SIDE EFFECTS OF ORAL CONTRACEPTIVES

1. Unscheduled Bleeding and Spotting
Unscheduled bleeding or spotting is likely to occur while you are taking LYBREL. Unscheduled bleeding or spotting occurs most often during the first seven pill packs of LYBREL use. It tends to decrease with subsequent pill packs of use, but may occur after you have been taking LYBREL for some time. In a study of LYBREL, 60% of women had bleeding and/or spotting during the sixth pill pack of use. Bleeding and/or spotting decreased to 48% during pill pack 9, and to 41% during pill pack 13. In this study, the percentage of women who discontinued treatment, at least in part, due to unscheduled bleeding or spotting was 18%.

The following figure shows by pill pack, the percentage of women using LYBREL in a North American study, who experienced unscheduled bleeding or spotting only.

Percentage of Subjects Reporting Bleeding or Spotting Only per Pill Pack

 
The following figure shows the percentage of women using LYBREL in a North American study who had 4 or more and 7 or more days of bleeding and/or spotting during each pill pack. During pill pack 2, 67% of women experienced 4 or more days of bleeding and/or spotting and 54% of these women experienced 7 or more days of bleeding and/or spotting. During the final pill pack of use of LYBREL (pill pack 13), these percentages were 31% and 20%, respectively.

Percentage of Subjects Reporting Greater Than or Equal to 4 or 7 Days of Bleeding and/or Spotting per Pill Pack (Study 313-NA)

 
It is important to continue taking your pills at the same time each day according to your daily routine, even if you are having unscheduled bleeding or spotting. If the unscheduled bleeding and/or spotting continue for an extended period of time (for example, 7 consecutive days) or if the bleeding is heavy, contact your health care professional.

2. Contact Lenses
If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your health care professional.

3. Fluid Retention
Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your health care professional.

4. Melasma
A spotty darkening of the skin is possible, particularly of the face.

5. Other Side Effects
Other side effects may include nausea, breast tenderness, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections, inflammation of the pancreas, and allergic reactions.

If these or any other side effects bother you, contact your health care professional.

GENERAL PRECAUTIONS

1. Use of Oral Contraceptives Before or During Early Pregnancy
Because regular monthly bleeding does not occur on LYBREL, an unexpected pregnancy may be difficult to recognize. If you suspect you may be pregnant, or if you have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, a pregnancy test should be performed and you should contact your health care professional. Stop taking LYBREL if you are pregnant. Pregnancy is unlikely if the pill is taken as directed.

There is no conclusive evidence that oral contraceptive use