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The product code for this leaflet is: PL 00031/0228

 

Anexate 500 micrograms/5ml Solution for Injection or Infusion

Company Details

Roche Products Limited


Hexagon Place6 Falcon WayShire ParkWelwyn Garden CityHertfordshireAL7 1TW
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WWW:http://www.rocheuk.com
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Medical Information e-mail:medinfo.uk@roche.com
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Patient Information Leaflet

Anexate® 500 micrograms/5 ml Solution for Injection or Infusion

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

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1. 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.

Anexate is also used in children (more than 1 year old) to wake them up after they have been given a ‘benzodiazepine’ medicine to make them sleepy during a medical procedure.

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2. 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 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, anti-depressants 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.

Important information about some of the ingredients of Anexate

This medicine contains 3.7 mg sodium per ml (18.5 mg per 5 ml vial). Dosages over 600 micrograms contain more than 1 mmol sodium (23 mg). To be taken into consideration by patients on a controlled sodium diet.

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3. 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.

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4. Possible side effects

Like all medicines Anexate can cause side effects, although not everyone gets them.

Common (affect less than 1 in 10 people):

  • Feeling sick or being sick especially if you have also had any opiate drugs (eg morphine)

Uncommon (affect less than 1 in 100 people):

  • Being aware of your heart rate (palpitations)
  • Feeling anxious or frightened
  • These effects are most likely to happen if you have woken up too quickly.

Rare (affect less than 1 in 1,000 people):

  • Sudden swelling of the throat, face, lips or mouth (anaphylaxis). This can make it difficult to breathe or swallow.
  • Sudden swelling of the hands, feet or ankles (hypersensitivity)
  • Skin rash or itching (hypersensitivity)

Unknown (frequency of people affected unknown):

  • Panic attacks (in people who have had panic attacks in the past)
  • Abnormal crying
  • Feeling agitated
  • Being aggressive
  • 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.
  • Increased blood pressure on waking up (short lived)
  • Increased heart rate on waking up (short lived)
  • Feeling cold (most likely to happen if you have woken up too quickly)
  • Redness of the face and neck (flushing).
  • Withdrawal symptoms, for example:
    • Feeling agitated, anxious, confused, dizzy, sweaty,
    • Having mood swings, distorted senses, an increased heart rate.
    Withdrawal symptoms usually happen if you are given high doses of Anexate quickly and/or when you have recently taken ‘benzodiazepine’ medicines (for example to help you sleep or to treat anxiety). This may happen even if you stopped taking these medicines a few days or weeks before having Anexate.

The side effects seen in children are similar to those seen in adults. If Anexate has been used to wake up children after a medical test it may cause them to cry abnormally, feel agitated or be aggressive.

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.

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5. 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.
  • Anexate does not need any special storage conditions.
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6. Further information

What Anexate contains

The active substance in Anexate 500 micrograms/5 ml solution for injection or infusion 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

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
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This leaflet was last approved in June 2011


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