Flumazenil Solution for injection

What is this medicine?

FLUMAZENIL helps to reverse the effects of certain sedative drugs called benzodiazepines. Examples include diazepam, alprazolam, and many others. It is often used following a medical procedure where sedative drugs have been used. It is also used as an antidote after a drug overdose.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• drug abuse or addiction

• head injury

• heart disease

• liver disease

• long time use of benzodiazepines (such as diazepam, alprazolam, or others)

• lung or breathing disease, like asthma

• mental disturbances

• seizures

• an unusual or allergic reaction to flumazenil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Flumazenil is for injection or infusion into a vein. It is given in a hospital or clinic by a health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply; this medicine is not for regular use.

What may interact with this medicine?

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• nalmefene

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. You will need to avoid alcohol and the use of most non-prescription medicines for at least a day after receiving this medicine or undergoing your procedure.

You will receive specific instructions your should follow after your procedure or treatment. Follow all directions of your health care professional. Report any unusual effects.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in emotions or moods

• confusion

• fast heartbeat or palpitations

• seizures

• tremor

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• blurred vision

• dizziness

• flushing

• headache

• pain or irritation at the injection site

• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.