Flumazenil 100 micrograms/ml solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Flumazenil is and what it is used for
2. What you need to know before you are given Flumazenil
3. How Flumazenil is given
4. Possible side effects
5. How to store Flumazenil
6. Contents of the pack and other information

• allergic (hypersensitive) to Flumazenil or any of the other ingredients of this medicine (listed in section 6).
• taking benzodiazepines to control a life-threatening condition such as an increase in brain pressure (raised intracranial pressure) or a serious epileptic seizure (status epilepticus).

Before you receive Flumazenil, tell your doctor if you:

• have epilepsy and have taken benzodiazepines for a long period. Flumazenil can cause seizures.
• have liver problems.
• have or in the past have had a serious head injury Flumazenil can cause increased pressure in your brain.
• were anxious before an operation or had an anxious seizure or have long term anxiety.
• had panic attacks in the past. Flumazenil can cause new attacks.
• had long-term or high dosage treatment of benzodiazepines. A rapid injection of Flumazenil at a dose higher than 1000 micrograms can cause withdrawal symptoms.
• have a history of alcoholism or other substance abuse you have a higher risk of benzodiazepine tolerance and dependence and therefore a higher risk of withdrawal symptoms. Your anaesthetist will adjust your dose carefully.

Beware also the following

Flumazenil only reverses the effects of benzodiazepines.

• if lowering of consciousness or sedation is caused by another agent, it is unlikely that Flumazenil will counteract it.
• although Flumazenil is given to reverse drowsiness, you may experience a return of drowsiness for up to 24 hours after Flumazenil is given. This is because the sedative effects of benzodiazepines lasts longer than the anti-sedative effects of Flumazenil. Therefore you will be monitored, if possible in intensive care, until all possible effects of the benzodiazepine have worn off.
• if you undergo an operation that is particularly invasive and causes a lot of pain, the anaesthetist may keep you in a sedated condition.
• Flumazenil is not recommended to treat benzodiazepine addiction or the symptoms of it.

If Flumazenil 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.

In children previously sedated with midazolam: These children should be closely observed in intensive care units for at least 2 hours after administration of Flumazenil because repeated sedation or difficulty with breathing can occur. In case of sedation by other benzodiazepines, the monitoring must be adjusted according to their expected duration.

Children should only receive Flumazenil after deliberate sedation. There are insufficient data for any other indications. The same applies for children below the age of 1 year

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This information is needed so that your anaesthetist can adjust your dose carefully.

In particular please tell your doctor or nurse if you are taking any of the following medicines:

• zopiclone and triazolopyridazine (used to treat insomnia)
• benzodiazepines (e.g. diazepam, midazolam)
• tricyclic or tetracyclic antidepressants like amitriptyline, nortriptyline, clomipramine, mirtazapine, mianserin and imipramine

When using Flumazenil in cases of an accidental overdose it has to be taken into account that the toxic effects of other psychotropic medicinal products (especially tricyclic antidepressants like Imipramine) taken concurrently, may increase with the subsidence of the benzodiazepine effect.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

The risk to the unborn foetus in humans has not been determined, therefore, Flumazenil is not recommended for use during pregnancy, unless the benefits to the patient clearly outweigh the risks to the unborn foetus, such as in a life-threatening, emergency situation.

It is not known whether Flumazenil is excreted in breast milk. Therefore it is better not to breast-feed for 24 hours after Flumazenil has been given.

The effect of Flumazenil is shorter than the effect of benzodiazepines and so it is possible that you may feel sleepy again. Do not drive motor vehicles and do not operate any tools or machines for a period of 24 hours after the administration of Flumazenil.

This medicinal product contains 3.7 mg sodium (main component of cooking/table salt) per ml.

• Each 5 mL ampoule of the product contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free’.
• Each 10 mL ampoule of the product contains 37 mg sodium. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.

The dosage depends on the situation; usually, an initial dose of 200 micrograms is administered into your vein over 15 seconds. If your state of consciousness does not improve sufficiently after 60 seconds, another dose of 100 micrograms can be administered. This can repeated after 60 seconds until you reach a sufficient state of consciousness. The maximum dose that can be administered is 1000 micrograms after anaesthesia and 2000 micrograms in intensive care.

The treatment is discontinued every 6 hours in order to determine if sedation re-occurs.

Usually, an initial dose of 10 micrograms per kilogram body weight (up to 200 micrograms) is administered into a vein over 15 seconds. If the state of consciousness does not improve sufficiently after 45 seconds, another dose of 10 micrograms per kilogram body weight (up to 200 micrograms) can be administered. This can be repeated after 60 seconds up to four times to a maximum total dose of 50 micrograms per kilogram body weight or 1000 micrograms, whichever is lower.

There is little information about the use of Flumazenil in children under 1 year of age. Your doctor will decide if it is necessary to give Flumazenil to your child of this age.

Elderly people are generally more sensitive to the effects of Flumazenil and should be treated with due caution.

If you have liver problems your doctor may give you a reduced dose.

In general the undesirable effects in children do not differ much from that in adults. When using Flumazenil to awake a child from sedation, abnormal crying, agitation and aggressive behaviour have been reported.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is flumazenil.

1 ml solution for injection/infusion contains 100 micrograms flumazenil.

1 ampoule with 5 ml solution contains 500 micrograms flumazenil.

1 ampoule with 10 ml solution contains 1000 micrograms flumazenil.

The other ingredients are disodium edetate, glacial acetic acid, sodium chloride, sodium hydroxide and water for injections.

Flumazenil is a clear and colourless solution in glass ampoules.

Boxes of 5 or 10 ampoules with 5 ml.

Boxes of 5 or 10 ampoules with 10 ml.

Not all pack sizes may be marketed.

PL 01502/0128