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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 14.04.2022
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WHAT CHAMPIX IS AND WHAT IT IS USED FOR
CHAMPIX contains the active substance varenicline. CHAMPIX is a medicine used in adults to help them quit smoking.
CHAMPIX can help relieve anxiety and withdrawal syndrome associated with quitting smoking.
CHAMPIX can also reduce the pleasure of cigarettes if you smoke during treatment.
HOW TO TAKE CHAMPIX
Follow the instructions for administration of this medication is indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
You are more likely to quit smoking if you are motivated to do so. Your doctor or pharmacist can provide you with advice, support, and additional information to help ensure that your attempt to quit is successful.
Usually before you start your treatment with CHAMPIX should decide on a date during the second week of treatment (between Day 8 and day 14) when you will stop smoking. If you do not want or cannot set a quit date within those 2 weeks, you can choose your quit date within 5 weeks of starting treatment. You should write this date on the packaging as a reminder.
CHAMPIX is supplied as white tablets(0.5 mg) and light blue tablets (1 mg). It will start with white tablets and will normally switch to light blue. See below for the table with the usual administration instructions to follow from Day 1.
| Week 1 | Dose |
| Day 1-3 | From Day 1 to day 3, you should take one white film-coated tablet of CHAMPIX 0.5 mg once a day. |
| Day 4-7 | From Day 4 to day 7, you should take one white film-coated tablet of CHAMPIX 0.5 mg twice a day, once in the morning and once in the afternoon, at about the same time each day. |
| Week 2 | |
| Day 8 – 14 | From Day 8 to day 14, you should take one light blue film-coated tablet of CHAMPIX 1 mg twice a day, once in the morning and once in the afternoon, at about the same time each day. |
| Weeks 3 - 12 | |
| Day 15-end of treatment | From day 15 to the end of treatment, you should take one light blue film-coated tablet of CHAMPIX 1 mg twice a day, once in the morning and once in the afternoon, at about the same time each day. |
If you have stopped smoking after 12 weeks of treatment, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX 1 mg film-coated tablets twice daily to help you stop smoking again.
If you are unable or unwilling to stop smoking immediately, you should reduce tobacco use during the first 12 weeks of treatment and quit at the end of that treatment period. You should then continue to take CHAMPIX 1 mg film-coated tablets twice daily for another 12 weeks, for a total of 24 weeks of treatment.
If you experience side effects that you cannot tolerate, your doctor may decide to reduce the dose temporarily or permanently to 0.5 mg twice daily.
If you have kidney problems, you should consult your doctor before taking CHAMPIX. You may need a lower dose.
CHAMPIX is given by mouth.
Tablets should be swallowed whole with water or taken with or without food.
If you take more CHAMPIX than you should
If you have accidentally taken more CHAMPIX than your doctor prescribed, immediately consult your doctor or go to the nearest hospital. Take your box of tablets.
If you forget to take CHAMPIX
Do not take a double dose to make up for forgotten doses. It is important that you take CHAMPIX regularly at the same time each day. If you forget to take a dose, take it as soon as you can. However, if 3 to 4 hours are left for your next dose, do not take the forgotten tablet.
If you stop taking CHAMPIX
It has been shown in clinical trials that if you take all doses of your medicine at the right times and during the treatment period recommended and described above, you will increase your chances of quitting. Therefore, unless your doctor instructs you to stop treatment, it is important to continue taking CHAMPIX as described in the table above.
In smoking cessation therapy, the risk of re-smoking may be elevated in the period immediately following the end of treatment. Temporarily, when you stop taking CHAMPIX, you may experience increased irritability, need to smoke, depression, and/or sleep disorders. Your doctor may decide to gradually reduce your dose of CHAMPIX at the end of treatment.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
See also:
What is the most important information I should know about Champix 0.5mg+1mg?
Before using Champix 0.5mg+1mg, tell your doctor if you have heart disease, circulation problems, kidney disease, or a history of depression or mental illness.
You may choose from 2 ways to use Champix 0.5mg+1mg. Ask your doctor which of the following methods is best for you:
To improve your chances for successful smoking cessation, be sure to quit smoking on your planned quit date.
After you stop smoking, the doses of any medications you are using may need to be adjusted. Tell your doctor about all other medicines you use, especially insulin, blood thinners, or asthma medication.
Stop using this medication and call your doctor at once if you have: any mood or behavior changes, confusion, anxiety, panic attacks, hallucinations, extreme fear, or if you feel impulsive, agitated, aggressive, restless, hostile, depressed, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Champix 0.5mg+1mg may impair your thinking or reactions. You may also have mood or behavior changes when you quit smoking. Until you know how Champix 0.5mg+1mg and the smoking cessation process is going to affect you, be careful if you drive or do anything that requires you to be cautious and alert.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone suffers from them.
Quitting smoking with or without treatment can lead to various symptoms, including mood swings (such as feeling depressed, irritable, frustrated, or anxious), insomnia, difficulty concentrating, decreased heart rate, and increased appetite or weight gain.
You should be aware of the possible occurrence of severe neuropsychiatric symptoms, such as agitation, depressive mood, or changes in behavior during an attempt to quit smoking with or without CHAMPIX and should contact a doctor or pharmacist if you experience these symptoms.
