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FLUMAZENIL 0.1 MG/ML INJECTION

Active substance(s): FLUMAZENIL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

hameln

Read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.

Flumazenil 0.1 mg/ml Injection
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 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 may also be used in children (older than 1
year) to wake them up after they have been held under
sedative conditions with benzodiazepines.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN FLUMAZENIL
Flumazenil will be given to you by a specially trained
doctor under strict supervision.
You must NOT be given Flumazenil if you are:
- allergic (hypersensitive) to Flumazenil or any of the
other ingredients (see section 6 for a complete list of
ingredients).
- taking benzodiazepines to control a life-threatening
condition such as an increase in brain pressure
(raised intracranial pressure) or a serious epileptic
seizure (status epilepticus).
Warnings and precautions
Before you receive Flumazenil, tell your doctor if you:
- have epilepsy and have taken benzodiazepines for a
long period. Flumazenil can cause seizures.
- have liver problems.
- have or in the past have had a serious head injury
Flumazenil can cause increased pressure in your
brain.
- were anxious before an operation or had an anxious
seizure or have long term anxiety.
- had panic attacks in the past. Flumazenil can cause
new attacks.
- had long-term or high dosage treatment of
benzodiazepines. A rapid injection of Flumazenil
at a dose higher than 1 mg can cause withdrawal
symptoms.
- have a history of alcoholism or other substance abuse
you have a higher risk of benzodiazepine tolerance
and dependence and therefore a higher risk of
withdrawal symptoms. Your anaesthetist will adjust
your dose carefully.
Beware also the following
Flumazenil only reverses the effects of benzodiazepines.
o if lowering of consciousness or sedation is caused
by another agent, it is unlikely that Flumazenil will
counteract it.
o although Flumazenil is given to reverse drowsiness,
you may experience a return of drowsiness for up to
24 hours after Flumazenil is given. This is because the
sedative effects of benzodiazepines lasts longer than
the anti-sedative effects of Flumazenil. Therefore you
will be monitored, if possible in intensive care, until all
possible effects of the benzodiazepine have worn off.
o if you undergo an operation that is particularly invasive
and causes a lot of pain, the anaesthetist may keep
you in a sedated condition.
o
Flumazenil
is
not
recommended
to
treat
benzodiazepine addiction or the symptoms of it.
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.
Children
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 duration.

Children should only receive Flumazenil after deliberate
sedation. There are insufficient data for any other
indications. The same applies for children below the age
of 1 year
Other medicines and Flumazenil
Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines,
including medicines obtained without a prescription.
This information is needed so that your anaesthetist can
adjust your dose carefully.
In particular please tell your doctor or nurse if you are
taking any of the following medicines:
• zopiclone and triazolopyridazine (used to treat
insomnia)
• benzodiazepines (e.g. diazepam, midazolam)
• tricyclic or tetracyclic antidepressants like amitriptyline,
nortriptyline, clomipramine, mirtazapine, mianserin
and imipramine
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 antidepressants like Imipramine)
taken concurrently, may increase with the subsidence of
the benzodiazepine effect.
Pregnancy and breast-feeding
The risk to the unborn foetus in humans has not been
determined, therefore, Flumazenil is not recommended
for use during pregnancy, unless the benefits to the
patient clearly outweigh the risks to the unborn foetus,
such as in a life-threatening, emergency situation.
It is not known whether Flumazenil is excreted in breast
milk. Therefore it is better not to breast-feed for 24 hours
after Flumazenil has been given.
Driving and using machines
The effect of Flumazenil is shorter than the effect of
benzodiazepines and so it is possible that you may feel
sleepy again. Do not drive motor vehicles and do not
operate any tools or machines for a period of 24 hours
after the administration of Flumazenil.
Important information about some of the ingredients
of Flumazenil
This medicinal product contains 3.7 mg sodium per ml
(18.5 mg per 5 ml ampoule or 37 mg per 10 ml ampoule).
To be taken into consideration by patients on a controlled
sodium diet.
3. HOW FLUMAZENIL IS GIVEN
Flumazenil is administered in the vein (intravenously)
either diluted or undiluted. Flumazenil will be given to
you under strict supervision of a doctor with experience
in anaesthesia. The doctor will determine how much
Flumazenil to give. This depends on your age, weight,
how well your liver and kidneys are working and what
you need the medicine for. Flumazenil can be used in
combination with other agents, which are used to return
somebody to consciousness.
Adults
The dosage depends on the situation; usually, an
initial dose of 0.2 milligram is administered into your
vein during 15 seconds. If your state of consciousness
does not improve sufficiently after 60 seconds, another
dose of 0.1 milligram can be administered. This can
repeated after 60 seconds until you reach a sufficient
state of consciousness. The maximum dose that can
be administered is 1 milligram after anaesthesia and 2
milligrams in intensive care.
The treatment is discontinued every 6 hours in order to
determine if sedation re-occurs.
Children older than 1 year
Usually, an initial dose of 0.01 milligram per kilogram
body weight (up to 0.2 milligram) is administered into
a vein during 15 seconds. If the state of consciousness
does not improve sufficiently after 45 seconds, another
dose of 0.01 milligram per kilogram body weight (up to
0.2 milligram) can be administered. This can be repeated
after 60 seconds up to four times to a maximum total
dose of 0.05 milligram per kilogram body weight or 1
milligram, whichever is lower.
There is little information about the use of Flumazenil in
children under 1 year of age. Your doctor will decide if it
is necessary to give Flumazenil to your child of this age.
Elderly
Elderly people are generally more sensitive to the effects
of Flumazenil and should be treated with due caution.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:

