NICORETTE*105 CHEWING GUM 4MG 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 quit smoking if you have decided to do so. 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 the medicine
Do not use NICORETTE if:
• you are allergic to the active substance or any of the other ingredients of this medicine (listed in paragraph 6);
• you are not a smoker;
• you have recently had a heart attack or stroke;
• you have chest pain that occurs even at rest (unstable or aggravated angina, Prinzmetal's angina);
• you have a heart condition that affects the 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 severe heart diseases (e.g., peripheral occlusive arterial disease, cerebrovascular conditions, heart failure) or blood vessel diseases (vasospasms);
• you have severe 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 inflammation of the oesophagus (oesophagitis);
• you have a history of epilepsy or seizures.

Please note: if you have dentures, you may have difficulty chewing NICORETTE. The gums may 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.

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

Common side effects (may affect up to 1 in 10 people)
• hypersalivation, 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, hives);
• difficulty breathing (bronchospasm, dyspnoea, throat tightness), altered voice (dysphonia), stuffy nose sensation (nasal congestion), sore throat, sneezing;
• sensation of heartbeat (palpitations) or fast heartbeat (tachycardia);
• belching, inflammation of the tongue (glossitis), blisters and exfoliation of the oral mucosa, altered mouth sensitivity (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 mouth sensitivity (hypoesthesia), retching;

Side effects with unknown frequency (frequency cannot be estimated from the available clinical data)
• skin redness (erythema), swelling of the face, eyes, lips, throat (angioedema) with difficulty breathing, possible signs of severe allergic reactions (anaphylactic reaction);
• mouth irritation, dry throat, feeling thirsty, stomach and intestinal discomfort, 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 smoking, dizziness and headache, painful ulcers in the oral cavity, 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.