Patient Leaflet Updated 08-Dec-2025 | Brancaster Pharma Limited
Varenicline 0.5 mg + 1 mg film-coated tablets
Varenicline 0.5 mg film-coated tablets
Varenicline 1 mg film-coated tablets
Varenicline 0.5 mg + 1 mg film-coated tablets (initiation pack)
1. What varenicline is and what it is used for
2. What you need to know before you take varenicline
3. How to take varenicline
4. Possible side effects
5. How to store varenicline
6. Contents of the pack and other information
Varenicline film-coated tablets contain the active substance varenicline. Varenicline is a medicine which is used in adults to help them stop smoking.
Varenicline can help to relieve the craving and withdrawal symptoms associated with stopping smoking.
Varenicline can also reduce the enjoyment of cigarettes if you do smoke when on treatment.
Talk to your doctor or pharmacist before taking varenicline.
There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking varenicline. If you are taking varenicline 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 varenicline 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 varenicline, may alter the way other medicines work. Therefore, in some cases an adjustment of the dose may be necessary. See below under ‘Other medicines and varenicline’ for further details.
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 varenicline. 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 you start varenicline treatment. Some people have reported seizures while taking varenicline.
Hypersensitivity reactions
Stop taking varenicline 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 varenicline. If you develop a rash or if your skin starts to peel or blister you should stop taking varenicline and seek emergency medical help.
Varenicline is not recommended for use in paediatric patients as efficacy was not demonstrated.
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 varenicline, 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 varenicline as this may cause increased blood levels of varenicline.
Use of varenicline with other therapies for smoking cessation
Consult your doctor before using varenicline in combination with other smoking cessation therapies.
There have been some reports of increased intoxicating effects of alcohol in patients taking varenicline. However, it is not known if varenicline actually increases alcohol intoxication.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is preferable to avoid the use of varenicline while you are pregnant. Talk to your doctor if you are intending to become pregnant.
Although it was not studied, varenicline may pass into breast milk. You should ask your doctor or pharmacist for advice before taking varenicline.
Varenicline 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.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 varenicline 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.
Varenicline comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the light blue tablet. See the chart 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 varenicline 0.5 mg film-coated tablet once a day.
Day 4 – 7 From day 4 to day 7, you should take one white varenicline 0.5 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Week 2
Day 8 – 14 From day 8 to day 14, you should take one light blue varenicline 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Weeks 3 – 12
Day 15 – end of treatment From day 15 until the end of treatment, you should take one light blue varenicline 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12 weeks of treatment with varenicline 1 mg film-coated tablets twice daily to help avoid returning back to smoking.
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. You should then continue to take varenicline 1 mg film-coated tablets twice daily for a further 12 weeks resulting in a total of 24 weeks of treatment.
Should you experience adverse effects that you cannot tolerate, your doctor may decide to reduce your dose temporarily or permanently to 0.5 mg twice daily.
If you have problems with your kidneys, you should speak to your doctor before taking varenicline. You may need a lower dose.
Varenicline is for oral use.
The tablets should be swallowed whole with water and can be taken with or without food.
If you accidentally take more varenicline 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.
Do not take a double dose to make up for a forgotten tablet. It is important that you take varenicline 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.
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 varenicline, according to the instructions described in the table above.
In smoking cessation therapy, risk of returning to smoking may be elevated in the period immediately following the end of treatment. You may temporarily experience increased irritability, urge to smoke, depression and/or sleep disturbances when you stop taking varenicline. Your doctor may decide to gradually lower your dose of varenicline at the end of treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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. 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.
You should be aware of the possible emergence of serious neuropsychiatric symptoms, such as agitation, depressed mood, or changes in behaviour during a quit attempt with or without varenicline 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 varenicline: 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, pharmacist or nurse. 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.
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 outer carton and blister foil. The expiry date refers to the last day of that month.
This medicinal product 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.
Varenicline 0.5 mg film-coated tablets are white coloured, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “0.5” on the other side.
Varenicline 1 mg film-coated tablets are blue coloured, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “1” on the other side.
Varenicline 0.5 mg film-coated tablets are available in cartons of 56 x 0.5 mg film-coated tablets in aluminium/aluminium blister packs.
Varenicline 1 mg film-coated tablets are available in cartons of 56 x 1 mg film-coated tablets in aluminium/aluminium blister packs.
Varenicline 0.5 mg + 1 mg film-coated tablets (initiation pack) are available:
Not all pack sizes may be marketed.
This leaflet was last revised in 10-2024.
Detailed information on this medicine is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) website: http://www.mhra.gov.uk.
Church House, 48 Church Street, Reigate, Surrey, RH2 0SN
+44 (0)1737 243 407
+44 (0)1737 243 407
http://www.brancasterpharma.com
+44 (0)1737 243 407
+44 (0)1737 243 407
