NicoBai Tablet 0.5 mg (Varenicline Salicylate)

Adult dosage

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting smoking between Day 8 and Day 35 after starting this medicine. This medicine should be taken after meals with plenty of water. The recommended dosage of this medicine is as follows: after 1 week of dose titration, take 1 mg twice daily. Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8 until the end of treatment 1 mg twice daily For patients who cannot tolerate 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 first 12 weeks of treatment, an additional 12 weeks of this medicine is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, consider gradually reducing smoking while taking this medicine. Reduce the amount smoked by 50% from the pretreatment level within the first 4 weeks after starting this medicine, and by an additional 50% within the next 4 weeks. Continue reducing the amount smoked to achieve complete smoking cessation by Week 12. Take 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 during the first 12 weeks of treatment or who resume smoking after treatment should review the reasons for failure and try again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who failed to quit smoking during the first 12 weeks of treatment or 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. In elderly patients, renal function is more likely to be reduced, so use caution when selecting the dose; monitoring renal function may be useful.

Children's dosage

Under 18 years of age: The safety and efficacy of this medicine have not been established in children; therefore, use is not recommended in patients under 18 years of age.

This medication is used to aid smoking cessation, and attention should be paid to neuropsychiatric symptoms and suicide tendencies. During treatment, mental health issues such as depression, anxiety, hallucinations, and aggressive behavior may occur; if these symptoms arise, consult a physician immediately. Patients with hypersensitivity or a history of allergic reactions to this medication should not take it. Women who are pregnant or breastfeeding should use this medication cautiously and must consult a doctor before use. Side effects such as nausea, headache, insomnia, and abnormal dreams can frequently occur. Especially, this medication has been reported to cause some cardiac-related adverse reactions in patients with cardiovascular diseases, so those with heart conditions should consult their physicians before taking it. Seizures may occur during treatment, thus patients with a history of seizures or at high risk of seizures should exercise extra caution. Drowsiness or dizziness may be experienced when driving or operating machinery, so caution is advised. Additionally, alcohol intake may lead to abnormal behaviors, thus it is advisable to avoid or minimize alcohol consumption during treatment. This medication is not recommended for children and older adults may require dose adjustments based on renal function. In case of overdose, notify medical personnel immediately and seek appropriate treatment. Finally, this medication should be stored out of the reach of children and kept in its original container to maintain quality.

Suicidal ideation, suicidal behavior, suicide, changes in behavior or thoughts, depression, mania, psychosis, aggressive behavior, hallucinations, paranoia, delusions, thoughts of murder, hostility, restlessness, anxiety, panic state, discomfort, depressive mood, insomnia, irritability, frustration, anger, difficulty concentrating, fidgeting, decreased heart rate, increased appetite, weight gain, decreased platelet count, weight gain, decreased appetite, increased appetite, abnormal dreams, insomnia, abnormal thoughts, fidgeting, mood changes, decreased libido, discomfort, mental relaxation, headache, drowsiness, dizziness, taste disturbance, tremors, drowsiness, sensory loss, speech disorders, motor coordination disorders, taste reduction, circadian rhythm sleep disorder, conjunctivitis, eye pain, scotoma, glare, tinnitus, angina pectoris, tachycardia, palpitations, increased heart rate, atrial fibrillation, decreased electrocardiogram segment height, reduced electrocardiogram amplitude, increased blood pressure, facial flushing, upper respiratory tract disorders, dyspnea, cough, upper respiratory tract inflammation, airway congestion, phonation disorders, allergic rhinitis, throat irritation, sinus congestion, upper respiratory cough syndrome, runny nose, snoring, nausea, gastroesophageal reflux disease, vomiting, constipation, diarrhea, abdominal distension, abdominal pain, toothache, indigestion, bloating, dry mouth, passage of blood in stool, gastritis, belching, aphthous stomatitis, gum pain, hematemesis, rash, itching, erythema, acne, hyperhidrosis, arthralgia, myalgia, back pain, muscle cramps, joint stiffness, frequent urination, nocturia, diabetes, polyuria, excessive menstruation, sexual dysfunction, chest pain, fatigue, discomfort in the chest, influenza-like illness, fever, weakness, lethargy, abnormal liver function tests, anemia, lymphadenopathy, leukocytosis, thrombocytopenia, splenomegaly, arrhythmia, bradycardia, ventricular ectopy, myocardial infarction, heart flutter, coronary artery disease, cor pulmonale, acute coronary syndrome, dizziness, hearing loss, Meniere's disease, thyroid disease, dry eyes, eye irritation, blurriness, vision disturbances, acquired night blindness, transient visual loss, lens opacification, ocular vascular diseases, floaters, gingivitis, dysphagia, enterocolitis, gastrointestinal bleeding, oral ulcers, esophagitis, peptic ulcers, intestinal obstruction, acute pancreatitis, edema, thirst, chills, gallbladder disorders, hypersensitivity reactions, drug hypersensitivity reactions, abnormal electrocardiogram, increased muscle enzymes, abnormal urine tests, diabetes mellitus, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorder, sensory disorders, amnesia, migraine, altered smell, psychomotor hyperactivity, restless legs syndrome, syncope, balance disorders, cerebrovascular events, convulsions, facial nerve paralysis, mental disorders, multiple sclerosis, eye twitching, psychomotor dysfunction, transient ischemic attack, visual field defects, anxiety, depression, emotional disorders, irritability, aggressiveness, restlessness, disorientation, dissociation, euphoria, hallucinations, suicidal ideation, 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, photosensitivity reactions, hypotension, peripheral ischemia, thrombosis, insomnia, abnormal dreams, sleep disorders, depression, nightmares, excessive dreaming, anxiety, abnormal thoughts, suicidal ideation, hallucinations, headache, drowsiness, dizziness, brain fog, taste disturbances, syncope, fatigue, lethargy, weakness, chest discomfort, chest pain, loss of appetite, increased appetite, itching, rash, dyspnea, increased sputum, myalgia, gum swelling, nipple pain, seizures, traffic accidents, near traffic incidents, drowsiness, dizziness, loss of consciousness, decreased concentration, relief, sleep disorders, smoking urges, increased irritability, abnormal and aggressive behaviors, amnesia, vascular edema, Stevens-Johnson syndrome, erythema multiforme, ischemia, hemorrhagic reactions, cerebrovascular events, myocardial infarction, unstable angina, edema, thirst, nausea, insomnia, indigestion, headache, anxiety, nightmares, excessive dreaming, sleep disorders, depression, exacerbation of malignancy, alopecia, memory disturbances, coldness, deterioration of condition, irritation, burning sensation, decreased blood pressure, increased blood pressure

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

White or gray-white, double convex rectangular film-coated tablet

Package unit

11 tablets (11 tablets/PTP*1)