2 DOSAGE AND ADMINISTRATION • Take one tablet daily by mouth at the same time every day. ( 2.1 ) • Tablets must be taken in the order directed on the blister pack. ( 2.1 ) 2.1 How to Take Loryna (drospirenone and ethinyl estradiol tablets) Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, drospirenone and ethinyl estradiol tablets must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. 2.2 How to Start Loryna (drospirenone and ethinyl estradiol tablets) Instruct the patient to begin taking Loryna tablets either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start During the first cycle of Loryna tablets use, instruct the patient to take one peach drospirenone and ethinyl estradiol tablet daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one peach Loryna tablet daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Loryna tablets should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Loryna tablets can be taken without regard to meals. If drospirenone and ethinyl estradiol tablets are first taken later than the first day of the menstrual cycle, Loryna tablets should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. Sunday Start During the first cycle of Loryna tablets use, instruct the patient to take one peach Loryna tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one peach Loryna tablet daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Loryna tablets should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Loryna tablets can be taken without regard to meals. Loryna tablets should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should begin her next and all subsequent 28-day regimens of Loryna tablets on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her peach tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Loryna tablets are started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a peach Loryna tablets daily for seven consecutive days. When switching from a different birth control pill When switching from another birth control pill, Loryna tablets should be started on the same day that a new pack of the previous oral contraceptive would have been started. When switching from a method other than a birth control pill When switching from a transdermal patch or vaginal ring, Loryna tablets should be started when the next application would have been due. When switching from an injection, Loryna tablets should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Loryna tablets should be started on the day of removal. Withdrawal bleeding usually occurs within 3 days following the last peach tablet. If spotting or breakthrough bleeding occurs while taking Loryna tablets, instruct the patient to continue taking Loryna tablets by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider. Although the occurrence of pregnancy is low if Loryna tablets are taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Loryna tablets if pregnancy is confirmed. The risk of pregnancy increases with each active peach tablet missed. For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the FDA Approved Patient Labeling . If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of peach tablets on the proper day. For postpartum women who do not breastfeed or after a second trimester abortion, start Loryna tablets no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Loryna tablets postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Loryna tablets for 7 consecutive days. 2.3 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3 to 4 hours after tablet-taking, this can be regarded as a missed tablet.