FLUMAZENIL B. BRAUN 0.1 mg/ml INJECTABLE SOLUTION
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How to use FLUMAZENIL B. BRAUN 0.1 mg/ml INJECTABLE SOLUTION
Introduction
Package Leaflet: Information for the User
Flumazenil B. Braun 0.1 mg/ml Solution for Injection EFG
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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Contents of the Package Leaflet:
- What is Flumazenil B. Braun and what is it used for
- What you need to know before you use Flumazenil B. Braun
- How to use Flumazenil B. Braun
- Possible side effects
- Storage of Flumazenil B. Braun
- 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 sedative, sleep-inducing, and muscle-relaxing properties. They are used to induce sleep and calm you if you are anxious. Flumazenil can completely or partially reverse these effects.
Flumazenil can be used
- in anesthesia to wake you up after surgery or certain diagnostic tests
- if you have been kept in a sedated state in intensive care
Flumazenil can also be used for the diagnosis and treatment of benzodiazepine overdoses or poisonings.
Flumazenil is used in children over 1 year of age to wake them up after they have received benzodiazepines to induce sleep during a medical procedure.
2. What you need to know before you use Flumazenil B. Braun
Do not use Flumazenil B. Braun
- If you are allergicto flumazenil or any of the other ingredients of this medicine (listed in section 6).
- If you have been given benzodiazepines to control a life-threatening situation(e.g., control of brain pressure or a severe epileptic seizure)
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you start using Flumazenil B. Braun.
Special care should be taken
- If you are epileptic and have received long-term treatment with benzodiazepines, administration of flumazenil may cause seizures.
- If you have severe brain damage (and/or unstable brain pressure), as Flumazenil B. Braun may cause an increase in brain pressure.
- If you have liver disease. Your doctor will carefully adjust the administration of Flumazenil B. Braun.
- If you have had panic attacks in the past, as Flumazenil B. Braun may cause new attacks.
- If you are very nervous due to your operation or if you have a history of anxiety. Your doctor will carefully adjust the administration of Flumazenil B. Braun.
- If you have been treated for long periods with high doses of benzodiazepines, as there is a risk of withdrawal symptoms (withdrawal symptoms are listed in section 4, "Possible side effects").
- If you are addicted to alcohol or drugs. In this case, you have a higher risk of tolerance to benzodiazepines and dependence.
- If you have coronary heart disease. You should inform your doctor so that you can be kept under sedation for a longer period.
Your level of alertness and vital signs (such as blood pressure, heart rate, and breathing) will be monitored for a suitable period after you have received flumazenil. As the action of flumazenil is usually shorter than that of benzodiazepines, sedation may recur.You will be closely monitored, possibly in the intensive care unit, until the effects of Flumazenil have completely disappeared.
If flumazenil 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.
Your doctor will consider the possibility of post-operative pain after major surgery before giving you Flumazenil B. Braun.
If you do not wake upafter administration of flumazenil, another reason for this should be considered, as flumazenil specifically reverses the effects of benzodiazepines.
Your doctor will avoid rapid injection of Flumazenil B. Braun. If you have received prolonged treatment (chronic) with benzodiazepines, rapid injectionof high doses of Flumazenil B. Braun (more than 1 mg) may cause withdrawal symptoms.
Flumazenil B. Braun is not recommended for the treatment of benzodiazepine dependenceor benzodiazepine withdrawal symptoms.
Your doctor will administer Flumazenil B. Braun with special caution in case of mixed overdoses with benzodiazepines and certain types of antidepressants (so-called tricyclic antidepressants such as imipramine, clomipramine, mirtazapine, or mianserin). The toxicity of these antidepressants can be masked by the protective effects of the benzodiazepine (see also section 2, "Use of Flumazenil with other medicines"). Signs of a significant overdose with tricyclic antidepressants include:
- pupil dilation, inability to urinate, dry mouth,
- serious or potentially life-threatening conditions such as agitation, respiratory problems, seizures, heart problems, and coma.
