TOREMIFENE CITRATE ORAL (FARESTON) BOXED WARNING: FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * This medicine can be taken with or without food, REGARDLESS of meal times. If stomach upset occurs, take with food. WARNINGS/PRECAUTIONS: TOP * This medicine is CONTRAINDICATED for use during pregnancy. CALL YOUR DOCTOR IMMEDIATELY IF PREGNANT or intend to become pregnant. * Use with caution in patients receiving drugs that affect the QTc interval e.g. Cisapride, Erythromycins, Antipsychotics and Tricyclic Antidepressants. * It is important that you do not stop taking your medications without consulting your doctor. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Decreased appetite; Confusion; Chest pain; Difficulty breathing; Leg pain / cramps; Vaginal bleeding; Muscle weakness; Visual disturbances. Other Common Side Effects: TOP Hot sensation and redness of face; Sweating; Headache; Slowing of cardiac contraction; High calcium level; Vomiting; Swelling of feet or lower legs; Dizziness; Vaginal discharge; Nausea; Liver problems. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved