UK
Roche
Anexate 500 micrograms/5 ml Ampoule
Flumazenil
Please read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
- 1. What Anexate is and what it is used for
- 2. Before you are given Anexate
- 3. How Anexate will be given
- 4. Possible side effects
- 5. How Anexate is stored
- 6. Further information
What Anexate is and what it is used for
Anexate contains a medicine called flumazenil. It is used to wake you up after you have been made sleepy by a medicine called a ‘benzodiazepine’.
Anexate reverses the effects of the ‘benzodiazepine’ medicine. It is used to:
- Wake you up after an operation or medical test.
- Help you to breathe for yourself and wake up if you have been on a ventilator in intensive care.
Before you are given Anexate
You must not be given Anexate if you are allergic (hypersensitive) to:
- Flumazenil or any of the other ingredients of Anexate (listed in Section 6: Further information).
- ‘Benzodiazepine’ medicines. These include diazepam, midazolam and temazepam.
You must not be given Anexate if any of the above apply to you. If you are not sure, talk to your doctor or
nurse before having Anexate.
You must not be given Anexate if:
- You are already taking a ‘benzodiazepine’ medicine to treat a very serious illness (such as raised intra-cranial pressure or status epilepticus).
- You have taken a ‘benzodiazepine’ medicine and certain anti-depressant medicines at the same time and this has made you ill. These anti-depressant medicines (known as tricyclic or tetracyclic anti-depressants) include medicines such as amitriptyline, imipramine and dothiepin hydrochloride.
You must not be given Anexate if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Anexate.
Take special care with Anexate
Check with your doctor or nurse before having Anexate if:
- You have a head injury.
- You have epilepsy and are being treated with a ‘benzodiazepine’ medicine.
- You are very nervous about having your operation or medical test.
- You have a history of anxiety.
- You have heart disease or liver problems.
If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you have Anexate.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Anexate can affect the way some other medicines work. Also some other medicines can affect the way Anexate works.
In particular, tell your doctor or nurse if you are taking any of the following medicines:
- ‘Benzodiazepine’ medicines, even if you have not taken them in the last few weeks. These include diazepam, midazolam and temazepam.
- Zopiclone (used to help you sleep).
- Medicines that change your mood or behaviour. These include medicines called tranquillizers, antidepressants and sedatives.
Pregnancy and breast-feeding
Talk to your doctor or nurse before having Anexate if you are pregnant, might become pregnant or are
breast-feeding.
Driving and using machines
- Do not drive or use any tools or machines for at least 24 hours after having Anexate.
- Do not do anything that is physically or mentally demanding for at least 24 hours after having Anexate.
This is because the effects of the ‘benzodiazepine’ medicine may return and you may start to feel sleepy
again.
How Anexate will be given
Anexate will be given to you by a doctor. It will be given to you as a slow injection into one of your veins.
The dose of Anexate varies from one patient to another. It depends on your age, weight, how well your liver and kidneys are working and what you need the medicine for. The doctor will work out how much to give
you.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Anexate Side Effects
Like all medicines Anexate can cause side effects, although not everyone gets them.
Allergic reactions (very rare)
If you have an allergic reaction, see a doctor straight away. The signs may include:
- Sudden swelling of the throat, face, lips or mouth. This can make it difficult to breathe or swallow.
- Sudden swelling of the hands, feet or ankles.
- Skin rash or itching.
Other possible side effects:
Stomach and gut
- Feeling sick or being sick.
Heart and circulation
- Redness of the face and neck (flushing).
- Increased blood pressure and increased heart rate. These effects have been seen in people having Anexate in intensive care.
- Changed heart rate. This is most likely in people given Anexate after an overdose of more than one
medicine, including at least one ‘benzodiazepine’, especially if taken with certain anti-depressants.
Mind and nervous system
- Feeling agitated, anxious or frightened. These effects can happen to people who have woken up too quickly.
- Panic attacks (in people who have had panic attacks in the past).
- Convulsions (seizures). These are more likely in people who already have epilepsy or severe liver problems or in people who have taken ‘benzodiazepine’ medicines for a long time. Convulsions are also more likely in people given Anexate after an overdose of more than one medicine, including at least one ‘benzodiazepine’, especially if taken with certain anti-depressants.
Withdrawal symptoms
- If you have recently been taking ‘benzodiazepine’ medicines (for example to help you sleep or to treat anxiety), you may get withdrawal symptoms after having Anexate. This may happen even if you stopped taking these medicines a few days or weeks before having Anexate. Withdrawal symptoms include disturbed sleep, depression, feeling nervous, feeling irritable, feeling dizzy, a rapid heartbeat, diarrhoea and sweating.
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
How Anexate is stored
- Your doctor or pharmacist is responsible for storing Anexate. They are also responsible for disposing of any unused Anexate correctly.
- Keep out of the reach and sight of children.
- Do not use after the expiry date which is stated on the pack.
- Do not store above 30ºC.
Further information
What Anexate contains
The active substance in Anexate 500 micrograms/5 ml Ampoule is flumazenil. Each millilitre (ml) of liquid medicine contains 100 micrograms of flumazenil. Each ampoule (small glass bottle) contains 500 micrograms of flumazenil (in 5 ml of liquid).
The other ingredients are disodium edetate, glacial acetic acid, sodium chloride, sodium hydroxide and water for injections.
What Anexate looks like and contents of the pack
Anexate is a clear almost colourless liquid (‘solution for injection or infusion’). This liquid may be further diluted to make it weaker before it is given to you.
Anexate is supplied in clear glass ampoules in packs of 5 or 25. Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder and Manufacturer is:
This leaflet was last approved in November 2008.
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