Fareston

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor right away if your condition worsens (such as you get new breast lumps).

See also Warning section.

Hot flashes, sweating, nausea, vomiting, dry eyes, or dizziness may occur. If any of these side effects last or get worse, tell your doctor promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: bone/joint/muscle pain or swelling, constipation, mental/mood changes (such as depression), trouble walking/clumsiness, swelling ankles/feet, unusual tiredness, vision changes (such as blurred vision, eye pain), easy bleeding/bruising, signs of infection (such as sore throat that doesn't go away, fever, chills), symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

Toremifene may increase your risk of uterine cancer. Tell your doctor right away if you develop changes in menstrual period, unusual vaginal bleeding/discharge or pain/pressure below your "belly button" (navel).

Toremifene has rarely caused very serious (possibly fatal) blood clots in the lungs/legs, brain (stroke), and heart (heart attack). Get medical help right away if you develop pain/swelling in the groin/calf, pain in the chest/jaw/left arm, confusion, fainting, severe sudden headache, trouble speaking, sudden vision changes, shortness of breath, or weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking toremifene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bone cancer (metastases), blood disorders (such as anemia, low platelets), diabetes, stroke, blood clots (such as in the legs, lungs), heart disease (such as heart attack, irregular heartbeat), high blood pressure, liver disease, uterus problems such as endometrial hyperplasia.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Tell your doctor if you will be having surgery or will be confined to a chair/bed for a long time (such as on a long plane flight).

During pregnancy, toremifene should be used only when clearly needed. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor right away. Women of childbearing age should use reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. Discuss the use of birth control, the risks and benefits of this medication, and any other concerns about using this medication with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), estrogens, tibolone.

Many drugs besides toremifene may affect the heart rhythm (QT prolongation), including amiodarone, granisetron, pimozide, procainamide, quinidine, sotalol, and macrolide antibiotics (such as erythromycin), among others.

Other medications can affect the removal of toremifene from your body, which may affect how toremifene works. Examples include azole antifungals (such as ketoconazole), rifamycins (such as rifabutin), drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), St. John's Wort, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, calcium levels, liver function, pelvic exam) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.