Nicowinner Tablet 1 mg (Varenicline Salicylate)

Adult dose

1. 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. 2. 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. 3. 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

Administration to patients under 18 years of age is not recommended.

This medication is used to help quit smoking. During treatment, serious psychiatric symptoms such as suicidal thoughts or behavior, depression, anxiety, hallucinations, etc., may occur. If such symptoms appear, you should stop taking the medication immediately and consult a doctor. If there is a history of psychiatric disorders, it is essential to inform your doctor before taking this medication. Care should be taken when used during pregnancy or lactation, and consultation with a professional is advised if necessary. This medication may cause various side effects including nausea, headache, insomnia, and abnormal dreams. Particularly, nausea is a common side effect, and initial dose adjustment is important. Caution is necessary as drowsiness or impaired concentration may occur while driving or operating machinery. Patients with cardiovascular diseases should inform their doctor immediately if new or worsening symptoms occur. Dose adjustment may be necessary based on kidney function, and caution is needed for the elderly or those with impaired kidney function. In case of overdose, seek medical attention immediately for appropriate treatment. This medication is not recommended for children. The interaction with other drugs is minimal, but it is advisable to avoid or minimize alcohol consumption.

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, 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 relaxation, headache, drowsiness, dizziness, taste disturbance, trembling, somnolence, sensory loss, dysarthria, motor coordination disorder, taste hypesthesia, circadian rhythm sleep disorders, conjunctivitis, eye pain, scotoma, photophobia, tinnitus, angina, tachycardia, palpitations, increased heart rate, atrial fibrillation, ST segment depression on electrocardiogram, decreased amplitude on electrocardiogram, increased blood pressure, facial flushing, upper respiratory disorders, dyspnea, cough, upper respiratory inflammation, airway congestion, voice disturbances, allergic rhinitis, throat irritation, sinus congestion, upper respiratory cough syndrome, rhinorrhea, snoring, nausea, gastroesophageal reflux disease, vomiting, constipation, diarrhea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth, 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, menorrhagia, sexual dysfunction, chest pain, fatigue, chest discomfort, influenza-like illness, fever, asthenia, lethargy, liver function test abnormalities, anemia, lymphadenopathy, leukocytosis, splenomegaly, arrhythmia, bradycardia, premature ventricular contractions, myocardial infarction, cardiac arrhythmia, coronary artery disease, cor pulmonale, acute coronary syndrome, hearing loss, Ménière's disease, thyroid disease, dry eyes, eye irritation, blurred vision, visual impairment, acquired night blindness, transient vision loss, cataract under the lens, ocular vascular disease, vitreous floaters, gingivitis, dysphagia, small intestine and colon inflammation, gastrointestinal bleeding, oral ulcer, esophagitis, peptic ulcer, intestinal obstruction, acute pancreatitis, edema, thirst, chills, gallbladder disease, hypersensitivity reaction, drug hypersensitivity, electrocardiogram abnormalities, muscle enzyme increase, urine test abnormalities, diabetes, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorder, sensory disorders, amnesia, migraine, dysosmia, psychomotor hyperactivity, restless legs syndrome, syncope, balance disorders, cerebrovascular events, seizures, facial nerve paralysis, mental disorders, multiple sclerosis, eye twitching, psychomotor dysfunction, transient ischemic attack, visual field loss, anxiety, depression, emotional disorders, irritability, aggression, restlessness, disorientation, dissociation, euphoria, hallucinations, suicidal thoughts, nephrolithiasis, abnormal urine, urethral syndrome, acute kidney failure, urinary retention, erectile dysfunction, epistaxis, respiratory diseases, asthma, pleuritis, pulmonary embolism, dermatitis, dry skin, eczema, psoriasis, urticaria, photosensitivity, hypotension, peripheral ischemia, thrombosis, sleep disorders, nightmares, excessive dreaming, hallucinations, sleep disorders, nightmares, excessive dreaming, increased sputum, pneumonia exacerbation, arterial stenosis, nipple pain, worsening of malignant neoplasms, brain fog, unpleasant sensation, mental anguish, hair loss, memory abnormalities, cold sensation, worsening condition, stimuli, burning sensation, decreased blood pressure, increased blood pressure, excessive muscle tension syndrome, gastric ulcer, seizures, traffic accidents, near traffic accidents, drowsiness, dizziness, loss of consciousness, decreased concentration, sense of relief, sleep disorders, increased irritability, abnormal and aggressive behavior, amnesia, vascular edema, Stevens-Johnson syndrome, erythema multiforme

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Light blue, double convex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu X2)