Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
Do not take varenicline • 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 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.
Children and adolescents Varenicline is not recommended for use in paediatric patients as efficacy was not demonstrated.
Other medicines and varenicline 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.
Varenicline with food and drink 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.
Pregnancy and breast-feeding 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.
Driving and using machines 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.
Varenicline contains sodium 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 take more varenicline than you should 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.
If you forget to take varenicline 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.
If you stop taking varenicline 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).
• Very common: may affect more than 1 in 10 people: • Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache
• Nausea
• Common: may affect up to 1 in 10 people: • 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
• Uncommon: may affect up to 1 in 100 people: • Fungal infection, viral infection
• Feeling of panic, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations, changes in sex drive
• Seizure, tremor, feeling sluggish, less sensitive to touch
• Conjunctivitis, eye pain
• Ringing in the ears
• Angina, rapid heart rate, palpitations, increased heart rate
• Increased blood pressure, hot flush
• Inflammation of nose, sinuses and throat, congestion of nose, throat and chest, hoarseness, hay fever, throat irritation, congested sinuses, excess mucous from nose causing cough, runny nose
• Red blood in stools, irritated stomach, change of bowel habit, belching, mouth ulcers, pain in the gums
• Reddening of the skin, acne, increased sweating, night sweats
• Muscle spasms, chest wall pain
• Abnormally frequent urination, urination at night
• Increased menstrual flow
• Chest discomfort, flu like illness, fever, feeling weak or unwell
• High blood sugar
• Heart attack
• Suicidal thoughts
• Changes in thinking or behaviour (such as aggression)
• Rare: may affect up to 1 in 1,000 people • 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 heartbeat 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)
• Not known • Transient loss of consciousness
Reporting of side effects 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.
What varenicline contains • The active substance is varenicline: • Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate).
• Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
• The other ingredients are: • In the tablet core: • Low-substituted hydroxypropyl cellulose (LH-21)
• Dibasic calcium phosphate, anhydrous
• Magnesium stearate
• In the film-coating: • Hypromellose
• Hydroxypropylcellulose LF
• Triacetin
• Titanium dioxide (E171)
• Indigo carmine (E132) (1 mg film-coated tablets only)
What varenicline looks like and contents of the pack 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:
• in cartons of 25 tablets containing 11 x 0.5mg film-coated tablets in one blister strip and 14 x 1mg film-coated tablets in a second blister strip in aluminium/aluminium blister packs;
• in cartons of 53 tablets containing 11 x 0.5mg film-coated tablets in one blister strip and 42 x 1mg film-coated tablets in three blister strips in aluminium/aluminium blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Brancaster Pharma Limited
Church House
48 Church Street
Reigate
Surrey
RH2 0SN
United Kingdom
Manufacturer Cross Vetpharm Group UK Limited
Unit 2
Bryn Cefni
Llangefni
Anglesey
LL77 7XA
United Kingdom
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 .
Brancaster Pharma Limited
Address
Church House, 48 Church Street, Reigate, Surrey, RH2 0SN
Telephone
+44 (0)1737 243 407
Medical Information Direct Line
+44 (0)1737 243 407
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)1737 243 407
Stock Availability
+44 (0)1737 243 407
WWW
http://www.brancasterpharma.com
• Contact us
• Links
• Accessibility
• Legal and privacy notice
• Cookie notice
• Cookie Settings
• Glossary
• Site Maps
Delivered to you by
Varenicline 0.5 mg film-coated tablets comes as tablet containing 0.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Varenicline 0.5 mg film-coated tablets is varenicline tartrate.
Medicines with the same active substance, strength and form include: CHAMPIX 0.5 mg film-coated tablets (Maintenance Pack), Varenicline 0.5 mg film coated tablets, Varenicline 0.5 mg film-coated tablets. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Varenicline 0.5 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Varenicline is indicated for smoking cessation in adults.
Posology
The recommended dose is 1 mg varenicline twice daily following a 1-week titration as follows:
Days 1 – 3
0.5 mg once daily
Days 4 – 7
0.5 mg twice daily
Day 8 – end of treatment
1 mg twice daily
The patient should set a date to stop smoking. Varenicline dosing should usually start at 1-2 weeks before this date (see section 5.1). Patients should be treated with varenicline for 12 weeks.
For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with varenicline at 1 mg twice daily may be considered for the maintenance of abstinence (see section 5.1).
A gradual approach to quitting smoking with varenicline should be considered for patients who are not able or willing to quit abruptly. Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period. Patients should then continue taking varenicline for an additional 12 weeks for a total of 24 weeks of treatment (see section 5.1).
Patients who are motivated to quit and who did not succeed in stopping smoking during prior varenicline therapy, or who relapsed after treatment, may benefit from another quit attempt with varenicline (see section 5.1).
Patients who cannot tolerate adverse reactions of varenicline may have the dose lowered temporarily or permanently to 0.5 mg twice daily.
In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment. In patients with a high risk of relapse, dose tapering may be considered (see section 4.4).
