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Warning Mania/Hypomania: - During premarketing clinical trials in a patient population comprised primarily of unipolar depressives, hypomania or mania occurred in approximately 1% of fluoxetine treated patien ts. The incidence in a general patient population which might also include bipolar depressives is unknown. The likelihood of hypomanic or manic episodes may be increased at the higher dosage levels. S uch reactions require a reduction in dosage or discontinuation of the drug.

What special precautions should I follow? Children—This medicine has been tested in a limited number of children 7 to 18 years of age. These studies indicate that Prozac may help to treat depression and obsessive-compulsive disorder in child en. However, unusual excitement, restlessness, irritability, and trouble in sleeping may be especially likely to occur in children, who seem to be more sensitive than adults to the effects of Prozac. Prozac 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. More study i s needed to be sure Prozac is safe and effective in children.

Adverse Effects Allergic or Toxic:
Frequent: Rash, pruritus.

Infrequent: Chills and fever, urticaria, maculopapular rash.

Rare: Allergic reaction, erythema multiforme, vesiculobullous rash, se rum sickness, contact dermatitis, erythema nodosum, purpuric rash, leukocytoclastic vasculitis, leukopenia, thrombocythemia, arthralgia, angioedema, bronchospasm, lung fibrosis, allergic alveolitis, l arynx edema, respiratory distress.

Drug Interactions When you are taking Prozac, it is especially important that your health care professional know if you are taking any of the following:

- Astemizole (e.g., Hismanal)—Higher blood levels of a temizole may occur, which increases the chance of having a very serious change in the rhythm of your heartbeat
- Buspirone (e.g., BuSpar) or
- Bromocriptine (e.g., Parlodel) or
- Dextro methorphan (cough medicine) or
- Levodopa (e.g., Sinemet) or
- Lithium (e.g., Eskalith) or
- Meperidine (e.g., Demerol) or
- Nefazodone (e.g., Serzone) or
- Pentazocine (e.g., Talwin) or

Why is this medication prescribed? Prozac is prescribed for the treatment of depression--that is, a continuing depression that interferes with daily functioning. The symptoms of major depression often include changes in appetite, sleep habits, and mind/body coordination; decreased sex drive; increased fatigue; feelings of guilt or worthlessness; difficulty concentrating; slowed thinking; and suicidal thoughts.

Prozac is a lso prescribed to treat obsessive-compulsive disorder. An obsession is a thought that won't go away; a compulsion is an action done over and over to relieve anxiety. The drug is also used in the treat ment of bulimia (binge-eating followed by deliberate vomiting). It has also been used to treat other eating disorders and obesity.

What side effects may occur? Check with your doctor as soon as possible if any of the following side effects occur:

- difficulty in concentration, drowsiness, excessive hunger, fast heartbeat, headache, shakiness or unst eady walk, or unusual tiredness or weakness; symptoms of hyponatremia (low blood sodium), including confusion, convulsions (seizures), drowsiness, dryness of mouth, increased thirst, lack of energy; symptoms of serotonin syndrome, including diarrhea, fever, increased sweating, mood or behavior changes, overactive reflexes, racing heartbeat, restlessness, shivering or shaking; talking, feeling, and acting with excitement and activity you cannot control; trouble in breathing; unusual or incomplete body or facial movements;

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