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FLUMAZENIL 0.1 MG/ML SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): FLUMAZENIL

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0,5 mm 9 mm 1,5 mm

20 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Flumazenil 0.1 mg/ml
solution for injection / concentrate for solution for infusion










In this leaflet
1. What Flumazenil is and what it is used for
2. Before Flumazenil is given to you
3. How to use Flumazenil
4. Possible side effects
5. How to store Flumazenil
6. Further information

Taking other medicines

1. WHAT FLUMAZENIL IS AND WHAT IT IS USED FOR

Pregnancy and breast-feeding

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 hold under sedative
conditions. Flumazenil may also be used for treatment of intoxications or
overdose with benzodiazepines.

2. BEFORE FLUMAZENIL IS GIVEN TO YOU
Do not use Flumazenil












if you are allergic (hypersensitive) to flumazenil or any of the other
ingredients (see Section 6 for a list of other ingredients).
if benzodiazepines have been given to you to control a life-threatening
condition (e.g. pressure on the brain or a serious epileptic fit).
if you have taken too much of a benzodiazepine with other medicines
such as tricyclic and/or tetracyclic antidepressants (e.g. Imipramin,
Clomipramin, Mirtazepine or Mianserin). Harmful effects of these other
antidepressants may not be seen if benzodiazepines are also being
used. If you have signs of overdose with other antidepressants,
Flumazenil must not be used.

Take special care with Flumazenil
















the effects of flumazenil usually wear off more quickly than those of
benzodiazepines. This means that the relaxing effects of the
benzodiazepines can come back. You will be checked until the effects
of flumazenil have worn off.
if you have taken benzodiazepines for a long time flumazenil can cause
withdrawal symptoms (see Section 4 for details).
if you have epilepsy and have been taking benzodiazepines for a long
period of time Flumazenil can cause fits (convulsions).
if you have a serious brain injury (e.g. pressure on the brain or a
serious epileptic fit) because Flumazenil can increase the pressure on
the brain.
if you are dependent (rely) on benzodiazepines or if you have
benzodiazepine withdrawal symptoms. You should not use
Flumazenil in these cases.

if you have had panic or anxiety attacks in the past, Flumazenil can
cause new attacks.
if you are dependent (rely on) on alcohol or some other medicines.
There is a risk of you becoming benzodiazepine tolerant (where you no
longer get any benefit) or benzodiazepine dependent.
children and infants should only receive Flumazenil to reverse
conscious sedation (where they remain awake). Children should be
closely observed for at least 2 hours after receiving Flumazenil.

Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Harmful effects of other medicines (especially tricyclic antidepressants like
Imipramin) may worsen when the effects of benzodiazepines are treated
with Flumazenil.
Ask your doctor or pharmacist for advice before taking any medicine.
Because of insufficient experience during pregnancy 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.

Driving and using machines

After you have received Flumazenil the effects of benzodiazepines can
come back. You must not drive a car, operate machinery or do strenuous
activity for at least 24 hours after Flumazenil treatment.

Important information about some of the ingredients of
Flumazenil

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 if you are on a controlled sodium diet.

3. HOW TO USE FLUMAZENIL
Flumazenil is administered as an intravenous (into a vein) injection or
may be diluted for infusion (injection over a longer period).
Flumazenil will be given by your anesthetist or an experienced physician. It
may be used with other treatments given to revive (resuscitate) you.
This medicinal product is for single use only. Any unused medicine should
be thrown away. The solution should be inspected before use. It should
only be used if it is clear, colourless and free from particles.
The dose will be defined by your doctor according to the need. It depends
from the circumstances and must be decided case by case. More details for
healthcare professionals are given at the end of the package leaflet.

