When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to toremifene citrate, or if you are pregnant. You should not use this medicine if you have a low potassium or magnesium in the blood; or heart rhythm problems (such as congenital or acquired long QT syndrome). This medicine should not be given to men and children.

How to Use This Medicine:
Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You may take this medicine with or without food.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a diuretic or "water pill" (such as hydrochlorothiazide [HCTZ]), carbamazepine (Carbatol®, Tegretol®), midazolam (Versed®), phenobarbital (Luminal®, Solfoton®), phenytoin (Dilantin®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), tolbutamide (Orinase®), medicine to treat fungal infection (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), medicine to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), steroid medicine (such as dexamethasone, Decadron®), a blood thinner (such as warfarin, Coumadin®), or St. John's wort.
• Make sure your doctor knows if you are also using medicine for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, Betapace®, Cardioquin®, Cordarone®, Norpace®, Procanbid®, Quinaglute®, or Tikosyn®), medicine for depression (such as amitriptyline, nefazodone, venlafaxine, Effexor®, Elavil®, or Serzone®), certain antibiotics (such as clarithromycin, erythromycin, levofloxacin, ofloxacin, telithromycin, Biaxin®, E-Mycin®, Eryc®, Ery-Tab®, Floxin®, Ketek®, or Levaquin®), medicine for nausea and vomiting (such as granisetron, ondansetron, Kytril®, or Zofran®), or medicine to treat mental illness (such as haloperidol, thioridazine, Haldol®, or Mellaril®).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby. .
• Make sure your doctor knows if you are breastfeeding, or if you have had a blood clot or have other medical conditions that might make you more likely to get one. Tell your doctor if you have liver problems (including cirrhosis), bone problems, congestive heart failure, heart rhythm problems (such as QT prolongation), or problems with your uterus (womb).
• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
• Hypercalcemia (high calcium in the blood) and tumor flare (increased size of a tumor) are more likely to occur in patients with bone problems who are taking this medicine. Stop using this medicine and check with your doctor right away if you have abdominal or stomach pain, confusion, constipation, depression, dry mouth, increased urination, loss of appetite, metallic taste, muscle weakness, pain and swelling in the bones and muscles surrounding a tumor, thirst, unusual tiredness, or weight loss.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may cause you to have bleeding from the vagina, especially when you first start using it. If the bleeding continues or is bothersome, check with your doctor right away.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Blood tests may be needed to check for unwanted effects. It is important for women to have regular gynecologic check-ups while taking this medicine.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Clouding of the eyes.
• Confusion, constipation, dry mouth, thirst, or unusual tiredness.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Swelling in your hands, ankles, or feet.
• Vaginal bleeding.

If you notice these less serious side effects, talk with your doctor:

• Dizziness or headache.
• Dry or painful eyes, trouble seeing, or double vision.
• Feeling unusually tired, weak, or sad.
• Hot flashes and sweating.
• Loss of appetite, or nausea or vomiting.
• Loss of coordination.
• Pain, tenderness, or redness in your joints, bones, muscles, trunk, or back.
• Swelling or bloating.
• Vaginal bleeding.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088