Niquitin Fruit

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

NiQuitin Fruit

2 mg, chewing gum, medicinal
Nicotinum

NiQuitin Fruit

4 mg, chewing gum, medicinal
Nicotinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 9 months of treatment you have not been able to stop smoking, consult your doctor.

Table of contents of the leaflet

• 1. What is NiQuitin Fruit and what is it used for
• 2. Important information before using NiQuitin Fruit
• 3. How to use NiQuitin Fruit
• 4. Possible side effects
• 5. How to store NiQuitin Fruit
• 6. Contents of the pack and other information

1. What is NiQuitin Fruit and what is it used for

NiQuitin Fruit chewing gum helps you stop smoking. The use of this type of medicine is called nicotine replacement therapy or NRT.
Nicotine in tobacco causes physical dependence on smoking cigarettes.

• NiQuitin Fruit chewing gum helps you quit smoking by replacing some of the nicotine you get from cigarettes.
• The nicotine it provides relieves some of the unpleasant symptoms caused by stopping smoking, such as feeling ill or irritable.
• The nicotine it provides also relieves cravings for nicotine and helps you resist the urge to smoke.

NiQuitin Fruit chewing gum does not carry the same health risks as smoking tobacco because it does not contain tar, carbon monoxide, or other poisons found in tobacco smoke.
Some patients may worry about becoming dependent on nicotine gum after stopping smoking. This dependence is very rare and even if it happens, it is less harmful to health and easier to overcome than smoking tobacco.
Your chances of quitting smoking can be improved by joining a support program. To find out about support programs, ask your doctor, pharmacist, or nurse.
Smoking tobacco has no health benefits. Therefore, it is better to quit smoking. Using Nicotine Replacement Therapy (NRT), such as NiQuitin Fruit chewing gum, can help you do this. Remember, the risks associated with smoking tobacco are greater than the side effects that may occur when using NRT.

2. Important information before using NiQuitin Fruit

When not to use NiQuitin Fruit:

• if you are allergic to nicotine or any of the other 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 Fruit, ask your doctor, pharmacist, or nurse:

• if you have recently had a heart attack or stroke, have severe heart rhythm disturbances, have unstable or worsening angina (chest pain), have uncontrolled high blood pressure, or nocturnal angina, you should try to stop smoking without using NRT unless your doctor has advised you to use NRT,
• if you have had seizures,
• if you have diabetes, you should monitor your blood sugar levels more often when using NiQuitin Fruit gum. Your insulin or diabetes medication requirements may need to change,
• if you have had an allergic reaction, such as swelling of the lips, face, and throat (angioedema) or itchy skin rash (hives), you should be cautious. NRT can sometimes cause these reactions,
• if you wear dentures, as there may be problems with chewing.
• Chewing nicotine gum can loosen dental fillings or implants.
• NRT should not be used in children under 12 years of age. Nicotine is more addictive in children than in adults and can cause severe poisoning in children, which can be fatal.

When trying to stop smoking, do not use NiQuitin Fruit chewing gum interchangeably with nicotine lozenges.

Ask your doctor, pharmacist, or nurse for advice:

• if you have severe liver or kidney problems, as you may be more likely to experience side effects,
• if you have uncontrolled overactive thyroid gland or a tumor of the adrenal gland (a tumor of the adrenal gland that affects blood pressure), as NRT may worsen the symptoms of the disease, which your doctor will inform you about,
• if you have stomach or duodenal ulcers, or esophagitis (inflammation of the esophagus), as swallowed nicotine can worsen the symptoms of the disease and may cause mouth ulcers. If your symptoms worsen, consult your doctor. It may be necessary to switch to a different form of nicotine replacement therapy, such as patches.

Children (under 12 years of age)

Even a dose suitable for adults can cause severe poisoning or death in small children. Therefore, it is essential to always keep NiQuitin Fruit out of sight and out of reach of children.

