Mibelas 24 Fe

2 DOSAGE AND ADMINISTRATION One tablet daily chewed and swallowed or swallowed whole taken at the same time of day. Follow with 8 ounces of water ( 2.1 ) Take one tablet by mouth at the same time every day for 28 days ( 2.1 ) Take tablets in the order directed on the blister pack ( 2.1 ) Tablets may be administered without regard to meals ( 12.3 ) 2.1 How to Take Mibelas 24 Fe To achieve maximum contraceptive effectiveness, Mibelas 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet may be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets, [see FDA-approved patient labeling]. Mibelas 24 Fe may be administered without regard to meals [see CLINICAL PHARMACOLOGY ( 12.3 )]. 2.2 How to Start Mibelas 24 Fe Instruct the patient to begin taking Mibelas 24 Fe 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 Mibelas 24 Fe use, instruct the patient to take one white Mibelas 24 Fe tablet daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one white Mibelas 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Mibelas 24 Fe should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Mibelas 24 Fe on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered. Sunday Start During the first cycle of Mibelas 24 Fe use, instruct the patient to take one white Mibelas 24 Fe tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white Mibelas 24 Fe tablet daily for 24 consecutive days, followed by one brown tablet daily on days 25 through 28. Mibelas 24 Fe should be taken in the order directed on the package at the same time each day. Mibelas 24 Fe 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 Mibelas 24 Fe on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her white Mibelas 24 Fe tablets on the next day after ingestion of the last brown tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Mibelas 24 Fe is started later than the day following administration of the last brown tablet, the patient should use another method of contraception until she has taken a white Mibelas 24 Fe tablet daily for 7 consecutive days. For postpartum women who do not breastfeed or after a second trimester abortion, start Mibelas 24 Fe no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Mibelas 24 Fe 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 Mibelas 24 Fe for 7 consecutive days. Mibelas 24 Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Mibelas 24 Fe immediately, additional contraceptive measures are not needed. 2.3 Switching from another Hormonal Method of Contraception If the patient is switching from a combination hormonal method such as: ○ Another pill ○ Vaginal ring ○ Patch Instruct her to take the first white Mibelas 24 Fe tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack, and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Mibelas 24 Fe. If she previously used a vaginal ring or transdermal patch, she should start using Mibelas 24 Fe on the day she would have resumed the previous product. If the patient is switching from a progestin-only method such as a: ○ Progestin-only pill ○ Implant ○ Intrauterine system ○ Injection She may switch any day from a progestin-only pill; instruct her to take the first white Mibelas 24 Fe tablet on the day she would have taken her next progestin-only pill. She should use a non-hormonal method of contraception for 7 consecutive days. If switching from an implant or injection, start the first white Mibelas 24 Fe tablet on the day her next injection would have been due or on the day of removal of her implant. If switching from an IUD, depending on the timing of removal, back-up contraception may be needed. 2.4 Advice in Case of Gastrointestinal Disturbances If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a white Mibelas 24 Fe tablet), she should follow the instructions in the "What to Do if You Miss Tablets" section [see FDA-approved patient labeling].

See official label

1 INDICATIONS AND USAGE Mibelas 24 Fe is an estrogen/progestin COC indicated for use by women to prevent pregnancy ( 1 ) The efficacy in women with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 ) Mibelas™ 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see CLINICAL STUDIES ( 14 )].