drug-medicine : anexate

Patient Product Information

Anexate® 500 micrograms/5ml Ampoule

Flumazenil

Please read this leaflet carefully. If you have any questions or are not sure about anything, ask your doctor, dentist or pharmacist.

What is Anexate?

Anexate is a solution for injection or infusion, which contains the active ingredient flumazenil. 1ml of solution contains 100 micrograms of flumazenil. Each ampoule contains 500 micrograms of flumazenil in 5ml solution.

Anexate reverses the effects of a group of medicines known as benzodiazepines which are sometimes used to induce strong sleep. It is given by a slow, single or continuous injection into a vein. It works rapidly although the effects may wear off within a few hours and sleep may re-occur.

Anexate also contains the inactive ingredients disodium edetate, glacial acetic acid, sodium chloride, sodium hydroxide and water for injection.

This medicine is available in 500 micrograms/5ml ampoules in packs of 5.

What is Anexate used for?

Anexate is used for the complete or partial reversal of benzodiazepine sedation and general anaesthesia following certain diagnostic tests and operations. It is also used in intensive care patients who are on artificial ventilators. By reversing the effects of benzodiazepines, it raises the level of consciousness and allows the person to return to independent breathing.

When must Anexate not be used?

If you are allergic to flumazenil, benzodiazepines (e.g. diazepam, midazolam, temazepam), or to any of the ingredients Anexate contains.
If you are epileptic and have been receiving benzodiazepine treatment for a long period of time.
If you have been taking benzodiazepines and certain antidepressants (e.g. amitriptyline, imipramine, dothiepin hydrochloride) at the same time.
If you are taking benzodiazepines to control a potentially life-threatening condition.

When should you be extra careful when using Anexate?

Before starting treatment, make sure your doctor knows if :

you have a head injury.
you have a history of anxiety or are particularly anxious about the operation.
you suffer from coronary heart disease, epilepsy or severe liver disease.
you are taking other medicines, including those not prescribed by your doctor. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved. It is especially important to tell your doctor if you are taking zopiclone (for insomnia) or antidepressants (e.g. amitriptyline, imipramine).

Driving and operating machinery

Anexate may affect your ability to drive or operate machinery. You should not drive or operate machinery or take part in any physically or mentally demanding activity for 24 hours after receiving this medicine.

May Anexate be used during pregnancy or while breast feeding?

You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should receive this medicine.

Anexate may pass into breast-milk. If you are breast feeding this medicine should be avoided, except in an emergency. Your doctor will advise you.

How should Anexate be given?

This product should only be given to you under the supervision of an experienced doctor.
Your doctor will decide on a suitable dose for you. Doses vary and will depend on the procedure you have received and the level of sedation. Your bodyweight, age, general condition of health and your response to the drug will also influence the dose you receive.
The starting dose is 200 micrograms given by slow injection into a vein over 15 seconds. If this does not achieve the level of consciousness required after 60 seconds, a further dose of 100 micrograms can be given. This dose can be repeated every 60 seconds as necessary until the correct level of consciousness is achieved, or until you have received a maximum total dose of 1mg, or in intensive care situations, 2mg. The usual dose is 300 - 600 micrograms.
- If you become drowsy again you may be given a slow, continuous injection (infusion) into a vein at a rate of 100 - 400 micrograms per hour until the correct level of consciousness is achieved.
- If after repeated doses there is no marked improvement in consciousness or independent breathing, your doctor will probably stop giving Anexate and use another method to raise your level of consciousness.
If you have received treatment with benzodiazepines, Anexate may give you withdrawal symptoms such as anxiety attacks, dizziness and sweating. The withdrawal symptoms may occur even if you stopped taking the benzodiazepines in the weeks before Anexate was given. Your doctor may give you a slow injection of diazepam or midazolam (benzodiazepines) into a vein to reduce this.
Anexate should only be given to children if it is considered appropriate by the doctor.
If you are elderly or have a liver condition your dose of Anexate will be adjusted with particular care.
If you think you have been given too much Anexate, you should feel no ill effects, however, it would be wise to contact your doctor, pharmacist or hospital as quickly as possible.

When and how does treatment with Anexate end?

Anexate treatment ends when you become fully conscious. However, because the effects of Anexate may wear off quickly and you may need repeat doses, you should remain under close medical supervision until all drowsiness has subsided.

What are the possible unwanted effects of Anexate?

Anexate can occasionally cause nausea, vomiting and flushing. It may cause you to become agitated, anxious or fearful but this is generally if you are awakened too quickly. Intensive care patients may have increases in blood pressure and heart rate. These effects usually disappear quickly without any treatment.

Very rarely seizures may occur, particularly if you suffer from epilepsy or severe liver disease.

Very rare cases of sudden and severe allergic reactions have occurred with Anexate. You should alert your doctor immediately if you experience hives (slightly raised, itchy, skin patches that are paler or redder than the surrounding skin), sudden swelling of the hands, feet, ankles, or swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing.

If you have received treatment with benzodiazepines you may experience withdrawal symptoms such as anxiety attacks, dizziness, sweating and palpitations even if you stopped taking the benzodiazepines in the weeks before Anexate was given. Such symptoms may be treated by your doctor with a slow injection into the vein of diazepam or midazolam.

If you are concerned about these or any other unwanted effects talk to your doctor.

How should Anexate be stored?

Do not store above 30°C.
Keep this medicine out of the reach and sight of children.
This medicine must not be used after the date (EXP) printed on the pack and the ampoule label.
REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.