Champix (varenicline) is a prescription medication specifically designed to assist adults in quitting smoking. It functions as a partial agonist selective for the α4β2 nicotinic acetylcholine receptor, reducing both the severity of nicotine withdrawal symptoms and the rewarding effects of smoking should a lapse occur. This dual-action mechanism provides a significant pharmacological advantage in the management of tobacco use disorder. Treatment with Champix, combined with a comprehensive support program, significantly increases the chances of long-term abstinence from smoking.

Features

• Active Pharmaceutical Ingredient: Varenicline (as varenicline tartrate).
• Presentation: Film-coated tablets available in 0.5 mg and 1 mg strengths.
• Mechanism of Action: Partial agonist at the α4β2 neuronal nicotinic acetylcholine receptor.
• Treatment Duration: Standard course is a 12-week treatment regimen, with an option for an additional 12-week course for successful quitters to maintain abstinence.
• Dosage Form: Oral tablet.
• Prescription Status: Prescription-only medication (POM).

Benefits

• Significantly reduces the urge to smoke by alleviating nicotine cravings and withdrawal symptoms.
• Diminishes the satisfaction derived from smoking if a cigarette is smoked, thereby reducing the reinforcing effects of a lapse.
• Provides a structured, titrated dosing schedule to optimize tolerability and efficacy.
• Clinically proven to more than double the chances of long-term smoking cessation compared to placebo.
• Offers a non-nicotine based therapeutic option for individuals seeking to quit.
• Supported by extensive clinical trial data and real-world evidence demonstrating its effectiveness.

Common use

Champix is indicated for smoking cessation in adults. It is used as part of a comprehensive quit attempt, which should include behavioral support, counseling, and educational materials. The goal of therapy is complete abstinence from smoking. Treatment is initiated before the patient’s designated quit date, allowing varenicline to reach steady-state concentrations and begin modulating the neuroreceptors involved in nicotine addiction. It is suitable for motivated individuals who are committed to stopping smoking.

Dosage and direction

The dosage of Champix must be individualized and administered under the direction of a physician. The following represents the standard dosing regimen:

• Days 1 to 3: 0.5 mg once daily.
• Days 4 to 7: 0.5 mg twice daily.
• Day 8 to end of treatment: 1 mg twice daily.
• The patient should set a target quit date between Day 8 and Day 14 of treatment.
• Tablets should be taken orally after eating and with a full glass of water to minimize potential nausea.
• The recommended treatment duration is 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment may be considered to further increase the likelihood of long-term abstinence.
• For patients who cannot tolerate adverse effects, dose reduction or temporary discontinuation may be considered.
• Specific dosing instructions apply for patients with severe renal impairment.

Precautions

• Neuropsychiatric Events: Patients should be monitored for changes in behavior, hostility, agitation, depressed mood, and suicide-related events (e.g., ideation, behavior, attempted suicide). Patients with a history of psychiatric illness may be at increased risk. Advise patients to discontinue Champix and contact a healthcare provider immediately if such symptoms occur.
• Nausea: Nausea is a common dose-related adverse effect. It is often transient and can be managed by taking the tablet with food and water. Dose escalation should follow the recommended schedule.
• Cardiovascular Disease: Patients with underlying cardiovascular (CV) disease should be monitored. While Champix has been studied in patients with stable CV disease, clinicians should weigh the benefits against potential risks.
• Seizures: Although rare, seizures have been reported. Use with caution in patients with a history of seizures or other factors that can lower the seizure threshold.
• Driving and Operating Machinery: Champix may cause dizziness and somnolence, which can affect the ability to drive or operate machinery. Patients should exercise caution until they are certain the medication does not adversely affect them.
• Pregnancy and Lactation: The benefits of quitting smoking during pregnancy are well-established. However, the risks of varenicline use during pregnancy and breastfeeding are not fully defined. Use only if the potential benefit justifies the potential risk to the fetus or infant.

Contraindications

Champix is contraindicated in the following populations:

• Patients with known hypersensitivity to varenicline tartrate or to any of the excipients listed in the product formulation.
• Its use is not recommended in patients with end-stage renal disease.

Possible side effect

Like all medicines, Champix can cause side effects, although not everybody gets them. Very common (≥1/10) and common (≥1/100 to <1/10) side effects include:

• Very Common: Nausea, insomnia, abnormal dreams, headache.
• Common: Abdominal pain, flatulence, vomiting, dyspepsia, constipation, dry mouth, dizziness, somnolence, sleep disorder, altered mood, agitation, anxiety, irritability, depressed mood, fatigue, malaise, increased appetite, weight gain, rhinorrhea. Uncommon, rare, and very rare side effects include seizures, hypersensitivity reactions, angioedema, erythema multiforme, and serious cardiovascular events. Patients should be instructed to read the package leaflet for a complete list and report any adverse reactions to their physician.

Drug interaction

Formal pharmacokinetic drug-drug interaction studies have shown no clinically meaningful interactions. However, based on its mechanism of action:

• Smoking Cessation Itself: Cessation of smoking, with or without treatment, may alter the pharmacokinetics of certain medications (e.g., theophylline, warfarin, insulin) due to the removal of the inductive effects of tobacco smoke. Dosage adjustment of these concomitant medications may be necessary.
• Cimetidine: Cimetidine increased the systemic exposure of varenicline by 29%.
• Other Active Treatments for Smoking Cessation: The safety and efficacy of concomitant use with other nicotine replacement therapy (NRT) products have not been established.

Missed dose

If a dose is missed, it should be taken as soon as remembered, unless it is nearly time for the next dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not take a double dose to make up for a forgotten dose.

Overdose

Cases of overdose have been reported. Symptoms are generally consistent with the known adverse effect profile of the drug and may include nausea, vomiting, drowsiness, dizziness, and tachycardia. In the event of suspected overdose, standard supportive measures should be initiated as required. Due to extensive renal excretion of varenicline, dialysis may be useful in cases of severe overdose, particularly in patients with renal impairment. The poison control center should be contacted for the latest guidance on management.

Storage

• Store below 30°C (86°F).
• Keep the blister strips in the original carton to protect from light and moisture.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

Disclaimer

This product card is for informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on the product’s Summary of Product Characteristics (SmPC) and may not be exhaustive.

Reviews

“After 25 years of smoking a pack a day, I had resigned myself to the habit. My physician prescribed Champix alongside a support program. The structured dosing and the noticeable reduction in cravings were pivotal. The first week was an adjustment, but the diminishing desire to smoke was remarkable. I have now been smoke-free for 18 months, a feat I previously thought impossible.” – J.A., 49

“As a cardiologist, I frequently counsel patients on smoking cessation. For motivated individuals, Champix is a valuable tool in our arsenal. Its dual mechanism provides a clear pharmacological benefit. While I monitor patients, particularly those with a history of mood disorders, its efficacy in helping patients achieve abstinence is well-documented and often life-changing from a cardiovascular risk perspective.” – Dr. E. Lawson, MD

“The initial nausea was a challenge, but taking the pills with a full meal completely mitigated it. The most profound effect was the disassociation from smoking; cigarettes simply lost their appeal. The psychological grip was broken. Completing the 12-week course gave me the foundation I needed, and I haven’t looked back.” – M. Thompson, 34