Soltamox

>10%

Hot flashes (64%)

Vaginal discharge (30%)

Amenorrhea (16%)

Menstrual changes (13%)

1-10%

Oligomenorrhea (9%)

Cataracts (8%)

Bone pain (6%)

Nausea (5%)

Cough (4%)

Edema (4%)

Fatigue (4%)

Musculoskeletal pain (3%)

Ovarian cyst (3%)

Depression (2%)

Abdominal cramps (1%)

Anorexia (1%)

<1%

Angioedema

Corneal changes

Loss of libido

Endometrial cancer

Pancreatitis

Retinal vein thrombosis

Stroke

Uterine fibroids

You should not use tamoxifen if you are allergic to it, or if you have:

• a history of blood clots in your veins or your lungs; or
• if you are also taking a blood thinner such as warfarin (Coumadin).

To make sure you can safely take tamoxifen, tell your doctor if you have any of these other conditions:

• liver disease;
• high cholesterol or triglycerides (a type of fat in the blood);
• a history of stroke or blood clot;
• a history of cataract; or
• if you are receiving chemotherapy or radiation.

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.

FDA pregnancy category D. Do not use tamoxifen if you are pregnant. It could harm the unborn baby. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 2 months after your treatment ends.

Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether tamoxifen passes into breast milk or if it could harm a nursing baby. However, this medication may slow breast milk production. You should not breast-feed while taking tamoxifen.

Your pharmacist can provide more information about tamoxifen.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Serious side effects have been reported with Soltamox. See the "Soltamox Precautions" section.

Common side effects of Soltamox include the following:

• Hot flashes  
• Vaginal discharge
• Absence of menstrual periods  
• Altered menstrual period timing
• Abnormally light menstrual periods  
• Bone Pain    
• Nausea  
• Cough
• Swelling of extremities  
• Fatigue  
• Muscle pain

This is not a complete list of Soltamox side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aminoglutethimide (Cytadren)
• anastrazole (Arimidex)
• bromocriptine (Parlodel)
• cancer chemotherapy medication such as cyclophosphamide (Cytoxan, Neosar) letrozole (Femara)
• medroxyprogesterone (Depo-Provera, Provera, in Prempro)
• phenobarbital
• rifampin (Rifadin, Rimactane)

This is not a complete list of Soltamox drug interactions. Ask your doctor or pharmacist for more information.

Soltamox can cause serious side effects which include:

• Changes in the lining (endometrium) or body of your uterus. These changes may mean serious problems are starting, including cancer of the uterus. The symptoms of these changes in the uterus include:
  • Vaginal bleeding or bloody discharge that could be a rusty or brown color. You should call your doctor even if only a small amount of bleeding occurs.
  • Change in your monthly bleeding, such as in the amount or timing of bleeding or increased clotting.
  • Pain or pressure in your pelvis (below your belly button).
• Blood clots in your veins or lungs. These can cause serious problems, including death. You may get clots up to 2-3 months after you stop taking Soltamox. The symptoms of blood clots include:
  • sudden chest pain, shortness of breath, coughing up blood
  • pain, tenderness, or swelling in one or both of your legs
• Stroke. Stroke can cause serious medical problems, including death. The symptoms of stroke include:
  • sudden weakness, tingling, or numbness in your face, arm or leg, especially on one side of your body
  • sudden confusion, trouble speaking or understanding
  • sudden trouble seeing in one or both eyes
  • sudden trouble walking, dizziness, loss of balance or coordination
  • sudden severe headache with no known cause
• Cataracts or increased chance of needing cataract surgery. The symptoms of these problems include slow blurring of your vision.
• Liver problems, including jaundice. The symptoms of liver problems include lack of appetite and yellowing of your skin or whites of your eyes.

Do not take Soltamox for any reason if you:

• Are pregnant or plan to become pregnant while taking Soltamox or during the 2 months after you stop taking Soltamox. Soltamox may harm your unborn baby. It takes about 2 months to clear Soltamox from your body. To be sure you are not pregnant, you can start taking Soltamox while you are having your menstrual period. Or, you can take a pregnancy test to be sure you are not pregnant before you begin. If you get pregnant while taking Soltamox, stop taking it right away and contact your doctor. Soltamox may harm your unborn baby.
• Are breastfeeding. We do not know if Soltamox can pass through your milk and harm your baby.
• Have had an allergic reaction to Soltamox or to any of its inactive ingredients.

Do not take Soltamox to lower your chance of getting breast cancer if:

• You ever had a blood clot that needed medical treatment.
• You are taking medicines to thin your blood, like warfarin, also called Coumadin.
• Your ability to move around is limited for most of your waking hours.
• You are at risk for blood clots. Your doctor can tell you if you are at high risk for blood clots.
• You do not have a higher than normal chance of getting breast cancer. Your doctor can tell you if you are a high-risk woman.

Soltamox can also cause dizziness. Do not drive or operate heavy machinery until you know how Soltamox affects you.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Tamoxifen can be taken with or without food.

While using tamoxifen, you may need frequent blood tests.

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

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.

Use tamoxifen regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep using this medication for up to 5 years.

Store at room temperature away from moisture, heat, or cold. Do not freeze.

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 at room temperature. Do not refrigerate or freeze.
• Store in original container.
• Throw away any part not used after 3 months.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Signs observed at the highest doses following studies to determine LD50 in animals were respiratory difficulties and convulsions.

Acute overdosage in humans has not been reported. In a study of advanced metastatic cancer patients which specifically determined the maximum tolerated dose of tamoxifen in evaluating the use of very high doses to reverse multidrug resistance, acute neurotoxicity manifested by tremor, hyperreflexia, unsteady gait and dizziness were noted. These symptoms occurred within 3-5 days of beginning tamoxifen and cleared within 2-5 days after stopping therapy. No permanent neurologic toxicity was noted. One patient experienced a seizure several days after tamoxifen was discontinued and neurotoxic symptoms had resolved. The causal relationship of the seizure to tamoxifen therapy is unknown. Doses given in these patients were all greater than 400 mg/m2 loading dose, followed by maintenance doses of 150 mg/m2 of tamoxifen given twice a day.

In the same study, prolongation of the QT interval on the electrocardiogram was noted when patients were given doses higher than 250 mg/m2 loading dose, followed by maintenance doses of 80 mg/m2 of tamoxifen given twice a day. For a woman with a body surface area of 1.5 m2 the minimal loading dose and maintenance doses given at which neurological symptoms and QT changes occurred were at least 6 fold higher in respect to the maximum recommended dose.

No specific treatment for overdosage is known; treatment must be symptomatic.