MOMETASONE FUROATE (ASMANEX TWISTHALER) Inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The growth of pediatric patients should be monitored routinely. The potential growth effects of prolonged therapy should be weighed against benefits. To minimize the systematic effects of drug, each patient should be titrated to his/her lowest effective dose. ------------------------------ CONTRAINDICATIONS ----------------- ------ • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. • Hypersensitivity to any ingredient BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP IMMUNE DEFICIENCY; INFECTION; GLAUCOMA; OSTEOPOROSIS; HIGH BLOOD PRESSURE; DIABETES; LACTOSE INTOLERANCE. * 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 * Patient should read specific "MEDICATION GUIDE" provided with this medicine before starting treatment and each time their prescription is renewed. * Follow proper INHALATION TECHNIQUE according to instructions provided with your medicine. Rinse mouth with water after each use. * This medicine is NOT meant to relieve ACUTE asthmatic symptoms, which should be treated with inhaled, short-acting bronchodilator (e.g. albuterol). * Take regularly as prescribed, even during symptom-free periods. * Patients whose oral corticosteroids were reduced or withdrawn should carry a WARNING CARD; supplemental steroids may be needed in severe asthma attack * Patients should use inhaled bronchodilators, if prescribed, several minutes before using this medicine to enhance penetration into the bronchial tree. 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. 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: Sore throat; Dry mouth; Skin rash. Other Common Side Effects: TOP Cough; Breathing difficulty; Altered voice; Headache. 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