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FLUMAZENIL 0.1 MG/ML SOLUTION FOR INJECTION

Active substance(s): FLUMAZENIL

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TEVA UK Ref:

Version:

231-30-87151-L LEA FLUMAZENIL 0.1mg/ml SOL FOR INJ 5ml TEVAH
5

19 January 2016

Pharma code reads 295

Flumazenil 0.1 mg/ml
solution for injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

The following information is intended for healthcare
professionals only:
Posology and method of administration
Flumazenil should be administered intravenously by an
anaesthetist or experienced physician.
Flumazenil may be administered as injection or as infusion and
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 required lies
between 0.3 and 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.
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.

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 or
pharmacist.
- 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Flumazenil is and what it is used for
What you need to know before you use Flumazenil
How to use Flumazenil
Possible side effects
How to store Flumazenil
Contents of the pack and other information

1

WHAT FLUMAZENIL IS AND WHAT IT IS USED
FOR

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 based on the patient’s response. No data are
available on the safety and efficacy of repeated administration of
flumazenil to children for re-sedation.

2

USE FLUMAZENIL

Do not use Flumazenil
- if you are allergic to flumazenil or any of the other ingredients
of this medicine (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, Mirtazepine
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
Children under the age of 1 year:
benzodiazepine effects.
There are insufficient data on the use of flumazenil in children
under 1 year. Therefore flumazenil should only be administered
Warnings and precautions
in children under 1 year if the potential benefits to the patient
Talk to your doctor or pharmacist before using Flumazenil
outweigh the possible risk.
- If you do not wake up after Flumazenil is administered,
another reason for this will be considered because Flumazenil
Patients with renal or hepatic impairment:
specifically reverses the effects of benzodiazepines.
In patients with impaired hepatic function, the elimination of
flumazenil may be delayed (see section 5.2) and therefore careful - If Flumazenil is administered to you at the end of your
operation to wake you up, it should not be given until the
titration of dosage is recommended. No dosage adjustments are
effects of muscle relaxants have gone away. As the action of
required in patients with renal impairment.
flumazenil is usually shorter than that of benzodiazepines,
Instructions for use
sedation may possibly recur. You will be closely observed,
After first opening the medicinal product should be used
possibly in the intensive care unit until the effects of
immediately.
flumazenil have gone away.
If
you have received long-term (chronic) treatment with
When Flumazenil is to be used in infusion, it must be diluted
benzodiazepines, rapid injection of high doses of flumazenil
prior to infusion. Flumazenil should only be diluted with sodium
(more
than 1 mg) should be avoided since this may cause
chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%)
withdrawal symptoms.
solution or 0.45% sodium chloride + 2.5% glucose.
If
you
have
been treated for long periods with high doses of
Compatibility between Flumazenil and other solutions for
benzodiazepines, the advantages of the use of Flumazenil
injection has not been established.
should be weighed against the risk of withdrawal symptoms.
Intravenous infusion solutions should be discarded after 24 hours. - In children previously sedated with Midazolam: These
children should be closely observed in intensive care units for
Chemical and physical in-use stability of the diluted product has
at least 2 hours after administration of Flumazenil because
been demonstrated for 24 hours at 25°C.
repeated sedation or difficulty with breathing can occur. In
From a microbiological point of view, the product should be used
case of sedation by other benzodiazepines, the monitoring
immediately. If not used immediately, in-use storage times and
must be adjusted according to their expected duration.
conditions prior to use are the responsibility of the user and
If
you are epileptic and have received benzodiazepine
would normally not be longer than 24 hours at 2 to 8°C, unless
treatment for a long period of time, the administration of
dilution has taken place in controlled and validated aseptic
flumazenil
is not recommended as flumazenil can cause
conditions.
seizures.
Storage conditions
- If you have serious brain injury (and/or instable pressure in
Keep the ampoule in the outer carton in order to protect from
your brain) care will be taken as Flumazenil can cause an
light. Do not refrigerate or freeze.
increased pressure in your brain.
- As Flumazenil is not recommended for the treatment of
Disposal
benzodiazepine-dependence or for the treatment of
Any unused product or waste material should be disposed of in
benzodiazepines-withdrawal-symptoms.
accordance with local requirements.
- 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 dependence.
- 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
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 is because flumazenil can
affect the way some other medicines work and because some
other medicines can affect the way flumazenil works.
Flumazenil can alter the effect of medicines with a similar
mechanism of action like zopiclone or triazolopyridazine
(medicines used to help you sleep).
When using Flumazenil injection in cases of an accidental
overdose it has to be taken into account that the toxic effects of

