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FLUMAZENIL 0.1 MG/ML SOLUTION FOR INJECTION / INFUSION

Active substance(s): FLUMAZENIL

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Flumazenil 0.1 mg/ml
solution for injection/infusion
Flumazenil

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
−− Keep this leaflet. You may need to read it again.
−− If you have any further questions, ask your doctor,
pharmacist or nurse.
−− This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
−− If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Flumazenil is and what it is used for
2. What you need to know before you are given
Flumazenil
3. How Flumazenil is given
4. Possible side effects
5. How to store Flumazenil
6. Contents of the pack and other information

1. WHAT FLUMAZENIL IS AND WHAT IT
IS USED FOR
Flumazenil contains a medicine called flumazenil. It is
used to wake you up after you have been made sleepy
by a medicine called a ‘benzodiazepine’.
Flumazenil 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.

Warnings and precautions
Talk to your doctor or nurse before having
Flumazenil.
Take special care with Flumazenil and check with
your doctor or nurse 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 applies to you, or if you are not
sure, talk to your doctor or nurse before having
Flumazenil.
Other medicines and Flumazenil
Tell your doctor or nurse if you are taking, have
recently taken or might take any other medicines. This
includes medicines that you buy without a prescription
and herbal medicines. This is because Flumazenil can
affect the way some other medicines work. Also some
other medicines can affect the way Flumazenil 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.

Flumazenil 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.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby, ask
your doctor or nurse for advice before having this
medicine.

2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN FLUMAZENIL

Driving and using machines
• Do not drive or use any tools or machines for at
least 24 hours after having Flumazenil.
• Do not do anything that is physically or mentally
demanding for at least 24 hours after having
Flumazenil. This is because the effects of the
‘benzodiazepine’ medicine may return and you
may start to feel sleepy again.

You must not be given Flumazenil if you are
allergic (hypersensitive) to:
• Flumazenil or any of the other ingredients of
Flumazenil (listed in Section 6).
• ‘Benzodiazepine’ medicines. These include
diazepam, midazolam and temazepam.
You must not be given Flumazenil if any of the above
apply to you. If you are not sure, talk to your doctor or
nurse before having this medicine.
You must not be given Flumazenil 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 Flumazenil if any of the above
applies to you. If you are not sure, talk to your doctor
or nurse before having this medicine.

Flumazenil contains sodium
This medicine contains 3.7 mg sodium per ml (18.5
mg per 5 ml ampoule and 37 mg per 10 ml ampoule).
To be taken into consideration by patients on a
controlled sodium diet.

3. HOW FLUMAZENIL IS GIVEN
Flumazenil 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 Flumazenil 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
• Feeling sick or being sick especially if you have
also had any opiate drugs (e.g. morphine)
Uncommon (may affect up to 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 (may affect up to 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)
Not known (frequency cannot be estimated from
available data):
• 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
Flumazenil 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 Flumazenil 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 Flumazenil.
The side effects seen in children are similar to those
seen in adults. If Flumazenil has been used to wake up
children after a medical test it may cause them to cry
abnormally, feel agitated or be aggressive.
Reporting of side effects
If you get any side effects, talk to your doctor or,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE FLUMAZENIL
Your doctor or pharmacist is responsible for storing
this medicine.
They are also responsible for disposing of any unused
Flumazenil correctly.
This medicinal product does not require any special
storage conditions.
Keep this medicine out of the sight and reach of
children.

Do not use this medicine after the expiry date which is
stated on the pack.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Flumazenil contains
The active substance in Flumazenil 0.1 mg/ml
solution for injection or infusion is flumazenil.
Each millilitre (ml) of liquid medicine contains
0.1 milligrams of flumazenil.
Each 5 ml ampoule contains 0.5 milligrams of
flumazenil (in 5 ml of liquid).
Each 10 ml ampoule contains 1 milligrams of
flumazenil ( in 10 ml liquid).
The other ingredients are disodium edetate, glacial
acetic acid, sodium chloride, sodium hydroxide, water
for injections.
What Flumazenil looks like and contents of the
pack
Flumazenil is a clear almost colourless sterile aqueous
solution, practically free from visible particles.
Flumazenil is supplied in practically free from
visible particles clear transparent one point-cut glass
ampoules in packs of 5 and 10.
Not all packs may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing authorization holder
ELC GROUP s.r.o.
Karolinská 650/1, Karlín, Prague 8
186 00 Czech Republic
Manufacturer
ROTEXMEDICA
Arzneimittelwerk-Bunsenstrasse 4
D-22946 TRITTAU
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Romania

Flumazenil ELC 0,1mg/ml, solutie
injectabila / perfuzabila

United
Kingdom

Flumazenil 0.1mg/ml, solution for
injection / infusion

This leaflet was last revised in May 2016.
The following information is intended for
healthcare professionals only:
This medicinal product must not be mixed with other
medicinal products except those mentioned in
section 6.6.
After opening: The chemical and physical stability of
flumazenil diluted in glucose 5%, lactated Ringer’s
or Nacl 0.9% solution has been demonstrated for 48
hours at 25°C.
Flumazenil may be administered as an infusion,
diluted in glucose 5%, lactated Ringer’s or NaCl 0.9%
solution.
Any flumazenil solution drawn up into a syringe or
diluted in sodium chloride 0.9% or glucose 5% should
be discarded after 24 hours.
No preparations other than those recommended should
be added to the Flumazenil ampoule or mixed with the
Flumazenil infusion solution.
Any unused medicinal product or waste material should
be disposed of in accordance with local requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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