Niquitin extra fresh

Package leaflet: Information for the user

NiQuitin Extra Fresh
2 mg, chewing gum, medicinal
Nicotinum
NiQuitin Extra Fresh
4 mg, chewing gum, medicinal
Nicotinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
You should always use this medicine exactly as described in this patient leaflet or as your
doctor, pharmacist or nurse has advised.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, please contact your doctor, nurse or pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, you should inform your doctor, pharmacist or nurse. See section 4.
• If after 9 months of treatment you have not been able to stop smoking, you should contact your doctor.
• In this leaflet, the medicine NiQuitin Extra Fresh, 2 mg and 4 mg, chewing gum, medicinal, is also referred to as “NiQuitin Extra Fresh gum”.

Leaflet contents

1. What NiQuitin Extra Fresh is and what it is used for
2. What you need to know before using NiQuitin Extra Fresh
3. How to use NiQuitin Extra Fresh
4. Possible side effects
5. How to store NiQuitin Extra Fresh
6. Contents of the pack and other information

1. What NiQuitin Extra Fresh is and what it is used for

NiQuitin Extra Fresh chewing gums help you to stop smoking. Using this type of medicine
is called nicotine replacement therapy (NRT).
Nicotine in tobacco causes physical dependence on cigarette smoking.

• NiQuitin Extra Fresh chewing gums help you to stop smoking by replacing some of the nicotine you previously obtained from cigarettes.
• The nicotine supplied helps relieve some of the unpleasant symptoms of cigarette withdrawal, including low mood and irritability.
• The supplied nicotine also helps reduce nicotine cravings and suppresses the urge to smoke a cigarette.

NiQuitin Extra Fresh chewing gums avoid the dangers associated with smoking tobacco, because
they do not contain tar, carbon monoxide or other poisons found in tobacco smoke.
Some people may be concerned about becoming dependent on nicotine chewing gum after quitting smoking.
Such dependence is very rare, and even if it occurs, it is less harmful to health and easier to overcome than smoking tobacco.
Your chances of quitting successfully can be improved by participating in a psychological support programme for stopping smoking.
For information about psychological support programmes to help you quit smoking, please contact your doctor, pharmacist or nurse.
Smoking tobacco brings no health benefits. Therefore, it is definitely better to quit.
Using Nicotine Replacement Therapy (NRT), such as NiQuitin Extra Fresh chewing gum, can help you achieve this.
Remember that the risks associated with smoking tobacco are greater than any possible side effects that may occur during NRT use.

2. Important information before using NiQuitin Extra Fresh

When not to use NiQuitin Extra Fresh:

• if the patient is allergic to nicotine or any of the ingredients of this medicine (listed in section 6),
• in children under 12 years of age,
• in non-smokers or occasional smokers.

Warnings and precautions
Before starting to use NiQuitin Extra Fresh, consult a doctor, pharmacist,
or nurse:

• if the patient has recently had a myocardial infarction or stroke, has severe cardiac arrhythmia, unstable or worsening angina pectoris (chest pain), uncontrolled hypertension, or nocturnal angina pectoris, quitting smoking should be attempted without using NRT, unless a doctor authorizes the use of NRT.
• if the patient has diabetes, blood glucose levels should be monitored more frequently than usual during use of NiQuitin Extra Fresh chewing gum. Dosing recommendations for insulin or antidiabetic medications may need adjustment.
• if the patient has ever experienced an allergic reaction such as swelling of the lips, face, and throat (angioedema) or itchy skin rash (urticaria), caution is advised. Nicotine Replacement Therapy (NRT) may occasionally cause such reactions.
• if the patient wears dental prostheses, as difficulties with chewing may occur.
• if the patient has had seizures (epilepsy) in the past.
• chewing nicotine medicinal gum may loosen dental fillings or implants.
• NRT should not be used in children under 12 years of age. Nicotine has a stronger effect on a child's body than in adults and may cause severe poisoning, which could be fatal.

