Learn more about usage, cautions, and possible side effects .
Chemical Name: VARENICLINE (var-EN-i-kleen)
This medicine is a smoking cessation agent used to help people quit smoking cigarettes.
SERIOUS MENTAL OR MOOD PROBLEMS (including depression, suicidal thoughts, suicidal attempts) and completed suicides have been reported in patients taking this medicine. Nicotine withdrawal may also have contributed to some of these events. However, these events have also occurred in patients who continued to smoke. These events have occurred both in patients with and without a history of mental or mood problems. Safety and effectiveness of this medicine in patients with a history of serious mental or mood problems (eg, schizophrenia, bipolar disorder, severe depression) have not been confirmed. WATCH PATIENTS WHO TAKE THIS MEDICINE CLOSELY. Stop taking this medicine and contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; hostility or agitation; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. Discuss the benefits and the risks of this medicine with your doctor. Discuss any other questions or concerns with your doctor. 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 nicotine replacement therapy or other medicine to stop smoking. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of kidney problems or dialysis; mental or mood problems (eg, bipolar disorder, depression, schizophrenia); suicidal thoughts or actions; allergies; pregnancy; or breast-feeding. Tell your doctor if you have tried to quit smoking before and experienced any unusual symptoms or side effects. Use of this medicine in children under age 18 is not recommended; safety and effectiveness in these children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
Follow the directions for taking this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Read it again each time you get this medicine refilled. SET A DATE TO QUIT SMOKING. Start treatment with this medicine 1 week before your quit date. TAKE THIS MEDICINE by mouth after a meal with a full glass (8 oz/240 mL) of water. STORE THIS MEDICINE at 77 degrees F (25 degrees C) away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Take this medicine on a regular schedule to get the most benefit from it. Taking it at the same time each day will help you remember to take it. Even if you smoke after your quit date, continue to try to quit. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. 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.
DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. DO NOT EXCEED THE RECOMMENDED DOSE without checking with your doctor. THIS MEDICINE MAY CAUSE DROWSINESS, DIZZINESS, OR VISION CHANGES. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. DO NOT DRIVE OR PERFORM OTHER POSSIBLY UNSAFE TASKS until you know how you react to it. Tell your doctor about any other medicines that you take. IF YOU ARE TAKING CERTAIN OTHER MEDICINES (eg, insulin, theophylline, warfarin), quitting smoking may affect their actions or side effects. Your dose of these medicines may need to be changed. Discuss any questions or concerns with your doctor. SOME PATIENTS HAVE EXPERIENCED CHANGES IN BEHAVIOR OR MOOD while taking this medicine. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; aggressive, agitated, or abnormal behavior; personality change; thoughts of hurting other people; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. PEOPLE WHO TRY TO QUIT SMOKING may experience symptoms that could be caused by nicotine withdrawal. These may include the urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, trouble concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. SOME PATIENTS MAY EXPERIENCE WORSENING of mental health problems they already have, such as depression. Be sure to tell your doctor if you have a history of any of these problems. Discuss any questions or concerns with your doctor. LAB TESTS, including kidney function, may be performed to monitor your condition or check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. USE THIS MEDICINE WITH CAUTION IN THE ELDERLY; they may be more sensitive to its effects. FOR WOMEN: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. DO NOT BREAST-FEED while taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include constipation; gas; headache; increased appetite; nausea; stomach upset; taste changes; trouble sleeping; vivid, strange, or unusual dreams; or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience behavior changes; chest pain; fast, slow, or irregular heartbeat; hallucinations; memory loss; new or worsening mental or mood problems (eg, agitation, aggression, anger, anxiety, depression, nervousness, thoughts of hurting other people); red, swollen, blistered, or peeling skin; seizures; severe or persistent nausea; suicidal thoughts or actions; or vision changes. 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; unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.
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