Pharma code reads 295

Pharma code reads 295

Pharma code reads 295

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).
If no clear effect on awareness and respiration is obtained after
It may therefore be used in anaesthesia to wake you up after
repeated dosing, it should be considered that the intoxication is
certain diagnostic tests or in intensive care if you have been held
not due to benzodiazepines.
Infusion should be discontinued every 6 hours to verify whether under sedative conditions. Flumazenil may also be used for the
diagnosis and treatment of intoxications or overdose with
re-sedation occurs.
benzodiazepines.
Older people:
Flumazenil is also used in children (more than 1 year old) to
In the absence of data on the use of flumazenil in older people, it wake them up after they have been given a benzodiazepine
should be noted that this population is generally more sensitive
medicine to make them sleepy during a medical procedure.
to the effects of medicinal products and should be treated with
due caution.
WHAT YOU NEED TO KNOW BEFORE YOU

TEVA UK Ref:

231-30-87151-L LEA FLUMAZENIL 0.1mg/ml SOL FOR INJ 5ml TEVAH
Version:

5

19 January 2016

Pharma code reads 295

3

HOW TO USE FLUMAZENIL

Pharma code reads 295

Flumazenil is administered as intravenous injection (into a vein)
or diluted as intravenous infusion (over a longer period).
Flumazenil will be given by your anaesthetist or experienced
physician. Flumazenil may be used at the same time as other
resuscitative measures.
Your doctor will decide on a suitable dose for you. Doses vary
and will depend on the procedure you have received and the
level of sedation. Your bodyweight, age, general condition of
health and your response to the drug will also influence the dose
you receive.
Use in anaesthesia
The recommended starting dose for adults is 0.2 mg given by
slow injection into a vein over 15 seconds. If the required level of
consciousness is not obtained after 60 seconds, a further dose of
0.1 mg can be given. This dose can be repeated every 60
seconds until the desired level of consciousness is achieved, up to
a maximum total dose of 1 mg. The usual dose is 0.3-0.6 mg.
Use in intensive care situations
The recommended starting dose for adults is 0.2 mg given by
slow injection into a vein over 15 seconds. If the required level of
consciousness is not obtained after 60 seconds, a further dose of
0.1 mg can be given. This dose can be repeated every 60
seconds until the desired level of consciousness is achieved, up to
a maximum total dose of 2 mg.
- If you become drowsy again you may be given a slow,
continuous injection (infusion) into a vein at a rate of 0.1-0.4 mg
per hour until the correct level of consciousness is achieved.
- If after repeated doses there is no marked improvement in
consciousness or independent breathing, your doctor will
probably stop giving Flumazenil and use another method to
raise your level of consciousness.
Use in children and adolescents
In case of children above 1 year of age, the,starting dose is
0.01 mg/kg body weight (up to 0.2 mg) administered
intravenously over a period of 15 seconds. This dose can be
repeated, 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.
Where necessary repeated injections 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 can be injected.
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 are older people or have a liver condition your dose of
Flumazenil will be adjusted with particular care. No dose
adjustment is required in patients with impaired kidney function.
If you use more Flumazenil than you should
If you think you have been given too much Flumazenil, you
should feel no ill effects, however, it would be wise to contact
your doctor, pharmacist or hospital as quickly as possible.
If you stop using Flumazenil
Flumazenil treatment ends when you become fully conscious.
However, because the effects of Flumazenil may wear off quickly
and you may need repeat doses, you should remain under close
medical supervision until all drowsiness has subsided.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The frequency of side effects is classified into the following
categories:
Very common:
may affect more than 1in 10 people
Common:
may affect up to 1 in 10 people
Uncommon:
may affect up to 1 in 100 people
Rare
may affects up to 1 in 1000 people
Very rare:
may affects up to 1 in 10,000 people
Not known:
Frequency cannot be estimated from the
available data
Immune system disorders
- Common:
hypersensitivity reactions (allergic reactions).
Psychiatric disorders
- Common:
Anxiety (after rapid injection, not requiring
treatment), strong emotional lability, having
problems in initiating and maintaining sleep
(insomnia), feeling sleepy (somnolence)

