SITAGLIPTIN + METFORMIN ORAL (JANUMET) BOXED WARNING: LACTIC ACIDOSIS • Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. • Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. • If acidosis is suspected, discontinue JANUMET and hospitalize the patient immediately. BEFORE USING THIS MEDICINE: Tell your doctor: TOP If you are PREGNANT. Tell your doctor if you are having any of the following conditions: TOP KIDNEY DISEASE; DIABETIC-TYPE 1; MAJOR SURGERY; DEHYDRATION; CONTRAST AGENT PROCEDURES. * 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 may be taken with or without food. Take at the same time each day. * A reduced-calorie DIET and increased physical activity are usually part of the treatment regimen. Follow prescribed diet and exercise programs. * Patient should read specific "MEDICATION GUIDE" provided with this medicine before starting treatment and each time their prescription is renewed. * Patients must receive full and complete instructions about the nature of DIABETES and learn to self-monitor blood glucose. WARNINGS/PRECAUTIONS: TOP * There are no adequate or well-controlled safety studies in pregnant women. NOTIFY YOUR DOCTOR IF PREGNANT or intend to become pregnant. * Self-monitor blood glucose. Test urine for glucose and ketones as prescribed. Have glycosylated hemoglobin tested regularly. * Patients should wear identification tags (Medic-Alert) to alert medical personnel, in case of an emergency, to your condition or drugs you're taking. * Inform MD of other medications you are taking concurrently including over-the-counter medicines and herbal or dietary supplements. * Pediatric: The safety or efficacy of this medicine in pediatric patients below 18 years of age has not been established. * Strictly limit alcohol consumption. LIVER PROBLEMS may be more likely to occur if you drink alcoholic beverages regularly while taking this medicine. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Diarrhea; Vomiting; Memory difficulty; Feeling of general discomfort. Other Common Side Effects: TOP Nausea; Bloating; Decreased appetite; Gas; Change in taste; Inflammation of the pharynx; Upper respiratory infection; Headache; Low blood sugar level; Stomach discomfort or pain; Muscle weakness; Swelling usually of face or lips; Hypersensitivity reactions; Skin rash; Severe skin reactions. 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