Brand Names: Soltamox

Generic Name: tamoxifen (Pronunciation: ta MOX i fen)

• What is tamoxifen (Soltamox)?
• What are the possible side effects of tamoxifen (Soltamox)?
• What is the most important information I should know about tamoxifen (Soltamox)?
• What should I discuss with my healthcare provider before taking tamoxifen (Soltamox)?
• How should I take tamoxifen (Soltamox)?
• What happens if I miss a dose (Soltamox)?
• What happens if I overdose (Soltamox)?
• What should I avoid while taking tamoxifen (Soltamox)?
• What other drugs will affect tamoxifen (Soltamox)?
• Where can I get more information?

What is tamoxifen (Soltamox)?

Tamoxifen blocks the actions of estrogen, a female hormone. Certain types of breast cancer require estrogen to grow.

Tamoxifen is used to treat and prevent some types of breast cancer.

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

Nolvadex 10 mg

round, white, imprinted with NOLVADEX 600, LOGO

Tamoxifen 10 mg-BAR

round, white, imprinted with barr, 446

Tamoxifen 10 mg-MYL

round, white, imprinted with M, 144

Tamoxifen 10 mg-TEV

round, white, imprinted with 93 784

Tamoxifen 20 mg-BAR

round, white, imprinted with barr, 904

Tamoxifen 20 mg-TEV

round, white, imprinted with 93 782

What are the possible side effects of tamoxifen (Soltamox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tamoxifen and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• chest pain, shortness of breath, or coughing up blood;
• pain or swelling in one or both legs;
• unusual vaginal bleeding or discharge;
• irregular menstrual periods;
• pain or pressure in your pelvic area;
• fever, chills, body aches, flu symptoms;
• pale skin, easy bruising or bleeding;
• new breast lumps; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• hot flashes, warmth or tingly feeling under your skin;
• bone, joint, or tumor pain;
• redness or skin changes;
• swelling in your hands or feet;
• vaginal itching or dryness;
• depressed mood, weakness;
• weight loss;
• nausea;
• cough, sore throat;
• decreased sex drive, impotence, or difficulty having an orgasm;
• headache, dizziness; or
• thinning hair.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tamoxifen (Soltamox)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using tamoxifen, tell your doctor if you are allergic to any drugs, or if you have liver disease, high triglycerides (fatty acids) in your blood, a history of cataract, or a history of stroke or blood clot. Also tell your doctor if you if you are receiving chemotherapy or radiation treatment.

If you are taking tamoxifen to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period. You may also need to have a pregnancy test before you start taking tamoxifen, to make sure you are not pregnant. Follow your doctor's instructions.

Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medication.

To be sure this medication is not causing harmful effects, your doctor may want you to have mammograms and to perform routine breast self exams on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.