Children
Children who have been previously sedated with midazolam should be closely monitored in the intensive care unit for at least 2 hours after administration of Flumazenil B. Braun. Re-sedation or respiratory difficulties may occur.
In the case of sedation with other diazepines, monitoring should be adjusted according to the expected duration.
Children under 1 year of age should only receive flumazenil if the risks have been carefully weighed against the benefits of treatment.
Children should only receive flumazenil after intentional sedation.There is not enough data for any other indication. The same applies to children under 1 year of age.
Use of Flumazenil B. Braun with other medicines
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Flumazenil counteracts the effect of all medicines that act through the benzodiazepine receptor. This includes medicines that do not belong to the group of benzodiazepines but have the same active ingredient, such as zopiclone (e.g., Zimovane), triazolopyridazine, and others.
Benzodiazepines can mask the toxic effects of certain psychotropic medicines (especially tricyclic antidepressants such as imipramine; see also section 2, "Warnings and precautions"). When flumazenil is used in cases of accidental overdose, it should be taken into account that the toxic effects of concomitantly taken medicines may increase with the disappearance of the benzodiazepine effect.
No interaction has been observed with alcohol or other central nervous system depressants.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Due to insufficient experience during pregnancy, Flumazenil B. Braun should only be used with caution and only if the benefitto you is greater than the potential riskto the fetus. Administration of Flumazenil during pregnancy is not contraindicated in an emergency situation.
It is not known whether Flumazenil is excreted in breast milk. You should not breastfeed for 24 hoursafter administration of Flumazenil B. Braun. Administration of Flumazenil B. Braun during breastfeeding is not contraindicated in an emergency situation.
Driving and using machines
After receiving Flumazenil B. Braun to correct the sedative effects of benzodiazepines, you should not drive, operate machinery, or start any other activitythat requires physical or mental effort for at least 24 hours, as sedation may recur.
Flumazenil B. Braun contains sodium
This medicine contains less than 23 mg (1 mmol) of sodium per ml (injectable solution), so it is essentially "sodium-free".
3. How to use Flumazenil B. Braun
Flumazenil should be administered by your anesthetist or experienced doctor. Flumazenil B. Braun is administered as an injectioninto a vein or diluted as an infusioninto a vein (over a prolonged period)
Flumazenil can be used at the same time as other resuscitation measures.
The recommended dose is as follows:
Adults | |
Anesthesia | Intensive Care |
Dosing 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 can be injected and repeated at 60-second intervals, if the level of consciousness is not achieved within 60 seconds, up to a maximum dose of 1.0 mg. | If necessary, an additional dose of 0.1 mg can be injected and repeated at 60-second intervals, if the level of consciousness is not achieved within 60 seconds, up to a maximum dose of 2.0 mg |
The usual required dose is between 0.3 and 0.6 mg, but may vary depending on the patient's characteristics and the benzodiazepine used. | If drowsiness recurs, a second rapid injection can be administered. An intravenous infusion of 0.1-0.4 mg/h may be useful. 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 recurs. Infants, children, and adolescents (from 1 to 17 years) |
Correction of intentional sedation |
Dosing Level: |
Injection of 0.01 mg/kg 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 achieved, a further injection of 0.01 mg/kg (up to 0.2 mg) can be administered. If necessary, repeated injections can be administered at 60-second intervals (up to a maximum of 4 times) up to a maximum dose of 0.05 mg/kg or 1 mg, depending on which is the lower dose. |
Newborns, infants under 1 year
There is 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 risks(see also section 2, "Warnings and precautions").
Patients with renal (kidney) or hepatic (liver) dysfunction
In patients with liver dysfunction, the elimination of flumazenil may be delayed, and therefore, careful dose adjustmentis recommended.
In patients with kidney dysfunction, dose adjustment is not required.
Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
For information for healthcare professionals, please see the corresponding section below.
4. Possible side effects
Like all medicines, Flumazenil B. Braun can cause side effects, although not everybody gets them.
