Medication info

Nicotin ES Tablet 1 mg (Varenicline Salicylate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Varenicline Salicylate›1.65mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Light blue, convex-shaped, film-coated tablets
Packaging
28 tablets (14 tablets/PTP X 2)
Approval status
Approval withdrawn

MFDS item code 202003083 · Approved 2020.04.27

This product's status changed to Approval withdrawn on 2024.12.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Smoking cessation support
Who takes it
Adults · Children
Adult dose
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 until end of treatment: 1 mg twice daily In patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period with this medicine is 12 weeks. For patients who successfully quit smoking with 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. Continue treatment with this medicine for an additional 12 weeks, for a total treatment period of 24 weeks. No dosage 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 necessary, the dose may be increased to a maximum of 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, the maximum dose is 0.5 mg once daily. No dosage adjustment is necessary in patients with hepatic impairment.
Child dose
Under 18 years: The safety and efficacy of this medicine have not been established in children; therefore, use in patients under 18 years of age is not recommended.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Smoking cessation support

View approved original text

The adjunct therapy for smoking cessation helps individuals who want to quit smoking to increase their chances of success. This therapy uses nicotine substitutes or medications to alleviate withdrawal symptoms and reduce the discomfort associated with quitting smoking. It also offers psychological support through behavioral therapy and counseling, helping to control cravings and maintain healthy lifestyle habits. The adjunct therapy plays an important role in achieving smoking cessation.

How to take

Adult dose

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 until end of treatment: 1 mg twice daily In patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period with this medicine is 12 weeks. For patients who successfully quit smoking with 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. Continue treatment with this medicine for an additional 12 weeks, for a total treatment period of 24 weeks. No dosage 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 necessary, the dose may be increased to a maximum of 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, the maximum dose is 0.5 mg once daily. No dosage adjustment is necessary in patients with hepatic impairment.

Child dose

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

Precautions

This medication is intended to assist with smoking cessation, and serious neuropsychiatric symptoms may occur during treatment, so caution is needed. If there is a history of psychiatric disorders, it is essential to inform your doctor before taking this medication, and if symptoms such as depression, anxiety, or suicidal thoughts occur during treatment, discontinue use immediately and consult a doctor. This medication should not be used in patients with hypersensitivity, and caution should be exercised in pregnant or breastfeeding women. The most common side effect is nausea, which is generally mild, but may persist in some patients. Additionally, quitting smoking itself can trigger various symptoms such as depression, insomnia, and anxiety, so care should be taken if these symptoms occur during treatment. This medication may increase the risk of seizures, so patients with a history of seizures or risk factors for seizures should consult a doctor before use. Caution is advised for activities requiring attention, such as driving or operating machinery, after taking this medication. Alcohol consumption may exacerbate side effects, so it is advised to avoid or minimize alcohol intake during treatment. This medication is excreted through the kidneys, so dosage adjustments may be necessary for patients with reduced kidney function, especially for the elderly. There is no specific antidote for overdose, so appropriate treatment should be received based on symptoms, and keep out of reach of children.

Side effects

  • Suicidal thoughts
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • psychosis
  • aggressive behavior
  • hallucinations
  • paranoia
Show 277 more
  • delusions
  • thoughts of murder
  • hostility
  • restlessness
  • anxiety
  • panic state
  • 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 swings
  • decreased libido
  • discomfort
  • mental slowness
  • headache
  • drowsiness
  • dizziness
  • taste disturbances
  • tremors
  • somnolence
  • sensory loss
  • speech disorders
  • motor coordination disorders
  • taste loss
  • circadian rhythm sleep disorders
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ECG ST segment depression
  • ECG T-wave amplitude reduction
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorders
  • dyspnea
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • vocal 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
  • dyspepsia
  • bloating
  • dry mouth
  • blood in stool
  • gastritis
  • belching
  • aphthous stomatitis
  • gum pain
  • hematemesis
  • rash
  • itching
  • erythema
  • acne
  • hyperhidrosis
  • arthralgia
  • myalgia
  • back pain
  • muscle spasms
  • joint stiffness
  • frequent urination
  • nocturia
  • diabetes
  • polyuria
  • menorrhagia
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • asthenia
  • 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
  • blurred vision
  • visual impairment
  • acquired night blindness
  • transient visual loss
  • lens opacities
  • ocular vascular diseases
  • vitreous floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcers
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reactions
  • drug hypersensitivity
  • abnormal ECG
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention disorders
  • sensory disorders
  • amnesia
  • migraine
  • abnormal olfaction
  • psychomotor hyperactivity
  • restless leg syndrome
  • syncope
  • balance disorders
  • cerebrovascular events
  • seizures
  • 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 thoughts
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute kidney 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
  • sleep disorders
  • nightmares
  • excessive dreaming
  • sleep disorders
  • nightmares
  • excessive dreaming
  • sleep disorders
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thinking
  • hallucinations
  • insomnia
  • anxiety
  • abnormal thinking
  • suicidal thoughts
  • hallucinations
  • headache
  • drowsiness
  • dizziness
  • mental fog
  • taste abnormalities
  • syncope
  • fatigue
  • weariness
  • asthenia
  • chest discomfort
  • chest pain
  • decreased appetite
  • loss of appetite
  • increased appetite
  • itching
  • rash
  • dyspnea
  • increased sputum
  • myalgia
  • gum swelling
  • nipple pain
  • seizures
  • traffic accident
  • near traffic accident
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • relief
  • sleep disorders
  • increased irritability
  • relief
  • sleep disorders
  • increased irritability
  • inadequate effect
  • unpleasant feeling
  • mental distress
  • hair loss
  • increased sputum
  • memory abnormalities
  • coldness
  • worsening condition
  • irritation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure
  • excessive muscle tension
  • gastric ulcer

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container to protect from air and moisture, at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Light blue, convex-shaped, film-coated tablets

Package unit

28 tablets (14 tablets/PTP X 2)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.