Singulair Tablets

GENERIC NAME: MONTELUKAST (mon-te-LOO-kast)

COMMON USES: This medicine is a leukotriene receptor antagonist used for the prevention and long-term treatment of asthma. It is used to prevent asthma attacks caused by exercise and to relieve the symptoms of allergic rhinitis in certain patients. Montelukast works by blocking substances in the body called leukotrienes. Blocking leukotrienes improves asthma and seasonal or perennial allergic rhinitis symptoms. It may also be used to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. This medicine may come with a patient leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE MAY BE TAKEN ON AN EMPTY STOMACH or with food. If you are taking this medicine for asthma, take it in the evening unless your doctor tells you otherwise. If taking for allergies, take the medicine at about the same time each day (either morning or evening). If you are taking this medicine for both asthma and allergies, take the medicine in the evening unless your doctor tells you otherwise. If you are taking this medicine for exercise-induced asthma, take the medicine at least 2 hours before exercise, as directed by your doctor. DO NOT TAKE MORE THAN ONE DOSE within 24 hours. STORE THIS MEDICINE at room temperature 77 degrees F (25 degrees C) in a tightly-closed container, away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE use it as soon as your remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. THIS MEDICINE WILL NOT STOP AN ASTHMA ATTACK once one has started. IF YOU ARE ALSO USING A BRONCHODILATOR INHALER, be sure to always carry the inhaler with you to use during asthma attacks. Consult your doctor or pharmacist for specific advice on all drug therapy. CONTACT YOUR DOCTOR PROMPTLY IF YOUR SYMPTOMS DO NOT IMPROVE or if they become worse while you are using this medicine. CONTACT YOUR DOCTOR PROMPTLY if your short-acting inhaler use increases or if use exceeds the 24-hour maximum prescribed by the doctor. DO NOT STOP OR LOWER YOUR DOSE OF THIS MEDICINE or other asthma medicines without first checking with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. Laboratory and/or medical tests, including lung function, will be performed periodically to monitor your progress or check for side effects. Consult your doctor for more information. If your asthma is sensitive to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen), continue to avoid those medicines as directed by your doctor. This medicine may cause drowsiness or dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. SOME PATIENTS TAKING THIS MEDICINE HAVE DEVELOPED MENTAL OR MOOD CHANGES, including suicidal thoughts or actions. Contact the doctor immediately if you experience symptoms such as agitation, aggression, hostility, anxiety, depression, strange dreams, trouble sleeping, sleepwalking, tremor, hallucinations, restlessness, irritability, or any unusual change in mood or behavior. Contact the doctor immediately if any signs of suicidal thoughts or actions occur. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include cough; dizziness; headache; indigestion; nausea; stomach upset or pain; stuffy nose; tiredness; or weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; dark urine; disorientation; fever; flu-like symptoms; irregular heartbeat; mental or mood changes (eg, agitation, aggression, hostility, anxiety, depression, strange dreams, trouble sleeping, sleepwalking, hallucinations, restlessness, irritability, or any unusual change in mood or behavior); muscle aches or cramps; new or worsening wheezing or other breathing problems; numbness or tingling of hands or feet; seizures; severe or persistent stomach pain; severe sinus pain or inflammation; suicidal thoughts or actions; swelling; tremor; unusual bruising or bleeding; upper respiratory tract infection; or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other asthma medicines, rifamycin antibiotics (such as rifampin), phenytoin, phenobarbital, or carbamazepine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including liver problems, mental or mood problems, suicidal thoughts or actions, allergies, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include hyperactivity, severe or persistent headache, stomach pain, unusual drowsiness or restlessness, unusual thirst, or vomiting.

ADDITIONAL INFORMATION: If you are taking this medicine for asthma, carry an identification card at all times that says you have asthma. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain necessary refills before your supply runs out.