Ravoquix 0,5 mg Film-Coated Tablets

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

RAVOQUIX should not be administered to you: • If you are hypersensitive (allergic) to varenicline or to any of the other ingredients of RAVOQUIX (listed in section 6). Warnings and precautions with RAVOQUIX Tell your doctor or health care provider before taking RAVOQUIX: Take special care should be taken with RAVOQUIX: • If you have kidney problems. Your doctor may prescribe a lower dose of RAVOQUIX 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 RAVOQUIX. If you are taking RAVOQUIX 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 RAVOQUIX and contact your doctor immediately for treatment assessment. • If you have a history of seizures (fits). Some people have reported seizures while taking RAVOQUIX. • 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 RAVOQUIX and tell your doctor immediately. • If you develop a rash or if your skin starts to peel or blister you should stop taking RAVOQUIX and seek emergency medical help. Potentially life-threatening skin rashes (Stevens-Johnson syndrome and Erythema Multiforme) have been reported with the use of RAVOQUIX. • 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 RAVOQUIX. 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 RAVOQUIX exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Always take RAVOQUIX 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 RAVOQUIX 1 - 2 weeks before this date. You can keep smoking during this time. You should be treated with RAVOQUIX for 12 weeks. The recommended dose of RAVOQUIX 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

RAVOQUIX can have side effects Not all side effects reported for RAVOQUIX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RAVOQUIX, please consult your health care provider for advice. If any of the following happens, stop taking / using RAVOQUIX 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 RAVOQUIX. 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. Tell your doctor if you notice any of the following: Frequent side effects • Inflammation of the nasal passages and sinuses • Abnormal dreams • Difficulty sleeping • Headache • Nausea • Inflammation of the air passages (bronchitis) • Inflammation of the sinuses • Increased weight • Loss of appetite • Increased appetite • Sleepiness • Dizziness • Changes in the way things taste • Tremors • Lack of energy • Tight muscles • Slurred speech • Abnormal coordination • Difficulty breathing • Cough • Heartburn • Vomiting • Constipation • Diarrhoea • Feeling bloated • Abdominal pain • Toothache • Indigestion • Flatulence • Dry mouth • Stomach discomfort • Joint ache • Muscle ache • Skin rash • Itching • Joint pain • Muscle pain • Back pain • Chest pain • Tiredness • Abnormal liver laboratory tests Less frequent side effects • Fungal infection • Viral infection • Decreased blood cell count • Loss of appetite • Feeling thirsty • Feeling of panic • Difficulty thinking • Mood swings • Changes in sex drive • General uneasy feeling • Restlessness • Reduced sense of taste • Changes in sleep patterns • Chest pain • Palpitations • Increased heart rate • Abnormal heart rhythm • Abnormal electrocardiogram • Increased blood pressure • Hot flushes • Inflammation of the eye • Eye pain • Disturbed vision • Eyeball discolouration • Dilated pupils • Sensitivity to light • Short-sightedness • Watery eyes • Ringing in the ears • Inflammation of nose, sinuses and throat • Congestion • Difficulty in speaking • Runny nose • Throat irritation • Congested sinuses • Hoarseness • Throat pain • Snoring • Postnasal drip • Red blood in stools • Irritated stomach • Change in bowel habits • Burping • Mouth ulcers • Pain in the gums • Blood in vomit • Abnormal stools • Coated tongue • Reddening of the skin • Acne • Increased sweating • Sweating at night • Muscle spasms • Chest wall and rib pain • Stiff joints • Inflammation of the cartilage in the rib cage • Frequent daytime urination (passing water) • Increased urination at night • Glucose in urine • Increased urine volume • Increased menstrual flow • Vaginal discharge • Changes in sexual function • Chest discomfort • Flu-like illness • Fever • Feeling weak or unwell • Feeling cold • Cysts • Abnormal semen • Increased liver protein levels • Decreased blood calcium levels If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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).