Varicose veins, aggravation of

Vomiting

Weight or appetite (increase or decrease), change in

The following adverse reactions have been reported in users of oral contraceptives:

Cataracts

Cystitis-like syndrome

Dysmenorrhea

Hemolytic uremic syndrome

Hemorrhagic eruption

Optic neuritis, which may lead to partial or complete loss of vision

Premenstrual syndrome

Renal function, impaired

OVERDOSAGE
Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

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 the 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

DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, LYBREL (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. Women who do not wish to become pregnant after discontinuation should be advised to immediately use another method of birth control. The dosage of LYBREL is one yellow tablet daily without any tablet-free interval.

It is recommended that LYBREL tablets be taken at the same time each day.

Initiation of Therapy
Instructions for beginning LYBREL are provided in Table 4 below.

Table 4 
Current contraceptive therapy
 
LYBREL start day
 
Nonhormonal back-up method of birth control needed when correctly starting LYBREL?
 
None  Day 1 of patient's menstrual cycle (during the first 24 hours of her period)  No 
21-day COC regimen
    OR
28-day COC regimen Day 1 of patient's withdrawal bleed, at the latest 7 days after her last active tablet  No 
Progestin-only pill  Day after taking a progestin-only pill  Yes, for the first 7 days of
LYB