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Active substance(s): FLUMAZENIL

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Product Name:
Type of Packaging:
Material number:
M0xxxxx/xx UK
Pharma-Code (Laetus)
180 x 588 mm


2-D-Matrix Code
M0xxxxx/xx UK
Code: –


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1. Draft
1. Corr
2. Corr
3. Corr
4. Corr

25.07.2014, 11:00
25.03.2015, 13:15
27.03.2015, 13:45
01.04.2015, 12:00
28.04.2016, 18:00

Variable Data:

Operator: Roberto Grill +43(0) 699-17181288

Smallest Size: 8


Flumazenil 0.1 mg/ml Solution for Injection
Read all of this leaflet carefully before you start
using 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, nurse or healthcare personnel.
- If you get any side effects talk to your doctor,
pharmacist, nurse or healthcare personnel. 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 use Flumazenil
3. How to use Flumazenil
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 is a counteragent (antidote) for the complete
or partial reversal of the central sedative effects of
benzodiazepines (specific group with sedative, sleep inducing,
muscle relaxing and anxiolytic properties).
It may therefore be used in anaesthesia to wake you up
after certain diagnostic tests or in intensive care if you have
been held under sedative conditions. Flumazenil may also
be used for the diagnosis and treatment of intoxications or
overdose with benzodiazepines.
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.
2. What you need to know before you use Flumazenil
Do not use Flumazenil
- if you are allergic (hypersensitive) to flumazenil or any
of the other ingredients (listed in section 6).
- if benzodiazepines have been administered to you to
control a potentially life-threatening situation (for
example control of pressure in the brain or a serious
epileptic seizure).
- in mixed intoxications with benzodiazepines and
certain types of other antidepressants (so called
tricyclic and tetracyclic antidepressants like Imipramine,
Clomipramine, Mirtazapine or Mianserin). The toxicity
of these antidepressants can be masked by protective
benzodiazepine effects. If you are showing signs of
a significant overdose of these antidepressants,
Flumazenil must not be used to reverse
benzodiazepine effects.


time within the weeks preceding flumazenil
administration, rapid injection of high doses of
flumazenil (more than 1 mg) should be avoided since
this may cause withdrawal symptoms (see section
4. Possible side effects).
If you have been treated for long periods with high
doses of benzodiazepines, the advantages of the use
of Flumazenil should be carefully weighed against the
risk of withdrawal symptoms.
In children previously sedated with midazolam.
These children should be closely observed in intensive
care units for at least 2 hours after administration
of Flumazenil because repeated sedation or
difficulty with breathing can occur. In case of
sedation by other benzodiazepines, the monitoring
must be adjusted according to their expected
If you are epileptic and have received benzodiazepine
treatment for a long period of time, the administration
of flumazenil is not recommended as flumazenil can
cause seizures.
Seizures or other toxic effects can be more severe in
cases of mixed drug overdose (e.g. intoxication with
benzodiazepines and cyclic antidepressents)
If you have serious brain injury (and/or instable
pressure in your brain) care willl be taken as Flumazenil
can cause an increased pressure in your brain.
As Flumazenil is not recommended for the treatment of
benzodiazepine-dependence or for the treatment of
If you have experienced panic attacks in the past
Flumazenil can cause new attacks.
If you are dependent on alcohol or medicines as you
have a higher risk of benzodiazepine tolerance and
if your liver is not working well flumazenil
elimination can be delayed.

- Children should only receive Flumazenil after deliberate
sedation. There are unsufficient data for any other
indications. The same applies for children below the
age of 1 year
Other medicines and Flumazenil
Tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a
When using Flumazenil in cases of an accidental overdose it
has to be taken into account that the toxic effects of other
psychotropic medicinal products (especially tricyclic
anti-depressants like Imipramine) taken concurrently, may
increase with the subsidence of the benzodiazepine effect.
Interaction with other central nervous system depressants
has not been observed.
Flumazenil with alcohol
There is no known interaction between ethanol and flumazenil.

