Serious ill effects have not been reported following accidental ingestion of large doses of hormonal contraceptives. Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in females. Given the nature and design of the ORTHO EVRA® patch, it is unlikely that overdosage will occur. Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. In case of suspected overdose, all ORTHO EVRA® patches should be removed and symptomatic treatment given.

ORTHO EVRA® should not be used in women who currently have the following conditions:

• Thrombophlebitis, thromboembolic disorders
• A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or past history)
• Valvular heart disease with complications¹⁰³
• Severe hypertension¹⁰³
• Diabetes with vascular involvement¹⁰³
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast or personal history of breast cancer Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use Acute or chronic hepatocellular disease with abnormal liver function¹⁰³
• Hepatic adenomas or carcinomas
• Known or suspected pregnancy
• Hypersensitivity to any component of this product

REFERENCES

103. Improving access to quality care in family planning: Medical eligibility criteria for contraceptive use. Geneva, WHO, Family and Reproductive Health, 1996 (WHO/FRH/FPP/96.9).

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