Champix Tablet 0.5 mg (Varenicline Salicylate)

Adult dose

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between day 8 and day 35 after starting this medicine. This medicine should be taken after a meal with plenty of water. The recommended dosage is as follows: after titrating the dose over 1 week, take 1 mg twice daily. Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8–end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions to this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking with the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medicine is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Reduce smoking by 50% from the pretreatment level within the first 4 weeks after starting treatment, and by an additional 50% within the following 4 weeks. Continue to reduce smoking so that complete cessation is achieved by 12 weeks. Continue taking this medicine for an additional 12 weeks for a total treatment period of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. Patients who do not quit smoking after the initial 12 weeks of treatment or who resume smoking after treatment should review the factors contributing to the unsuccessful attempt before trying again. However, there are no data establishing the efficacy of an additional 12 weeks of treatment in patients who did not quit smoking during the initial 12-week treatment or who resumed smoking after treatment. No dose adjustment is necessary in patients with mild (estimated creatinine clearance > 50 ml/min and ≤ 80 ml/min) to moderate (estimated creatinine clearance ≥ 30 ml/min and ≤ 50 ml/min) renal impairment. In patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended starting dose of varenicline is 0.5 mg once daily. If needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, a maximum dose of 0.5 mg once daily may be administered. No dose adjustment is necessary in patients with hepatic impairment. Because renal function is more likely to be reduced in elderly patients, use caution when selecting the dose; monitoring renal function may be useful.

Child dose

Patients under 18 years of age: Administration is not recommended because the safety and efficacy of this medicine have not been established in children.

This medication is used to help with smoking cessation, and there have been reports of neuropsychiatric symptoms and suicidal tendencies. Therefore, during treatment with this medication, caution is required as mental changes such as depression, anxiety, agitation, aggression, hallucinations, and suicidal thoughts may occur. This drug should not be administered to patients with hypersensitivity, and caution should be exercised if the patient is pregnant or breastfeeding. Various side effects such as nausea, headache, insomnia, and vivid dreams may occur during treatment; consult a doctor if any adverse symptoms arise. If seizures occur while taking this medication, it should be discontinued immediately, and medical personnel must be notified. Care should be taken when performing hazardous activities such as driving or operating machinery, as this medication may affect concentration or consciousness. Additionally, some cardiovascular side effects have been reported more frequently in patients with cardiovascular diseases, so consult a physician if there are heart issues. Although interactions with other medications are minimal, alcohol consumption may exacerbate side effects, so it is advisable to avoid or minimize alcohol intake during treatment. It is not recommended for children or adolescents under the age of 18, as safety and efficacy have not been established. Elderly patients may require dose adjustment and renal function testing, as impaired renal function can slow the elimination of the medication. Standard emergency treatment is needed for overdose, and this drug must be kept out of the reach of children. Finally, if there is a history of psychiatric disorders while taking this medication, it is essential to inform a doctor and seek immediate consultation if adverse symptoms develop.

