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NiQuitin 7 mg, 14 mg, 21 mg /24 hours Clear Transdermal Patches
Nicotine
What it is and what it is used for
NiQuitin are skin patches that release nicotine to help people quit smoking. This type of treatment is called Nicotine Replacement Therapy (NRT for short).
NiQuitin is available in three strengths: 21 mg, 14 mg and 7 mg/24 hours. People who want to quit smoking start with a stronger patch and gradually switch to lighter ones (see section 3: How to use NiQuitin). Each dosage has its own packaging.
It is the nicotine in cigarettes that can make you addicted to them. NiQuitin helps you quit smoking by replacing some of the nicotine absorbed from cigarettes. Each patch slowly releases nicotine into the body. This alleviates some of the unpleasant symptoms that smokers may experience when trying to quit, eases the craving for a cigarette, and helps you resist the urge to smoke.
• NiQuitin can be used with any oral NiQuitin/NiQuitinmint (mini lozenges) if you have relapsed after trying to quit with NRT, when one NiQuitin product is not enough to control your cravings, or if you are a heavy smoker (e.g. more than 10 cigarettes a day) (see section 3)
NRT 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 worry that they may become dependent on the nicotine in NRT instead. This is very rare, but if it does occur, it would 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. Such smoking cessation programs are known as behavioral support. For information on these, consult your doctor or pharmacist.
Smoking offers no health benefits. It is always better to quit smoking. The use of Nicotine Replacement Therapy (NRT) such as NiQuitin can help. In general, the dangers associated with smoking are far greater than any potential side effects associated with NRT.
What you need to know before taking the medicine
Do not use NiQuitin:
• if you are allergic to nicotine or any of the excipients of the medicine listed in section 6;
• if you are a non-smoker, occasional smoker, or under 12 years of age.
Warnings and precautions
Talk to your healthcare professional before using NiQuitin:
• if you are hospitalized for a heart attack, severe heart rhythm problems, or stroke. You should try to quit smoking without the aid of NRT products unless advised by your doctor. Once discharged from the hospital, you can use NRT normally;
• if you have diabetes. You should check your blood sugar levels more frequently than usual when you start using NiQuitin. It may be necessary to adjust the amount of insulin or other medications you take;
• if you have had allergic reactions with swelling of the lips, face, and throat or an itchy rash. The use of NRT can sometimes trigger this type of reaction;
• if you suffer from allergic eczema or dermatitis. You might experience a reaction to the patches;
• if you have a medical history of epilepsy (seizures);
• if you have gastric or duodenal ulcers or if you have inflammation of the esophagus (the passage between the mouth and the stomach). NRT can worsen symptoms;
• if you have a medical history of cardiovascular disorders (conditions affecting the heart or blood vessels, for example, heart disease, angina, or high blood pressure) and wish to use NiQuitin patches in combination with NiQuitin mini lozenges.
• if you suffer from severe liver or kidney problems. You may be more likely to experience side effects;
• if you have an uncontrolled and overactive thyroid or a pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure). Nicotine can worsen symptoms;
• if you fear becoming dependent or think you have become dependent on this product.
→ Talk to your doctor before using NiQuitin if any of these apply to you.
Children (under 12 years)
The nicotine levels contained in NRT are not suitable for children under 12 years. Nicotine affects children differently than adults. In children, nicotine can cause severe poisoning that can lead to death.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. At recommended doses, NiQuitin has not caused severe side effects.
Quitting smoking itself can lead to some symptoms such as weakness, dizziness, headache, cough, and flu-like symptoms.
Other symptoms may also be related to smoking cessation, such as mood changes, insomnia, sleep disturbances, inability to concentrate, or feelings of depression, irritability, anxiety, drowsiness, restlessness, or nervousness.
Very common (may affect more than 1 in 10 people)
• skin reactions at the patch application site
• sleep disturbances including insomnia and abnormal dreams
• nausea/vomiting
• headache
• dizziness
Common (may affect up to 1 in 10 people)
• nervousness
• tremor
• shortness of breath
• sore or swollen throat
• cough
• indigestion
• stomach pain
• diarrhea
• constipation
• dry mouth
• sweating
• joint, muscle, chest, and limb pain
• tiredness or weakness
• palpitations (sensation of the heart beating)
Uncommon (may affect up to 1 in 100 people)
• allergic reaction
• increased heart rate
• flu-like symptoms
Very rare (may affect up to 1 in 10,000 people)
• skin reactions
• skin sensitivity to sunlight
• severe allergic reaction - symptoms may include shortness of breath or chest tightness, rash, and feeling faint.
Not known (frequency cannot be estimated from the available data)
• epileptic seizures (convulsions)
Slight redness, itching, burning, and tingling may occur at the application site, which normally disappear quickly after the patch is removed. Rarely, a more severe reaction may occur at the site, including redness, swelling, or a rash that does not disappear after 4 days, or a generalized skin reaction. This is more likely if you have a history of dermatitis. If this occurs, stop using the patch and inform your doctor.
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.

