mesoridazine concentrate-oral, Serentil (cont.)

SIDE EFFECTS: Constipation, drowsiness, vision changes, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor. Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness, difficulty speaking, loss of balance, mask-like facial expression, trembling or shaking, lip smacking or other uncontrollable movements, difficulty urinating, skin rash/discoloration, muscle stiffness. Tell your doctor immediately if any of these highly unlikely but serious side effects occur: yellowing eyes or skin, vomiting, dark urine, hot dry skin, sore throat, stomach pain, unusual bleeding or bruising. Though highly unlikely to occur, notify your doctor immediately if you experience any of the following very serious side effects: fainting, irregular heartbeat, confusion, fever, seizures, severe muscle stiffness, increased sweating, prolonged/painful erection. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially: very high or very low blood pressure, liver disease, heart disease, irregular heartbeat, Reye's syndrome, alcohol or drug dependencies, nervous system problems, blood disorders, any allergies (especially any drug allergies). Use caution performing tasks that require alertness such as driving or operating machinery. Use of alcohol can cause extreme drowsiness. Avoid alcohol use. This medication may increase sensitivity to sunlight. Avoid prolonged sun exposure and wear a sunscreen and protective clothing when you are exposed to the sun. This medication can reduce sweating making you more susceptible to heat stroke. Avoid strenuous work or exercise in hot weather. Elderly patients are more sensitive to the effects of this drug. Use cautiously. Children should be monitored closely while using this drug. This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Certain medications closely related to mesoridazine pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

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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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