Fempro is in a class of medications known as nonsteroidal aromatase inhibitors. It decreases the amount of estrogen produced by the body.

Directions

Adult and Elderly Patients

The recommended dose of Fempro tablets is one 2.5mg tablet administered once daily with or without food. No dose adjustment is required for elderly patients.

Renal Impairment

No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥ 10 mL/min.

Hepatic Impairment

No dosage adjustment is recommended for patients with mild or moderate hepatic impairment, although letrozole blood concentrations were were modestly increased in subjects with moderate impairment due to cirrhosis. The dose of letrozole in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50%.The recommended dose for such patients is 2.5mg administered every other day.

Precautions

Before taking Fempro,

• tell your doctor and pharmacist if you are allergic to letrozole, any other medications, or any of the inactive ingredients in letrozole tablets. Ask your doctor or pharmacist for a list of the inactive ingredients.
• tell your doctor or pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: other medications to treat cancer, medications that contain estrogen such as hormone replacement therapy and hormonal contraceptives (birth control pills, patches, rings, and injections), tamoxifen (Nolvadex), and raloxifene (Evista). Your doctor may need to change the doses of your medications or monitor you carefully for side effects..
• tell your doctor if you have or have ever had any medical condition, especially liver disease and osteoporosis (condition in which the bones are weak and break easily).
• you should know that letrozole should only be used by women who have experienced menopause and cannot become pregnant. However, if you are pregnant or breastfeeding, you should tell your doctor before you begin taking this medication. Use a reliable method of birth control to prevent pregnancy during your treatment. Letrozole may harm the fetus.
• you should know that letrozole may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

Side Effects

Letrozole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• hot flushes
• night sweats
• nausea
• vomiting
• muscle, joint, or bone pain
• excessive tiredness
• headache
• dizziness
• muscle weakness
• swelling of the hands, feet, ankles, or lower legs
• loss of appetite
• constipation
• diarrhea
• stomach pain
• difficulty falling asleep or staying asleep
• vaginal bleeding or irritation
• breast pain
• flu-like symptoms
• difficulty urinating
• pain on urination
• cough
• rash

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• chest pain
• difficulty breathing

Letrozole may cause or worsen osteoporosis. Talk to your doctor about the risk of taking this medication and to find out what you can do to decrease this risk.

Letrozole may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Overdose Information

Isolated cases of letrozole overdose have been erported. In these instances, the highest single dose ingested was 62.5mg or 25 tablets. No serious adverse events were reported in these cases. Because of the limited data available, no firm recommendations for treatment can be made and therefore you should contact your doctor or health professinal immediately.

Storage

Store in a cool dry place.