Afaxys Inc.

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To achieve maximum contraceptive effectiveness, Chateal (levonorgestrel and ethinyl estradiol tablets, 0.15 mg/0.03 mg) must be taken exactly as directed and at intervals not exceeding 24 hours.

The dosage of Chateal is one white to off-white tablet daily for 21 consecutive days, followed by one green inert tablet daily for 7 consecutive days, according to prescribed schedule.

It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

During the first cycle of medication, the patient is instructed to begin taking Chateal on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white to off-white) is taken that day. One white to off-white tablet should be taken daily for 21 consecutive days, followed by one green inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white to off-white tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Chateal until a white to off-white tablet has been taken daily for 7 consecutive days and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on white to off-white tablets 7 days on green inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a white to off-white tablet daily for 7 consecutive days.

When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Chateal. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Chateal on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Chateal the next day. If switching from an implant or injection, the patient should start Chateal on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

Although the occurrence of pregnancy is highly unlikely if Chateal is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING below.

Any time the patient misses two or more white to off-white tablets, she should also use another method of contraception until she has taken a white to off-white tablet daily for seven consecutive days. If the patient misses one or more green tablets, she is still protected against pregnancy provided she begins taking white to off-white tablets again on the proper day.

If breakthrough bleeding occurs following missed white to off-white tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two white to off-white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white to off-white tablets are missed.

Chateal may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS) concerning thromboembolic disease. The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.

In the case of first-trimester abortion, if the patient starts Chateal immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.

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To achieve maximum contraceptive effectiveness, CyredTM must be taken exactly as directed and at intervals not exceeding 24 hours. CyredTM is available in a blister pack which is printed for a Sunday Start. Day 1 Start is also provided.

Day 1 Start

The dosage of CyredTM for the initial cycle of therapy is one white "active" tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1". Tablets are taken without interruption as follows: One white "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a white "active" tablet is taken the next day.

The use of CyredTM for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS: Nursing Mothers.) If the patient starts on CyredTM postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) white "active" tablet in Weeks 1, 2, or 3, the white "active" tablet should be taken as soon as she remembers. If the patient misses two (2) white "active" tablets in Week 1 or Week 2, the patient should take two (2) white "active" tablets the day she remembers and two (2) white "active" tablets the next day; and then continue taking one (1) white "active" tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) white "active" tablets in the third week or misses three (3) or more white "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Sunday Start

When taking CyredTM, the first white "active" tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first white "active" tablet is taken on that day. If switching directly from another oral contraceptive, the first white "active" tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One white "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a white "active" tablet is taken the next day (Sunday). When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

The use of CyredTM for contraception may be initiated 4 weeks postpartum. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS: Nursing Mothers.) If the patient starts on CyredTM postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) white active tablet in Weeks 1, 2, or 3, the white "active" tablet should be taken as soon as she remembers. If the patient misses two (2) white "active" tablets in Week 1 or Week 2, the patient should take two (2) white "active" tablets the day she remembers and two (2) white "active" tablets the next day; and then continue taking one (1) white "active" tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) white "active" tablets in the third week or misses three (3) or more white "active" tablets in a row, the patient should continue taking one white "active" tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

ADDITIONAL INSTRUCTIONS FOR ALL DOSING REGIMENS

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of oral contraceptives in the event of a missed menstrual period:

If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

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To achieve maximum contraceptive effectiveness, norethindrone tablets must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.

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Instruct patients to take one tablet orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.

The tablet can be taken with or without food.

If vomiting occurs within 3 hours of ella intake, consideration should be given to repeating the dose.

ella can be taken at any time during the menstrual cycle.