What is the most important information I should know about Estrostep® Fe?

Who should not take Estrostep Fe?

Do not take Estrostep Fe if you have or have ever had breast cancer or any cancer that is sensitive to hormones; liver disease, including liver tumors; unexplained bleeding from your vagina; blood clots in your arms, legs or lungs; a stroke, heart attack or chest pain; heart valve or heart rhythm problems that can cause blood clots to form in the heart; an inherited blood clotting problem; uncontrolled high blood pressure; diabetes with kidney, eye, or blood vessel damage; severe migraine headaches; if you are pregnant or if you are allergic to anything in Estrostep Fe.

What are the most serious risks of taking birth control pills:

Birth control pills increase the risk of serious blood clots. It is possible to die from a problem caused by a blood clot. Some examples of serious blood clots are blood clots in the legs, lungs, eyes, heart and brain.

A few women who take birth control pills may get rare cancerous or noncancerous liver tumors, gallbladder problems or high blood pressure.

Call your healthcare provider right away if you have: persistent pain in the calf (lower leg); sudden shortness of breath; sudden blindness, partial or complete; severe pain in your chest; sudden, severe headache; weakness or numbness in an arm or leg; trouble speaking or yellowing of the skin or eyeballs.

In clinical studies with Estrostep Fe the following side effects were observed: headache, rhinitis, amenorrhea, dysmenorrhea, abdominal pain, nausea and vomiting.

These are not all of the possible side effects of Estrostep Fe. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider:

• if you smoke

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

You should consider another birth control method if you are breastfeeding because birth control pills may decrease the amount and quality of your milk. A small amount of the pill's hormones are passed on to your baby in your milk.

If you need laboratory tests, tell your healthcare provider that you are taking birth control pills. Birth control pills may affect some blood tests.

Tell your healthcare provider about all the medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective. Some examples are rifampin, medicines used for epilepsy (such as barbiturates, topiramate, carbamazepine, and phenytoin), phenylbutazone, certain medicines used to treat HIV or AIDS, certain antibiotics, and the herbal product St. John's Wort. Consider using another birth control method when you take medicines that may make birth control pills less effective.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms, until you check with your healthcare provider.

For more information, refer to the Detailed Patient Package Insert section of the Full U.S. Prescribing Information.

Reference
1. Data on file, Medical Affairs Department, Warner Chilcott, Inc.