We have produced serious adverse effects with little or rarely in people trying to quit smoking with CHAMPIX: seizures, stroke, heart attack, suicidal thoughts, loss of contact with reality and an inability to think or judge clearly (psychosis), changes in thinking or behavior (such as aggressive behavior and abnormal), sleepwalking, diabetes and high blood sugar levels. Serious skin reactions have also been reported, including erythema multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious condition with blisters on the skin, mouth and around the eyes and genitals) and serious allergic reactions including angioedema (swelling of the face, mouth or throat)
- Very common side effects: which may affect more than 1 in 10 people:
- Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache
- Morning sickness
- Common side effects: may affect up to 1 in 10 people:
- Chest infection, inflammation of the sinuses
- Weight gain, decreased appetite, increased appetite
- Sleep, dizziness, changes in the sense of taste
- Difficult breathing, cough
- Heartburn, vomiting, constipation, diarrhea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth
- Rash, itching
- Joint pain, myalgia, back pain
- Chest pain, tiredness
- Uncommon side effects: may affect up to 1 in 100 people:
- Fungal infection, virus infection
- Feeling panic, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations, changes in sex drive
- Convulsions, tremor, feeling faint, less sensitivity to touch
- Conjunctivitis, eye pain,
- Ringing in the ears
- Angina, rapid heart rate, palpitations, increased heart rate
- Increased blood pressure, heating
- Inflammation of the nose, sinuses and throat, stuffy nose, throat and chest, hoarseness, hay fever, throat irritation, congested sinuses, excess nasal mucus with cough production, rhinorrhea
- Red blood in the stool, irritated stomach, change of bowel habit, belching, mouth ulcers, gum pain
- Redness of the skin, acne, increased sweating, night sweats
- Muscle spasms, chest wall pain
- Abnormally frequent urination, nocturnal urination
- Increased menstrual flow
- Chest discomfort, flu-like illness, fever, feeling weak or unwell
- High blood sugar levels
- Heart attack
- Suicidal thoughts
- Changes in thinking or behavior (such as aggression)
- Rare side effects: may affect up to 1 in 1,000 people:
- Excessive thirst
- Indisposition or feeling unhappy, slow thinking
- Stroke
- Increased muscle tension, difficulty in speech, difficulty in coordination, decreased sense of taste, altered sleep pattern
- Visual disturbances, discoloration of the eyeball, dilated pupils, sensitivity to light, myopia, watery eyes
- Irregular heartbeat or heart rhythm disturbances
- Sore throat, snoring
- Blood in vomit, abnormal stool, saburral tongue
- Numb joints, pain in the ribs
- Urine glucose, increased urine volume and frequency
- Vaginal discharge, changes in sexual capacity
- Feeling cold, cyst
- Diabetes
- Sleepwalking
- Loss of contact with reality and inability to think or judge clearly (psychosis)
- Abnormal behavior
- Severe skin reactions including erythema multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious condition with blisters on the skin, mouth and around the eyes and genitals)
- Severe allergic reactions including angioedema (swelling of the face, mouth or throat)
- Frequency not known
- Transient loss of consciousness
Reporting of adverse effects
If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish system of Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information about the safety of this medicine.
BEFORE YOU TAKE CHAMPIX
Do not take CHAMPIX
- If you are allergic to varenicline or any of the other ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor or pharmacist before you start taking CHAMPIX.
Cases of depression, suicidal ideation and behaviour and attempted suicide have been reported in patients receiving CHAMPIX. If you are taking CHAMPIX and have agitation, depressive mood, behavioral changes that worry you or your family, or if you develop suicidal thoughts or behavior, you should stop taking CHAMPIX and contact your doctor immediately for treatment evaluation.
Effects of quitting smoking
The effects of changes in your body as a result of quitting smoking, with or without treatment with CHAMPIX, may alter the action of other medicines. Therefore, in some cases a dose adjustment may be necessary. See below for more details in " other medicines and CHAMPIX"”
Quitting smoking, with or without treatment, has been linked in some people to an increased risk of experiencing changes in thinking or behavior, feelings of depression and anxiety and may be associated with a worsening of a psychiatric disorder. If you have a history of psychiatric disorder you should discuss it with your doctor.
Heart symptoms
Worsening or new cases of heart or blood vessel (cardiovascular) problems have been reported mainly in people who already had cardiovascular problems. Tell your doctor if you have any change in symptoms during treatment with CHAMPIX. If you have symptoms of a heart attack or stroke, seek emergency medical help immediately.
Seizure
Before starting treatment with CHAMPIX, tell your doctor if you have had seizures or if you are epileptic. Some people have seen seizures during treatment with CHAMPIX.
Hypersensitivity reactions
Stop taking Champix and tell your doctor immediately if you have any of the following signs and symptoms that may indicate a serious allergic reaction: swelling of the face, lips, tongue, gums, throat or body, or shortness of breath, wheezing.
Skin reactions
Cases of life-threatening rash (Stevens-Johnson syndrome and erythema multiform) with the use of Champix. If you develop a rash, blisters or skin flaking, you should stop taking Champix and seek urgent medical attention.
