Name
NICORETTE 10 mg/16 h semi-transparent transdermal patches
NICORETTE 15 mg/16 h semi-transparent transdermal patches
Nicotine


What it is and what it is used for
NICORETTE is a patch, which contains nicotine and can help you stop smoking if you have decided to stop.

This type of treatment is called nicotine replacement therapy (NRT). NICORETTE relieves nicotine withdrawal symptoms, including cravings, that you experience when you want to quit smoking.

When you suddenly stop smoking, your body no longer receives the nicotine previously provided by tobacco; this lack causes various types of unpleasant sensations, called withdrawal symptoms.
By using NICORETTE you can prevent or reduce these unpleasant sensations and the urge to smoke, because you continue to supply the body with a small amount of nicotine for a short period of time.
NICORETTE is not as dangerous to your health as tobacco, because it does not contain tar, carbon monoxide or other toxic agents from cigarette smoke.

Smokers of more than 10 cigarettes a day who have difficulty controlling the urge to smoke or who have not been able to stop smoking using Nicorette transdermal patches alone may combine these with Nicorette 2 mg chewing gum (all flavours) or Nicoretteicy 2mg lozenges.

To improve your chances of helping you stop smoking, combine treatment with NICORETTE with counselling and support therapy.


What you need to know before taking the medicine
Do not use NICORETTE:
• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have recently had a heart attack or stroke;
• if you have heart disease or suffer from high blood pressure;
• if you have an alteration in the rate or rhythm of your heart;
• if you have or have had blood circulation problems;
• if you have skin problems, for example lesions, on the skin where you want to apply the patch;
• in children and adolescents under 18 years of age.

Do not use NICORETTE if you are a non-smoker or an occasional smoker.


Warnings and precautions
Talk to your doctor or pharmacist before using NICORETTE if:
• has serious kidney disease;
• have liver disease (moderate or severe liver failure);
• has diabetes mellitus;
• has an overactive thyroid gland;
• has a tumor of the adrenal gland (pheochromocytoma);
• has a stomach or duodenal ulcer;
• have inflammation of the esophagus (esophagitis);
• has a history of epilepsy or seizures.

Please note :
• if you have to have an MRI scan, you must remove the patch before the exam to avoid the risk of burning your skin;
• STOP TREATMENT WITH NICORETTE if severe or persistent skin lesions appear.

Combination therapy
For warnings and precautions for use of the oral form chosen for combination therapy (Nicoretteicy 2mg lozenges or Nicorette 2mg chewing gum), please refer to the product information for that pharmaceutical form.

Children and adolescents under 18 years of age
Do not use NICORETTE in children and adolescents under 18 years of age.


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:

Very common side effects (may affect more than 1 in 10 people)
• itching.

Common side effects (may affect up to 1 in 10 people)
• headache, dizziness, difficulty falling asleep (insomnia);
• nausea, vomiting;
• appearance of skin lesions, such as spotty or widespread changes in colour (rashes, hives).

Uncommon side effects (may affect up to 1 in 100 people)
• increased sweating;
• alteration of sensitivity (paraesthesia);
• difficulty breathing (dyspnea);
• reaction at the site where you applied the patch;
• allergic reactions (hypersensitivity);
• abnormal dreams;
• malaise, fatigue, tiredness (asthenia), chest pain and discomfort, muscle pain;
• palpitations or fast heartbeat (tachycardia);
• redness, increased blood pressure.

Undesirable effects not known (frequency cannot be estimated from the available clinical data)
• convulsions

Other side effects
• redness of the skin (erythema), swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, possible signs of serious allergic reactions (anaphylactic reaction);
• stomach and intestinal disorders;
• pain in the legs and arms.

For side effects specific to the oral form chosen for combination therapy (Nicoretteicy 2mg lozenges or Nicorette 2mg chewing gum), please refer to the product information for that pharmaceutical form.

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, 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.