2.1 How to Take Layolis Fe

To achieve maximum contraceptive effectiveness, Layolis Fe must be taken exactly as directed. Chew and swallow one tablet without water at the same time every day. 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 pills, see FDA-Approved Patient Labeling. Layolis Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].

2.2 How to Start Layolis Fe

Instruct the patient to begin taking Layolis Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One light green tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days [see FDA-Approved Patient Labeling]. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Layolis Fe other than on the first day of her menstrual cycle.

For postpartum women who do not breastfeed or after a second trimester abortion, Layolis Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When combined oral contraceptives (COCs) are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception before starting COCs should also be considered.

If the patient is switching from a combination hormonal method such as:
- Another pill
- Vaginal ring
- Patch

• Instruct her to take the first light green pill on the day she would have started a new cycle of her previous birth control pack (Day 1).
  
• If she previously used a vaginal ring or transdermal patch, she should start using Layolis Fe on the day she would have restarted the ring or patch.
  
• Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days.

If the patient is switching from a progestin-only method such as:
- Progestin-only pill
- Implant
- Intrauterine system
- Injection

• Instruct her to take the first light green pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection.
  
• Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 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 or diarrhea occurs within 3-4 hours after taking a light green tablet, this can be regarded as a missed tablet [see FDA-Approved Patient Labeling].