Children under the age of 1 year

There is little information on the use of Flumazenil in children less than 1

--------------------------------------------------------------------------------------------------------------------------------------------------------------

The following information is intended for medical or
healthcare professionals only:
Flumazenil should be administered intravenously by an anaesthetist or
experienced physician.
Flumazenil may be administered as injection or as infusion (for instructions
on dilution of the product before administration, see chapter below).
Flumazenil may be used concomitantly with other resuscitative measures.
This medicinal product is for single use only. It should be inspected visually
prior to use and should only be used if the solution is clear and practically
free from particles.
If no clear effect on awareness and respiration is obtained after repeated
dosing with Flumazenil, the possibility should be considered that the
intoxication is due to agents other than benzodiazepines.
If Flumazenil is used in anaesthesiology at the end of surgery, it should not
be given until the effects of the muscle relaxants have been fully reversed.
Children who have been sedated with Midazolam should be closely
observed for at least 2 hours after Flumazenil administration, in case
repeated sedation or difficulty with breathing occurs. When other
benzodiazepines have been used the monitoring time must be adjusted
based on how long their effects last.

How to store Flumazenil

When Flumazenil is to be used as an infusion, it must be diluted prior
to use. Flumazenil should only be diluted with sodium chloride 9 mg/ml
(0.9% w/v) solution or glucose 50 mg/ml (5% w/v). Compatibility between
flumazenil and other solutions for injection has not been established.
From a microbiological perspective, the diluted Flumazenil should be
used immediately. If not used immediately, the in-use storage should not
be longer than 24 hours at 2 to 8°C, unless dilution has taken place in
controlled and validated aseptic conditions.
Flumazenil must not be mixed with other medicinal products except for
those mentioned above.

The recommended doses for Flumazenil
Adults:
Anaesthesia
The recommended starting dose is 0.2 mg administered intravenously
over 15 seconds. If the required level of consciousness is not obtained
within 60 seconds, a further dose of 0.1 mg can be injected and repeated
at 60-second intervals, up to a maximum dose of 1.0 mg. The usual dose
required lies between 0.3 and 0.6 mg, but may deviate depending on the
patient’s characteristics and the benzodiazepine used.

30 mm

Read all of this leaflet carefully before you start using this
medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Laetus
Barcode

Active substance: flumazenil







year old. Children of less than 1 year old should only be given Flumazenil if
the benefits are expected to be greater than the risk.

abnormal crying, agitation and aggressive reactions have been reported.

If you have any further questions on the use of Flumazenil, ask your doctor.

If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Patients with hepatic (liver) impairment

5. HOW TO STORE FLUMAZENIL

In patients with impaired liver function, the dosing must be managed
carefully.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Flumazenil can cause side effects, although not
everybody gets them.
The frequency of side effects is classified into the following categories:

Very common (in more than 1 in 10 patients)
• Feeling sick (nausea)

Common (1 - 10 in 100 patients)



























hypersensitivity (allergic reaction)
anxiety
mood swings (emotional lability)
difficulty sleeping (insomnia)
sleepiness (somnolence)
dizziness
headache
panic (agitation)
shaking (tremor)
dry mouth
rapid breathing (hyperventilation)
speech disorder
tingling or numbness of the hands or feet (paraesthesia)
double vision (diplopia)
squinting (strabismus)
watering eyes (lacrimation)
feeling your heartbeat (palpitations)
flushing
low blood pressure on standing (orthostatic hypotension)
high blood pressure on waking from the effects of benzodiazepines
vomiting
hiccups
sweating
fatigue
injection site pain

Uncommon (1 - 10 in 1,000 patients)










fits (convulsions)
abnormal hearing
irregular heartbeat
difficulty breathing
cough
blocked nose (nasal congestion)
chest pain
shivering

If you have been treated with benzodiazepines for a long time, Flumazenil
can cause withdrawal symptoms such as:
• tension
• panic (agitation)
• anxiety
• confusion
• abnormal sensory perceptions (hearing voices, seeing things that aren’t
there, sensations on the skin)
• shaking (tremor)
• fits (convulsions)
Similar effects can be seen in children. When Flumazenil has been used in children

