Marezine

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use cyclizine if you are allergic to it.

To make sure cyclizine is safe for you, tell your doctor if you have:

• bronchitis or other breathing problem;

• glaucoma; or

• enlarged prostate, urination problems.

FDA pregnancy category B. Cyclizine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cyclizine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Cyclizine should not be given to a child younger than 6 years old.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

The chewable tablet must be chewed before you swallow it.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, confusion, agitation, hallucinations, rapid heartbeats, fever, slowed breathing, seizure (convulsions), and uncontrollable movements of your lips, tongue, or face.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using cyclizine and call your doctor at once if you have:

• painful or difficult urination;

• little or no urinating;

• pounding heartbeats or fluttering in your chest; or

• a light-headed feeling, like you might pass out.

Common side effects may include:

• drowsiness, weakness, loss of coordination;

• nausea, dry mouth, constipation; or

• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to cyclizine: oral tablet

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dry mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to cyclizine: oral tablet, oral tablet chewable

Nervous system

Nervous system side effects have included drowsiness and sedation in many patients. Motor skills may be impaired. Cyclizine (the active ingredient contained in Marezine) may also cause restlessness, excitation, nervousness, and insomnia.[Ref]

Lingual-facial-buccal dyskinesias and generalized chorea occurred in an elderly patient, most probably due to the anticholinergic activity of cyclizine.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension, tachycardia, and palpitations. Cardiovascular changes recorded after intravenous administration of cyclizine (the active ingredient contained in Marezine) have included increase in heart rate, decrease in cardiac output, and increases in right atrial, pulmonary arterial, pulmonary artery wedge, and systemic arterial pressures.[Ref]

Gastrointestinal

Gastrointestinal side effects have been mild in nature. These have included nausea, dry mouth, and constipation.[Ref]

Ocular

Ocular side effects have included blurred vision, diplopia, and dry eyes due to its anticholinergic effects.[Ref]

Genitourinary

Genitourinary side effects have included urinary retention and dysuria.[Ref]

Hepatic

Hepatic side effects have included a case report of hepatitis in at least one child. This side effect was confirmed upon drug rechallenge.[Ref]

Hypersensitivity

Hypersensitivity side effects have included fixed drug eruptions.[Ref]

Some side effects of Marezine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.