Warnings and precautions
- If you do not wake up after Flumazenil is
administered, another reason for this will be considered
because Flumazenil specifically reverses the effects of
- If Flumazenil is administered to you at the end of your
operation to wake you up, it should not be given until
the effects of muscle relaxants have gone away.
- As the action of flumazenil is usually shorter than that
of benzodiazepines, sedation may possibly recur. You
will be closely observed, possibly in the intensive care
unit until the effects of flumazenil have gone away.
- If you have received high dose and/or long-term
(chronic) treatment with benzodiazepines, at any

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

Driving and using machines
After receiving Flumazenil for the reversal of the sedative
effects of benzodiazepines you must not drive a car, operate
machinery or engage in any other physically or mentally
demanding activity for at least 24 hours since sedation may
possibly recur.
Flumazenil contains sodium chloride
This medicinal product contains 3.7 mg sodium per ml (18.5
mg / 5 ml ampoule size or 37 mg / 10 ml ampoule size)
solution for injection. To be taken into consideration by
patients on a controlled sodium diet.

Patients with renal (kidney) or hepatic (liver)
In patients with impaired liver function, the elimination of
flumazenil may be delayed and therefore careful titration
of dosage is recommended.

Because of insufficient experience during pregnanacy
Flumazenil should only be used if the advantage for you
is higher than the potential risk for the unborn baby.
The administration of Flumazenil during pregnancy is not
contraindicated in an emergency situation.
It is not known whether flumazenil is excreted in breast
milk. Therefore it is recommended not to breast-feed 24
hours after administration of Flumazenil

No dosage adjustments are required in patients with
impaired kidney function.
Use in Children
Children above 1 year of age
Reversal of deliberate sedation

3. How to use Flumazenil
Flumazenil is administered as intravenous injection (into
a vein) or diluted as intravenous infusion (over a longer
Flumazenil will be given by your anaesthetist or experienced
physician. Flumazenil may be used at the same time as other
resuscitative measures.
This medicinal product is for single use only. Any unused
solution should be discarded. The solution should be
inspected visually prior to use. It should only be used if the
solution is clear, colourless and practically free from particles.
The recommended dose is described as follows:
Intensive Care
Dosage level:
Starting dose:
Starting dose:
0.2 mg administered
0.3 mg administered
intravenously over a period intravenously over a period
of 15 seconds.
of 15 seconds.
A further dose of 0.1 mg
A further dose of 0.1 mg can
can be injected and
be injected and repeated at
repeated at 60 second
60 second intervals, if required
level of consciousness is not
intervals, if required level of
consciousness is not obtained obtained within 60 seconds,
within 60 seconds, up to a
up to a maximum dose of
maximum dose of 1.0 mg.
2.0 mg.
If drowsiness recurs a second
The usual dose required
bolus injection may be
lies between 0.3 and
administered. An intravenous
0.6 mg, but may deviate
infusion of 0.1- 0.4 mg/h has
depending on the patients
also been shown useful. The
characteristics and the
dosage and rate of infusion
benzodiazepine used.
should be adjusted individually
to achieve the desired level of
The infusion can be given
additionally to the maximum
dose of 2 mg by injection.

Dosage level:
The recommended initial dose is 10 micrograms/kg (up
to 200 micrograms), administered intravenously over 15
seconds. If the desired level of consciousness is not obtained
after waiting an additional 45 seconds, further injection
of 10 micrograms//kg may be administered (up to 200
micrograms) and repeated at 60 second intervals where
necessary (a maximum of 4 times) to a maximum total dose
of 50 micrograms/kg or 1 mg, whichever is lower.
Children under the age of 1 year
There are insufficient data on the use of Flumazenil in
children under 1 year. Therefore Flumazenil should only
be administered in children under 1 year if the potential
benefits to the patient outweigh the possible risk.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
For information intended for healthcare professionals please
see accordant section below.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
hypersensitivity reactions (allergic reactions), anxiety
(after rapid injection, not requiring treatment), emotional
lability, having problems in initiating and maintaining sleep
(insomnia), feeling sleepy (somnolence), vertigo, headache,
agitation (after rapid injection, not requiring treatment),
unvoluntary trembling or quivering (tremor), dry mouth,
abnormal rapid and deep respiration (hyperventilation),
speech disorder, subjective cutaneous sensations (e.g.
cold, warmth, tingling, pressure, etc.) in the absence
of stimulation (paresthesia), double vision, strabismus
(squinting), lacrimation (production of tear fluid) increased,
heart palpitations (after rapid injection, not requiring
treatment), reddening of the skin (flushing), low blood
pressure on transition from lying to standing, transient
increased blood pressure (on awaking), vomitting, hiccup,
sweating, fatigue, injection site pain