When attempting to quit smoking, do not interchangeably use NiQuitin Extra Fresh chewing gum
with nicotine-containing lozenges.
Consult a doctor, pharmacist, or nurse if:

• the patient has severe or moderately severe liver or kidney impairment, due to an increased risk of adverse effects,
• the patient has uncontrolled hyperthyroidism or a pheochromocytoma (adrenal gland tumor affecting blood pressure), as symptoms of the disease may worsen, as advised by a doctor,
• the patient has peptic ulcer disease of the stomach or duodenum, or esophagitis (inflammation of the esophagus, the part of the digestive tract between the mouth and stomach), because swallowed nicotine may worsen symptoms or cause oral ulceration. If symptoms worsen, consult a doctor. It may be necessary to switch from oral forms of nicotine replacement therapy to transdermal patches.

Children (under 12 years of age)
Even a dose appropriate for adults may cause severe poisoning or death in young children. Therefore, it is essential to always store NiQuitin Extra Fresh out of sight and reach of children.

NiQuitin Extra Fresh and other medicines
Inform your doctor, pharmacist, or nurse about all medicines currently used, recently used, or planned for use.
Quitting smoking may affect the efficacy of other medicines the patient is taking.
If you have any questions or doubts, consult your doctor, pharmacist, or nurse.
This is particularly important when using medicines containing:

• theophylline (used in the treatment of asthma),
• tacrine (used in the treatment of Alzheimer's disease),
• clozapine (used in the treatment of schizophrenia),
• ropinirole (used in the treatment of Parkinson's disease).

Taking NiQuitin Extra Fresh with food and drink
Do not eat or drink while chewing NiQuitin Extra Fresh gum.
Beverages that lower the pH in the oral cavity (e.g. fruit juices, coffee, carbonated drinks) may affect the absorption of nicotine in the mouth. To achieve optimal effectiveness, avoid consuming such beverages within 15 minutes before chewing NiQuitin Extra Fresh gum.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Smoking during pregnancy is dangerous for the unborn child and may lead to delayed fetal growth, premature birth, or stillbirth. Stopping smoking is the only effective way to improve the health of both the pregnant woman and her child. The sooner smoking cessation occurs, the better.
Pregnant women should quit smoking without using NRT. However, if this is not successful, a doctor, pharmacist, or nurse may recommend using NRT to support quitting smoking, as it would be more beneficial for the child's development than continuing to smoke. The decision to use NRT during pregnancy should be made as early as possible. NRT use is recommended for only 2 to 3 months. It is important to remember that quitting smoking is the primary goal. Medicinal products such as chewing gums may be preferable to patches, which release nicotine continuously throughout the day. Patches may be more suitable if nausea or vomiting occurs.
Exposure of breastfed infants to tobacco smoke causes breathing difficulties and other health problems. Breastfeeding women should quit smoking without using NRT. However, if this is not successful, a doctor, pharmacist, or nurse may recommend using NRT. When a breastfeeding woman uses NRT, the amount of nicotine passed to the infant through breast milk is low.
It is most beneficial to use NRT that delivers single doses of nicotine during the day (e.g. chewing gum or lozenges, rather than patches). It is best to breastfeed the baby just before using the chewing gum, so that the infant receives the lowest possible dose of nicotine.

Driving and operating machinery
There are no known effects of NiQuitin Extra Fresh on the ability to drive or operate machinery. However, bear in mind that quitting smoking may cause behavioral changes that could affect the ability to drive or operate machinery.

NiQuitin Extra Fresh contains:

• Sodium – this medicine contains less than 1 mmol of sodium (23 mg) per gum, meaning the medicine is considered "sodium-free".
• Sorbitol (E420) – the medicine contains 148.65 mg of sorbitol in each 2 mg gum and 137.55 mg of sorbitol in each 4 mg gum. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking this medicine.
• Butylated hydroxytoluene (E321) – this medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use NiQuitin Extra Fresh

This medicine should always be used according to the instructions provided in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

During treatment with NiQuitin Extra Fresh, smoking must be stopped. However, if a cigarette is smoked by mistake, treatment should not be discontinued.
If difficulties persist in stopping smoking, advice should be sought from a doctor, pharmacist, or nurse.