Children and adolescents
The use of CHAMPIX in children or adolescents under 18 years of age is not recommended as safety and effectiveness have not been established in this age group.
Other medicines and CHAMPIX
Tell your doctor or pharmacist if you are using, have recently used or may need to use any other medicines.
In some cases, as a result of quitting smoking, with or without CHAMPIX, a dose adjustment of other medicines may be necessary. Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to reduce blood clotting) and insulin (a medicine to treat diabetes). If you have any questions, consult your doctor or pharmacist.
If you have severe kidney disease you should avoid taking cimetidine (a medicine for gastric problems) at the same time as CHAMPIX as this may cause increased blood levels of CHAMPIX.
Using CHAMPIX with other smoking cessation therapies
Consult your doctor before using CHAMPIX in combination with other smoking cessation therapies.
Using CHAMPIX with food and drink
There have been some reports of increased intoxicating effects of alcohol in patients taking CHAMPIX. However, it is not known whether CHAMPIX increases the effects of alcohol.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.
It is preferable to avoid using CHAMPIX while pregnant. Consult your doctor if you plan to become pregnant.
Although it has not been studied, CHAMPIX can pass into human breast milk. You should consult your doctor or pharmacist before taking CHAMPIX.
Driving and using machines
CHAMPIX can be associated with dizziness, drowsiness and transient loss of consciousness. You should not drive, operate complex machinery or perform any other potentially dangerous activity until you know if this medicine affects your ability to perform these activities.
See also:
What are the possible side effects of Champix 0.5mg+1mg?
Smoking cessation with or without treatment is associated with various symptoms. For example, dysphoric or depressed mood; insomnia, irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; decreased heart rate; increased appetite or weight gain have been reported in patients attempting to stop smoking. Smoking cessation, with or without pharmacotherapy, has also been associated with the exacerbation of underlying psychiatric illness. No attempt has been made in either the design or the analysis of the Champix 0.5mg+1mg studies to distinguish between adverse events associated with study drug treatment or those possibly associated with nicotine withdrawal.
Pre-marketing development clinical trials included approximately 4,000 patients treated with Champix 0.5mg+1mg for up to 1 year (average exposure 84 days). In general, when adverse reactions occurred, onset was in the first week of therapy; severity was generally mild to moderate and there were no differences by age, race or gender with regard to the incidence of adverse reactions.
In patients treated with the recommended dose of 1 mg BID following an initial titration period the adverse event most commonly reported was nausea (28.6%). In the majority of cases nausea occurred early in the treatment period, was mild to moderate in severity and seldom resulted in discontinuation.
The treatment discontinuation rate due to adverse events was 11.4% for Champix 0.5mg+1mg compared with 9.7% for placebo. In this group, the discontinuation rates for the most common adverse events in Champix 0.5mg+1mg treated patients were as follows: nausea (2.7% vs. 0.6% for placebo), headache (0.6% vs. 1.0% for placebo), insomnia (1.3% vs. 1.2% for placebo), and abnormal dreams (0.2% vs. 0.2% for placebo).
All adverse drug reactions (ADRs) listed in the table as follows are presented by the Medical Dictionary for Regulatory Activities (MedDRA, Version 16) System Organ Class (SOC), based on evaluation of data from pre-marketing phase 2-3 studies and updated based on pooled data from 18 placebo-controlled pre -and post-marketing studies, including approximately 5,000 patients treated with Champix 0.5mg+1mg. Within each category, the ADRs are presented in order of frequency, and then by decreasing order of clinical importance.
Post-Marketing Experience: The following adverse events have been reported during post-approval use of Champix 0.5mg+1mg. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been reports of depressed mood, agitation, changes in behavior or thinking, anxiety, psychosis, mood swings, aggressive behavior, suicidal ideation and suicide in patients attempting to quit smoking while taking Champix 0.5mg+1mg. Smoking cessation with or without treatment is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness. Not all patients in these reports had known pre-existing psychiatric illness and not all had discontinued smoking. The role of Champix 0.5mg+1mg in these reports is not known.
There have also been reports of hypersensitivity reactions, such as angioedema and of rare but severe cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients taking Champix 0.5mg+1mg.
Champix 0.5mg+1mg tartrate (Champix 0.5mg+1mg) 500 mcg film-coated tablet: Each film-coated tablet contains Varenicline tartrate equivalent to 500 mcg of Champix 0.5mg+1mg.
Champix 0.5mg+1mg tartrate (Champix 0.5mg+1mg) 1 mg film-coated tablet: Each film-coated tablet contains Varenicline tartrate equivalent to 1 mg of Champix 0.5mg+1mg.
Champix 0.5mg+1mg tartrate (Champix 0.5mg+1mg) film-coated tablets contain the active ingredient, Champix 0.5mg+1mg (as the tartrate salt), which is a partial agonist selective for α4β2 nicotinic acetylcholine receptor subtypes.
Champix 0.5mg+1mg, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h] benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water.
Champix 0.5mg+1mg tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3·C4H6O6.
However, we will provide data for each active ingredient