Flumazenil Injection SDZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 SDZ 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 nonmedicinal ingredients are:

sodium chloride for isotonicity, edetate disodium 0.1 mg, acetic acid 0.1 mg, sodium hydroxide to adjust pH and water for injection.

What dosage forms it comes in:

Flumazenil Injection SDZ 0.1 mg/mL is available in single use ampoules of 5 mL, boxes of 5.

WARNINGS AND PRECAUTIONS

• Flumazenil Injection SDZ 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 SDZ is given to reverse drowsiness, you may experience a return of drowsiness for up to 24 hours after Flumazenil Injection SDZ 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 SDZ 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 SDZ during pregnancy.

• are breast-feeding as flumazenil may pass into breast milk.

  Therefore, breast-feeding should be interrupted for 24 hours when Flumazenil Injection SDZ 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 SDZ. These medicines include:

• medicines within the benzodiazepine group (examples:

  clonazepam, chlordiazepoxide, diazepam, flurazepam or bromazepam)

These medicines are affected by Flumazenil Injection SDZ. 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 SDZ.

PROPER USE OF THIS MEDICATION

Usual dose:

Flumazenil Injection SDZ should be administered intravenously by a physician with experienced in anaesthesiology at your IMPORTANT: PLEASE READ

Flumazenil Injection SDZ Page 27 of 27

doctor’s office, hospital or clinic. Your doctor will decide what dose you will receive which will depend on your particular condition.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications Flumazenil Injection SDZ 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 SDZ.

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

  panicdisorders

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 SDZ. This may happen even if you stopped taking these medicines a few days or weeks before having Flumazenil Injection SDZ. Withdrawal symptoms include disturbed sleep, depression, feeling nervous, feeling irritable, feeling dizzy, a rapid heartbeat, diarrhea and sweating.

  This is not a complete list of side effects. For any unexpected effects while taking Flumazenil Injection SDZ, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

• Keep Flumazenil Injection SDZ in a cool dry place stored between 15°C - 30°C.
• Keep this medicine out of the reach of children.
• Discard unused portion.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at

  www.healthcanada.gc.ca/medeffect

• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:

1-800-361-3062

or by written request at:

145 Jules-Léger

Boucherville QC

J4B 7K8

Or by e-mail at :

medinfo@sandoz.com