Flumazenil b.braun 0.1 mg/ml solution for injection

Patient Leaflet: Information for the User

Flumazenil B. Braun, 0.1 mg/ml, solution for injection
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• Speak to your doctor or pharmacist if you need advice or further information.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• It may harm someone else, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet Contents

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

Flumazenil B. Braun is an antidote for a specific group of medicines called benzodiazepines. Benzodiazepines have calming, sleep-inducing, and muscle-relaxing effects. They are used to induce sleep and relieve anxiety. Flumazenil B. Braun can completely or partially reverse these effects.
Therefore, Flumazenil B. Braun may be used:

• in anaesthesia, to reverse sedation following a surgical procedure or certain diagnostic tests;
• or in intensive care, for patients who have been treated with sedative medicines.

Flumazenil B. Braun may also be used in the diagnosis and treatment of benzodiazepine poisoning or overdose.
Flumazenil B. Braun can be used in children after the age of 1 year to reverse sedation induced by benzodiazepines used to help them sleep during a medical procedure.

2. Important information before using Flumazenil B. Braun

When not to use Flumazenil B. Braun

• if the patient is allergic to flumazenil or any of the other ingredients of this medicine (listed in section 6).
• In cases where benzodiazepines have been administered in potentially life-threatening situations (e.g. control of intracranial pressure or severe epileptic seizure).

Warnings and precautions
Special caution is required:

• in patients with epilepsy who have been treated with benzodiazepines for a long time. In such cases, administration of Flumazenil B. Braun may trigger seizures.
• in patients with severe brain injury (and/or unstable intracranial pressure), because Flumazenil B. Braun may increase intracranial pressure.
• in patients with liver disease. In such cases, the physician will carefully adjust the dose of Flumazenil B. Braun.
• in patients with a history of panic attacks, because Flumazenil B. Braun may provoke new attacks.
• in cases of preoperative stress or history of anxiety disorders. In such cases, the physician will carefully adjust the dose of Flumazenil B. Braun.
• after prolonged treatment with high doses of benzodiazepines due to the risk of withdrawal symptoms (Withdrawal symptoms are listed in section 4 "Possible side effects").
• in patients with alcohol or drug dependence. In such cases, the risk of tolerance to benzodiazepines and dependence on them may be higher.
• in patients with ischemic heart disease. In such cases, inform the physician, as he or she may decide to maintain sedation for a longer period.

For an appropriate period after administration of Flumazenil B. Braun, the patient's consciousness and vital functions (i.e. blood pressure, heart rate, respiratory rate) will be monitored. Since the effect of Flumazenil B. Braun is usually shorter than that of benzodiazepines, recurrence of sedation is possible. The patient will be closely observed, possibly in an intensive care unit, until the effect of Flumazenil B. Braun has completely subsided.
When Flumazenil B. Braun is used at the end of a surgical procedure to awaken the patient, this medicine should not be administered until the effect of muscle relaxants has worn off.
The physician should consider that postoperative pain may occur after major surgery before administering Flumazenil B. Braun.
If the patient does not awaken after administration of Flumazenil B. Braun, other causes should be considered, as Flumazenil B. Braun specifically reverses the effects of benzodiazepines only.
The physician should avoid rapid injection of Flumazenil B. Braun. In patients after long-term (chronic) treatment with benzodiazepines, rapid injection of high doses of Flumazenil B. Braun (greater than 1 mg) may cause withdrawal symptoms.
Flumazenil B. Braun is not recommended for the treatment of benzodiazepine dependence or withdrawal symptoms.
The physician should exercise caution when administering Flumazenil B. Braun in cases of poisoning with multiple drugs, including benzodiazepines and certain types of antidepressants (so-called tricyclic antidepressants such as imipramine, clomipramine, mirtazapine or mianserin).
The toxicity of these antidepressants may be masked by the protective effect of benzodiazepines (see also section 2 "Other medicines and Flumazenil B. Braun").
Symptoms of overdose with tricyclic antidepressants:

• dilated pupils, urinary retention, dry mouth.
• Severe or potentially life-threatening symptoms: agitation, breathing difficulties, seizures, cardiac disturbances, and coma.

Children
Children who have previously received midazolam should remain under close observation in an intensive care unit for at least 2 hours after administration of Flumazenil B. Braun.
Sedation or breathing difficulties may recur. In cases of sedation induced by other benzodiazepines, the observation period should be adjusted according to the expected duration of action of the administered drug.
Flumazenil B. Braun may be administered to children aged 1 year or younger only if the benefits of treatment outweigh the risks associated with its use.
Children should receive Flumazenil B. Braun only to reverse sedative effects.
There is insufficient data on other indications. This also applies to children under the age of 1 year.

Other medicines and Flumazenil B. Braun
Inform the physician about all medicines recently taken, including those available without a prescription.
Flumazenil B. Braun reverses the effects of all drugs acting via the benzodiazepine receptor. This includes drugs not belonging to the benzodiazepine class but having the same mechanism of action, such as zopiclone (e.g. Zimovane), triazolopyridazines, and others.
Benzodiazepines may mask the toxic effects of certain psychotropic medicinal products (especially tricyclic antidepressants such as imipramine; see also section 2 "Warnings and precautions"). When using Flumazenil B. Braun in cases of accidental overdose, it should be considered that the toxic effects of such co-ingested drugs may become apparent or worsen as the effects of benzodiazepines wear off.
No interactions have been observed with other central nervous system depressants or alcohol.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a physician before using this medicine.
Due to insufficient clinical 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 administering 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 using Flumazenil B. Braun during breastfeeding in emergency situations.

