pizotifen-oral (cont.)

HOW TO USE: This drug is taken by mouth, generally starting with a bedtime dose, then increased slowly to 3 times daily. The maximum dose is 6 mg daily. Take exactly as directed regularly. Effects should be seen within 4 weeks. If your doctor plans to stop the drug for a period of time, the dose should be reduced slowly over 2 weeks to decrease the chance of increased headaches reoccurring. After a period of time, this medicine may not work as well as it had before. Consult your doctor if this occurs.

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.

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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