pizotifen-oral (cont.)

SIDE EFFECTS: Increased appetite and weight gain, drowsiness, fatigue, nausea, unusual weakness, dizziness, headache or dry mouth may occur. If these persist or worsen, notify your doctor promptly. Very unlikely but report promptly: vision changes, confusion, stomach pain, swelling, mood changes, sexual function problems. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this drug, tell your doctor your medical history including: any allergies (especially drug allergies), narrow angle glaucoma, trouble urinating (e.g., enlarged prostate gland), stomach/intestinal blockages, diabetes, heart or blood vessel problems, kidney or liver disease. Limit alcohol intake as it may increase the side effects of this drug. Use caution performing tasks requiring mental alertness such as driving because this drug may cause drowsiness. This drug is not recommended for children under 12 years old. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known if this drug is excreted into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medications you may use, especially of: MAO inhibitors (e.g., selegiline, furazolidone, tranylcypromine, phenelzine, moclobemide, linezolid). Also mention drugs that cause drowsiness such as: cough-and- cold products that contain drowsiness-causing antihistamines (e.g., diphenhydramine), psychiatric medicines, anti-seizure drugs, narcotic pain relievers such as codeine, tranquilizers, sedatives, muscle relaxants. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include drowsiness, fast pulse, nausea, and loss of sense of balance.

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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