NiQuitin Extra Fresh 2 mg chewing gums are intended for people who smoke fewer than 20 cigarettes per day.
NiQuitin Extra Fresh 4 mg chewing gums are intended for people who smoke 20 or more cigarettes per day.

Do not chew NiQuitin Extra Fresh gums like ordinary chewing gum continuously and rapidly, as this may cause too rapid release of nicotine, leading to discomfort (e.g. heartburn or hiccups).

To use NiQuitin Extra Fresh, remove the paper covering and take the gum out of the blister pack. Place the gum in the mouth and chew slowly until a taste is perceived (approximately 1 minute). Then stop chewing and place the gum between the gum and the cheek. Begin chewing again when the taste fades. Repeat this process several times over 30 minutes, until the gum loses its taste. During gum use, do not eat or drink, as this may reduce nicotine absorption. Do not use more than 15 gums per day. If continued use of the medicine beyond 9 months is desired, consult a doctor, pharmacist, or nurse.

NiQuitin Extra Fresh should be used according to the following dosing schedule:
Adults (aged over 18 years)

• At the beginning of treatment, use 8 to 12 gums per day. Chew a gum whenever you feel the urge to smoke.
• Within no more than 3 months, gradually reduce the number of gums used (see table below).
• Treatment should be completed when the number of gums used decreases to 1 to 2 per day.

Even after completing therapy, the urge to smoke may still occur; in such cases, a gum may still be used.

Use in children and adolescents
Adolescents (aged 12 to 17 years)
The medicine may be used in adolescents aged 12 to 17 years only on medical advice.
Do not use a higher dose than recommended. Smoking cigarettes or using nicotine in any other form must be avoided during treatment.
The medicine should be used as directed and no more than 15 pieces of gum should be taken per day (24 hours).
Children under 12 years of age
NiQuitin Extra Fresh must not be used in children under 12 years of age.
If the patient is concerned about relapse into smoking
If the patient is concerned about relapse into smoking or has difficulties discontinuing the use of
the medicine, they should speak to a doctor, pharmacist, or nurse. In case of relapse into smoking,
the doctor, pharmacist, or nurse will advise on how best to use the next NRT (nicotine replacement therapy).
Use of a higher than recommended dose of NiQuitin Extra Fresh
If a higher than recommended dose of NiQuitin Extra Fresh is used, symptoms such as nausea, dizziness, and general malaise may occur.
In such cases, the use of the medicine should be stopped immediately and medical advice should be sought promptly from a doctor or hospital emergency department.
The package leaflet or medicine packaging should be brought along to show to the healthcare professional.
The medicine is not suitable for children under 12 years of age. If accidentally ingested by a child, symptoms of nicotine overdose may occur, such as headache, vomiting, abdominal pain, and diarrhoea.
A child who has used or eaten the medicine should be taken immediately to a hospital emergency department or a doctor should be contacted. If possible, show the doctor the package leaflet or medicine packaging.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everyone will experience them.
No serious adverse effects have been observed with the recommended dosage of NiQuitin Extra Fresh.
The act of stopping smoking itself may cause symptoms such as dizziness, headache, sleep disturbances, cough, and flu-like symptoms. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be caused by stopping smoking.
You should consult a doctor and discontinue use of NiQuitin Extra Fresh if any of the following symptoms of an allergic reaction occur:
Very rare adverse effects (may occur less frequently than in 1 out of 10,000 people):

• swelling of the face, tongue or throat,
• difficulty swallowing,
• hives and breathing difficulties,
• heart rhythm disturbances.
• severe allergic reactions manifesting as sudden onset of wheezing or a feeling of tightness in the chest, skin rash, or a sensation of impending fainting.

