Patient Leaflet Updated 05-Jun-2020 | hameln pharma ltd
Flumazenil 100 micrograms/ml solution for injection/infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Flumazenil 100 micrograms/ml solution for injection/infusion
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
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 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:
Warnings and precautions
Before you receive Flumazenil, tell your doctor if you:
Beware also the following
Flumazenil only reverses the effects of benzodiazepines.
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.
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:
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
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 you are given this medicine.
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.
Flumazenil contains sodium
This medicinal product contains 3.7 mg sodium (main component of cooking/table salt) per ml.
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.
The dosage depends on the situation; usually, an initial dose of 200 micrograms is administered into your vein over 15 seconds. If your state of consciousness does not improve sufficiently after 60 seconds, another dose of 100 micrograms 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 1000 micrograms after anaesthesia and 2000 micrograms 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 10 micrograms per kilogram body weight (up to 200 micrograms) is administered into a vein over 15 seconds. If the state of consciousness does not improve sufficiently after 45 seconds, another dose of 10 micrograms per kilogram body weight (up to 200 micrograms) can be administered. This can be repeated after 60 seconds up to four times to a maximum total dose of 50 micrograms per kilogram body weight or 1000 micrograms, 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 people are generally more sensitive to the effects of Flumazenil and should be treated with due caution.
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 (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Common after rapid injection (not requiring treatment):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
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.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLUMAZENIL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Flumazenil contains
The active substance is flumazenil.
1 ml solution for injection/infusion contains 100 micrograms flumazenil.
1 ampoule with 5 ml solution contains 500 micrograms flumazenil.
1 ampoule with 10 ml solution contains 1000 micrograms 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
Marketing Authorisation Number
This medicinal product is authorised in the Member States of the EEA under the following names:
DE Flumazenil-hameln 0,1 mg/ml Injektions-/Infusionslösung
DK Flumazenil hameln
FI Flumazenil hameln 0,1 mg/ml injektio-/infuusioneste, liuos
IT Flumazenil hameln 0,1 mg/ml soluzione iniettabile o per infusione
NL Flumazenil hameln 0,1 mg/ml, oplossing voor injectie / infusie
NO Flumazenil hameln 0,1 mg/ml injeksjons-/infusjonsvæske, oppløsning
SE Flumazenil hameln
This leaflet was last revised in April 2020.
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