Elderly
No dosage adjustment is necessary for elderly patients (see section 5.2). Because elderly patients are more likely to have decreased renal function, prescribers should consider the renal status of an elderly patient.
Renal impairment
No dosage adjustment is necessary for patients with mild (estimated creatinine clearance > 50 ml/min and ≤ 80 ml/min) to moderate (estimated creatinine clearance ≥ 30 ml/min and ≤ 50 ml/min) renal impairment.
For patients with moderate renal impairment who experience adverse reactions that are not tolerable, dosing may be reduced to 1 mg once daily.
For patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended dose of varenicline is 1 mg once daily. Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily. Based on insufficient clinical experience with varenicline in patients with end stage renal disease, treatment is not recommended in this patient population (see section 5.2).
Hepatic impairment
No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
Paediatric population
Varenicline is not recommended for use in paediatric patients because its efficacy in this population was not demonstrated (see sections 5.1 and 5.2).
Method of administration
Varenicline is for oral use and the tablets should be swallowed whole with water.
Varenicline can be taken with or without food.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Effect of smoking cessation
Physiological changes resulting from smoking cessation, with or without treatment with varenicline, may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin). As smoking induces CYP1A2, smoking cessation may result in an increase of plasma levels of CYP1A2 substrates.
Neuropsychiatric symptoms
Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with varenicline in the post-marketing experience.
A large randomised, double-blind, active and placebo-controlled study was conducted to compare the risk of serious neuropsychiatric events in patients with and without a history of psychiatric disorder treated for smoking cessation with varenicline, bupropion, nicotine replacement therapy patch (NRT) or placebo. The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in post-marketing experience.
The use of varenicline in patients with or without a history of psychiatric disorder was not associated with an increased risk of serious neuropsychiatric adverse events in the composite primary endpoint compared with placebo (see section 5.1 Pharmacodynamic properties – Study in Subjects with and without a History of Psychiatric Disorder).
Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal.
Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment. If serious neuropsychiatric symptoms occur whilst on varenicline treatment, patients should discontinue varenicline immediately and contact a healthcare professional for re-evaluation of treatment.
History of psychiatric disorders
Smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e.g. depression).
Varenicline smoking cessation studies have provided data in patients with a history of psychiatric disorders (see section 5.1).
In a smoking cessation clinical trial, neuropsychiatric adverse events were reported more frequently in patients with a history of psychiatric disorders compared to those without a history of psychiatric disorders, regardless of treatment (see section 5.1).
Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.
Seizures
In clinical trials and post-marketing experience there have been reports of seizures in patients with or without a history of seizures, treated with varenicline. Varenicline should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Treatment discontinuation
At the end of treatment, discontinuation of varenicline was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients. The prescriber should inform the patient accordingly and discuss or consider the need for dose tapering.
Cardiovascular events
Patients taking varenicline should be instructed to notify their doctor of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke (see section 5.1).
Hypersensitivity reactions
There have been post-marketing reports of hypersensitivity reactions including angioedema in patients treated with varenicline. Clinical signs included swelling of the face, mouth (tongue, lips, and gums), neck (throat and larynx) and extremities. There were rare reports of life-threatening angioedema requiring urgent medical attention due to respiratory compromise. Patients experiencing these symptoms should discontinue treatment with varenicline and contact a health care provider immediately.
Cutaneous reactions
There have also been post-marketing reports of rare but severe cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients using varenicline. As these skin reactions can be life threatening, patients should discontinue treatment at the first sign of rash or skin reaction and contact a healthcare provider immediately.
Excipient information
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
Based on varenicline characteristics and clinical experience to date, varenicline has no clinically meaningful drug interactions. No dosage adjustment of varenicline or co-administered medicinal products listed below is recommended.
In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Furthermore since metabolism of varenicline represents less than 10% of its clearance, active substances known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of varenicline (see section 5.2) and therefore a dose adjustment of varenicline would not be required.
In vitro studies demonstrate that varenicline does not inhibit human renal transport proteins at therapeutic concentrations. Therefore, active substances that are cleared by renal secretion (e.g., metformin - see below) are unlikely to be affected by varenicline.
Metformin
Varenicline did not affect the pharmacokinetics of metformin. Metformin had no effect on varenicline pharmacokinetics.
Cimetidine
Co-administration of cimetidine, with varenicline increased the systemic exposure of varenicline by 29% due to a reduction in varenicline renal clearance. No dosage adjustment is recommended based on concomitant cimetidine administration in subjects with normal renal function or in patients with mild to moderate renal impairment. In patients with severe renal impairment, the concomitant use of cimetidine and varenicline should be avoided.
Digoxin
Varenicline did not alter the steady-state pharmacokinetics of digoxin.
Warfarin
Varenicline did not alter the pharmacokinetics of warfarin. Prothrombin time (INR) was not affected by varenicline. Smoking cessation itself may result in changes to warfarin pharmacokinetics (see section 4.4).
Alcohol
There are limited clinical data on any potential interaction between alcohol and varenicline. There have been post marketing reports of increased intoxicating effects of alcohol in patients treated with varenicline. A causal relationship between these events and varenicline use has not been established.