hameln

PREPARATION GUIDE FOR:

Flumazenil 0.1 mg/ml Injection
Please refer to Summary of Product Characteristics for
full prescribing and other information.
1. Incompatibilities
This medicinal product must not be mixed with other
medicinal products except for following:
Sodium chloride 9 mg/ml (0.9%) solution, dextrose
50 mg/ml (5%) solution or sodium chloride 4.5 mg/ml
(0.45%) + dextrose 25 mg/ml (2.5%) solution (10, 20, 50
ml Flumazenil 0.1 mg/ml in 500 ml solution). Compatibility
between flumazenil and other solutions for injection has
not been established.
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.
2. Posology and method of administration
This medicinal product is for single use only and any
unused solution should be discarded.

When flumazenil is to be used in infusion, it must be
diluted prior to infusion.
Flumazenil should be administered intravenously by an
anaesthetist or experienced physician.
Flumazenil may be administered as infusion.
Flumazenil may be used concomitantly with other
resuscitative measures.
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 is 0.3 to 0.6 mg, but may deviate
depending on the patient’s characteristics and the
benzodiazepine used.
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.

Patients with liver impairment
If you have liver problems your doctor may give you a
reduced dose.
If you have any further questions on how this product will
be given, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Flumazenil can cause side effects,
although not everybody gets them. If any of the side
effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
If you experience any of the following tell the doctor
or nurse immediately. Flumazenil may cause allergic
reactions. Symptoms of allergic reactions include,
swelling of the face, lips throat or tongue, rash and
difficulty breathing.
The following side effects have been reported:
Very common (affects more than 1 user in 10):
- nausea
Common (affects 1 to 10 users in 100):
- allergic reactions
- strong emotional lability
- having problems in initiating and maintaining sleep
(insomnia)
- feeling sleepy (somnolence)
- dizziness
- headache
- involuntary trembling or quivering (tremor)
- dry mouth
- hyperventilation
- speech disorder
- individual cutaneous sensations (e.g. cold, warmth,
tingling, pressure, etc.) in the absence of stimulation
(paresthesia)
- double vision
- strabismus (a condition in which the eyes are not
properly aligned with each other)
- increase in lacrimation
- reddening of the skin
- low blood pressure on transition from lying to standing
- transient increased blood pressure
- vomiting
- hiccup
- sweating
- pain at the injection site
Common after rapid injection (not requiring treatment):
- anxiety
- agitation
- heart palpitations
Uncommon (affects 1 to 10 users in 1,000):
- fear
- convulsions
- abnormal hearing
- slow or rapid heart action
- premature beat of your heart (extrasystole)
- difficulty in breathing
- cough
- nasal congestion
- chest pain
- shivering
Rare (affects 1 to 10 users in 10,000):
- severe allergic reactions
If you have been treated with high doses of
benzodiazepines or for long periods Flumazenil
can induce withdrawal symptoms such as tension,
agitation, anxiety, strong emotional lability, confusion,
hallucinations, dizziness, sweating, rapid heart action,
tremor and convulsions, panic attacks, abnormal crying,
agitation and aggressive behaviour.