Driving and operating machinery
After receiving Flumazenil B. Braun to reverse the sedative effects of benzodiazepines, patients must not drive, operate machinery, or engage in any other activities requiring physical or mental alertness 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 injection solution, meaning the medicine is essentially "sodium-free".

3. How to use Flumazenil B. Braun

Flumazenil B. Braun is administered by an anesthesiologist or experienced physician. Flumazenil B. Braun
is given as an intravenous injection (administration into a vein) or as a diluted solution for intravenous infusion
(slow administration into a vein).
Flumazenil B. Braun may be used simultaneously with other agents for the restoration of
vital functions.
The following dosage is recommended:

Every 6 hours, the infusion should be interrupted to check whether drowsiness recurs.
Infants, young children, children and adolescents (from completed 1st year of life to 17 years of age)
Reversal of sedative effects with preservation of consciousness
Dosage:
An intravenous dose of 0.01 mg/kg body weight (up to 0.2 mg) administered over 15 seconds. If an adequate level of consciousness has not been restored after 45 seconds, a further dose of 0.01 mg/kg body weight (up to 0.2 mg) may be administered.
If necessary, repeat injections every 60 seconds (up to a maximum of 4 times), up to a maximum total dose of 0.05 mg/kg body weight or 1 mg, whichever is lower.
Neonates, infants and young 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 may be administered to children under 1 year of age only when the potential benefits to the patient outweigh the possible risks (see also section 2 "Warnings and precautions, Children").

Patients with renal or hepatic impairment
In patients with impaired liver function, elimination of Flumazenil B. Braun may be delayed; therefore, careful dose adjustment is recommended.
Dose adjustment is not required in patients with impaired renal function.
In case of doubt, consult a physician or pharmacist.
Information for healthcare professionals is provided in one of the sections below.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may be serious. If any of the following adverse reactions occur,
stop taking the medicine and contact a doctor immediately:
Common (may occur in more than 1 in 10 patients):

• abnormally rapid and deep breathing (hyperventilation),
• speech disturbance.

Uncommon (may occur in more than 1 in 100 patients):

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

Unknown frequency (frequency cannot be estimated from available data):

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

Additional adverse reactions include:
Common (may occur in more than 1 in 10 patients):

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

Uncommon (may occur in more than 1 in 100 patients):

• restlessness and anxiety (after rapid injection, does not require treatment),
• awareness of heartbeat (palpitations after rapid injection, does not require treatment),
• hearing disturbances,
• cough, nasal congestion,
• skin redness,
• chills.

Unknown frequency (frequency cannot be estimated from available data):

• panic attacks in patients with a previous history of panic attacks,
• transient increase in blood pressure (after awakening),
• emotional instability,
• unusual crying, agitation, and aggressive behaviour.

In patients treated long-term with benzodiazepines, Flumazenil B. Braun may cause withdrawal symptoms (frequency unknown). Symptoms include: agitation, anxiety, emotional instability, disorientation, and sensory disturbances.
Generally, adverse reactions in children are usually similar to those occurring in adults. When Flumazenil B. Braun is used to reverse sedation in a child, excessive crying, agitation, and aggressive reactions may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Flumazenil B. Braun

Keep this 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 the specified month.
Do not store above 25°C.
The medicinal product is intended for single use only.
Storage period after first opening: the medicinal product should be used immediately.
Storage period after dilution: 24 hours.
Chemical and physical stability ensuring suitability for use is 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 duration and conditions ensuring suitability for use lies with the user and should not exceed 24 hours at a temperature between 2°C and 8°C, unless the concentrate has been diluted under controlled and validated aseptic conditions.
Before use, this solution should be carefully inspected. Do not use Flumazenil B. Braun if the solution is not clear, colourless, and free from particulate matter.
Any unused solution should be disposed of in accordance with local requirements.
Medicines must 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. Contents of the package and other information

What Flumazenil B. Braun contains
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 ingredients are: glacial 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, colourless solution for injection and concentrate for infusion, supplied in ampoules made of colourless glass.
The following pack sizes are available:
Cartons containing 5 or 10 ampoules with 5 ml of solution.
Cartons containing 5 or 10 ampoules with 10 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation 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 is authorised in the European Economic Area under the following names:
Austria Flumazenil B. Braun 0.1 mg/ml Injection solution and concentrate for
preparation of an infusion solution
Belgium Flumazenil B. Braun 0.1 mg/ml solution for injection
Germany Flumazenil B. Braun 0.1 mg/ml Injection solution and concentrate for
preparation of an infusion solution
Spain Flumazenil B. Braun 0.1 mg/ml solution for injection 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 Injection solution and concentrate for
preparation of an infusion solution
Netherlands Flumazenil B. Braun 0.1 mg/ml solution for injection
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

Information intended exclusively for medical professionals:

If Flumazenil B. Braun is to be administered by infusion, it must first be diluted.
Flumazenil B. Braun should only be diluted with sodium chloride solution 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 injection solutions has not been established.
The medicinal product must not be mixed with other medicinal products except those mentioned in this section.