Use with other therapies for smoking cessation
Bupropion
Varenicline did not alter the steady-state pharmacokinetics of bupropion.
Nicotine replacement therapy (NRT)
When varenicline and transdermal NRT were co-administered to smokers for 12 days, there was a statistically significant decrease in average systolic blood pressure (mean 2.6 mmHg) measured on the final day of the study. In this study, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone.
Safety and efficacy of varenicline in combination with other smoking cessation therapies have not been studied.
Pregnancy
A moderate amount of data on pregnant women indicated no malformative or foetal/neonatal toxicity of varenicline (see section 5.1).
Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of varenicline during pregnancy (see section 5.1).
Breast-feeding
It is unknown whether varenicline is excreted in human breast milk. Animal studies suggest that varenicline is excreted in breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with varenicline should be made taking into account the benefit of breast-feeding to the child and the benefit of varenicline therapy to the woman.
Fertility
There are no clinical data on the effects of varenicline on fertility.
Non-clinical data revealed no hazard for humans based on standard male and female fertility studies in the rat (see section 5.3).
Varenicline may have minor or moderate influence on the ability to drive and use machines. Varenicline may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability to drive and use machines. Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.
Summary of the safety profile
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. No attempt has been made in either the design or the analysis of the varenicline studies to distinguish between adverse reactions associated with study drug treatment or those possibly associated with nicotine withdrawal. Adverse drug reactions are 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 varenicline.
In patients treated with the recommended dose of 1 mg twice daily 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.
Tabulated summary of adverse reactions
In the table below all adverse reactions, which occurred at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000)). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class
Adverse Drug Reactions
Infections and infestations
Very common
Nasopharyngitis
Common
Bronchitis, sinusitis
Uncommon
Fungal infection, viral infection
Blood and lymphatic system disorders
Rare
Platelet count decreased
Metabolism and nutrition disorders
Common
Weight increased, decreased appetite, increased appetite
Uncommon
Hyperglycaemia
Rare
Diabetes mellitus, polydipsia
Psychiatric disorders
Very common
Abnormal dreams, insomnia
Uncommon
Suicidal ideation, aggression, panic reaction, thinking abnormal, restlessness, mood swings, depression*, anxiety*, hallucinations*, libido increased, libido decreased
Rare
Psychosis, somnambulism, abnormal behaviour, dysphoria, bradyphrenia
Nervous system disorders
Very common
Headache
Common
Somnolence, dizziness, dysgeusia
Uncommon
Seizure, tremor, lethargy, hypoaesthesia
Rare
Cerebrovascular accident, hypertonia, dysarthria, coordination abnormal, hypogeusia, circadian rhythm sleep disorder
Not known
Transient loss of consciousness
Eye disorders
Uncommon
Conjunctivitis, eye pain
Rare
Scotoma, scleral discolouration, mydriasis, photophobia, myopia, lacrimation increased
Ear and labyrinth disorders
Uncommon
Tinnitus
Cardiac disorders
Uncommon
Myocardial infarction, angina pectoris, tachycardia, palpitations, heart rate increased
Rare
Atrial fibrillation, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased
Vascular disorders
Uncommon
Blood pressure increased, hot flush
Respiratory, thoracic and mediastinal disorders
Common
Dyspnoea, cough
Uncommon
Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upper-airway cough syndrome, rhinorrhoea
Rare
Laryngeal pain, snoring
Gastrointestinal disorders
Very common
Nausea
Common
Gastrooesophageal reflux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth
Uncommon
Haematochezia, gastritis, change of bowel habit, eructation, aphthous stomatitis, gingival pain
Rare
Haematemesis, abnormal faeces, tongue coated
Skin and subcutaneous tissue disorders
Common
Rash, pruritus
Uncommon
Erythema, acne, hyperhidrosis, night sweats
Rare
Severe cutaneous reactions, including Stevens Johnson Syndrome and Erythema Multiforme, angioedema
Musculoskeletal and connective tissue disorders
Common
Arthralgia, myalgia, back pain
Uncommon
Muscle spasms, musculoskeletal chest pain
Rare
Joint stiffness, costochondritis
Renal and urinary disorders
Uncommon
Pollakiuria, nocturia
Rare
Glycosuria, polyuria
Reproductive system and breast disorders
Uncommon
Menorrhagia
Rare
Vaginal discharge, sexual dysfunction
General disorders and administration site conditions
Common
Chest pain, fatigue
Uncommon
Chest discomfort, influenza like illness, pyrexia, asthenia, malaise
Rare
Feeling cold, cyst
Investigations
Common
Liver function test abnormal
Rare
Semen analysis abnormal, C-reactive protein increased, blood calcium decreased
* Frequencies are estimated from a post-marketing, observational cohort study
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
No cases of overdose were reported in pre-marketing clinical trials.
In case of overdose, standard supportive measures should be instituted as required.
Varenicline has been shown to be dialyzed in patients with end stage renal disease (see section 5.2), however, there is no experience in dialysis following overdose.
Ask anything about Varenicline 0.5 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.