NICORETTE*7 TRANSDERMAL PATCHES 10MG/16H

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 containing nicotine that can help you quit smoking if you have decided to stop.

This type of treatment is called nicotine replacement therapy (NRT). NICORETTE relieves nicotine withdrawal symptoms, including the urge to smoke, which occur when you want to quit smoking.

When you suddenly stop smoking, your body no longer receives the nicotine previously supplied 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 your body with a small amount of nicotine for a short period of time.
NICORETTE is not as dangerous for your health as tobacco, because it does not contain tar, carbon monoxide or other toxic agents found in cigarette smoke.

Smokers of more than 10 cigarettes a day who have difficulty controlling the urge to smoke or who have been unable to quit smoking using only Nicorette transdermal patches can combine them with Nicorette 2 mg chewing gum (all flavors) or Nicoretteicy 2mg lozenges.

To improve your chances of quitting smoking, combine NICORETTE treatment with counseling 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 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 heart rate or rhythm;
• if you have or have had blood circulation problems;
• if you have skin disorders, 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 not a smoker or if you are an occasional smoker.

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

Pay attention:
• if you need to have an MRI, you must remove the patch before the examination to avoid the risk of skin burns;
• STOP TREATMENT WITH NICORETTE if severe or persistent skin lesions appear.

Combination therapy
For warnings and precautions for use of the chosen oral form for combination therapy (Nicoretteicy 2mg lozenges or Nicorette 2mg chewing gum), 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 everyone gets them.

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

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, e.g. patchy or widespread color changes (rashes, hives).

Uncommon side effects (may affect up to 1 in 100 people)
• increased sweating;
• altered sensation (paresthesia);
• difficulty breathing (dyspnea);
• reaction at the application site of 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.

Side effects with unknown frequency (frequency cannot be estimated from available clinical data)
• seizures

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

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

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

Reporting of side effects
If you get any side effects, including those 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.