NICORETTE*105 CHEWING GUM 2MG ME

NICORETTE 2 mg medicated chewing gum
NICORETTE 4 mg medicated chewing gum
NICORETTE 2 mg medicated chewing gum strong mint flavour
NICORETTE 4 mg medicated chewing gum strong mint flavour
Nicotine

What it is and what it is used for
NICORETTE is a chewing gum that contains nicotine and can help you stop smoking if you have decided to quit. This type of treatment is called nicotine replacement therapy (NRT).

Consult your doctor if you do not feel better or feel worse after 12 months of treatment.

What you need to know before taking this medicine
Do not use NICORETTE if:
• you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• you are a non-smoker;
• you have recently had a heart attack or stroke;
• you have chest pain that occurs even at rest (unstable or worsening angina, Prinzmetal's angina);
• you have a heart condition that affects your heart rate or rhythm (severe cardiac arrhythmia);
• you are pregnant;
• you are breastfeeding:
• you are under 18 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using NICORETTE if:
• you suffer from high blood pressure that is not controlled by medication;
• you have serious heart diseases (e.g., peripheral occlusive arterial disease, cerebrovascular disease, heart failure) or blood vessel diseases (vasospasms);
• you have serious kidney diseases;
• you have liver diseases (moderate or severe hepatic insufficiency);
• you have diabetes;
• your thyroid is overactive (uncontrolled hyperthyroidism);
• you have a tumour of the adrenal gland (phaeochromocytoma);
• you have a stomach or duodenal ulcer;
• you have an inflammation of the oesophagus (oesophagitis);
• you have a history of epilepsy or seizures.

Please note: if you have dentures, you may find it difficult to chew NICORETTE. The gums can stick to dentures and in rare cases damage them.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you notice any of the following during NICORETTE therapy:

Common side effects (may affect up to 1 in 10 people)
• excessive salivation, dry mouth, burning sensation or inflammation of the mouth (stomatitis), cough, hiccups, throat irritation;
• headache, altered taste (dysgeusia), altered sensation (paraesthesia);
• abdominal pain, indigestion (dyspepsia), intestinal gas (flatulence), nausea, vomiting, diarrhoea;
• fatigue.

Uncommon side effects (may affect up to 1 in 100 people)
• sweating, itching, appearance of skin lesions (rashes, urticaria);
• difficulty breathing (bronchospasm, dyspnoea, throat tightness), altered voice (dysphonia), stuffy nose (nasal congestion), sore throat, sneezing;
• awareness of heartbeat (palpitations) or fast heartbeat (tachycardia);
• belching, inflammation of the tongue (glossitis), blisters and exfoliation of the oral mucosa, altered sensation in the mouth (paraesthesia), jaw pain;
• abnormal dreams;
• malaise, fatigue (asthenia), chest pain and discomfort;
• redness, increased blood pressure.

Rare side effects (may affect up to 1 in 1000 people)
• difficulty swallowing, decreased sensation in the mouth (hypoesthesia), retching;

Side effects of unknown frequency (frequency cannot be estimated from the available clinical data)
• skin redness (erythema), swelling of the face, eyes, lips, throat (angioedema) with respiratory distress, possible signs of severe allergic reactions (anaphylactic reaction);
• mouth irritation, dry throat, feeling of thirst, stomach and intestinal problems, lip pain;
• blurred vision, increased tearing;
• anxiety, depression, muscle tension;
• seizures.

Side effects due to smoking cessation
Symptoms such as mood changes, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience, decreased heart rate (bradycardia), increased appetite or body weight, intense craving for cigarettes, dizziness and headache, painful oral ulcers, may be related to nicotine withdrawal.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.