In order to assist people stop smoking, varenicline is used along with guidance and education. Varenicline belongs to the category of drugs known as smoking cessation aids. By preventing nicotine’s (from smoking) pleasurable effects on the brain, it works.

Varenicline is available as an oral tablet. Initially taken once day, it is then typically taken twice daily in the morning and evening. Following a meal, take varenicline with a full glass of water (8 ounces [240 mL]). Use varenicline every day at around the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take the medication precisely as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Your doctor will likely begin your varenicline treatment with a low dose and gradually raise it over the first week.

There are 3 ways that you can take varenicline to help you quit smoking.

• A week before to your intended date of quitting smoking, you can start taking varenicline. During the first week of your varenicline treatment, you are permitted to continue smoking, but you must make an effort to quit by the date you have set.
• In the 8 to 35 days following the start of your varenicline treatment, you may decide to stop smoking.
• You can start taking varenicline and stop smoking gradually over the course of 12 weeks of treatment if you are unsure that you will be able to or if you do not want to stop smoking abruptly. You should strive to smoke half as many cigarettes each day during weeks 1-4 as opposed to your usual quantity. Try to limit your cigarette consumption to one-fourth of your initial daily intake for weeks four through eight. You should aim to smoke less cigarettes every day for weeks 9 to 12 until you are completely smoke-free. By the end of the 12-week period, or sooner if you feel ready, try to entirely stop using.

You might not experience varenicline’s full benefits for a few weeks. You could trip and smoke while receiving therapy. You could still be able to stop smoking if this occurs. Continue taking varenicline and make an effort to quit smoking.

Varenicline will likely be prescribed to you for 12 weeks. Your doctor could advise you to continue taking varenicline for an additional 12 weeks if you have successfully quit smoking after the initial 12 weeks. This can prevent you from lighting up once again.

After 12 weeks, if you still haven’t quit, consult your doctor. Your doctor can try to explain to you why you were unable to stop smoking so that you can plan to try to stop once more.

When you start taking varenicline for the first time and every time you need a prescription refill, your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before taking varenicline,

• If you have a drug allergy, be sure to let your doctor and pharmacist know right away.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter medications, vitamins, herbal items, nutritional supplements, and any drugs you are now taking or intend to take. Any of the following should be mentioned: Warfarin (Coumadin, Jantoven), insulin, other antidepressants like bupropion (Aplenzin, Forfivo, Wellbutrin, Zyban, in Contrave), nicotine gum, inhalation devices, lozenges, nasal spray, or skin patches, and theophylline are examples of anticoagulants (‘blood thinners’) (Elixophyllin, Theo-24, Theocron). Depending on whatever drugs you are taking, your doctor may need to adjust the dosage once you stop smoking.
• Inform your doctor if you’ve ever experienced withdrawal symptoms from quitting smoking, have epilepsy (seizures), have heart, blood vessel, or kidney illness, or if you’ve ever tried to quit smoking in the past.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while taking varenicline. If you are nursing while taking varenicline, keep a close eye out for seizures, vomiting, or more frequent spitting up in your infant. If your infant exhibits any of these signs, contact your doctor right once.
• You should be aware that varenicline may cause you to feel sleepy, lightheaded, pass out, or have trouble focusing. There have been accounts of people who were using varenicline getting into car accidents, having near-misses, and suffering other forms of injuries. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
• You should be aware that some persons who take varenicline have experienced behavioural changes, aggression, agitation, sad moods, and suicidal thoughts (thinking about harming or killing oneself or making plans to do so). While persons who stop smoking with or without medicine may experience changes in their mental health owing to nicotine withdrawal, it is unclear what function varenicline plays in creating these mood changes. Yet, some of these symptoms also appeared in patients who continued to smoke while taking varenicline. Some individuals had these symptoms as soon as they started using varenicline, while others did not until several weeks had passed or after discontinuing the medication. These symptoms have appeared in people who have no prior history of mental illness and have gotten worse in those who already did. Inform your doctor if you currently suffer from or have ever suffered from depression, bipolar disorder (a mood disorder characterised by swings between depressed and abnormally excited states), schizophrenia (a mental illness characterised by distorted or unusual thinking, loss of interest in life, and strong or inappropriate emotions), or any other mental illness. Stop using varenicline and contact your doctor right away if you suffer any of the following symptoms: suicidal ideas or behaviours; fresh or intensifying panic, anxiety, or depression crises; agitation; restlessness; violent or irrational behaviour; risky behaviour Hallucinations (seeing or hearing objects or voices that are not real), the impression that people are against you, confusion, or any other abrupt or unusual changes in behaviour, thinking, or mood are examples of mania (frenzied, unusually exuberant mood or discourse). Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help. Unless your symptoms disappear, your doctor will keep a careful eye on you.
• Inquire with your doctor if drinking alcohol is okay for you to do while taking varenicline. Alcohol’s effects may be enhanced by varenicline.
• See your physician for guidance and written materials to assist you in quitting smoking. If you receive guidance and help from your doctor, you have a higher chance of successfully quitting smoking while taking varenicline.

Keep eating normally unless your doctor instructs you otherwise.

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

Side effects from varenicline are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Nausea
• Constipation
• Diarrhea
• Gas
• Abdominal pain
• Vomiting
• Heartburn
• Negative aftertaste
• Mouth ache
• Greater or lesser appetite
• Toothache
• Difficulty sleeping or staying asleep
• Strange nightmares or dreams
• Headache
• Not enough energy
• Joint, muscular, or back pain
• Irregular cycles of menstruation

Some adverse effects may be severe. Stop using varenicline and seek emergency medical attention if you suffer any of the following symptoms or those noted in the SPECIAL PRECAUTIONS sections:

• Swelling in the hands, arms, feet, ankles, or lower legs; throat; tongue; lips; eyes; gums; and neck
• Hoarseness
• Breathing or swallowing challenges
• Rash
• Skin that is bloated, red, peeling, or blistering
• Mouthful of blisters
• Chest discomfort, pressure, or squeezing
• Discomfort or pain in the back, neck, jaw, or stomach, as well as one or both arms
• Breathing difficulty
• Sweating
• Chest pain together with nausea, vomiting, or lightheadedness
• Slow or challenging speech
• Abrupt numbness or weakness in a leg or arm, particularly on one side of the body
• Walking with calf pain
• Seizures
• Sleepwalking

In clinical investigations, those who used varenicline had a higher risk of suffering a heart attack, a stroke, or other major heart or blood vessel issues than those who did not take it. Smokers, however, are also more likely to experience these issues. If you currently have or have ever had heart or blood vessel problems, discuss with your doctor the risks and advantages of taking varenicline.

Further negative effects of varenicline are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Call 1-800-222-1222 to reach the poison control hotline in the event of an overdose. You can get information online at https://www.poisonhelp.org/help. Call emergency services at 911 right away if the sufferer has fallen, experienced a seizure, is having problems breathing, or cannot be roused.

Keep all of your doctor’s appointments.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.