HAILEY Fe 1/20 (Page 4 of 6)

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.

NON-CONTRACEPTIVE HEALTH BENEFITS

The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol (79 to 84).

Effects on menses:

Increased menstrual cycle regularity
Decreased blood loss and decreased incidence of iron deficiency anemia
Decreased incidence of dysmenorrhea

Effects related to inhibition of ovulation:

Decreased incidence of functional ovarian cysts
Decreased incidence of ectopic pregnancies

Effects from long-term use:

Decreased incidence of fibroadenomas and fibrocystic disease of the breast
Decreased incidence of acute pelvic inflammatory disease
Decreased incidence of endometrial cancer
Decreased incidence of ovarian cancer

DOSAGE AND ADMINISTRATION

The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets.

Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days.

Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.

The possibility of ovulation and conception prior to initiation of use should be considered.

Dosage and Administration for 28-Day Dosage Regimen

To achieve maximum contraceptive effectiveness, Hailey Fe 1/20 should be taken exactly as directed and at intervals not exceeding 24 hours.

Hailey Fe 1/20 provides a continuous administration regimen consisting of 21 white to off-white tablets of Hailey Fe 1/20 and 7 brown to dark brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no “off-tablet days.”

A. Sunday-Start Regimen: The patient begins taking the first white to off-white tablet from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins. When the menstrual flow begins on Sunday, the first white to off-white tablet is taken on the same day. The patient takes one white to off-white tablet daily for 21 days. The last white to off-white tablet in the dispenser will be taken on a Saturday. Upon completion of all 21 white to off-white tablets, and without interruption, the patient takes one brown to dark brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday white to off-white tablet in the top row. Adhering to this regimen of one white to off-white tablet daily for 21 days, followed without interruption by one brown to dark brown tablet daily for seven days, the patient will start all subsequent cycles on a Sunday.

B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label strip that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one white to off-white tablet daily, beginning with the first white to off-white tablet in the top row. After the last white to off-white tablet (at the end of the third row) has been taken, the patient will then take the brown to dark brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last white to off-white tablet, again starting with the first tablet in the top row after placing the appropriate day label strip over the preprinted days on the tablet dispenser. Following this regimen of 21 white to off-white tablets and 7 brown to dark brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course.

Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.

Special Notes on Administration

Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown to dark brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking white to off-white tablets, continue medication without interruption.

If the patient forgets to take one or more white to off-white tablets, the following is suggested:

One tablet is missed

take tablet as soon as remembered
take next tablet at the regular time

Two consecutive tablets are missed (week 1 or week 2)

take two tablets as soon as remembered
take two tablets the next day
use another birth control method for seven days following the missed tablets

Two consecutive tablets are missed (week 3)

Sunday-Start Regimen:

take one tablet daily until Sunday
discard remaining tablets
start new pack of tablets immediately (Sunday)
use another birth control method for seven days following the missed tablets

Day-1 Start Regimen:

discard remaining tablets
start new pack of tablets that same day
use another birth control method for seven days following the missed tablets

Three (or more) consecutive tablets are missed

Sunday-Start Regimen:

take one tablet daily until Sunday
discard remaining tablets
start new pack of tablets immediately (Sunday)
use another birth control method for seven days following the missed tablets

Day-1 Start Regimen:

discard remaining tablets
start new pack of tablets that same day
use another birth control method for seven days following the missed tablets

The possibility of ovulation occurring increases with each successive day that scheduled white to off-white tablets are missed. While there is little likelihood of ovulation occurring if only one white to off-white tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive white to off-white tablets are missed.

If the patient forgets to take any of the seven brown to dark brown tablets in week four, those brown to dark brown tablets that were missed are discarded and one brown to dark brown tablet is taken each day until the pack is empty. A back-up birth control method is not required during this time. A new pack of tablets should be started no later than the eighth day after the last white to off-white tablet was taken.

In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet dispenser on the next Sunday or the first day (Day-1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.

Use of Oral Contraceptives in the Event of a Missed Menstrual Period

1. If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out.

2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.

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