Champix Tablets

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.

You are 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 help ensure your attempt to stop smoking is successful.

Before starting your course of Champix you should usually decide on a date in the second week of treatment (between day 8 and day 14) when you will stop smoking. If you are not willing or able to set a target quit date within 2 weeks, you may choose your own target quit date within 5 weeks after starting treatment. You should write this date on the pack as a reminder.

The recommended dose is as follows:

Champix tablets should be swallowed whole with water and can be taken with or without food.

• Day 1-3: 0.5mg to be taken once daily
• Day 4-7: 0.5mg to be taken twice daily
• Day 8 onwards: 1mg twice a daily up to a total period of 12 weeks.

If you are not able or willing to quit smoking straight away, you should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period.

Treatment may be continued for up to 24 weeks following review and on the advice of your prescriber.

If you take more Champix than you should

If you accidentally take more Champix than your doctor prescribed, you must seek medical advice or go to the nearest hospital casualty department immediately. 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. 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 remember. If, it is within 3-4 hours before your next dose, do not take the tablet that you have missed.

If you stop taking Champix

It has been shown in clinical trials 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. Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking Champix, according to the instructions described in the table above.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects are temporary with continued treatment or disappeared when treatment is stopped.

Giving up smoking with or without treatment can cause various symptoms. These could include changes of mood (like feeling depressed, irritable, frustrated or anxious), sleeplessness, difficulty concentrating, decreased heart rate and increased appetite or weight gain.

Side Effects

Very Common

• Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache,
• Nausea

Common

• Chest infection, inflammation of the sinuses
• Increased weight, decreased appetite, increased appetite
• Sleepiness, dizziness, changes in the way things taste
• Shortness of breath, cough
• Heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Skin rash, itching
• Joint ache, muscle ache, back pain
• Chest pain, tiredness

Serious Side Effects

Rare

• Excessive thirst
• Feeling unwell or unhappy, slow thinking
• Stroke
• Increased muscle tension, difficulty with speech, difficulty with coordination, reduced sense of taste, altered sleep pattern
• Disturbed vision, eyeball discolouration, dilated pupils, sensitivity to light,
• shortsightedness, watery eyes
• Irregular heart beat or heart rhythm disturbances
• Throat pain, snoring
• Blood in vomit, abnormal stools, coated tongue
• Stiff joints, rib pain
• Glucose in urine, increased urine volume and frequency
• Vaginal discharge, changes in sexual ability
• Feeling cold, cyst
• Diabetes
• Sleep walking
• Loss of contact with reality and unable to think or judge clearly (psychosis)
• Abnormal behaviour
•  Severe skin reactions including Erythema Multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals)
• Serious allergic reactions including angioedema (swelling of the face, mouth, or throat)

You should be aware of the possible emergence of serious neuropsychiatric symptoms: agitation, depressed mood, or changes in behaviour during a quit attempt with or without Champix and you should contact a doctor or pharmacist if you experience such symptoms.

Serious side effects of either an uncommon or rare frequency have occurred in people attempting to quit smoking with Champix: seizure, stroke, heart attack, suicidal thoughts, loss of contact with reality and unable to think or judge clearly (psychosis), changes in thinking or behaviour (such as aggression and abnormal behaviour). There have also been reports of severe skin reactions including Erythema Multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals) and serious allergic reactions including angioedema (swelling of the face, mouth, or throat).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Warning & Precautions

Talk to your doctor or pharmacist before taking Champix.

There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking Champix. If you are taking Champix and develop agitation, depressed mood, changes in behaviour that are of concern to you or your family or if you develop suicidal thoughts or behaviours you should stop taking Champix and contact your doctor immediately for treatment assessment.

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. Therefore, in some cases an adjustment of the dose may be necessary.

For some people, stopping smoking with or without treatment has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety and can be associated with a worsening of psychiatric disorder. If you have a history of psychiatric disorder you should discuss this with your doctor.

Heart symptoms

New or worse heart or blood vessel (cardiovascular) problems have been reported primarily in people who already have cardiovascular problems. Tell your doctor if you have any changes in symptoms during treatment with Champix. Get emergency medical help right away if you have symptoms of a heart attack or stroke.

Seizures

Tell your doctor if you have experienced seizures or have epilepsy before your start Champix treatment. Some people have reported seizures while taking Champix.

Hypersensitivity reactions

Stop taking Champix and tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: swelling of the face, lips, tongue, gums, throat or body and/or difficulty breathing, wheezing.

Skin reactions

Potentially life-threatening skin rashes (Stevens-Johnson syndrome and Erythema Multiforme) have been reported with the use of Champix. If you develop a rash or if your skin starts to peel or blister you should stop taking Champix and seek emergency medical help.

Age Restrictions

Adults aged 18 years and above

Other Medicines and Conditions

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In some cases as a result of stopping smoking, with or without Champix, an adjustment of the dose 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 in doubt, you should consult your doctor or pharmacist.

If you have severe kidney disease you should avoid taking cimetidine (a medicine used for gastric problems) at the same time as Champix as this may cause increased blood levels of Champix.

Use of Champix with other therapies for smoking cessation

Consult your doctor before using Champix in combination with other smoking cessation therapies.

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 if Champix actually increases alcohol intoxication.

Driving and using machines

Champix may be linked with dizziness, sleepiness and transient loss of consciousness. You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

Pregnancy and Breastfeeding

This medicine is not suitable for use in pregnancy and breastfeeding.

Patient Information Leaflet

Initiation Pack https://www.medicines.org.uk/emc/files/pil.13451.pdf

Maintenance Pack https://www.medicines.org.uk/emc/files/pil.7944.pdf

Ingredients

• Active Ingredients: 0.5mg & 1mg varenicline
• Other Ingredients: 0.5mg & 1mg Tablet core: Cellulose, Microcrystalline, Calcium Hydrogen Phosphate Anhydrous, Croscarmellose, Sodium, Silica, Colloidal Anhydrous, Magnesium Stearate. 0.5mg Tablet Coating: Hypromellose, Titanium dioxide (E171), Macrogol 400, Triacetin. 1mg Tablet Coating: Hypromellose, Titanium dioxide (E171), Macrogol 400, Indigo Carmine Aluminium Lake (E132), Triacetin

Product Information

• Brand Name: Champix
• Route of Administration: Oral
• Legal Classification: Prescription Only Medication (POM)
• Strength: 0.5mg & 1mg
• Dosage From: Film-coated Tablet

Storage

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the card packaging or carton after EXP. The expiry date refers to the last day of that month.
• Blisters: Store below 30°C
• Bottle: This medicine does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Advice & Helpful Links

https://www.nhs.uk/better-health/quit-smoking/