Anexate Consumer Medicine Information
Flumazenil
0.5mg in 5mL injection
What is in this leaflet
This leaflet answers some common questions about ANEXATE injection. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of your being given ANEXATE injection against the benefits expected for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What ANEXATE is used for
ANEXATE is used to reverse the effects of benzodiazepines, a class of anti-anxiety or sedative medicines. Common benzodiazepines are diazepam (Valium®, Pro-Pam®, Diazemuls®, Stesolid®, D-Pam®), midazolam (Hypnovel®), lormetazepam (Noctamid®), lorazepam (Ativan®, Lorapam®, Lorzem®), oxazepam (Benzotran®, Ox-Pam®, Serepax®), temazepam (Euhypnos®, Normison®, Somapam®), clobazam (Frisium®), triazolam (Hypam®, Trycam®, Halcion®), nitrazepam (Insoma®, Nitrados®), clonazepam (Rivotril®), and alprazolam (Xanax®).
ANEXATE is given to arouse people after surgery or in cases of suspected or known benzodiazepine overdose.
Your doctor may have prescribed ANEXATE for another reason. Ask your doctor if you have any questions why ANEXATE has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you are given ANEXATE
You should not be given ANEXATE if:
- you have had an allergic reaction to ANEXATE or any of the ingredients listed at the end of this leaflet
- you are taking a benzodiazepine to control a potentially life-threatening condition.
Before you are given ANEXATE
Your doctor must know about all the following before you are given ANEXATE.
You must tell your doctor if:
- you are allergic to any other medicines or any other substances such as foods, preservatives or dyes
- you suffer from epilepsy
- you have been taking a benzodiazepine for a long time or in high doses
- you have taken an overdose of one or more medicines or other substances
- you have had a recent head injury
- you are pregnant.
Things to be careful of
Do not drive or operate machinery until you know how ANEXATE affects you.
Some people may become drowsy or dizzy after taking ANEXATE due to the possibility of resedation within the first 24 hours after administration. Make sure you know how you react to ANEXATE before you drive a car or operate machinery or do anything else that could be dangerous if you are drowsy, dizzy or not alert.
Be careful if you are elderly, unwell or taking other medicines.
Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness in the first 24 hours after administration which may increase the risk of a fall.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy supermarket or healthfood shop.
Some medicines that may interfere with ANEXATE are:
- zopiclone (Imovane®, Zo-Tab®)
- triazolopyridazines, a class of medicines similar to benzodiazepines.
Your doctor has a complete list of medicines to avoid if you have been given ANEXATE.
If you have not told your doctor about any of the above, tell your doctor before you are given ANEXATE.
How ANEXATE is given
ANEXATE is given as an injection or an infusion ("drip") into a vein. ANEXATE must only be given by an anaesthetist or experienced physician.
Your doctor will decide what dose of ANEXATE you will receive. This depends on your condition.
Usually only a single dose of ANEXATE is required.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well after you have been given ANEXATE.
ANEXATE helps most people who experience an overdose with benzodiazepine medicines but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- feeling anxious or fearful
- rapid or irregular heart beat
- seizures or convulsions.
These may be related to the reversal of anaesthetic.
Storage
ANEXATE will be stored in the pharmacy or on the ward. It is kept in a cool dry place where the temperature stays below 30°C.
Product Description
What ANEXATE looks like
ANEXATE is available as a clear solution at a concentration of 0.1mg per mL.
Ingredients
ANEXATE does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
Active ingredients
Each 5 mL ANEXATE ampoule contains 0.5 mg flumazenil.
Inactive ingredients
Each ampoule also contains disodium edetate, glacial acetic acid, sodium chloride, sodium hydroxide and water for injection.
This leaflet was prepared on 23 March 2001.
Reference: Roche Australia leaflet 24 October 1997, with updates from New Zealand data sheet dated 13 June 2000.
