NICORETTE 2 MG MEDICATED CHEWING GUMS 105 GUMS

Name
NICORETTE 2 mg medicated chewing gum
NICORETTE 4 mg medicated chewing gum
NICORETTE 2 mg medicated chewing gum, strong mint flavor
NICORETTE 4 mg medicated chewing gum, strong mint flavor
Nicotine


What is it and what is it for?
NICORETTE is a chewing gum that contains nicotine and can help you quit smoking if you've decided to quit. 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 to any of the other ingredients of this medicine (listed in section 6);
• is a non-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. The gum can stick to the 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 rapid heartbeat (tachycardia);
• belching, inflammation of the tongue (glossitis), blisters 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 1,000 people)
• difficulty swallowing, decreased sensation in the mouth (hypoesthesia), retching;

Side 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 tearing;
• anxiety, depression, muscle tension;
• convulsions.

Side effects of quitting smoking
Symptoms such as mood swings, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience, slow heartbeat (bradycardia), increased appetite or weight gain, intense cravings, dizziness and headaches, and painful mouth ulcers may be related to nicotine withdrawal.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to 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.