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Adverse Effects
Adverse Events Leading to Discontinuation of Treatment: - 16% (656/4126) of patients who received paroxetine in worldwide clinical trials discontinued treatment due to an adverse experience. The most
common events (reported by at least 1% of subjects) associated with discontinuation included: asthenia, headache, nausea, somnolence, insomnia and abnormal ejaculation. All other events associated wit
h discontinuation occurred at rates of 1% or less.
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Possible food and drug interactions when taking this medication
Occupational Hazards: - Although paroxetine did not cause sedation or interfere with psychomotor performance in placebo-controlled studies in normal subjects, patients should be advised to avoid drivi
ng a car or operating hazardous machinery until they are reasonably certain that paroxetine does not affect them adversely.
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What special precautions should I follow?
The presence of other medical problems may affect the use of Paxil. Make sure you tell your doctor if you have any other medical problems, especially:
- Brain disease or damage or
- Mental r
etardation or
- Epilepsy or seizures (history of)¡XThe risk of seizures may be increased.
- Glaucoma, narrow angle¡XPatients with this condition should use Paxil with caution.
- Heart d
ease or
- Heart attack, recent¡XUse must be determined by your doctor.
- Kidney disease, severe, or
- Liver disease, severe¡XHigher blood levels of Paxil may occur, increasing the chanc
of side effects
- Mania (history of)¡XThe condition may be activated
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What special precautions should I follow?
Children¡XPaxil has not be shown to be safe and effective in children or adolescents, 18 years of age or younger. Children may be especially sensitive to the effects of Paxil for the treatment of depr
ssion. This may increase the chance of a child planning to commit suicide or attempting to commit suicide. Talk to your doctor about the risks and benefits of taking this medication.
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How should you take this medication?
Paxil is taken once a day, with or without food, usually in the morning. Inform your doctor if you are taking or plan to take any prescription or over-the-counter drugs, since they may interact unfavo
rably with Paxil.
Shake the oral suspension well before using.
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Side Effects of This Medicine
Side effects from Paxil are common, and include:
- upset stomach
- drowsiness
- weakness or tiredness
- excitement or anxiety
- insomnia
- nightmares
- dry mout
h
- changes in appetite or weight
Tell your doctor if any of these symptoms are severe or do not go away:
- constipation
- difficulty urinating
- frequent urination
- blurred vision
- changes in sex drive or ability
- excessive sweating
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