Flumazenil B. Braun 0.1 mg/ml solution for injection EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Flumazenil B. Braun is and what it is used for
- 2. What you need to know before using Flumazenil B. Braun
- 3. How to use Flumazenil B. Braun
- 4. Possible adverse effects
- 5. Storage of Flumazenil B. Braun
- 6. Contents of the pack and other information
Package leaflet: Information for the user
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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Package leaflet:
- What Flumazenil B. Braun is and what it is used for
- What you need to know before using Flumazenil B. Braun
- How to use Flumazenil B. Braun
- Possible side effects
- How to store Flumazenil B. Braun
- Contents of the pack and other information
1. What Flumazenil B. Braun is and what it is used for
Flumazenil B. Braun is an antagonist agent (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 to calm anxiety. Flumazenil can completely or partially reverse these effects.
Flumazenil may be used
- during anaesthesia to wake you up after surgery or certain diagnostic procedures
- if you have been maintained under sedation in intensive care
Flumazenil may also be used for the diagnosis and treatment of benzodiazepine poisoning or overdose.
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 using Flumazenil B. Braun
Do not use Flumazenil B. Braun
- If you are allergic to flumazenil or to any of the other ingredients of this medicine (listed in section 6).
- If you have been given benzodiazepines to control a life-threatening condition (e.g. control of intracranial pressure or a severe epileptic seizure).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Flumazenil B. Braun.
Special caution is needed
- If you have epilepsy and have received long-term treatment with benzodiazepines, as administration of flumazenil may trigger seizures.
- If you have severe brain damage (and/or unstable intracranial pressure), since Flumazenil B. Braun may increase pressure in your brain.
- If you have liver disease. Your doctor will carefully adjust the administration of Flumazenil B. Braun.
- If you have previously experienced panic attacks, as Flumazenil B. Braun may provoke further episodes.
- If you are very anxious due to your surgery or 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 described in section 4, “Possible side effects”).
- If you are addicted to alcohol or medications. In this case, you have a higher risk of tolerance to benzodiazepines and dependence.
- If you have coronary artery disease. Your doctor should be informed so that you can remain 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 an appropriate period after receiving flumazenil. Since the action of flumazenil is usually shorter than that of benzodiazepines, sedation may return. You will be closely observed, possibly in an intensive care unit, until the effects of Flumazenil have completely disappeared.
If flumazenil is administered at the end of your surgery to wake you up, it must not be given until the effects of muscle relaxants have worn off.
Your doctor will consider the possibility of postoperative pain after major surgery before administering Flumazenil B. Braun.
If you do not wake up after receiving flumazenil, another cause 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 (chronic) treatment with benzodiazepines, rapid injection of 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 dependence or benzodiazepine withdrawal symptoms.
Your doctor will administer Flumazenil B. Braun with special caution in cases of mixed intoxication involving benzodiazepines and certain types of antidepressants (so-called cyclic antidepressants such as imipramine, clomipramine, mirtazapine, or mianserin). The toxicity of these antidepressants may be masked by the protective effects of benzodiazepines (see also section 2, “Use of Flumazenil with other medicines”). Signs of significant overdose with cyclic antidepressants include:
- dilated pupils, inability to urinate, dry mouth,
- serious or potentially life-threatening conditions such as agitation, breathing difficulties, seizures, heart problems, and coma.
Children
Children previously sedated with midazolam must be closely monitored in intensive care units for at least 2 hours after administration of Flumazenil B. Braun. Repeated sedation or respiratory difficulties may occur.
When sedation has been performed with other benzodiazepines, monitoring should be adjusted according to their expected duration.
Children aged 1 year or younger should only receive flumazenil if risks have been carefully weighed against the benefits of treatment.
Children should only receive flumazenil after intentional sedation. There is insufficient data available 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, have recently used, or might need to use any other medicines.
Flumazenil counteracts the effect of all medicines acting through the benzodiazepine receptor. This includes medicines not belonging to the benzodiazepine group but which have the same active principle, such as zopiclone (e.g. Zimovane), triazolopyridazines, and others.
Benzodiazepines may mask the toxic effects of certain psychotropic drugs (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 borne in mind that the toxic effects of concomitantly administered drugs may increase as the benzodiazepine effect disappears.
No interaction has been observed with alcohol or other central nervous system depressants.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Due to insufficient experience during pregnancy, Flumazenil B. Braun should only be used with caution and only if the benefit to you outweighs the potential risk to 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 must not breastfeed for 24 hours after administration of Flumazenil B. Braun. Administration of Flumazenil B. Braun during breastfeeding is not contraindicated in an emergency.
Driving and use of machines
After receiving Flumazenil B. Braun to reverse the sedative effects of benzodiazepines, you must not drive, operate machinery, or engage in any other activity requiring 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 (injection solution), and is therefore considered essentially "sodium-free".
3. How to use Flumazenil B. Braun
Flumazenil must be administered by your anaesthetist or an experienced doctor. Flumazenil B. Braun is given as an intravenous injection (into a vein) or diluted as an intravenous infusion (over a prolonged period).