M0xxxxx/00 UK

Uncommon (may affect up to 1 in 100 people)
Fear (after rapid injection, not requiring treatment),
convulsions (in patients suffering from epilepsy or severe
liver insufficiency, mainly after long-term treatment with
benzodiazepines or mixed drug overdose (see section 2
warnings and precautions), abnormal hearing, slow or rapid
heart rate, premature beat of your heart (extrasystole),
difficulty breathing (dyspnoea), cough, nasal congestion,
chest pain, shivering (after rapid injection, not requiring

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information.
What Flumazenil contains
The active substance is flumazenil.

Not known (frequency cannot be estimated from the
available data)
Withdrawal symptoms (see below); panic attacks (in patients
with a history of panic reactions); abnormal crying, agitation,
aggressive reactions, severe allergic reactions (anaphylaxis).
If you were treated for a long period with benzodiazepines
flumazenil can induce withdrawal symptoms. The
symptoms are: tension, agitation, anxiety, emotional
lability, confusion, hallucinations, involuntary trembling or
quivering (tremor) and convulsions.
In general the undesirable effects in children do not
differ much from that in adults. When using Flumazenil to
awaken a child from sedation, abnormal crying, agitation
and aggressive reactions have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this leaflet. You can
also report side effects directly (see details below).

Each millilitre contains 0.1 mg = 100 micrograms flumazenil.
Each ampoule with 5 ml contains 0.5 mg = 500 micrograms
Each ampoule with 10 ml contains 1.0 mg = 1000
micrograms flumazenil.
The other ingredients are disodium edetate, glacial acetic
acid, sodium chloride, sodium hydroxide solution 4%, water
for injections.
What Flumazenil looks like and contents of the pack
Flumazenil is a clear and colourless solution for injection
and concentrate for solution for infusion in colourless glass
Following packaging sizes are available:
Carton boxes with 5 or 10 ampoules containing 5 ml
Carton boxes with 5 or 10 ampoules containing 10 ml

United Kingdom
Yellow Card Scheme

Not all packaging sizes may be marked.

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517

Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park, Runcorn
Cheshire WA7 1NT
United Kingdom

Marketing Authorisation Holder and Manufacturer

This leaflet was last revised 05/2016

By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Flumazenil
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 label and carton. The expiry date refers to the
last day of that month.
Do not store above 25°C
This medicinal product is for single use only.
Shelf life after first opening: the medicinal product should
be used immediately.
Shelf life after dilution: 24 hours.
Chemical and physical in-use stability has been
demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of
the user and would normally not be longer than 24 hours at
2 to 8 °C, unless dilution has taken place in controlled and
validated aseptic conditions.
Do not use this medicine if the solution is not clear and free
from particles.
Any unused solution should be discarded in accordance with
local requirements.

The following information is intended for healthcare professionals only:
Detailed storage conditions can be found in section 5. How to store Flumazenil.
When Flumazenil is to be used in infusion, it must be diluted prior to infusion. Flumazenil should only be diluted with sodium
chloride 9 mg/ml (0.9% w/v) solution, glucose 50 mg/ml (5% w/v) or sodium chloride 4.5 mg/ml (0.45% w/v) + glucose 25 mg/ml
(2.5% w/v) solution. Compatibility between flumazenil and other solutions for injection has not been established.
This medicinal product must not be mixed with other medicinal products except for those mentioned in this section.
For further information on dosage instructions please see section 3 of the Package Information Leaflet.

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