NiQuitin Fruit and other medicines

Tell your doctor, pharmacist, or nurse about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Stopping smoking can affect the way other medicines work. If you have any questions or concerns, ask your doctor or pharmacist.
This is especially important if you are taking medicines containing

• theophylline (used to treat asthma),
• tacrine (used to treat Alzheimer's disease),
• clozapine (used to treat schizophrenia),
• ropinirole (used to treat Parkinson's disease).

Using NiQuitin Fruit with food and drink

Do not eat or drink while chewing NiQuitin Fruit gum.
Acidic drinks (such as fruit juices, coffee, or fizzy drinks) may affect nicotine absorption in the mouth. To get the best effect from the medicine, do not consume these types of drinks within 15 minutes before taking NiQuitin Fruit.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Smoking during pregnancy is dangerous for your baby. It may cause growth restriction, premature birth, or stillbirth. Stopping smoking is the only effective way to improve the health of both you and your baby. The sooner you stop smoking, the better.
Pregnant women should stop smoking without using NRT. However, if this is not possible, your doctor, pharmacist, or nurse may recommend using NRT to help you stop smoking, as it will be better for your baby's development than continuing to smoke. The decision to use NRT during pregnancy should be made as early as possible. Treatment should only be used for 2 to 3 months. Remember, the most important thing is to stop smoking. Medicines like chewing gum may be more suitable than patches, which release nicotine throughout the day. Patches may be more suitable if you experience nausea or vomiting.
Tobacco smoke exposure in breastfed babies can cause breathing difficulties and other health problems. Breastfeeding women should stop smoking without using NRT. However, if this is not possible, your doctor, pharmacist, or nurse may recommend using NRT. When a breastfeeding woman uses NRT, the amount of nicotine that the baby gets from breast milk is small.
The best option is to use NRT that provides a single dose of nicotine during the day (e.g., chewing gum or lozenges, and not patches). It is best to breastfeed your baby just before using the chewing gum, as the baby will then get the smallest possible dose of nicotine.

Driving and using machines

There are no known effects of NiQuitin Fruit on the ability to drive or use machines. However, remember that stopping smoking can cause changes in behavior that can affect your ability to drive or use machines.

What NiQuitin Fruit contains

• Sodium - The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.
• Sorbitol (E420) - The medicine contains 112.60 mg of sorbitol in each 2 mg gum and 101.48 mg of sorbitol in each 4 mg gum. Sorbitol is a source of fructose. If you have been previously diagnosed with intolerance to some sugars or previously diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking the medicine.
• Butylhydroxytoluene (E321) - The medicine may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

3. How to use NiQuitin Fruit

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor, pharmacist, or nurse. If you are unsure, ask your doctor, pharmacist, or nurse.
During NiQuitin Fruit therapy, you should stop smoking tobacco. If you are unable to stop smoking and smoke a cigarette, do not stop treatment.
If you continue to have difficulty stopping smoking, consult your doctor, pharmacist, or nurse.
NiQuitin Fruit 2 mg chewing gum is recommended for those who smoke less than 20 cigarettes a day.
NiQuitin Fruit 4 mg chewing gum is recommended for those who smoke 20 or more cigarettes a day.
Do not chew NiQuitin Fruit gum like normal gum, quickly and continuously, as the nicotine is released too intensely. This can cause discomfort (such as heartburn or hiccups).
Use NiQuitin Fruit after removing the paper wrapper and taking the gum out of the blister pack. Place the gum in your mouth, chew slowly until you feel the taste (about 1 minute), then stop chewing and place the gum between your cheek and gum. Start chewing again when the taste fades. Repeat this process several times for 30 minutes until the gum loses its taste. Do not eat or drink while chewing the gum, as this can reduce nicotine absorption. Do not use more than 15 pieces of gum per day. If you need to use the medicine for longer than 9 months, consult your doctor, pharmacist, or nurse.
Use NiQuitin Fruit according to the following dosage schedule:

Adults (over 18 years of age)

• Initially, use 8 to 12 pieces of gum per day. Chew a piece of gum when you feel the urge to smoke.
• After no more than 3 months, gradually reduce the number of pieces of gum used (see the table below).
• Stop treatment when the number of pieces of gum used per day is 1 to 2.