Flumazenil may be used simultaneously with 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 may be injected and repeated at intervals of 60 seconds 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 may be injected and repeated at intervals of 60 seconds if the level of consciousness is not achieved within 60 seconds, up to a maximum dose of 2.0 mg |
The usual dose required ranges between 0.3 and 0.6 mg, but may vary depending on patient characteristics and the benzodiazepine used. | If somnolence recurs, a second rapid injection may be administered. An intravenous infusion of 0.1–0.4 mg/h may be useful. The infusion rate should be individually adjusted to achieve the desired level of consciousness. |
The infusion should be interrupted every 6 hours to check whether sedation recurs. Infants, children and adolescents (from 1 to 17 years) |
Reversal of deliberate sedation |
Dosing level: |
Inject 0.01 mg/kg body weight (up to 0.2 mg) intravenously over a period of 15 seconds. If, after a waiting period of 45 seconds, the required level of consciousness is not achieved, a subsequent injection of 0.01 mg/kg (up to 0.2 mg) may be administered. Repeated injections may be given as needed at intervals of 60 seconds (up to a maximum of 4 times) up to a maximum dose of 0.05 mg/kg or 1 mg, whichever is lower. |
Newborns and infants under 1 year of age
There is insufficient 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 benefits to the patient outweigh the possible risks (see also section 2, “Warnings and precautions”).
Patients with renal (kidney) or hepatic (liver) impairment
In patients with hepatic impairment, elimination of flumazenil may be delayed, and therefore careful dose adjustment is recommended.
In patients with renal impairment, no dose adjustment is required.
Always follow exactly the instructions for administration provided by your doctor or pharmacist. In case of doubt, please consult your doctor or pharmacist again.
For information to healthcare professionals, please see the corresponding section below.
4. Possible adverse effects
Like all medicines, Flumazenil B. Braun may have adverse effects, although not everyone experiences them.
The following adverse effects can be serious. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Common (may affect up to 1 in 10 patients):
- Abnormally rapid and deep breathing (hyperventilation)
- Speech disorders
Uncommon (may affect up to 1 in 100 patients):
- Slow or fast heart rate, premature heartbeat (extrasystoles)
- Difficulty breathing
- Chest pain
Frequency not known (cannot be estimated from available data):
- Seizures (in patients with epilepsy or severe hepatic insufficiency, especially after long-term treatment with benzodiazepines or abuse of multiple drugs)
- Allergic reactions may occur, including severe allergic reactions related to the response (anaphylaxis)
Other adverse effects include:
Common (may affect up to 1 in 10 patients):
- Agitation (after rapid injection, does not require treatment)
- Problems with sleep onset and maintenance (insomnia), feeling of sleepiness (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 (paraesthesia)
- Double vision, squinting (strabismus), increased production of lacrimal fluid (increased tearing)
- Sweating
- Low blood pressure, low blood pressure when changing from lying to upright position (orthostatic hypotension)
- Discomfort: vomiting (after surgery), hiccups
- Fatigue
- Pain at the injection site
Uncommon (may affect up to 1 in 100 patients):
- Anxiety and fear (after rapid injection, does not require treatment)
- Awareness of your heartbeat (palpitations, occurring after rapid injection, does not require treatment)
- Abnormal hearing
- Cough, nasal congestion
- Skin redness
- Chills
Frequency not known (cannot be estimated from available data):
- Panic attacks in patients who have previously shown panic reactions
- Transient increase in blood pressure (upon waking)
- Emotional lability
- Abnormal crying, agitation, and aggressive reactions
If you have been treated for prolonged periods with benzodiazepines, flumazenil may induce withdrawal symptoms (frequency unknown). The symptoms include: agitation, anxiety, emotional lability, confusion, and abnormal sensory perception.
In general, adverse effects in children are usually similar to those in adults. When Flumazenil B. Braun is used to awaken your child from sedation, abnormal crying, agitation, and aggressive reactions may occur.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 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. 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.
Period of validity after first opening of the container: the medicine should be used immediately.
Period of validity 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 administered immediately. If not administered immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution has taken place under controlled and validated aseptic conditions.
The solution should be visually inspected before use. Do not use Flumazenil B. Braun if the solution is not clear, colourless 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. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Flumazenil B. Braun
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% sodium hydroxide solution, and water for injection.
Appearance of the product and contents of the container
Flumazenil B. Braun is a clear, colourless infusion solution in colourless glass ampoules.
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
- Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Telephone: +49/5661/71-0
Fax: +49/5661/71-4567
This medicinal product is authorised in the EEA Member States under the following names:
By the applicant B. Braun
Austria | Flumazenil B. Braun 0.1 mg/ml injection solution 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 injection solution and concentrate for solution for infusion |
Spain | Flumazenil B. Braun 0.1 mg/ml injectable solution EFG |
Finland | Flumazenil B. Braun 0.1 mg/ml injection solution, solution |
Iceland | Flumazenil B. Braun 0.1 mg/ml injection solution |
Italy | Flumazenil B. Braun 0.1 mg/ml injectable solution |
Luxembourg | Flumazenil B. Braun 0.1 mg/ml injection solution 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 injectable solution |
Sweden | Flumazenil B. Braun 0.1 mg/ml injectable solution, solution |
Date of the last review of this leaflet: 02/2018
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices: http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
If Flumazenil B. Braun is to be used for infusion, it must be diluted prior to administration. Flumazenil should only be diluted with sodium chloride solution 9 mg/ml (0.9%), glucose solution 50 mg/ml (5%), or sodium chloride 4.5 mg/ml (0.45%) + glucose 25 mg/ml (2.5%). Compatibility between Flumazenil and other injectable solutions has not been established.
This medicinal product must not be mixed with other medicinal products not mentioned in this section.