Nervous system disorders
- Common:
dizziness, 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).
- Uncommom: convulsions (in patients suffering epilepsy or
severe liver insufficiency, mainly after
long-term treatment with benzodiazepines or
multiple medicinal products abuse).
Eye disorders
- Common:
double vision, strabismus (squinting),
lacrimation (production of tear fluid) increased.
Ear disorders
- Uncommon: abnormal hearing.
Cardiac disorders
- Common:
heart palpitations (after rapid injection, not
requiring treatment).
- Uncommon: slow or rapid heart rate, premature beat of
your heart (extrasystole).
Vascular disorders
- Common:
reddening of the skin, low blood pressure on
transition from lying to standing, transient
increased blood pressure (on awaking).
Respiratory, chest and mediastinal disorders
- Uncommon: difficulty breathing, cough, nasal congestion,
chest pain.
Gastrointestinal disorders
- Very common: nausea
- Common:
vomitting, hiccup
Skin and subcutaneous tissue disorders
- Common:
sweating.
General disorders and administration site conditions
- Common:
fatigue, injection site pain.
- Uncommon: shivering
If you were treated for a long period with benzodiazepines
flumazenil can induce withdrawal symptoms. The symptoms are:
tension, agitation, anxiety, confusion, hallucinations, involuntary
trembling or quivering (tremor) and convulsions.
Additional side effects in children and adolescents
In general the undesirable effects in children do not differ much
from that in adults. When using Flumazenil injection to awaken
a child from sedation, abnormal crying, agitation and aggressive
reactions have been reported.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist. 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 use this medicine after the expiry date which is stated on
the label after EXP. The expiry date refers to the last day of that
month.
Keep ampoules in the outer carton in order to protect from light.
Do not refrigerate or freeeze.
This medicinal product is for single use only. After first opening
the medicinal product should be used immediately. 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.
Chemical and physical in-use stability of the diluted product 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 you notice unclear solution and
particles.
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
- Each ml contains 0.1 mg flumazenil
1 ampoule with 5 ml contains 0.5 mg flumazenil
- 1 ampoule with 10 ml contains 1 mg flumazenil
- The other ingredients are sodium chloride, disodium edetate
dihydrate, glacial acetic acid (E260), sodium hydroxide,
hydrochloric acid and water for injections.
What Flumazenil looks like and contents of the pack
Flumazenil is a clear, almost colourless, solution for injection and
concentrate for solution for infusion, free from foreign matter.
This medicine is supplied as a ready to use injectable solution
and comes in two sizes:
Pack sizes:
• 1 or 5 glass ampoules containing 5 ml solution packed in
folded carton box
• 1 or 5 glass ampoules containing 10 ml solution packed in
folded carton box
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG.
Manufacturer
Teva Pharmaceutical Works Private Limited Company, H-2100
Gödöllő, Táncsics Mihály út 82, Hungary
This leaflet was last revised: May 2013
87151-L
3-29119580/C
PL 00289/1191

Pharma code reads 295

Pharma code reads 295

other psychotropic medicinal products (especially tricyclic
antidepressants like Imipramin) taken concurrently, may increase
with the subsidence of the benzodiazepine effect.
Interaction with other central nervous system depressants has
not been observed.
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
pharmacist for advice before taking this medicine.
Because of insufficient experience during pregnancy Flumazenil
injection should only be used if the advantage for you is higher
than the potential risk for the unborn baby. The administration of
Flumazenil injection 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 injection.
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.
Important information about some of the ingredients of
Flumazenil
This medicinal product contains 9.3 mg sodium chloride per ml
(3.7 mg sodium per ml) (for 46.5 mg/ 5 ml ampoule size or
93 mg/10 ml ampoule size). To be taken into consideration by
patients on a controlled sodium diet.

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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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