flumazenil-injection, Romazicon (cont.)

HOW TO USE: This medication is given by injection by a health care professional. The dose and frequency of use is based on your condition and response. You will be monitored closely while receiving this medication.

SIDE EFFECTS: Headache, sweating, irritation at the injection site, blurred vision, flushing, nausea, vomiting or dizziness may occur. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor immediately if you develop: rapid heart rate, skin rash, mood changes, irritability, anxiety, mental confusion, nervousness, tremor, abnormal/jerky muscle movements, depression. Avoid intake of alcoholic beverages or any prescription or nonprescription medication for at least one day unless directed to do so by your doctor. Be aware that sedation may persist and that your memory and judgment may be impaired for up to one day. Therefore, avoid driving and do not perform tasks requiring alertness until you no longer feel dizzy. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor if you have a history of: seizures, panic attacks, alcohol or drug dependency, breathing disorders, heart disease, liver disease, head injury, allergies (especially drug allergies). This drug should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known if this medication appears in breast milk. Consult your doctor before breast-feeding. This drug is not recommended for use in children.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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