QUININE SULFATE ORAL BOXED WARNING: Qualaquin use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolyticuremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with Qualaquin use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Take this medicine WITH food, a meal, or a snack. Do not take on an empty stomach. WARNINGS/PRECAUTIONS: TOP * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):- * This medicine is CONTRAINDICATED for use during pregnancy. CALL YOUR DOCTOR IMMEDIATELY IF PREGNANT or intend to become pregnant. * SYMPTOMS OF HYPERSENSITIVITY (eg, fever, rash, itching, difficulty breathing, vision problems, fatigue, nausea, vomiting, diarrhea, abdominal pain). * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to 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. 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: Blurred vision; Vomiting; Nausea; Diarrhea; Ringing in ears; Skin rash; Stomach discomfort or pain; Hot sensation and redness of face; Itching. Other Common Side Effects: TOP Headache; Low blood sugar level; Liver inflammation; Abnormally low platelet count. 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