Name
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 stop. This type of treatment is called nicotine replacement therapy (NRT).

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


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


Warnings and precautions
Talk to your doctor or pharmacist before using NICORETTE if:
• suffers from high blood pressure that is not controlled by medication;
• have serious heart disease (e.g. peripheral occlusive arterial disease, cerebrovascular disease, heart failure) or blood vessel disease (vasospasm);
• has serious kidney disease;
• have liver disease (moderate or severe liver failure);
• has diabetes;
• your thyroid is overactive (uncontrolled hyperthyroidism);
• has a tumor of the adrenal gland (pheochromocytoma);
• has a stomach or duodenal ulcer;
• has inflammation of the esophagus (esophagitis);
• has a history of epilepsy or seizures.

Please note : If you have dentures, you may have difficulty chewing NICORETTE. Gum 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 during treatment with NICORETTE:

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

Uncommon side effects (may affect up to 1 in 100 people)
• sweating, itching, appearance of skin lesions (rashes, hives);
• difficulty breathing (bronchospasm, dyspnoea, throat tightness), voice alteration (dysphonia), sensation of blocked nose (nasal congestion), sore throat, sneezing;
• awareness of heartbeat (palpitations) or fast heartbeat (tachycardia);
• belching, inflammation of the tongue (glossitis), blistering and peeling of the mucous membrane of the mouth, changes in sensation in the mouth (paraesthesia), pain in the jaw;
• abnormal dreams;
• malaise, tiredness (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;

Undesirable effects of unknown frequency (frequency cannot be estimated from the available clinical data)
• redness of the skin (erythema), swelling of the face, eyes, lips, throat (angioedema) with difficulty breathing, possible signs of serious allergic reactions (anaphylactic reaction);
• mouth irritation, dry throat, feeling of thirst, stomach and intestinal disturbances, sore lips;
• blurred vision, increased tear production;
• anxiety, depression, muscle tension;
• convulsions.

Side effects due to smoking cessation
Symptoms such as mood changes, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience, slow heartbeat (bradycardia), increased appetite or weight gain, intense desire to smoke, dizziness and headache, painful ulcers in the mouth, may be related to nicotine withdrawal.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.