Macklin 1 mg Tablets (Varenicline Salicylate)

Adult dose

Usual dosage for adults 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. 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.

Child dose

Patients 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 acts on the nicotine receptors in the brain to alleviate withdrawal symptoms that may occur when attempting to quit smoking. During treatment, neuropsychiatric symptoms such as depression, anxiety, aggression, and hallucinations may appear; if such symptoms occur, treatment should be stopped immediately and a doctor should be consulted. Patients with a history of psychiatric disorders should use this medication with particular caution and must inform their doctor of their past medical history before starting treatment. Women who are pregnant or breastfeeding should consult their doctor before taking this medication and carefully consider its potential impact on the fetus or newborn. This medication may cause various side effects such as nausea, headache, insomnia, and abnormal dreams, so if symptoms are severe, it is advisable to consult a doctor. Care should be taken when performing activities that require focus, such as driving or operating machinery, as this medication may cause drowsiness or dizziness. Drug interactions are relatively few, but concomitant use with alcohol may increase side effects, so it is advisable to avoid alcohol consumption if possible. Elderly patients with impaired kidney function may require dosage adjustments, so they should take this medication according to their doctor's instructions. In case of overdose, visit a medical institution immediately for appropriate treatment, and keep it out of reach of children.

Suicidal ideation, suicidal behavior, suicide, changes in behavior or thoughts, depression, mania, psychosis, aggressive behavior, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, anxiety, panic, discomfort, depressed 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 disturbances, tremors, hypersomnia, sensory loss, speech disturbance, motor coordination disorder, taste reduction, circadian rhythm sleep disorder, conjunctivitis, eye pain, scotoma, photophobia, tinnitus, angina, tachycardia, palpitations, increased heart rate, atrial fibrillation, reduction in electrocardiogram segment elevation, reduction in electrocardiogram 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 distension, abdominal pain, toothache, indigestion, bloating, dry mouth, bloody stools, gastritis, belching, aphthous stomatitis, gum pain, hematemesis, rash, itching, erythema, acne, sweating, joint pain, muscle pain, back pain, muscle spasms, joint stiffness, frequent urination, nocturia, diabetes, polyuria, heavy menstrual flow, sexual dysfunction, chest pain, fatigue, chest discomfort, influenza-like illness, fever, asthenia, malaise, abnormal liver function tests, anemia, lymphadenopathy, leukocytosis, thrombocytopenia, splenomegaly, arrhythmia, bradycardia, ventricular extrasystole, myocardial infarction, cardiac tremor, coronary artery disease, pulmonary heart disease, acute coronary syndrome, hearing loss, Meniere's disease, thyroid disease, dry eyes, eye irritability, blurred vision, visual disturbances, acquired night blindness, transient visual loss, cloudy cataract, ocular vascular disease, vitreous floaters, gum inflammation, dysphagia, enterocolitis, gastrointestinal bleeding, oral ulcers, esophagitis, peptic ulcers, intestinal obstruction, acute pancreatitis, edema, thirst, chills, gallbladder disease, hypersensitivity reactions, drug hypersensitivity reactions, abnormal electrocardiogram, increased muscle enzymes, abnormal urine tests, diabetes, dyslipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorder, sensory disturbances, amnesic syndrome, migraine, olfactory dysfunction, psychomotor hyperactivity, restless legs syndrome, syncope, balance disorder, cerebrovascular events, seizures, facial nerve palsy, mental disorders, multiple sclerosis, eye twitching, psychomotor dysfunction, transient ischemic attacks, visual field defects, anxiety, depression, emotional disorders, hypersensitivity, aggression, agitation, disorientation, dissociation, euphoria, hallucinations, suicidal ideation, nephrolithiasis, abnormal urine, urethral syndrome, acute kidney failure, urinary retention, menstrual disorders, erectile dysfunction, nasal bleeding, respiratory diseases, asthma, pleurisy, pulmonary embolism, dermatitis, skin dryness, eczema, psoriasis, urticaria, photosensitivity reactions, hypotension, peripheral ischemia, thrombosis, insomnia, sleep disorders, nightmares, excessive dreaming, anxiety, abnormal thinking, hallucinations, headache, drowsiness, dizziness, feeling of fog in the head, taste distortions, syncope, fatigue, malaise, asthenia, itching, rash, dyspnea, increased sputum, muscle pain, gum swelling, nipple pain, seizures, traffic accidents, near traffic accidents, drowsiness, dizziness, loss of consciousness, decreased concentration, relief, sleep disorders, smoking urges, increased irritability, abnormal and aggressive behavior, amnesia, suicide attempts, Stevens-Johnson syndrome, erythema multiforme, angioedema, facial edema due to angioedema, swelling of the mouth, throat, limbs, angina, chest pain, peripheral edema, hypertension, palpitations, non-fatal myocardial infarction, non-fatal stroke, need for coronary artery revascularization, transient ischemic attacks, peripheral vascular disease, unpleasant sensations, psychological distress, hair loss, memory disturbances, coldness, worsening condition, irritation, burning sensation, decreased blood pressure, increased blood pressure

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

Appearance

Light blue, biconvex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/PTPX2)