What it is and what it is used for

for The name of your medicine is Varenicline 0.5 mg and 1 mg film-coated tablets (called Varenicline throughout this leaflet). Varenicline contains 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.

What you need to know before you take it

e Varenicline 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, pharmacist or nurse 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.

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 your 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, pharmacist or nurse 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, pharmacist or nurse. 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

Day 4 – 7

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.

Week 2 Day 8 – 14

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, pharmacist or nurse 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, pharmacist or nurse 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 film-coated tablet that is to say essentially 'sodium-free'.

How to take it

Varenicline Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. You are more likely to stop smoking if you are motivated to stop. Your doctor, pharmacist or nurse 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 light 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 Day 1 – 3

Dose From day 1 to day 3, you should take one white Varenicline 0.5 mg filmcoated tablet once a day.

Weeks 3 – 12 Day 15

• End of treatment

From day 4 to day 7, you should take one white Varenicline 0.5 mg filmcoated tablet twice daily, once in the morning and once in the evening, at about the same time each day. Dose From day 8 to day 14, you should take one light blue Varenicline 1 mg filmcoated tablet twice daily, once in the morning and once in the evening, at about the same time each day. Dose 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 filmcoated 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 filmcoated 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, pharmacist or nurse. 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. 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, pharmacist or nurse 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 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 StevensJohnson 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 frequency cannot be estimated from the available data
• 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

Possible side effects

, you can help provide more information on the safety of this medicine.

How to store it

Varenicline 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 blister and the carton after 'EXP'. The expiry date refers to the last day of that month. Do not store above 30 °C.

Packed into OPA/Alu/PVC-Alu blister and PVC/PCTFE-Alu blisters. Pack sizes: Maintenance packs: Varenicline 0.5 mg: 28, 56 film-coated tablets. Varenicline 1 mg: 28, 56, 112 film-coated tablets. Initiation packs: 11 film-coated tablets of Varenicline 0.5 mg and 14 film-coated tablets of Varenicline 1 mg. 11 film-coated tablets of Varenicline 0.5 mg and 42 film-coated tablets of Varenicline 1 mg. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Manufacturer apis labor GmbH Resslstraβe 9 9065 Ebenthal in Kärnten Austria This leaflet was last revised in March 2024

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.

Contents of the pack and other information

What Varenicline contains The active substance is varenicline.

• Each 0.5 mg film-coated tablet contains varenicline tartrate equivalent to 0.5 mg of varenicline.
• Each 1 mg film-coated tablet contains varenicline tartrate equivalent to 1 mg of varenicline. The other ingredients are: Tablet core: cellulose, microcrystalline (E460); calcium hydrogen phosphate, anhydrous; hyprolose (E463); croscarmellose sodium (E468); silica, colloidal anhydrous; magnesium stearate (E572). Tablet coating: hypromellose (E464), titanium dioxide (E171), triacetin, for Varenicline 1 mg film-coated tablets indigo carmine AL (E132). What Varenicline looks like and contents of the pack Varenicline 0.5 mg film-coated tablets: White to off-white coloured, capsule shaped, biconvex film-coated tablets debossed with "S47" on one side and plain on the other side with dimensions approx. 8 x 4 mm. Varenicline 1 mg film-coated tablets: Light blue coloured, capsule shaped, biconvex film-coated tablets debossed with "S48" on one side and plain on the other side with dimensions approx. 10 x 5 mm.

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