- 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.
- Shelf-life after dilution:
Chemical and physical in-use stability of the dilutions
has been demonstrated for 24 hours at 25°C. From
the microbiological point of view, the dilutions should
be used immediately. If not used immediately, inuse 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.
6. CONTENTS OF
INFORMATION

THE

PACK

AND

OTHER

What Flumazenil contains
The active substance is flumazenil.
1 ml solution for injection contains 0.1 mg flumazenil.
1 ampoule with 5 ml solution contains 0.5 mg flumazenil.
1 ampoule with 10 ml solution contains 1.0 mg flumazenil.
The other ingredients are disodium edetate, glacial
acetic acid, sodium chloride, sodium hydroxide and
water for injections.
What Flumazenil looks like and contents of the pack
Flumazenil is a clear and colourless solution in glass
ampoules.
Boxes of 5 or 10 ampoules with 5 ml.
Boxes of 5 or 10 ampoules with 10 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
hameln pharma plus gmbh
Langes Feld 13
31789 Hameln, Germany
Marketing Authorisation Number
PL 25215/0001
Distributor
hameln pharmaceuticals ltd
Gloucester, United Kingdom
Manufacturer
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln, Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
DE Flumazenil-hameln 0,1 mg/ml Injektionslösung und
Konzentrat zur Herstellung einer Infusionslösung
DK Flumazenil Hameln
FI Flumazenil-hameln 0,1 mg/ml injektioneste, liuos
IT Flumazenil-hameln 0,1 mg/ml, soluzione iniettabile
NL Flumazenil-hameln 0,1 mg/ml, oplossing voor
injectie
NO FLUMAZENIL
HAMELN
injeksjonsvaeske,
opplosning 0,1 mg/ml
SE Flumazenil Hameln 0,1 mg/ml injektionsvätska,
lösning
This leaflet was last approved in July 2014.

Additional side effects in children
In general the undesirable effects in children do not differ
much from that in adults. When using Flumazenil to
awake a child from sedation, abnormal crying, agitation
and aggressive behaviour have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor 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
- Keep this medicine out of the sight and reach of
children.
- Do not store above 25°C. Do not freeze. Keep the
ampoules in the outer carton in order to protect from
light.
- After opening the solution has to be used immediately.
- Any unused solution from opened ampoules should
be discarded.
- Do not use this medicine if you notice that the solution
is not clear and colourless.
- Do not use Flumazenil after the expiry date which is
stated on the packaging after “EXP:” The expiry date
refers to the last day of that month.

45847/30/14

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------If drowsiness recurs, a second bolus injection of
flumazenil may be administered. An intravenous infusion
of 0.1-0.4 mg/h may be useful.
The dosage and rate of infusion should be adjusted
individually to achieve the desired level of consciousness.
If a significant improvement in consciousness or
respiratory function is not obtained after repeated doses
of flumazenil, a non-benzodiazepine aetiology must be
assumed.
Infusion should be discontinued every 6 hours to verify
whether re-sedation 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.
Special Populations
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.

Patients with renal or hepatic impairment
Since flumazenil is primarily metabolised in the liver,
careful titration of dosage is recommended in patients
with impaired hepatic function. No dosage adjustments
are required in patients with renal impairment.
Paediatric population
Children above 1 year of age
For the reversal of conscious sedation induced with
benzodiazepines in children >1 year of age, the
recommended initial dose is 0.01 mg/kg (up to 0.2
mg), administered intravenously over 15 seconds. If
the desired level of consciousness is not obtained after
waiting an additional 45 seconds, further injection of 0.01
mg/kg may be administered (up to 0.2 mg) and repeated
at 60 second intervals where necessary (a maximum of
4 times) to a maximum total dose of 0.05 mg/kg or 1 mg,
whichever is lower. The dose should be individualised
to the patient’s response. No data are available on
the safety and efficacy of repeated administration of
flumazenil to children for re-sedation.
Children under the age of 1 year
There are insufficient data on the use of flumazenil in
children younger than 1 year.
Therefore flumazenil should only be administered in
children younger than 1 year if the potential benefits to
the patient outweigh the possible risk.

45847/30/14

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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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