Nicowinner Tablet 0.5 mg (Varenicline Salicylate)

Adult dose

Usual dosage in adults 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. Take this medicine after meals with plenty of water. The recommended dosage is as follows: after dose titration over 1 week, administer 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 of this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking after the first 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, consider gradually stopping smoking while taking this medicine. Reduce smoking by 50% compared with baseline within the first 4 weeks after starting treatment, and by an additional 50% over the next 4 weeks. Continue to reduce smoking so that complete cessation is achieved by week 12. Continue 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 fail to quit after 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 efficacy for an additional 12 weeks of treatment in patients who fail to quit during the initial 12 weeks or resume smoking after treatment. Patients with renal impairment No dose adjustment is required 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. Older adults and patients with hepatic impairment No dose adjustment is required in patients with hepatic impairment. Because renal function is more likely to be reduced in older adults, use caution when selecting the dose; monitoring renal function may be useful.

Child dose

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

This medication may cause neuropsychiatric symptoms and suicidal tendencies, so if mood changes or unusual behavior occur during treatment, consult a doctor immediately. Avoid use in cases of hypersensitivity or during pregnancy and breastfeeding unless prescribed and taken with caution. Initially, common symptoms like nausea, headache, insomnia, and abnormal dreams may appear, which can lead to discontinuation of the medication. This medication may induce seizures, hence special caution is required in patients with a history of seizures, and immediate discontinuation is necessary if seizures occur. Drowsiness or dizziness may occur when driving or operating machinery, so caution is advised. This medication can affect physical and mental symptoms associated with smoking cessation, so observation of mood changes or anxiety symptoms during cessation is necessary. If angioedema or severe skin reactions occur, discontinue medication immediately and inform healthcare professionals. Patients with cardiovascular diseases should discuss potential risks and benefits with their doctor before taking this medication. This medication has few drug interactions, but side effects may increase with alcohol consumption, so alcohol use should be avoided during treatment. Consider risks to the fetus when using during pregnancy, and consult a doctor regarding the potential for this medication to be passed through breast milk and whether to discontinue breastfeeding. Safety and efficacy have not been established for children and adolescents under 18; hence, use is not recommended. Elderly patients may need dose adjustments due to decreased kidney function, and they should take the medication according to the doctor's instructions. In case of overdose, standard treatment should be administered, and dialysis may be considered for patients with severely reduced kidney function. Store out of reach of children, and keep in the original container to prevent misuse and degradation of medication quality.

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, restlessness, decreased heart rate, increased appetite, weight gain, decreased platelet count, weight gain, decreased appetite, increased appetite, abnormal dreams, insomnia, abnormal thoughts, restlessness, mood changes, decreased libido, discomfort, mental restlessness, headache, drowsiness, dizziness, taste disturbances, trembling, hypersomnia, sensory loss, dysarthria, motor coordination disorders, gustatory hypesthesia, circadian rhythm sleep disorders, conjunctivitis, eye pain, scotoma, glare, tinnitus, angina, tachycardia, palpitations, increased heart rate, atrial fibrillation, decreased electrocardiogram segment elevation, reduced electrocardiogram wave amplitude, increased blood pressure, facial flushing, upper respiratory tract disorders, dyspnea, cough, upper respiratory tract inflammation, airway congestion, vocal cord dysfunction, 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 bloody 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, hypermenorrhea, sexual dysfunction, chest pain, fatigue, chest discomfort, influenza-like illness, fever, asthenia, lethargy, abnormal liver function tests, anemia, lymphadenopathy, leukocytosis, thrombocytopenia, splenomegaly, arrhythmia, bradycardia, premature ventricular contractions, myocardial infarction, cardiac flutter, coronary artery disease, pulmonary heart disease, acute coronary syndrome, dizziness, hearing loss, Meniere's disease, thyroid disorders, dry eyes, eye irritation, blurred vision, vision impairment, acquired night blindness, transient visual loss, cataracts, ocular vascular diseases, vitreous floaters, gingivitis, dysphagia, enterocolitis, gastrointestinal bleeding, oral ulcers, esophagitis, peptic ulcers, intestinal obstruction, acute pancreatitis, edema, thirst, chills, gallbladder disease, hypersensitivity, drug hypersensitivity, electrocardiogram abnormalities, muscle enzyme elevation, urine test abnormalities, diabetes mellitus, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorders, sensory disorders, amnestic syndrome, migraine, olfactory disturbances, psychomotor hyperactivity, restless legs syndrome, syncope, balance disorders, cerebrovascular events, seizures, facial nerve paralysis, mental disorders, multiple sclerosis, eye twitching, psychomotor dysfunction, transient ischemic attacks, visual field defects, anxiety, depression, emotional disorders, irritability, 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, hives, phototoxic reactions, hypotension, peripheral ischemia, thrombosis, seizures, traffic accidents, near traffic accidents, drowsiness, dizziness, loss of consciousness, decreased concentration, relief, sleep disorders, increased irritability, suicide attempts, angioedema, Stevens-Johnson syndrome, erythema multiforme, ischemic and hemorrhagic responses, cerebrovascular events, myocardial infarction, angioedema, facial swelling, oral swelling, neck swelling, limb swelling, dyspnea due to angioedema, insomnia, nightmares, excessive dreaming, sleep disorders, malignant neoplasm exacerbation, memory disturbances, hair loss, uncomfortable feelings, mental distress, stimulation, burning sensations, decreased blood pressure, increased blood pressure, hypertonicity.

This medication should be stored in a sealed container to protect it from air and moisture. It is recommended to keep the medication at room temperature between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance

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

Package unit

11 tablets (11 tablets/Alu-AluX1)