Introduction

Flumazenil (floo-MAZ-e-nil)

Treats drowsiness caused by sedative medicines called benzodiazepines, following surgery or drug overdose.

Brand Name(s)

There may be other brand names for this medicine.

Romazicon

When This Medicine Should Not Be Used

You should not use this medicine if you are allergic to flumazenil, or to any benzodiazepines such as Halcion®, Versed®, or Xanax®. Do not use this medicine if you are using benzodiazepines to treat a long-term condition. You should not use this medicine if you have taken an excess dose of medicine for depression.

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using medicine for depression such as amitriptyline, nortriptyline, imipramine, Norpramin®, or Vivactil®.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breast feeding.
• Make sure your doctor knows if you are using any benzodiazepine medicine to treat seizures, epilepsy, or any other medical condition.
• Make sure your doctor knows if you have had a head injury, panic disorder, or liver disease.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Chest pain, fast or uneven heartbeat.
• Problems with speech, hearing or vision.
• Seizures

If you notice these less serious side effects, talk with your doctor:

• Anxiety, nervousness, tremors, dry mouth, or sweating.
• Red skin rash, pain, itching, burning, swelling or a lump under your skin where the needle is placed.
• Warmth or redness in your face, neck, arms, or upper chest.
• Nausea, vomiting, or hiccups.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088