Topix 0.5 mg (Varenicline Salicylate)

Adult dose

1. Usual dose in adults Smoking cessation treatment is more likely to succeed in patients who are motivated to quit and receive additional advice and support. Appropriate educational materials and counseling should be provided to support patients' attempts to quit smoking. Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may quit smoking between days 8 and 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dose is 1 mg twice daily after titration over 1 week, as follows: 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 unable to 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 during 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 unable or unwilling to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Patients should reduce the amount they smoke by 50% from baseline within the first 4 weeks after starting treatment, reduce it by a further 50% within the next 4 weeks, and continue reducing smoking so that they can achieve complete abstinence 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 smoking during the first 12 weeks of treatment, or who resume smoking after treatment, should review the factors contributing to failure and try again. However, data demonstrating the efficacy of an additional 12 weeks of treatment in patients who failed to quit during the initial 12 weeks or resumed smoking after treatment are not available. 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 used. 3. Elderly patients 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 elderly patients, care should be taken when selecting the dose, and 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 medicine is intended to aid in smoking cessation, but serious mental health issues such as depression, anxiety, and suicidal thoughts may occur during use. Therefore, individuals with a psychiatric history or significant mood changes should exercise caution. Pregnant or breastfeeding women must consult a physician before using this medication. Common side effects include nausea, headache, insomnia, and abnormal dreams, and some patients may experience worsening symptoms. If severe skin rashes or difficulty breathing occur, discontinue use immediately and consult healthcare professionals. Patients with cardiovascular diseases should also exercise caution when using this medicine and report any new symptoms to their doctor right away. This medication may enhance side effects when taken with alcohol, so it is advisable to avoid or minimize alcohol during use. Caution is advised when engaging in hazardous activities such as driving or operating machinery, as drowsiness or dizziness may occur after taking this medication. Safety and efficacy have not been established in children or adolescents under 18 years of age, and its use is not recommended. Elderly patients may need dose adjustment depending on renal function and should take it according to a physician's guidance. In case of overdose, seek medical attention immediately for appropriate treatment. Store this medication out of reach of children and keep it in its original container to prevent misuse.

Suicidal thoughts, suicidal behavior, suicide, changes in behavior or thoughts, depression, mania, psychosis, aggressive behavior, hallucinations, paranoia, delusions, homicidal thoughts, hostility, restlessness, anxiety, panic state, discomfort, depressed 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, hypogeusia, circadian rhythm sleep disorder, conjunctivitis, eye pain, scotoma, photophobia, tinnitus, angina pectoris, tachycardia, palpitations, increased heart rate, atrial fibrillation, reduced electrocardiogram segment depression, decreased electrocardiogram wave amplitude, increased blood pressure, facial flushing, upper respiratory tract disorders, dyspnea, cough, upper respiratory tract inflammation, airway congestion, voice disorders, allergic rhinitis, throat irritation, sinus congestion, upper respiratory cough syndrome, rhinorrhea, snoring, nausea, gastroesophageal reflux disease, vomiting, constipation, diarrhea, abdominal distension, abdominal pain, toothache, indigestion, bloating, dry mouth, bloody stools, gastritis, belching, aphthous stomatitis, gum pain, hematemesis, rash, itching, erythema, acne, hyperhidrosis, arthralgia, myalgia, back pain, muscle cramps, joint stiffness, increased frequency of urination, nocturia, diabetes, polyuria, heavy menstrual bleeding, sexual dysfunction, chest pain, fatigue, chest discomfort, 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, pulmonary heart disease, acute coronary syndrome, dizziness, hearing loss, Meniere's disease, thyroid disease, dry eyes, eye irritation, blurriness, vision disturbances, acquired night blindness, transient visual loss, subcapsular cataract, ocular vascular disease, 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, increased muscle enzymes, urine test abnormalities, diabetes mellitus, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, myositis, attention deficit disorder, sensory disturbances, amnesia, migraine, abnormal olfaction, psychomotor hyperactivity, restless legs syndrome, syncope, balance disorders, cerebrovascular events, seizures, facial nerve paralysis, mental disorders, multiple sclerosis, eye tremors, psychomotor dysfunction, transient ischemic attacks, visual field defects, anxiety, depression, emotional disorders, hyperreactivity, aggression, restlessness, disorientation, dissociation, euphoria, hallucinations, suicidal thoughts, nephrolithiasis, abnormal urine, urethral syndrome, acute renal failure, urinary retention, erectile dysfunction, epistaxis, respiratory diseases, asthma, pleurisy, pulmonary embolism, dermatitis, dry skin, eczema, psoriasis, urticaria, photosensitivity, hypotension, peripheral ischemia, thrombosis, angioedema, Stevens-Johnson syndrome, erythema multiforme, seizures, traffic accidents, near traffic accidents, drowsiness, dizziness, loss of consciousness, decreased concentration, euphoria, sleep disorders, increased irritability, euphoria, excessive dreaming, sleep disturbances, nightmares, excessive dreaming, nightmares, insomnia, anxiety, abnormal thoughts, suicidal thoughts, hallucinations, fatigue, lethargy, weakness, increased sputum, nipple pain, feeling dazed, discomfort, mental suffering, hair loss, memory disturbances, coldness, worsening condition, stimulation, burning sensation, decreased blood pressure, increased blood pressure

This medication should be stored in a tightly closed container to prevent air and moisture from entering. Additionally, it should be kept in a place that avoids extreme heat or cold, ideally at a temperature between 1 to 30 degrees Celsius, which is considered normal room temperature.

Appearance

White or grayish-white, bi-convex, rectangular film-coated tablet

Package unit

11 tablets (11 tablets/Alu-AluX1)