Keep out of the reach and sight of children.
Flumazenil must not be used 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 medicine is for single use only and should be used immediately after
opening. If diluted, Flumazenil should not be stored for longer than 24
hours at 2-8°C.
Flumazenil should only be used if the solution is clear and free from particles.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Flumazenil contains
The active substance is flumazenil.
Each ml of solution for injection contains 0.1 mg flumazenil.
Each 5 ml ampoule contains 0.5 mg flumazenil.
Each 10 ml ampoule contains 1.0 mg flumazenil.
The other ingredients are
• disodium edetate
• glacial acetic acid
• sodium chloride (3.7 mg per ml)
• hydrochloric acid 36% for pH adjustment
• sodium hydroxide for pH adjustment
• water for injections

What Flumazenil looks like and contents of the pack

Flumazenil is a clear and colourless solution for injection, or for dilution
before infusion. Flumazenil comes in colourless glass ampoules.
Following pack sizes are available:
Carton boxes with 5 or 50 (10x5) ampoules containing 5 ml solution.
Carton boxes with 5 or 50 (10x5) ampoules containing 10 ml solution
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B - Fervença
2705-906 Terrugem SNT - Portugal
This medicinal product is authorised in the Member State of the EEA under
the following names:
Austria

Germany

Italy

Portugal

United Kingdom


Flumazenil 0,1 mg/ml Injektionslösung und Konzentrat
zur Herstellung einer Infusionslösung
Flumazenil 0,1 mg/ml Injektionslösung und Konzentrat
zur Herstellung einer Infusionslösung
Flumazenil Hikma 0,1 mg/ml soluzione

iniettabile/concentrato per soluzione per infusione
Flumazenilo Hikma 0,1 mg/ml solução

injectável/concentrado para solução para perfusão
Flumazenil 0.1 mg/ml solution for

injection / concentrate for solution for infusion

This leaflet was last approved in 05/2010.

-----------------------------------------------------------------------------------------------------------------------------------------------------------------Intensive Care
The recommended starting dose is 0.2 mg administered intravenously over
15 seconds. If the required level of consciousness is not obtained within
60 seconds, a further dose of 0.1 mg can be injected and repeated at
60-second intervals, up to a total dose of 2 mg or until the patient awakes.
If drowsiness recurs, an intravenous infusion of 0.1 – 0.4 mg/h may be useful.
The rate of infusion should be adjusted individually to achieve the desired
level of consciousness.
If no clear effect on awareness and respiration is obtained after repeated
dosing, it should be considered that the intoxication is not due to
benzodiazepines.
Infusion should be discontinued every 6 hours to verify whether resedation
occurs.
To avoid withdrawal symptoms in patients treated for a long period of time
with high doses of benzodiazepines in the intensive care unit, the dosage
of flumazenil has to be titrated individually and the injection has to be
administered slowly.
Elderly
In the absence of data on the use of flumazenil in elderly patients, it should
be noted that this population is generally more sensitive to the effects of
medicinal products and should be treated with due caution.

Children and adolescents (from 1 to 17 years)
For the reversal of conscious sedation induced by benzodiazepines in
children older than 1 year the recommended starting dose is 0.01 mg/kg
(up to 0.2 mg), administered intravenously over a period of 15 seconds. If,
after a waiting period of 45 seconds, the required level of consciousness
is not obtained a follow-up injection of 0.01 mg/kg (up to 0.2 mg) may
be administered and where necessary repeated at 60-second intervals (up
to a maximum of 4 times) to a maximum dose of 0.05 mg/kg or 1 mg,
depending on which is the lowest dose. The dose should be adjusted to
the patient’s response. There are no data on safety and efficacy of repeated
flumazenil administration in children in case of resedation.
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.
Patients with renal or hepatic impairment
In patients with impaired hepatic function, the elimination of flumazenil
may be delayed (see section 5.2) and therefore careful titration of dosage
is recommended. No dosage adjustments are required in patients with
renal impairment.

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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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