Vagifem (Progesterone)

Vagifem is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Vagifem is sometimes used as part of cancer treatment in women and men.

Vagifem may also be used for other purposes not listed in this medication guide.

Take Vagifem exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Long-term Vagifem treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using Vagifem long-term.

Taking progestin while using Vagifem may lower your risk of uterine cancer. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using Vagifem.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using Vagifem. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.

If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking Vagifem.

Vagifem is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Store progesterone at room temperature away from moisture, heat, and light.

You should not take progesterone if you are allergic to it, or if you have:

• liver disease;
• abnormal vaginal bleeding that a doctor has not checked;
• any type of breast, uterine, or hormone-dependent cancer;
• a recent history of heart attack or stroke;
• if you are pregnant;
• if you have ever had a blood clot (especially in your lung or your lower body); or
• if you are allergic to any medicines or food dyes.

• heart disease;
• kidney disease;
• family history of blood clots;
• a history of jaundice caused by pregnancy or taking hormones;
• endometriosis;
• lupus;
• porphyria;
• gallbladder disease;
• underactive thyroid;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• low levels of calcium in your blood; or
• if you have had your uterus removed (hysterectomy).

Symptoms of low thyroid levels include fatigue, muscle aches, constipation, dry skin, weight gain, slow heart rate, sensitivity to cold, or dry brittle hair that tends to fall out easily. These symptoms should disappear as your body adjusts to the medication. If they persist or become bothersome, notify your doctor promptly.

Headache, nervousness, trembling, sweating, increased appetite, diarrhea, weight loss or insomnia may occur. If any of these effects persist or worsen, notify your doctor promptly.

In rare instances, some hair loss may occur during the first few months of starting this drug. This effect is usually temporary as your body adjusts to this medication. If this effect persists or worsens, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if you have any of these very unlikely but serious side effects: chest pain, rapid or irregular heartbeat, shortness of breath, seizures.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Laboratory and/or medical tests (e.g., thyroid function tests) should be done periodically to monitor the effectiveness of this medication. Inform your doctor if you change to a different brand of thyroid hormone.