Suicidal thoughts, suicidal behavior, suicide, changes in behavior or thoughts, depression, mania, mood changes, psychosis, aggressive behavior, hallucinations, paranoia, delusions, homicidal thoughts, hostility, restlessness, anxiety, panic state, discomfort, depressive mood, insomnia, irritability, frustration, anger, difficulty concentrating, agitation, decreased heart rate, increased appetite, weight gain, decreased platelet count, weight gain, decreased appetite, increased appetite, abnormal dreams, insomnia, abnormal thoughts, agitation, mood changes, decreased libido, discomfort, mental relaxation, headache, drowsiness, dizziness, taste disturbances, tremors, sleepiness, sensory loss, speech disorders, motor coordination disorders, taste loss, circadian rhythm sleep disorders, conjunctivitis, eye pain, scotoma, glare, tinnitus, angina, tachycardia, palpitations, increased heart rate, atrial fibrillation, decreased electrocardiogram segment elevation, decreased electrocardiogram wave amplitude, increased blood pressure, facial flushing, upper respiratory disorders, dyspnea, cough, upper respiratory inflammation, airway congestion, voice disorders, allergic rhinitis, throat irritation, sinus congestion, upper respiratory cough syndrome, runny nose, snoring, nausea, gastroesophageal reflux disease, vomiting, constipation, diarrhea, abdominal bloating, abdominal pain, toothache, dyspepsia, flatulence, dry mouth, blood in stool, gastritis, belching, aphthous stomatitis, gum pain, hematemesis, rash, itching, erythema, acne, sweating, joint pain, muscle pain, back pain, muscle cramps, joint stiffness, frequent urination, nocturia, diabetes, polyuria, excessive menstruation, sexual dysfunction, chest pain, fatigue, chest discomfort, influenza-like illness, fever, weakness, lethargy, liver function tests abnormal, anemia, lymphadenopathy, leukocytosis, splenomegaly, arrhythmia, bradycardia, ventricular premature contractions, myocardial infarction, heart palpitations, coronary artery disease, pulmonary heart disease, acute coronary syndrome, dizziness, hearing loss, Meniere's disease, thyroid disorders, eye dryness, eye irritation, blurred vision, visual impairment, acquired night blindness, transient visual loss, cataract, retinal vascular diseases, vitreous floaters, gingivitis, dysphagia, small intestine colitis, gastrointestinal bleeding, oral ulcer, esophagitis, peptic ulcer, intestinal obstruction, acute pancreatitis, edema, thirst, chills, gallbladder disease, hypersensitivity, drug hypersensitivity, electrocardiogram abnormalities, increased muscle enzymes, urinalysis abnormalities, diabetes, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorder, sensory disturbances, amnesia, migraines, olfactory disturbances, psychomotor hyperactivity, restless legs syndrome, syncope, balance disorders, cerebrovascular events, seizures, facial nerve paralysis, mental disorders, multiple sclerosis, eye twitching, psychomotor function disorder, transient ischemic attack, visual field defect, anxiety, depression, emotional disorders, hypersensitivity, aggression, restlessness, disorientation, dissociation, euphoria, hallucinations, suicidal thoughts, nephrolithiasis, abnormal urine, urethral syndrome, acute renal failure, urinary retention, menstrual disorders, erectile dysfunction, nasal bleeding, respiratory diseases, asthma, pleuritis, pulmonary embolism, dermatitis, dry skin, eczema, psoriasis, urticaria, phototoxic reactions, hypotension, peripheral ischemia, thrombosis, seizures, traffic accidents, near misses, drowsiness, dizziness, loss of consciousness, disability, decreased concentration, relief feelings, sleep disorders, smoking urges, increased hypersensitivity, abnormal and sometimes aggressive behavior, amnesia, angioedema, Stevens-Johnson syndrome, erythema multiforme, ischemic and hemorrhagic responses, cerebrovascular events, myocardial infarction, angioedema, facial edema, lip swelling, tongue swelling, gums swelling, neck swelling, laryngeal swelling, limb swelling, unstable angina, palpitations, arrhythmia, bradycardia, ventricular premature contractions, myocardial infarction, heart palpitations, coronary artery disease, pulmonary heart disease, acute coronary syndrome, dizziness, hearing loss, Meniere's disease, thyroid disorders, eye dryness, eye irritation, blurred vision, visual impairment, acquired night blindness, transient visual loss, cataract, retinal vascular diseases, vitreous floaters, gingivitis, dysphagia, small intestine colitis, gastrointestinal bleeding, oral ulcer, esophagitis, peptic ulcer, intestinal obstruction, acute pancreatitis, edema, thirst, chills, gallbladder disease, hypersensitivity, drug hypersensitivity, electrocardiogram abnormalities, increased muscle enzymes, urinalysis abnormalities, diabetes, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorder, sensory disturbances, amnesia, migraines, olfactory disturbances, psychomotor hyperactivity, restless legs syndrome, syncope, balance disorders, cerebrovascular events, seizures, facial nerve paralysis, mental disorders, multiple sclerosis, eye twitching, psychomotor function disorder, transient ischemic attack, visual field defect, anxiety, depression, emotional disorders, hypersensitivity, aggression, restlessness, disorientation, dissociation, euphoria, hallucinations, suicidal thoughts, nephrolithiasis, abnormal urine, urethral syndrome, acute renal failure, urinary retention, menstrual disorders, erectile dysfunction, nasal bleeding, respiratory diseases, asthma, pleuritis, pulmonary embolism, dermatitis, dry skin, eczema, psoriasis, urticaria, phototoxic reactions, hypotension, peripheral ischemia, thrombosis, insomnia, abnormal dreams, sleep disorders, nightmares, excessive dreaming, anxiety, abnormal thoughts, suicidal thoughts, hallucinations, headache, drowsiness, dizziness, brain fog, taste disturbances, syncope, fatigue, lethargy, weakness, chest discomfort, chest pain, decreased appetite, anorexia, itching, rash, dyspnea, increased sputum, muscle pain, gum swelling, nipple pain

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 degree Celsius and 30 degrees Celsius at room temperature.

Appearance

White or grayish-white, biconvex, rectangular film-coated tablets

Package unit

11 tablets/blister