DO NOT use the patches if you: • are allergic to nicotine or to any of the other ingredients in the patches  • are a non-smoker or occasional smoker • have a skin disease that might be aggravated by the patches • are under 12 years of age, except on the advice of a doctor.

Take special care with Nicotinell Patches Before using the patches, tell your doctor, nurse or pharmacist if you: • have heart disease (including heart attack, worsening chest pain, disorders of heart rate and/ or rhythm), uncontrolled high blood pressure or stroke for which you are in hospital.

Using nicotine replacement therapy is better than continuing to smoke • have serious liver or kidney problems • have ever had a stomach ulcer • are diabetic (see “Taking other medicines”) • have an overactive thyroid gland • have a tumour of the adrenal gland (phaeochromocytoma) • are taking any other medicines  • are pregnant or breast-feeding .

Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effect of some medicines can be altered when you stop smoking. • If you are already taking regular medication you should tell your doctor, nurse or pharmacist, • Diabetics should monitor their blood sugar levels more often than usual when starting to use a patch because insulin/medication requirements may alter.

Pregnancy Smoking during pregnancy is associated with risks such as poor growth of the baby before birth, premature birth or still birth. Stopping smoking is the single most effective way to improve both your health and that of your baby. The earlier smoking stops, the better. Ideally, stopping smoking during pregnancy should be done without nicotine replacement therapy. However, if you have tried and this is not possible, nicotine replacement therapy may be used because the risk to the developing baby is less than that expected from continued smoking. The decision to use nicotine replacement therapy should be made as early on in the pregnancy as possible with the aim of discontinuing use after 2–3 months. Patches may be preferred if you have nausea or sickness. If patches are used, they should be removed before going to bed at night. Ask your doctor for advice before taking any medicine

. Breast-feeding It is better to use nicotine replacement therapy products that can be taken intermittently (not patches). Try to breast-feed at a time just before you take the product to ensure that the baby gets the smallest amount of nicotine possible. If you need to use nicotine replacement therapy to help you give up smoking, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the secondhand smoke they would otherwise be breathing in.

Driving and using machines These patches are unlikely to affect your ability to drive or operate machinery. Nicotinell Patches contain Aluminium Remove the patch before a medical scan or cardiac procedure to regulate your heart rate as aluminium is present in one of the layers of the patch.

Like all medicines, Nicotinell Patches can cause side effects, although not everybody gets them. STOP using the patches and seek medical help immediately if you have any of the following allergic reactions: • difficulty breathing or swallowing, swelling of the face, lips, tongue or throat. • severe itching of the skin, with a red rash or raised lumps. Some side effects are very common (may affect more than 1 in 10 people) • application site reactions such as itching, redness, oedema (becoming swollen) and burning sensation where the patch is placed In the event of a severe skin reaction which will not go away, you should stop treatment and consult your doctor or pharmacist to find another form of nicotine replacement therapy. These effects are usually caused by not changing the site of application each day. Changing the site each day will allow any irritation to disappear naturally and cause you very little discomfort.

Some side effects are common (may affect between 1 and 10 in every 100 people) • agitation, anxiety, nervousness, difficulty sleeping, abnormal dreams • headache, dizziness or disorder in muscle condition • cough • nausea, abdominal pain or indigestion • muscle discomfort or arthritis These effects are often mild and will wear off naturally and rapidly once you have removed the patch Some side effects are uncommon (may affect between 1 and 10 in every 1000 people) • disturbance in attention, sleepiness, mood changes, irritability, depressed mood or confusional state • tingling or numbness, changes in taste or blurred vision • palpitations (feeling of heartbeats) • high blood pressure or hot flushes • chest infections • vomiting, constipation, diarrhoea, flatulence or dry mouth • excessive sweating • joint pain, muscle cramp or back pain • feeling of weakness, pain or discomfort

Some side effects are rare (may affect between 1 and 10 in every 10,000 people) • tremor • chest pain, shortness of breath or irregular heart beat • skin discolouration or inflammation of blood vessels often with skin rash Mouth ulcers may be related to stopping smoking and not to your treatment.

What Nicotinell Patches contain • The active substance is nicotine. • Nicotinell TTS 30 (Step 1) patches contain 52.5mg of nicotine and deliver on average 21mg of nicotine over 24 hours. • Nicotinell TTS 20 (Step 2) patches contain 35mg of nicotine and deliver on average 14mg of nicotine over 24 hours. • Nicotinell TTS 10 (Step 3) patches contain 17.5mg of nicotine and deliver on average 7mg of nicotine over 24 hours.

The other ingredients are: acrylate esters vinylacetate, copolymers, fractionated coconut oil, methacrylic acid esters co-polymers, aluminised and siliconised polyester films