The following side effects may be serious. If you think you have any of these side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common(may affect up to 1 in 10 people):
- abnormal rapid and deep breathing (hyperventilation)
- speech disorders
Uncommon(may affect up to 1 in 100 people):
- slow or fast heart rate, premature heartbeat (extrasystole)
- difficulty breathing
- chest pain
Frequency not known(cannot be estimated from the available data):
- seizures (in patients who suffer from epilepsy or severe liver failure, especially after long-term treatment with benzodiazepines or abuse of multiple medicines)
- allergic reactions, including severe allergic reactions related to the response (anaphylaxis), may occur
Other side effects include:
Common(may affect up to 1 in 10 people):
- agitation (after rapid injection, does not require treatment)
- problems with sleep initiation and maintenance (insomnia), feeling of sleep (somnolence)
- dizziness, headache
- involuntary trembling movements or tremors
- dry mouth
- subjective skin sensations (e.g., cold, heat, tingling, pressure, etc.) in the absence of stimulation (paresthesia)
- double vision, squinting (strabismus), increased tear production (increased lacrimation)
- sweating
- low blood pressure, low blood pressure when changing from a lying to a standing position (orthostatic hypotension)
- discomfort: vomiting (after surgery), hiccups
- fatigue
- pain at the injection site
Uncommon(may affect up to 1 in 100 people):
- anxiety and fear (after rapid injection, does not require treatment)
- awareness of heartbeat (palpitations, which occur after rapid injection, does not require treatment)
- abnormal hearing
- cough, nasal congestion
- redness of the skin
- chills
Frequency not known(cannot be estimated from the available data):
- panic attacks in patients who have already shown panic reactions
- transient increase in blood pressure (when waking up)
- emotional lability
- abnormal crying, agitation, and aggressive reactions
If you are treated for prolonged periods with benzodiazepines, flumazenil may induce withdrawal symptoms (frequency not known). The symptomsinclude: agitation, anxiety, emotional weakness, confusion, and abnormal sensory perception.
In general, the undesirable effectsin childrenare similar to those in adults. When Flumazenil B. Braun is used to wake up your child from sedation, abnormal crying, agitation, and aggressive reactions may occur.
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 through 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 B. Braun
Keep this medicine out of the sight and reach of children.
Do not use Flumazenil B. Braun 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 first opening of the container: 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 times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the dilution has been made in controlled and validated aseptic conditions.
The solution should be inspected visually before use. Do not use Flumazenil B. Braun if the solution is not clear, colorless, and free of particles.
Any 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 no longer required. This will help protect the environment.
6. Container contents and additional information
Composition of Flumazenil B. Braun
The active 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.
The other componentsare: disodium edetate, glacial acetic acid, sodium chloride, 4% sodium hydroxide solution, and water for injection.
Appearance of the product and container contents
Flumazenil B. Braun is a clear and colorless solution for infusion 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
- Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Mailing address:
34209 Melsungen, Germany
Phone: +49/5661/71-0
Fax: +49/5661/71-4567
This medicinal product is authorized in the EEA Member States under the following names:
By the applicant B. Braun
Austria | Flumazenil B. Braun 0.1 mg/ml solution for injection and concentrate for solution for infusion |
Belgium | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Germany | Flumazenil B. Braun 0.1 mg/ml solution for injection and concentrate for solution for infusion |
Spain | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Finland | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Iceland | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Italy | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Luxembourg | Flumazenil B. Braun 0.1 mg/ml solution for injection and concentrate for solution for infusion |
Netherlands | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Poland | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Portugal | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Sweden | Flumazenil B. Braun 0.1 mg/ml solution for injection |
Date of last revision of this leaflet: 02/2018
The detailed informationof this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products. http://www.aemps.gob.es/
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This information is intended only for healthcare professionals:
If Flumazenil B. Braun is to be used for infusion, it must be diluted before use. Flumazenil should only be diluted with sodium chloride 9 mg/ml (0.9%) solution, glucose 50 mg/ml (5%) solution, or sodium chloride 4.5 mg/ml (0.45%) + glucose 25 mg/ml (2.5%) solution. The compatibility of Flumazenil with other injectable solutions has not been determined.
This medicinal product must not be mixed with other medicinal products except those mentioned in this section.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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