Seasonale (Levonorgestrel / Ethinyl Estradiol) - Drug Interactions, Contraindications, Overdosage, etc

8. DRUG INTERACTIONS

OVERDOSAGE

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

NONCONTRACEPTIVE HEALTH BENEFITS

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on menses:

• May decrease blood loss and may decrease incidence of iron-deficiency anemia
• May decrease incidence of dysmenorrhea

Effects related to inhibition of ovulation:

• May decrease incidence of functional ovarian cysts
• May decrease incidence of ectopic pregnancies

Effects from long-term use:

• May decrease incidence of fibroadenomas and fibrocystic disease of the breast
• May decrease incidence of acute pelvic inflammatory disease
• May decrease incidence of endometrial cancer
• May decrease incidence of ovarian cancer

OVERDOSAGE

Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your healthcare provider or pharmacist.

CONTRAINDICATIONS

Oral contraceptives should not be used in women who currently have the following conditions:

• Thrombophlebitis or thromboembolic disorders
• A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or history)
• Valvular heart disease with thrombogenic complications
• Uncontrolled hypertension
• Diabetes with vascular involvement
• 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 pill use
• Hepatic adenomas or carcinomas, or active liver disease
• Known or suspected pregnancy
• Hypersensitivity to any component of this product

OTHER INFORMATION

Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is appropriate to postpone it. You should be reexamined at least once a year. Be sure to inform your healthcare provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your healthcare provider, because this is a time to determine if there are early signs of side effects of oral contraceptive use.

Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills.

NONCONTRACEPTIVE HEALTH BENEFITS

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on menses:

• May decrease blood loss and may decrease incidence of iron-deficiency anemia
• May decrease incidence of dysmenorrhea

Effects related to inhibition of ovulation:

• May decrease incidence of functional ovarian cysts
• May decrease incidence of ectopic pregnancies

Effects from long-term use:

• May decrease incidence of fibroadenomas and fibrocystic disease of the breast
• May decrease incidence of acute pelvic inflammatory disease
• May decrease incidence of endometrial cancer
• May decrease incidence of ovarian cancer

If you want more information about birth control pills, ask your doctor or pharmacist. They have a more technical leaflet called the Professional Labeling which you may wish to read.

MANUFACTURED BY:

DURAMED PHARMACEUTICALS, INC.

A subsidiary of Barr Laboratories, Inc.

Pomona, NY 10970-0519

Revised September 2003

310905825001

BR 9058