Cyclivert

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.

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.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking cyclizine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with cyclizine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Cyclivert affects you.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Cyclivert while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Cyclivert, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Cyclivert. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Cyclivert (cyclizine).

Review Date: October 4, 2017

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