Consumer Information for: VISANNE

Serious Warnings and Precautions

VISANNE can decrease the bone mineral density (BMD) in adolescent girls (12 to < 18years). This effect may not be completely reversible once treatment is stopped.

Effects on BMD may be greater with increasing duration of use. It is unknown if the use of VISANNE during adolescence will reduce peak bone mass and increase the risk of developing osteoporosis (brittle bones).

The risks and benefits of this treatment in adolescents should be re-evaluated on a regular basis.

Before starting VISANNE, you must be sure that you are not pregnant and must stop taking any form of birth control that contains hormones such as the pill, patch, intrauterine system, injection, or ring.

While using VISANNE you must use a nonhormonal birth control method such as condoms or a diaphragm. DO NOT use any form of birth control that contains hormones.

VISANNE is not a birth control method and will not prevent pregnancy.

VISANNE should not be used in women who have not had their first menstrual cycle.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. Smoking may also increase adverse effects on bone density. You should not smoke while taking VISANNE.

BEFORE you use VISANNE, talk to your doctor or pharmacist if you:

• have ever had a medical condition related to a blood clot (thromboembolic disorder) or anyone in your immediate family has had a blood clot at a relatively early age
• have a close relative who has had breast cancer
• suffer or have suffered from depression
• have uncontrolled high blood pressure
• have a history of liver disease. Symptoms may include yellowing of the skin or eyes or itching all over your body. Inform your doctor also if such symptoms occurred during a previous pregnancy.
• have diabetes or had diabetes temporarily during a previous pregnancy
• have ever had chloasma (golden-brown patches on the skin, particularly on the face)
• have lactose intolerance. VISANNE tablets contain lactose.

The Risks of Using VISANNE

1. Circulatory Disorder (including blood clots in the legs, lungs, heart, eyes, or brain)

Some studies have suggested that women who use progestin-only medications might have a slightly higher risk of blood clots; however, the results are not certain. You should discuss risk factors for blood clots with your doctor.

Be alert for the following symptoms and signs of serious adverse effects associated with blood clots. Call your doctor immediately if they occur:

• Sharp pain in the chest, coughing blood, or sudden shortness of breath.
• Pain and/or swelling in the calf.
• Crushing chest pain or heaviness.
• Sudden, severe, or worsening headache or vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg.
• Sudden partial or complete loss of vision.

Breast Cancer

The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include onset of menstrual periods before age 12 years, never having children, having your first full-term pregnancy after the age of 30 years, never having breastfed a child, and daily alcohol consumption.

Some studies have shown that the risk of developing breast cancer does not appear to be increased by using progestin-only therapies like VISANNE. However, more thorough studies are needed to confirm that there is no increased risk. You should also discuss breast self-examination with your doctor and report any breast lumps. A yearly breast examination by a health care professional is recommended for all women.

Diabetes

Patients with diabetes who use VISANNE should have their blood glucose levels closely monitored.

Ectopic Pregnancy

If you become pregnant while taking VISANNE, you are at a slightly increased risk of having an ectopic pregnancy (the embryo develops outside the womb). Before you start taking VISANNE, tell your doctor if you had an ectopic pregnancy in the past or have an impaired function of the fallopian tubes.

Liver Tumors

In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors, have been reported in women taking hormones. Contact your doctor if you have unusually severe stomach pain.

Changes in Bone Mineral Density

The long-term use of VISANNE may decrease the bone mineral density of adolescents (12 to < 18 years) and, therefore, your doctor will carefully weigh the benefits of using VISANNE against other potential risks for bone loss. Your doctor may decide that your bone mineral density should be monitored.

If you use VISANNE, it will help your bones if you engage in regular weight-bearing exercise and have a healthy diet, including an adequate intake of calcium (e.g. in dairy products) and vitamin D (e.g. in oily fish such as salmon).