Other adverse effects listed below are grouped according to the likelihood of their occurrence.
Very common: may occur in more than 1 out of 10 people

• Malaise

Common: may occur in less than 1 out of 10 people

• stomach discomfort,
• sore throat, pain and (or) dryness in the mouth, irritation or ulceration of the oral mucosa, pharyngitis, cough,
• sleep disturbances, headache, irritability, dizziness,
• vomiting, hiccups, indigestion, bloating, diarrhoea, constipation,
• jaw pain.

The above-mentioned adverse effects are usually mild and often resolve spontaneously within a few days of treatment.
Uncommon: may occur in less than 1 out of 100 people

• increased heart rate, palpitations (sensation of strong heartbeat),
• breathing difficulties, chest pain,
• disturbance/distortion of taste sensation,
• skin redness, hives, excessive sweating,
• joint and (or) muscle pain or swelling,
• inflammation of the oral mucosa,
• tremor,
• general malaise.

Rare: may occur in less than 1 out of 1,000 people
rapid and irregular heartbeat (atrial fibrillation)
Frequency not known (cannot be estimated from available data):

• seizures, difficulty swallowing, burping, increased salivation, weakness (lack of energy), fatigue (tiredness), flu-like illnesses (flu-like symptoms), hypersensitivity, unusual dreams, itching or rash, numbness or tingling in the mouth.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store NiQuitin Extra Fresh

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack and outer carton. The expiry date refers to the last day of the specified month.
• Do not store above 25 °C.
• Store in the original packaging to protect from moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What NiQuitin Extra Fresh contains

• The active substance is nicotine. Each chewing gum contains 2 mg or 4 mg of nicotine (as nicotine polacrilex).
• Other ingredients are: butylated hydroxytoluene (E321), sorbitol (E420), xylitol (E967), calcium carbonate (E170), anhydrous sodium carbonate (E500), glycerol (E422), acesulfame potassium (E950), sucrose, mannitol (E421), gum arabic (E414), titanium dioxide (E171), carnauba wax, talc, and flavourings: Optacool, Eukamentol and Lewomentol.

What NiQuitin Extra Fresh looks like and contents of the pack
NiQuitin Extra Fresh is in the form of white or almost white rectangular chewing gums.
Each blister contains 4 or 10 chewing gums.
The pack contains 4, 10, 30, 100 or 200 chewing gums. Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel.: +48 (22) 852 55 51

Manufacturer:
Fertin Pharma A/S
Dandyvej 19
7100 Vejle
Denmark
Logiters, Logistica Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050 – 544
Portugal

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following trade names:

Belgium: NiQuitin freshmint 2 mg & 4mg Gomme à mâcher médicamenteuse
Croatia: NiQuitin GUM Icy Fresh Mint 2 mg & 4mg ljekovita guma za žvakanje
Czech Republic: NiQuitin Freshmint
Estonia: NiQuitin Mint 2 mg & 4 mg ravimnärimiskumm
Hungary: NiQuitin Menthol Fresh 2 mg & 4mg gyógyszeres rágógumi
Ireland: NiQuitin Fresh Mint 2mg & 4mg Medicated Chewing Gum
Latvia: NiQuitin Mint 2 mg & 4mg ārstnieciskā košļājamā gumija
Lithuania: NiQuitin Mint 2 mg & 4mg vaistinė kramtomoji guma
Luxembourg: NiQuitin freshmint 2 mg & 4mg Gomme à mâcher médicamenteuse
Netherlands: NiQuitin Mint 2 mg & 4 mg Kauwgom
Poland: NiQuitin Extra Fresh 2 mg & 4 mg guma do żucia, lecznicza
Portugal: NiQuitin Mint 2mg & 4 mg gomas para mascar medicamentosas
Slovakia: NiQuitin Freshmint 2 mg & 4 mg mg liečivé žuvačky
Spain: NiQuitin Mint 2 mg & 4 mg chicles medicamentosos
Sweden: NiQuitin Mint 2 mg & 4 mg medicinskt tuggummi
United Kingdom (Northern Ireland): Nicabate Extra Fresh Mint 2 mg & 4 mg Medicated Chewing Gum

Further information
Detailed information about this medicinal product is available on the website of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.