Flumazenil B. Braun 0,5 mg/5 ml Solution

FLUMAZENIL B. BRAUN is a counteragent (antidote) for a specific group of medicines called benzodiazepines. Benzodiazepines have sedative, sleep inducing and muscle relaxing properties. They are used to make you sleepy and tranquillize you if you are anxious. FLUMAZENIL B. BRAUN may completely or partially reverse these effects.

Adult patients FLUMAZENIL B. BRAUN may therefore be used:

• in anesthesia to wake you up after surgery or certain diagnostic tests.
• for the diagnosis and treatment of intoxications or overdose with benzodiazepines.

Do not use FLUMAZENIL B. BRAUN:

• if you are allergic to FLUMAZENIL B. BRAUN or any of the other ingredients of FLUMAZENIL B. BRAUN (listed in section 6)
• if benzodiazepines have been administered to you to control a potentially life-threatening situation (for example control of pressure in the brain or a serious epileptic seizure).

Warnings and Precautions

Special care should be taken with FLUMAZENIL B. BRAUN:

• if you are epileptic and have received benzodiazepine treatment for a long period of time. In this case the administration of FLUMAZENIL B. BRAUN can cause seizures
• if you have a serious brain injury (and/or instable pressure in your brain) as FLUMAZENIL B. BRAUN can cause an increased pressure in your brain
• if you suffer from liver disease. Your doctor will carefully adjust the dosage of FLUMAZENIL B. BRAUN
• if you have experienced panic attacks in the past as FLUMAZENIL B. BRAUN can cause new attacks
• if you are very nervous about having your operation or have a history of anxiety. Your doctor will carefully adjust the dosage 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 dependent on alcohol or medicines. In this case you have a higher risk of benzodiazepine tolerance and dependence
• if you have a coronary heart disease. Your doctor should be informed as she / he might decide to keep you longer under sedation.

Your alertness and vital signs (like blood pressure, heart and breathing rate) will be controlled for an adequate period of time after you received FLUMAZENIL B. BRAUN. As the action of Flumazenil is usually shorter than that of benzodiazepines, sedation may recur. You will be closely observed, possibly in the intensive care unit, until the effects of FLUMAZENIL B. BRAUN have gone away.

If FLUMAZENIL B. BRAUN is administered to you at the end of your operation to wake you up, it should not be given until the effects of muscle relaxants have gone away. Your doctor will consider that postoperative pain may occur after major surgery before giving you FLUMAZENIL B. BRAUN. If you do not wake up after FLUMAZENIL B. BRAUN is administered, another reason for this will be considered because FLUMAZENIL B. BRAUN specifically reverses the effects of benzodiazepines.

Your doctor will avoid rapid injection of FLUMAZENIL B. BRAUN. If you have received long-term (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 benzodiazepines-withdrawal symptoms.

Your doctor will administer FLUMAZENIL B. BRAUN only with particular caution in case of mixed intoxications with benzodiazepines and certain types of other antidepressants (so called cyclic antidepressants like Imipramin, clomipramin, mirtazapine or mianserin). The toxicity of these antidepressants can be masked by protective benzodiazepine effects (see also section 2 "Other medicines and Flumazenil").

Signs of a significant overdose with cyclic antidepressants include:

• dilation of the pupil, inability to urinate, dry mouth, severe or potentially life threatening conditions like agitation, breathing problems, convulsions, heart problems and coma.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself FLUMAZENIL B. BRAUN. It will be given to you by a person who is qualified to do so.

If you are given more FLUMAZENIL B. BRAUN than you should Since a health care provider will administer FLUMAZENIL B. BRAUN, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If FLUMAZENIL B. BRAUN has not been given to you Since a health care provider will administer FLUMAZENIL B. BRAUN, it is unlikely that the dose will be missed.

FLUMAZENIL B. BRAUN can have side effects. Not all side effects reported for FLUMAZENIL B. BRAUN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FLUMAZENIL B. BRAUN, please consult your health care provider for advice.

The following side effects may be serious. If any of the following happens, stop using this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Frequent : abnormal rapid and deep respiration (hyperventilation)
• speech disorder.

Less Frequent :

• slow or rapid heart rate, premature beat of your heart (extrasystole)
• difficulty in breathing
• chest pain.

Frequency Not known :

• convulsions (in patients suffering from epilepsy or severe liver insufficiency, mainly after long-term treatment with benzodiazepines or multiple medicinal products abuse)
• allergic reactions, including severe allergic response - related reactions (anaphylaxis), may occur.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Other side effects include:

• Frequent : agitation (after rapid injection, not requiring treatment)
• having problems in initiating and maintaining sleep (insomnia), feeling sleepy (somnolence)
• dizziness, headache
• involuntary trembling or quivering (tremor)
• dry mouth
• sensations on the skin (e.g. cold, warmth, tingling, pressure, etc.) in the absence of stimulation (paresthesia)
• double vision, squinting (strabismus)
• increased production of tear fluid (increased lacrimation)
• sweating
• low blood pressure, drop of blood pressure on transition from lying to standing (orthostatic hypotension)
• feeling sick: vomiting (after surgery), hiccups
• fatigue
• pain at the injection site.

Less frequent:

• anxiety and fear (occurring after rapid injection, not requiring treatment)
• being aware of your heart rate (palpitations, occurring after rapid injection, not requiring treatment)
• abnormal hearing
• cough, nasal congestion
• reddening of the skin
• shivering.

Frequency Not known:

• panic attacks in patients that already showed panic reactions
• transient increased blood pressure (on awaking)
• emotional lability
• abnormal crying, agitation and aggressive reactions
• reddening of the skin.

If you were treated for a long period with benzodiazepines, Flumazenil can induce withdrawal symptoms (frequency not known). The symptoms include: agitation, anxiety, emotional lability, confusion and abnormal sensory perception.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects talk to your doctor, or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://primaryreporting.who-umc.org/ZA. By reporting side effects, you can help provide more information on the safety of FLUMAZENIL B. BRAUN.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after “EXP.” The expiry date refers to the last day of that month. Store at or below 25 °C. This 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 in-use 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, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions. The solution should be inspected visually prior to use. Do not use FLUMAZENIL B. BRAUN if the solution is not clear, colourless and free from particles. Any unused solution should be discarded in accordance with local requirements. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.