Consumer Information for: FLUMAZENIL INJECTION
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Reversing drowsiness, sedation and other effects caused by a medicine within a group of medicines called benzodiazepines. It may be used to wake you up after anesthesia or if you have been in intensive care.
What it does
Flumazenil Injection contains the active ingredient flumazenil. Flumazenil is a benzodiazepine antagonist. It works by blocking receptors in the brain and central nervous system that benzodiazepines need to reach to be active, which helps reduce drowsiness and sedation caused by benzodiazepines.
When it should not be used
- If you have had an allergic reaction to flumazenil or to benzodiazepines in the past
- If you are allergic to any of the ingredients it contains (see ‘What the nonmedicinal ingredients are’)
- If you are taking a benzodiazepine for control of a life- threatening condition (eg. increased pressure in the head, seizures).
- If you are experiencing side effects due to an overdose of a medicine used to treat depression
What the medicinal ingredient is
Flumazenil
What the non-medicinal ingredients are
1.8 mg methylparaben, 0.2 mg propylparaben, 0.1 mg disodium edetate, 9.0 mg sodium chloride and 0.1 mg acetic acid; sodium hydroxide and hydrochloric acid to adjust pH and water for injection.
What dosage form it comes in
Flumazenil Injection is a sterile liquid for intravenous
injection and contains 0.1 mg flumazenil per mL of
solution. Flumazenil Injection is available in multipledose
glass vials:
C402405: 5 mL fill in a 6.5 mL vial; packaged in trays of
10 vials
C402410: 10 mL fill in a 10 mL vial; packaged
individually
Warnings and precautions
- Flumazenil Injection may affect your ability to be alert. Driving, operating machinery and other hazardous activities should therefore be avoided altogether for at least 24 hours.
- You must not consume alcohol or other drugs that affect your central nervous system.
- Although Flumazenil Injection is given to reverse drowsiness, you may experience a return of drowsiness for up to 24 hours after Flumazenil Injection is given. If you notice a return of drowsiness or experience shortness of breath, contact your doctor as soon as possible.
BEFORE you use Flumazenil Injection talk to your doctor or pharmacist if you:
- have liver problems
- have anxiety or panic disorders
- have heart problems or irregular heart beat
- are pregnant or planning to become pregnant, discuss with your doctor the benefits and risks of using Flumazenil Injection during pregnancy.
- are breast-feeding as flumazenil may pass into breast milk. Therefore, breast-feeding should be interrupted for 24 hours when Flumazenil Injection is used.
Interactions with this medication
Tell your doctor if you are taking any other medicines
including any that you have bought from a pharmacy,
supermarket or healthfood store without a
prescription.
Some medicines may interfere with Flumazenil Injection.
These medicines include:
- medicines within the benzodiazepine group (examples: clonazepam, chlordiazepoxide, diazepam, flurazepam or bromazepam)
These medicines are affected by Flumazenil Injection. Your
doctor or pharmacist can tell you what to do if you are taking
any of these medicines.
If you have not told your doctor about any of the
above, tell him/her before you start taking Flumazenil
Injection.
Proper use of this medication
Usual dose
Flumazenil Injection should be administered intravenously by a physician with experience in anesthesiology at your doctor’s office, hospital or clinic. Your doctor will decide what dose you will receive which will depend on your particular condition.
Side effects and what to do about them
Like all medications Flumazenil Injection can cause some
side effects. For most patients these side effects are likely to
be minor and temporary as your body adjusts to the medicine.
However, some may be serious. Consult your doctor or
pharmacist as soon as you can if you do not feel well while
taking Flumazenil Injection.
Seek urgent medical attention if you experience:
- Allergic reactions (very rare)
If you have an allergic reaction, see a doctor straight away. The signs may include: sudden swelling of the throat, face, lips or mouth. This can make it difficult to breathe or swallow; sudden swelling of the hands, feet or ankles; skin rash or itching.
- Convulsions (seizures)
These are more likely to happen in people who already have epilepsy or severe liver problems or people who have taken medicines called benzodiazepines for a long time.
The most common side effects are:
- Nausea
- Vomiting
Less common possible side effects are:
- Feeling of anxiousness, fear or panic
- Dizziness and sweating
- Increase of blood pressure (flushing) and heart rate
- Headaches, mood swings and chills
- Rash, blurred vision, tremors, low blood pressure, urinary incontinence, and constipation
- Panic attacks in patients that have a history of panic disorders.
Withdrawal symptoms
- If you have recently been taking a benzodiazepine (for example to help you sleep or to treat anxiety), you may get withdrawal symptoms after having Flumazenil Injection. This may happen even if you stopped taking these medicines a few days or weeks before having Flumazenil Injection. Withdrawal symptoms include disturbed sleep, depression, feeling nervous, feeling irritable, feeling dizzy, a rapid heartbeat, diarrhea and sweating.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| agitation | ✔ | ||
| crying/tears | ✔ | ||
| headache | ✔ | ||
| anxiety/anxious feeling | ✔ | ||
| seizures/ convulsions | ✔ | ||
| dizziness | ✔ | ||
| nausea | ✔ | ||
| vomiting | ✔ | ||
| increased blood pressure | ✔ | ||
| increased heart rate | ✔ | ||
| shivering/cold | ✔ | ||
| Uncommon | |||
| flushing | ✔ | ||
| abnormal heart rate | ✔ | ||
| difficulty breathing | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Flumazenil Injection, contact your doctor, nurse or pharmacist.
How to store
Flumazenil Injection should be stored between 15 ºC and
30 ºC.
Multidose vial. Discard unused portion 28 days after initial
puncture.
Infusion solutions containing flumazenil should be used
within 24 hours, and unused portions discarded.
Keep this medicine out of the reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full Product Monograph, prepared
for health professionals, can be obtained by contacting the
sponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.
This leaflet was prepared by
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON, M9W 0C8
Last revised: July 10, 2018
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