2.1 How to Start Tri Femynor

Tri Femynor tablets are dispensed in a blister pack [see How Supplied/Storage and Handling (16)]. Tri Femynor may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

2.2 How to Take Tri Femynor

Starting Tri Femynorafter Abortion or Miscarriage

First-trimester

• After a first-trimester abortion or miscarriage, Tri Femynor may be started immediately. An additional method of contraception is not needed if Tri Femynor is started immediately.
• If Tri Femynor is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Tri Femynor.

Second-trimester

• Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Tri Femynor, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Tri Femynor. [See Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting Tri Femynorafter Childbirth

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri Femynor following the instructions in Table 1 for women not currently using hormonal contraception.
• Tri Femynor is not recommended for use in lactating women [see Use in Specific Populations (8.3)].

If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri Femynor. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

SET THE DAY:

 Day 1 Start: Take the first pill of the first blister pack during the first 24 hours of your period.

 Sunday Start: Take the first pill of the first blister pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the blister pack that same day.

2.3 Missed Tablets

2.4 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 to 4 hours after taking a light pink, light red or red “active” tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

2.5 Tri Femynor Use for Acne

The timing of initiation of dosing with Tri Femynor for acne should follow the guidelines for use of Tri Femynor as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions.