CHAMPIX 1 mg. 28 tablets
CHAMPIX contains the active substance varenicline. CHAMPIX is a medicine used in adults to help them stop smoking.
CHAMPIX can help to relieve the symptoms of craving and withdrawal associated with stopping smoking.
Although it is not recommended to smoke after the date of cessation, CHAMPIX can also reduce the enjoyment of cigarettes if you smoke while on treatment. (Date of smoking cessation is the day in the second week of treatment when you will stop smoking, see Section 3.)
2. What you need to know before taking CHAMPIX?
Do not take CHAMPIX:
- If you are allergic to varenicline tartrate or any of the other ingredients of this medicine (listed in section 6) ..
Warnings and Precautions
Talk to your doctor or pharmacist before you take CHAMPIX
There have been reports of depression, suicidal thoughts, suicidal behavior and suicide attempts in patients taking CHAMPIX. If you are taking CHAMPIX and develop agitation,
depressed mood, changes in behavior that worry you, your family or doctor or if you have thoughts of suicide and suicidal behavior, you should stop the treatment and immediately contact your doctor.
The effects of stopping smoking
The effects of changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may alter the way other medicines work. For this reason, in some cases it may be necessary to adjust the dose. For further information see "Other medicines and CHAMPIX".
For some people stopping smoking, with or without treatment, is associated with an increased risk for the occurrence of changes in thinking or behavior, feelings of depression and anxiety and can be associated with a worsening of psychiatric illness. If you have a history of mental illness, you should discuss this with your doctor or pharmacist.
Depressed mood may appear during smoking cessation with or without treatment. Depression, rarely including suicidal thoughts and suicide attempts in patients undergoing attempt to stop smoking. These feelings are reported when trying to quit smoking with CHAMPIX. If these symptoms persist when you stop taking CHAMPIX, your doctor should continue to monitor you carefully until they disappear.
The occurrence of new or worsening heart and vascular (cardiovascular) problems mainly in people who already have. Tell your doctor if you have any changes in symptoms during treatment with CHAMPIX. Get medical attention immediately if you have symptoms of a heart attack or stroke.
Tell your doctor if you have experienced seizures or epilepsy before you start treatment with CHAMPIX. Some people have reported seizures while taking CHAMPIX.
Discontinuation of CHAMPIX
You may temporarily experience increased irritability, urge to smoke, depression and / or sleep disturbances when you stop taking CHAMPIX. Your doctor may decide to gradually lower your dose of CHAMPIX at the end of treatment.
Children and adolescents
CHAMPIX is not recommended for use in children or adolescents under 18 years since safety and efficacy have not yet been established in this age group.
Other medicines, CHAMPIX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may alter the way other medicines work. For this reason, in some cases you may need a dose adjustment. 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 are not sure, ask your doctor or pharmacist.
If you have severe kidney disease should avoid concomitant administration of cimetidine (a medicine to treat stomach problems) and CHAMPIX, as this can cause increases in blood CHAMPIX.
CHAMPIXs use of other means of smoking cessation The safety and benefits of taking CHAMPIX in combination with other medicines for stopping smoking have not been studied. For this reason, the use of CHAMPIX in combination with other smoking cessation is not recommended.
CHAMPIX with food and drink
CHAMPIX can be taken with or without food. Pregnancy and lactation
You should not take CHAMPIX while you are pregnant.
Tell your doctor if you plan to become pregnant. If you want to start treatment with CHAMPIX, your treatment should be timed so that you have completed the course before becoming pregnant.
Although no study has been done, CHAMPIX may pass into breast milk. You should consult with your doctor or pharmacist before taking CHAMPIX.
Driving and using machines
CHAMPIX may cause dizziness and drowsiness. Do not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medication affects your ability to perform such activities.
3. How to take CHAMPIX?
More likely to stop smoking if you are motivated to stop. Your doctor and pharmacist can provide advice, support and sources of further information to ensure success of your attempt to stop smoking.
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Before starting your course of CHAMPIX, usually you must specify the date of the second week of treatment (between day 8 and day 14) when you will stop smoking. If you do not want or can not specify a date within 2 weeks, you can choose your date within 5 weeks after starting treatment. You should write this date on the pack as a reminder.
CHAMPIX tablets should be swallowed whole with water.
CHAMPIX is in the form of white tablets (0.5 mg) and blue tablet (1 mg). You begin your treatment with the white tablet and then usually go to the blue tablet. Look at the table below for the usual dosing instructions which you should follow from Day 1.
Week 1 Dose
Day 1-3: From day 1 to day 3, you should take one white CHAMPIX tablet of 0,5 mg once daily.
Day 4-7: From day 4 to day 7, you should take one white CHAMPIX tablet of 0,5 mg twice daily, once in the morning and one in the evening, at about the same time each day.
Day 8-14: From day 8 to day 14, you should take one light blue tablet CHAMPIX 1 mg twice daily, once in the morning and one in the evening, at about the same time each day.
Day 15 - end of treatment From day 15 until the end of treatment, you should take one light blue tablet CHAMPIX 1 mg twice daily, once in the morning and one in the evening, at about the same time each day.
If you have kidney problems, you should consult with your doctor before taking CHAMPIX. You may need a lower dose.
If you experience side effects that you can not tolerate your doctor may decide to temporarily or permanently reduce your dose to 0,5 mg twice daily.
After 12 weeks of treatment if you have stopped smoking, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX tablets 1 mg twice daily.
In the treatment for smoking cessation, risk for relapse to smoking is elevated in the period immediately after the end of treatment. Your doctor may decide to gradually lower your dose of CHAMPIX at the end of treatment.
If you take more dose of CHAMPIX
If you accidentally take more CHAMPIX, than your doctor prescribed, you must seek medical advice or go to the nearest unit for medical emergencies. Take your box of tablets with you.
If you forget to take CHAMPIX
Do not take a double dose to make up for a forgotten tablet. More 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 remember. If it is almost time for your next dose, do not take the tablet that you have missed.
If you stop taking CHAMPIX
In clinical trials has been shown that taking all doses of your medicine at the appropriate times and for the recommended duration of treatment described above will increase your chances of stopping smoking. It is therefore important to keep taking CHAMPIX, according to the instructions described in the table above, unless your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Giving up smoking with or without treatment can cause various symptoms. They may include mood changes (such as feeling depressed, irritable, frustrated or anxious), sleeplessness, difficulty concentrating, decreased heart rate and increased appetite or weight gain.
If you are taking CHAMPIX and develop agitation, depressed mood, changes in behavior or suicidal thoughts you should stop treatment and contact your doctor immediately.
- Very common side effects which may affect more than 1 in 10 people are listed below:
- Difficulty sleeping, abnormal dreams
- Common side effects which may affect up to 1 in 10 people are listed below:
- Increased appetite, changes in taste, dry mouth
- Drowsiness, fatigue, dizziness
- Vomiting, constipation, diarrhea, feeling bloated, stomach discomfort, indigestion,
- Uncommon side effects which may affect up to 1 in 100 people are listed below:
- Infection of the lower respiratory tract, discomfort or pain, inflammation of the sinus
- Fever, feeling cold, feeling weak or unwell, viral infection, shortness of breath, cough, hoarseness, pain and throat irritation, congested sinuses, runny nose, snoring
- Loss of appetite, feeling thirsty, increased weight
- Depression, anxiety, hallucinations
- Feeling of panic, difficulty thinking, mood swings
- Fainting, tremor, difficulty with coordination, difficulty with speech, less sensitive to touch, increased muscle tension, restlessness
- Heart rhythm disturbances, increased blood pressure, increased heart rate
- Impaired vision, change in color of the eyeball, eye pain, dilated pupils, shortsightedness, sensitivity to light, watery eyes.
- Ringing in the ears
- Blood in vomit, irritated stomach and heartburn, abdominal pain, abnormal stools, red blood in stools, belching, mouth ulcers, pain in the gums, coated tongue
- Skin rash, cyst, fungal infection, reddening of the skin, itching, acne, increased sweating
- Pain in the chest and rib pain, stiff joints, muscle spasms
- Sugar in urine, increased urine volume and urinary frequency
- Increased menstrual flow, vaginal discharge, changes in sexual desire or opportunities
- Rare side effects which may affect up to 1 in 1000 people is stroke.
Other side effects have occurred in a small number of people trying to stop smoking with CHAMPIX, but their exact frequency is unknown: heart attack, changes in thinking or behavior (such as aggression and abnormal behavior), suicidal thoughts, diabetes, high blood sugar and sleepwalking. There are also reports of serious allergic reactions including angioedema (swelling of the face, mouth or throat) and skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson (serious illness with blistering of the skin, mouth, around the eyes and genitals). You should stop taking CHAMPIX and immediately contact your doctor if you experience swelling of the face, mouth or throat, or if your skin starts to peel or blister.
Adverse event reporting
If you get any side effects with your doctor or pharmacist. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system referred to in Annex V. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.
5. How to store CHAMPIX?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the card packaging or carton. The expiry date refers to the last day of that month.
Blisters: Store below 30 ° C.
Tablet container High density polyethylene (HDPE): Does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
- The active substance is respectively 0,5 mg varenicline and 1 mg varenicline
- The other ingredients are:
Tablet Core - CHAMPIX 0,5 mg and 1 mg film-coated tablets
- Microcrystalline cellulose
- Calcium phosphate dibasic anhydrous
- Croscarmellose sodium
- Silica colloidal anhydrous
- Magnesium stearate
Tablet film coating - CHAMPIX 0,5 mg film-coated tablets
- Titanium dioxide (E171)
Tablet film coating - CHAMPIX 1 mg film-coated tablets
- Titanium dioxide (E171)
- Indigo carmine aluminum lake (E132)
How does CHAMPIX and contents of the pack?
- CHAMPIX 0,5 mg film-coated tablets are white film coated, capsule shaped, marked "Pfizer" and "CHX 0.5"
- CHAMPIX tablets 1 mg film-coated tablets are light blue, capsule-shaped, marked "Pfizer" and "CHX 1.0"