Toremifene tablets

What is this medicine?

TOREMIFENE (tore EM i feen) blocks the effects of estrogen. It is used to treat some types of breast cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• bone pain

• changes in vision

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of low magnesium like muscle cramps, pain, or weakness; tremors; seizures; or fast, irregular heartbeat

• signs and symptoms of low potassium like muscle cramps or muscle pain; chest pain; dizziness; feeling faint or lightheaded, falls; palpitations; breathing problems; or fast, irregular heartbeat

• vaginal bleeding or discharge

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• hot flashes

• loss of appetite

• nausea, vomiting

• sweating

• unusually weak or tired

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• dronedarone

• fluconazole

• pimozide

• posaconazole

• saquinavir

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• certain antibiotics like clarithromycin or telithromycin

• certain diuretics like hydrochlorothiazide

• certain medicines for fungal infections like itraconazole, ketoconazole, voriconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• certain medicines that treat or prevent blood clots like warfarin

• dexamethasone

• female hormones, like estrogens and birth control pills

• grapefruit juice

• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone

• rifabutin

• rifampin

• St. John's Wort

• tolbutamide

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from heat and light. Keep container tightly closed. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• high levels of calcium in the blood

• history of blood clots

• history of irregular heartbeat

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• low levels of magnesium or potassium in the blood

• an unusual or allergic reaction to toremifene, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need regular pelvic exams, breast exams, and mammograms.

If you have bone tumors, this medicine may cause bone pain and/or high blood calcium. Talk to your doctor about what symptoms are possible and what to do if you have these symptoms.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.