NIQUITINMINT*60PAST 2MG

Niquitinmint 2 mg lozenges
Nicotine

What it is and what it is used for
Niquitinmint is used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT.

Niquitinmint 2 mg is indicated for smokers who smoke 20 cigarettes or less per day.

Niquitinmint can help you stop smoking abruptly or gradually. If you think you can stop smoking abruptly, you should do so because it is the best approach. However, if you think this is too big a step, you should reduce the amount of cigarettes as a first step and then stop smoking completely. See section 3 How to use Niquitinmint for more details.

It is the nicotine in cigarettes that can make you physically dependent on them:
• Niquitinmint helps you stop smoking by replacing some of the nicotine you normally absorb from cigarettes;
• Nicotine relieves some unpleasant symptoms that smokers may experience when trying to quit, including feeling unwell or irritable;
• Nicotine can also relieve cigarette cravings and help you resist the urge to smoke.

Niquitinmint does not carry the health risks associated with tobacco, as it does not contain tar, carbon monoxide or other toxins present in cigarette smoke. Some people fear that after quitting smoking, they may become dependent on nicotine lozenges instead. This is very rare, and if it does occur, it would still be less harmful than continuing to smoke. It is also an easier habit to break.
If you participate in a support program, you will increase your chances of quitting smoking. Such smoking cessation programs are known as behavioural support. For information on smoking cessation programs, contact your doctor or pharmacist.

Smoking has no health benefits. It is always better to quit smoking. The use of Nicotine Replacement Therapy (NRT) for example with Niquitinmint, can help you. In general, any possible side effects associated with NRT are far less than the well-known risks associated with smoking.

What you need to know before taking the medicine
Do not use Niquitinmint:
- if you are allergic (hypersensitive) to nicotine or any of the other ingredients of this medicine (listed in section 6);
- if you are a non-smoker;
- if you are under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Niquitinmint If you have recently had a heart attack or a stroke, or if you suffer from severe heart rhythm problems, unstable or worsening angina (chest pain) or angina at rest, you should try to stop smoking without the aid of NRT unless advised by your doctor.
• If you suffer from diabetes, when you start using Niquitinmint you should check your blood sugar levels more frequently than usual. It may be necessary to change the amount of insulin or medication.
• If you have a medical history of epilepsy (seizures).
• If you have had allergic reactions with swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria). The use of NRT can sometimes trigger these types of reactions.

Do not alternate Niquitinmint with nicotine gum when trying to quit smoking.

If you are pregnant or breastfeeding, it is best to quit smoking without the use of NRT. However, it is better to quit smoking using NRT than to continue smoking (see the section on pregnancy and breastfeeding for more information).

Ask your doctor for advice and help in the following cases:
• If you have heart or circulation problems or blood pressure problems, including heart failure, stable angina, hypertension or peripheral arterial occlusive disease.
• If you suffer from severe or moderate liver problems or severe kidney problems as you may be more easily exposed to side effects.
• If you suffer from uncontrolled overactive thyroid or phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) - your doctor will have already told you about this - as nicotine can worsen symptoms.
• If you suffer from gastric or duodenal ulcer or inflammation of the oesophagus (the passage between the mouth and the stomach), because the ingestion of nicotine can exacerbate the symptoms. It can also cause mouth ulcers. If symptoms worsen, consult your doctor. It may be preferable to use a non-oral form of NRT, such as patches.
• If you have had convulsions (seizures).
• If you have any doubt of becoming dependent or if you think you have become dependent on this product.

Children and adolescents
This medicine should not be used by children under 12 years of age as it can cause severe poisoning or be fatal for children. It is therefore essential to always keep Niquitinmint out of the sight and reach of children.

Possible side effects
Like all medicines, Niquitinmint can cause side effects, although not everyone gets them. At recommended doses, Niquitinmint has not caused serious side effects.
Stop using this medicine and consult a doctor immediately if you have the following symptoms:
- Allergic reactions, tremor, angioedema (swelling of the skin or mucous membranes, face, tongue and throat causing breathing difficulties), dyspnoea (shortness of breath).

Quitting smoking itself can lead to certain symptoms such as dizziness, headache, sleep disturbances, cough and cold-like symptoms.
Symptoms such as depression, irritability, anxiety, restlessness, increased appetite and insomnia may be associated with withdrawal symptoms resulting from smoking cessation.

Other side effects are listed below, grouped according to the likelihood with which they may occur.

Very common (may affect more than 1 in 10 people)
• Nausea

Common (may affect up to 1 in 10 people)
• Sore throat
• Dry mouth
• Pain or irritation and ulceration of the mouth or tongue
• Vomiting
• Stomach upsets
• Diarrhoea
• Constipation
• Digestive difficulties/heartburn
• Belching
• Flatulence
• Hiccups
• Pharyngitis
• Increased appetite
• Difficulty sleeping, abnormal dreams
• Anxiety
• Irritability
• Restlessness
• Headache
• Dizziness
• Cough

Uncommon (may affect up to 1 in 100 people)
• Nervousness
• Depression
• Sleep disturbances
• Nocturia (frequent urination during the night)
• Variable mood
• Appetite disturbances
• Altered taste (dysgeusia)
• Palpitations (you feel your heart beating)
• Increased heart rate
• Chest pain
• Rash
• Pain, leg pain
• Swelling in the legs
• Vascular disease
• Itching or rash, swelling of the skin or mucous membranes, skin redness, increased sweating
• Tightness in the throat
• Worsening of asthma
• Irritation of the nose and throat
• Nasal congestion
• Respiratory infections
• Nosebleeds
• Dry lips, dry throat
• Toothache and jaw pain
• Oral paraesthesia (numbness or tingling of the mouth)
• Bleeding gums
• Indigestion
• Dysphagia (difficulty swallowing)
• Stomach ulcer
• Hiatal hernia
• Acid regurgitation
• Gastric and oesophageal irritation
• Abnormal gastrointestinal sounds
• Overdose symptoms

Very rare (may affect up to 1 in 10,000 people)
• Symptoms of severe allergic reaction including sudden wheezing or chest tightness, rash and feeling faint.

Not known (frequency cannot be estimated from the available data)
• Seizures (convulsions)
• Increased salivation
• Fatigue and general feeling of unwellness
• Flu-like illness (flu-like symptoms)
• Hypersensitivity
• Angioedema (swelling of the skin or mucous membranes, face, tongue and throat causing breathing difficulties)
• Tremor
• Dyspnoea (shortness of breath)

Reporting of side effects
If you get 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.