SPARFLOXACIN ORAL (ZAGAM) * This medicine, a fluoroquinolone, may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body). * These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. * Stop taking this medicine and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. * This medicine, a fluoroquinolone, may worsen muscle weakness in persons with a condition known as myasthenia gravis. Avoid this medicine if you have a known history of myasthenia gravis. * This medicine, a fluoroquinolone increases the risk for possibly permanent nerve damage. Contact your healthcare providers if you develop symptoms of peripheral neuropathy. BOXED WARNING: Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis BEFORE USING THIS MEDICINE: Tell your doctor: TOP IF YOU ARE TAKING DRUGS THAT AFFECT THE QT INTERVAL; IF YOU ARE TAKING ANTIARRHYTHMIC AGENTS. Tell your doctor if you are having any of the following conditions: TOP HIATAL HERNIA; THROAT (ESOPHAGUS) PROBLEMS; KIDNEY DISEASE; EPILEPSY; SEIZURES; HYPOKALEMIA; BRADYCARDIA; MYOCARDIAL ISCHEMIA; HISTORY OF CONVULSIONS; HISTORY OF QTc PROLONGATION. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. 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. * To help clear up your infection completely, FINISH COURSE OF THERAPY, even if your condition has improved. * DO NOT skip doses or discontinue unless directed by your doctor. * Notify physician if symptoms do not improve, or if they become worse. * This medicine should be taken WITH a full glass of water (6-8oz). * DO NOT take ANTACIDS containing magnesium or aluminum, or preparations containing iron or zinc within TWO hours of taking this medicine. WARNINGS/PRECAUTIONS: TOP * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):- * shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR. * This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT drive or operate machines until you know how you react to this medicine. * This medicine may cause increased sensitivity to the sun. You should AVOID prolonged or excessive exposure to direct and/or artificial sunlight. * To prevent drug resistance, this medication should be used to treat BACTERIAL INFECTIONS ONLY. It is not effective against viral infections. * Inform MD of other medications you are taking concurrently including over-the-counter medicines and herbal or dietary supplements. * Stop using and contact MD if you feel pain, tenderness or rupture of a tendon. Avoid exercise until tendonitis/ tendon rupture diagnosis is excluded. * This medicine may cause changes in the electrocardiogram (QTc interval prolongation). * Stop using and contact MD if symptoms of PERIPHERAL NEUROPATHY develop (pain, tingling, burning, numbness and/or weakness). * This medicine should be avoided in patients receiving Class IA (e.g. Quinidine, Procainamide) or Class III (Amiodarone, Sotalol) Antiarrhythmic drugs. * If DIARRHEA develops/persists and is severe or lasts more than 2 or 3 days, call your doctor. * Use with caution in patients receiving drugs that affect the QTc interval e.g. Cisapride, Erythromycins, Antipsychotics and Tricyclic Antidepressants. * Discontinue use and notify doctor at the first sign of a skin rash or other allergic reaction. * SPECIAL POPULATIONS: * GERIATRIC (>65 years): Elderly patients may be at a greater risk for complications. ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience: Shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Tendon pain/inflammation. Other Common Side Effects: TOP Increased sensitivity to sunlight; Diarrhea; Headache; Nausea; Stomach discomfort or pain; Indigestion; Dizziness; Itching; Difficulty falling asleep; Gas; Change in taste; Vomiting. 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. Taking this medication may cause the following mineral depletion: TOP BIOTIN FORTE; INOSITOL ORAL; VITAMIN B1 ORAL (THIAMINE); VITAMIN B2 ORAL(RIBOFLAVIN); VITAMIN B3 ORAL (NICOTINAMIDE); VITAMIN B6 ORAL (PYRIDOXINE); VITAMIN B12 ORAL; VITAMIN K. 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