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Overdosage
Human Experience:
There have been 3 cases of sertraline overdosage (approximately 4 to 10 times the maximum recommended daily dose). These 3 patients recovered completely without the need for spec
ific therapy
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Special Wanring
In clinical development programs, sertraline has been evaluated in 1902 subjects with depression. The most commonly observed adverse events associated with the use of sertraline were: gastrointestinal
complaints, including nausea, diarrhea/loose stools and dyspepsia; male sexual dysfunction (primarily ejaculatory delay); insomnia and somnolence; tremor; increased sweating and dry mouth; and dizzin
ess. In the fixed dose placebo controlled study, the overall incidence of side effects was dose related with a majority occurring in the patients treated with 200 mg dose.
The discontinuatio
n rate due to adverse events was 15% in 2710 subjects who received sertraline in premarketing multiple dose clinical trials.
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Other medical problems
Children¡XZoloft has been tested in children 6 to 17 years of age with obsessive-compulsive disorder. In effective doses, this medicine has not been shown to cause different side effects or problems t
an it does in adults. However, Zoloft can cause a decrease in appetite and children who take this medicine for a long time should have their growth and body weight measured by the doctor at regular vi
sits.
Zoloft must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. Mor
e study is needed to be sure Zoloft is safe and effective in children.
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Side Effects of This Medicine
Side effects from Zoloft are common:
- upset stomach
- drowsiness
- weakness or tiredness
- excitement or anxiety
- insomnia
- nightmares
- dry mouth
- ski
n more sensitive to sunlight than usual
- changes in appetite or weight
Tell your doctor if any of these symptoms are severe or do not go away:
- constipation
- difficult
y urinating
- frequent urination
- blurred vision
- changes in sex drive or ability
- excessive sweating
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Why is this drug prescribed?
Zoloft is prescribed for major depressive disorder¡Xa persistently low mood that interferes with everyday living. Symptoms may include loss of interest in your usual activities, disturbed sleep, chang
in appetite, constant fidgeting or lethargic movement, fatigue, feelings of worthlessness or guilt, difficulty thinking or concentrating, and recurrent thoughts of suicide.
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How should this medicine be used?
Zoloft comes as a tablet and concentrate to take by mouth. It is usually taken once daily and may be taken with or without food. Follow the directions on your prescription label carefully, and ask you
r doctor or pharmacist to explain any part you do not understand. Take Zoloft exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continu
e to take Zoloft even if you feel well. Do not stop taking Zoloft without talking to your doctor, especially if you have taken large doses for a long time. Your doctor probably will want to decrease y
our dose gradually. This drug must be taken regularly for a few weeks before its full effect is felt.
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