienced doctor. Flumazenil B. Braun is given as an intravenous injection (into a vein) or as a diluted solution as an intravenous infusion (slow injection into a vein). Flumazenil B. Braun can be used at the same time as other agents to restore basic life functions. The recommended dose is:

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

Infants, small children, children, and adolescents (from 1 year to 17 years of age)

Reversal of sedative effects with maintenance of consciousness

Dose:

Intravenous injection of 0.01 mg/kg body weight (up to 0.2 mg) administered over 15 seconds. If an adequate level of consciousness is not achieved after 45 seconds, a further dose of 0.01 mg/kg body weight (up to 0.2 mg) can be administered. If necessary, injections can be repeated at 60-second intervals (up to 4 times), up to a maximum dose of 0.05 mg/kg body weight or 1 mg, whichever is lower.

Newborns, infants, and small children under 1 year of age

There is insufficient data on the use of Flumazenil B. Braun in children under 1 year of age. Therefore, Flumazenil B. Braun can be administered to children under 1 year of age only if the potential benefit outweighs the risk (see also section 2 "Warnings and precautions, Children").

• 1. year of age.

Patients with renal or hepatic impairment

In patients with impaired liver function, the elimination of Flumazenil B. Braun may be delayed, and therefore, careful dose adjustment is recommended. There is no need to adjust the dose in patients with impaired renal function. In case of doubt, consult your doctor or pharmacist. Information intended for healthcare professionals can be found in one of the sections below.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious. If you experience any of the following side effects, stop taking the medicine and tell your doctor immediately:

Common(may affect more than 1 in 10 people):

• abnormal rapid and deep breathing (hyperventilation),
• speech disorders.

Uncommon(may affect more than 1 in 100 people):

• slow or fast heart rate, extra heartbeats,
• breathing difficulties,
• chest pain.

Rare(cannot be estimated from the available data):

• seizures (in patients with epilepsy or severe liver failure, mainly after long-term treatment with benzodiazepines or drug abuse),
• may cause allergic reactions, including severe reactions related to allergic response (anaphylactic).

Additional side effects include:

Common(may affect more than 1 in 10 people):

• agitation (after rapid injection, does not require treatment),
• difficulty falling asleep and sleeping (insomnia), feeling of drowsiness (somnolence),
• dizziness, headache,
• involuntary trembling,
• dry mouth,
• subjective skin sensations (e.g., cold, heat, tingling, pressure, etc.) without stimulus (paresthesia),
• double vision, strabismus (strabismus), increased tear production (excessive lacrimation),
• excessive sweating,
• low blood pressure, drop in blood pressure when changing position from lying to standing (orthostatic hypotension),
• nausea: vomiting (after surgery), hiccups,
• feeling of fatigue,
• pain at the injection site.

Uncommon(may affect more than 1 in 100 people):

• anxiety and fear (after rapid injection, does not require treatment),
• feeling of heartbeat (after rapid injection, does not require treatment),
• hearing disorders,
• cough, nasal congestion,
• redness of the skin,
• chills.

Rare(cannot be estimated from the available data):

• panic attacks in patients who have previously had panic attacks,
• short-term increase in blood pressure (after waking up),
• emotional instability,
• unusual crying, agitation, and aggressive behavior.

In cases of long-term treatment with benzodiazepines, Flumazenil B. Braun may cause withdrawal symptoms (frequency not known). Symptoms include: agitation, anxiety, emotional instability, disorientation, and sensory disturbances. In general, side effects in children are similar to those in adults. When using Flumazenil B. Braun to wake up a child, excessive crying, agitation, and aggressive reactions may occur.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, ul. Ząbkowska 41, 03-736 Warsaw, Tel. (22) 4921 301, Fax. (22) 4921 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flumazenil B. Braun

Keep the medicine out of the sight and reach of children. Do not use Flumazenil B. Braun after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. The medicinal product is for single use only. Shelf life after first opening: the medicinal product should be used immediately. Shelf life after dilution: 24 hours. Chemical and physical stability, ensuring the quality of the product, was maintained for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the responsibility for the storage time and conditions that ensure the quality of the product lies with the user and should not exceed 24 hours at 2°C to 8°C, unless the concentrate has been diluted in controlled and approved aseptic conditions. Before use, the solution should be inspected visually. Do not use Flumazenil B. Braun if the solution is not clear, colorless, and free of precipitates. Unused solution should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Flumazenil B. Braun contains

The active substance is 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 ingredients are acetic acid, sodium chloride, disodium edetate, sodium hydroxide, 1N solution, water for injections.

What Flumazenil B. Braun looks like and contents of the pack

Flumazenil B. Braun is a clear and colorless solution for injection and concentrate for infusion in ampoules made of colorless glass. The following packs are available: cardboard boxes of 5 or 10 ampoules containing 5 ml of solution. Cardboard boxes of 5 or 10 ampoules containing 10 ml of solution. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

Tel. +49 5661/71-0 Fax +49 5661/71-4567 This medicinal product has been authorized in the Member States of the European Economic Area under the following names: Austria Flumazenil B. Braun 0.1 mg/ml Injektionslösung und Konzentrat zur Herstellung einer Infusionslösung Belgium Flumazenil B. Braun 0.1 mg/ml oplossing voor injectie Germany Flumazenil B. Braun 0.1 mg/ml Injektionslösung und Konzentrat zur Herstellung einer Infusionslösung Spain Flumazenil B. Braun 0.1 mg/ml solucion inyectable EFG Finland Flumazenil B.Braun 0.1 mg/ml injektioneste, liuos Iceland Flumazenil B. Braun 0.1 mg/ml stungulyf Italy Flumazenil B. Braun 0.1 mg/ml, soluzione iniettabile Luxembourg Flumazenil B. Braun 0.1 mg/ml Injektionslösung und Konzentrat zur Herstellung einer Infusionslösung Netherlands Flumazenil B. Braun 0.1 mg/ml oplossing voor injectie Poland Flumazenil B. Braun 0.1 mg/ml roztwór do wstrzykiwań Portugal Flumazenilo B. Braun 0.1 mg/ml solução injectável Sweden Flumazenil B.Braun 0.1 mg/ml injektionsvätska, lösning Date of last revision of the leaflet: 2023-05-02 -----------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

If Flumazenil B. Braun is to be used as an infusion, it should be diluted first. Flumazenil B. Braun should be diluted only with sodium chloride 9 mg/ml (0.9% w/v), glucose 50 mg/ml (5% w/v), or sodium chloride 4.5 mg/ml (0.45% w/v) + glucose 25 mg/ml (2.5% w/v). The compatibility of Flumazenil B. Braun with other solutions for injection has not been established. The medicinal product should not be mixed with other medicinal products except those mentioned in this section.