NIQUITIN 7 MG/24 HOURS TRANSDERMAL PATCHES TRANSPARENT 7 TRANSDERMAL PATCHES IN PET/LDPE/AL/EVOH SACHETS

Name
NiQuitin 7 mg, 14 mg, 21 mg /24 hours Transparent 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 comes in three strengths: 21mg, 14mg and 7mg/24 hours. People who want to stop smoking start with a stronger patch and gradually move to lighter ones (see section 3: How to use NiQuitin) . Each strength 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 you absorb from cigarettes. Each patch slowly releases nicotine into your body. This relieves some of the unpleasant symptoms smokers can experience when trying to quit, reduces the craving for a cigarette, and helps you resist the urge to smoke.
• NiQuitin can be used together with any oral NiQuitin/Niquitinmint (mini lozenges) if you have had a relapse after trying to quit with NRT, when a Niquitin product is not enough to control your cravings, or if you are a heavy smoker (for example more than 10 cigarettes a day) (see section 3)
NRT does not carry the health risks of tobacco, as it does not contain tar, carbon monoxide, or other toxins found in cigarette smoke. Some people worry that they may become addicted to the nicotine in NRT. This is very rare, but if it does happen, it is less harmful than continuing to smoke. It is also an easier habit to break.

If you take part in a support programme , you will increase your chances of quitting. These 'smoking cessation programmes' are known as behavioural support. For information about these, ask your doctor or pharmacist.

Smoking has no health benefits. It is always best to stop smoking. Using a Nicotine Replacement Therapy (NRT) such as NiQuitin may help. In general, the dangers of smoking far outweigh any possible 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 other ingredients of the medicine listed in section 6;
• if you are a non-smoker, an occasional smoker or if you are under 12 years old.


Warnings and precautions
Talk to your healthcare professional before using NiQuitin:
• if you are admitted to hospital with a heart attack, serious heart rhythm problems or stroke . You should try to stop smoking without the use of NRT products unless your doctor advises you to do so. Once you are discharged from hospital you can use NRT as normal;
• 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 change the amount of insulin or other medicines you take;
• if you have had allergic reactions with swelling of the lips, face and throat or itchy skin rash. Using NRT can sometimes trigger these types of reactions;
• if you suffer from allergic eczema or dermatitis . You may experience a reaction to the patches;
• if you have a history of epilepsy ( convulsions );
• if you have stomach or duodenal ulcers or if you have inflammation of your oesophagus (the passage between your mouth and stomach). NRT may make your symptoms worse;
• if you have a 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 have severe liver or kidney problems. You may be more likely to have side effects;
• if you have an uncontrolled, overactive thyroid or pheochromocytoma (a tumor of the adrenal gland which can affect blood pressure). Nicotine may make the symptoms worse;
• if you fear that you may become addicted or think you may have become addicted to this product.
→ Talk to your doctor before using Niquitin if any of these apply to you.

Children (under 12 years)
The levels of nicotine in TNS are not suitable for children under 12. Nicotine affects children more 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 the recommended doses, NiQuitin has not caused serious side effects.

Quitting smoking itself can cause 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, trouble sleeping, inability to concentrate or feeling depressed, irritability, anxiety, drowsiness, restlessness or nervousness.
Very common (may affect more than 1 in 10 people)
• skin reactions in the area of ​​application of the patch
• sleep disturbances including insomnia and abnormal dreams
• nausea/vomiting
• heachache
• 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
• pain in joints, muscles, chest and limbs
• tiredness or weakness
• palpitations (sensation of the heart beating)

Uncommon (may affect up to 1 in 100 people)
• allergic reaction
• increased heart rate
• flu 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, skin rash and feeling faint.

Not known (frequency not known)
• epileptic seizures (convulsions)

Mild redness, itching, burning and stinging may occur at the application site, which usually disappears quickly after the patch is removed. Rarely, a more serious reaction may occur at the site, including redness, swelling or a rash that does not disappear after 4 days or a generalised skin reaction. This is more likely if you have a history of dermatitis. If this occurs, stop using the patch and tell your doctor.

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.