Victonex 0,5 mg/1 mg Film-Coated Tablets

VICTONEX is a medicine used to help you stop smoking, in addition to a behavioural modification programme. VICTONEX can help to relieve the craving and withdrawal symptoms associated with stopping smoking. It is recommended that you do not smoke while taking VICTONEX

VICTONEX should not be administered to you: • If you are hypersensitive (allergic) to varenicline or to any of the other ingredients of VICTONEX (listed in section 6). Warnings and precautions with VICTONEX Tell your doctor or health care provider before taking VICTONEX: Take special care should be taken with VICTONEX: • If you have kidney problems. Your doctor may prescribe a lower dose of VICTONEX for you. • If you have experienced depression or other mental health problems (e.g. schizophrenia, bipolar disorder). There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking VICTONEX. If you are taking VICTONEX 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 VICTONEX and contact your doctor immediately for treatment assessment. • If you have a history of seizures (fits). Some people have reported seizures while taking VICTONEX. • 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. Stop taking VICTONEX and tell your doctor immediately. • If you develop a rash or if your skin starts to peel or blister you should stop taking VICTONEX and seek emergency medical help. Potentially life-threatening skin rashes (Stevens-Johnson syndrome and Erythema Multiforme) have been reported with the use of VICTONEX. • If you have an existing heart condition, tell your doctor. 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 VICTONEX. Get emergency medical help right away if you have symptoms of a heart attack or stroke.

Do not share medicines prescribed for you with any other person. Always take VICTONEX exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Always take VICTONEX exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure. How much to take or give Choose the date to stop smoking. Start taking VICTONEX 1 - 2 weeks before this date. You can keep smoking during this time. You should be treated with VICTONEX for 12 weeks. The recommended dose of VICTONEX is 1 mg twice daily following a 1-week titration as follows: Day 1 -3: 0,5 mg once daily in the evening Day 4 -7 0,5 mg twice daily Day 8 -End of treatment: 1 mg twice daily

VICTONEX can have side effects Not all side effects reported for VICTONEX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VICTONEX, please consult your health care provider for advice. If any of the following happens, stop taking / using VICTONEX and tell your doctor immediately or go to the casualty department at your nearest hospital: • Itching or a rash • Difficulty breathing These are all very serious side effects. If you have them, you may have had a serious reaction to VICTONEX. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: • Increased heart rate • Abnormal heart rhythm • Chest pain • Feeling weak or unwell These are all serious side effects. You may need urgent medical attention.

Store at or below 25°C Protect from moisture Keep in original packaging until required for use. KEEP OUT OF REACH OF CHILDREN. Do not use after the expiry date stated on the label Return all unused medicine to your pharmacist Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).