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Anexate

flumazenil
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Anexate. It does not contain all the information that is known about Anexate. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What ANEXATE is used for

ANEXATE is used to reverse benzodiazepine overdose, both suspected and known.
It is given to arouse people after surgery or 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

When you must not be given it

Do not use 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 for control of a potentially life-threatening condition

Before you are given it

Your doctor must know about all the following before you are given ANEXATE.
You must tell your doctor if:

1. you are allergic to any other medicines or any other substances such as foods, preservatives or dyes

2. you suffer from epilepsy

3. you have severe liver disease

4. you suffer from panic disorder

5. you have been taking high doses of benzodiazepines and /or you have been taking benzodiazepines for a long time.

If you have not told your doctor about any of the above, tell them before you are given ANEXATE.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food shop.
Some medicines may interfere with ANEXATE or affect how well it works. These medicines include:
benzodiazepines eg diazepam, (Valium), bromazepam (Lexotan), temazepam (Temaze, Normison) etc
anticonvulsants
antidepressants

How ANEXATE is given

ANEXATE is given as an injection 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.

While you are using ANEXATE

Things to be careful of

Be careful driving or operating machinery until you know how ANEXATE affects you.
This medicine may cause drowsiness or dizziness in some people. This can be due to the possibility of re-sedation within the first 24 hours after administration of ANEXATE.
If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous
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.
There is also a possibility of other benzodiazepine effects such as difficulty in breathing, within the first 24 hours after administration.

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:
nausea with or without vomiting
dizziness, lightheadedness
feeling anxious or fearful
rapid or irregular heart beat
depression, tearfulness with or without agitation
allergic reactions, including sudden life threatening allergic reactions. Symptoms include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
These may be related to the reversal of anaesthetic.

After using ANEXATE

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 it looks like

ANEXATE is available as a clear, solution at a concentration of 0.1mg per mL in 5 mL glass ampoules.
ANEXATE comes in a pack of 5 ampoules.

Ingredients

Each 5 mL ANEXATE ampoule contains 0.5 mg flumazenil as the active ingredient.
It also contains:
disodium edetate
glacial acetic acid (260)
sodium chloride
sodium hydroxide
water for injections
This medicine does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Manufacturer

ANEXATE is distributed in Australia by:
Roche Products Pty Limited
ABN 70 000 132 865
4 - 10 Inman Road
Dee Why NSW 2099
Medical Enquiries: 1800 233 950
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Number
AUST R 13706
This leaflet was prepared on 23 June 2014.