Even after stopping treatment, you may still feel the urge to smoke. You can use the medicine again if this happens.

Use in children and adolescents

Adolescents (12 to 17 years of age)

The medicine can be used in adolescents aged 12 to 17 years only if recommended by a doctor.

Do not use more than the recommended dose. During treatment, do not smoke or use other nicotine products. Use the medicine as directed and do not take more than 15 pieces of gum per day.

Children (under 12 years of age)

Do not use NiQuitin Fruit in children under 12 years of age.

If you are concerned about relapse

If you are concerned about relapse or have difficulty stopping smoking, talk to your doctor, pharmacist, or nurse. If you start smoking again, your doctor, pharmacist, or nurse will advise you on how to use the next NRT most effectively.

Using more than the recommended dose of NiQuitin Fruit

If you use more than the recommended dose of NiQuitin Fruit, you may experience nausea, dizziness, and feeling unwell. Stop using the medicine and consult your doctor or hospital immediately. Take the leaflet or packaging with you to show them.
The medicine is not suitable for children under 12 years of age. If a child uses or swallows the medicine, they may experience symptoms of nicotine overdose, such as headache, vomiting, stomach pain, and diarrhea.
Take the child to the emergency room or consult a doctor immediately. If possible, show the doctor the leaflet or packaging of the medicine.
If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, NiQuitin Fruit can cause side effects, although not everybody gets them.
No serious side effects have been reported with the recommended use of NiQuitin Fruit.
Stopping smoking itself can cause symptoms such as dizziness, headaches, sleep disturbances, coughing, and flu-like symptoms. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be caused by stopping smoking.
Consult your doctor and stop using NiQuitin Fruit if you experience any of the following symptoms of an allergic reaction:
Very rare side effects (may affect less than 1 in 10,000 people)

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing,
• heart rhythm disturbances,
• severe allergic reactions with symptoms such as sudden wheezing, tightness of the chest, or feeling of impending collapse.

Other side effects are listed below by frequency:

• nausea

Very common: may affect more than 1 in 10 people

• discomfort in the stomach,
• sore throat, soreness and (or) dryness in the mouth, irritation or ulcers in the mouth, sore throat, cough,
• sleep disturbances, headache, irritability, dizziness,
• vomiting, hiccups, indigestion, bloating, diarrhea, constipation,
• jaw pain.

These side effects are usually mild and often disappear after a few days of treatment.
Uncommon: may affect less than 1 in 100 people

• rapid heartbeat, palpitations (feeling of strong heartbeat),
• breathing difficulties, chest pain,
• disturbance in taste,
• redness of the skin, hives, excessive sweating,
• joint or muscle pain or swelling,
• mouth ulcers,
• tremors,
• general feeling of being unwell.

Frequency not known (cannot be estimated from the available data)

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NiQuitin Fruit

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

6. Contents of the pack and other information

What NiQuitin Fruit contains

• The active substance is nicotine. Each piece of gum contains 2 mg or 4 mg of nicotine (as nicotine ion exchange resin).
• The other ingredients are butylhydroxytoluene (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 flavors: Optacool, Lewomentol, Aromat Optamint Tropical (including trioctan glycerol (E1518), alpha-tocopherol (E307)), Aromat Optamint Tropical SD (including gum arabic (E414) and sorbitol (E420)) Aromat Microcandy Fruit Cocktail (including mannitol (E421), trioctan glycerol (E1518), and mono- and diglycerides of fatty acids (E471)) and Optamint Grapefruit flavor.

What NiQuitin Fruit looks like and contents of the pack

The medicine is a white or almost white rectangular chewing gum.
Each blister pack contains 4 or 10 pieces of chewing gum.
The pack contains 4, 10, 30, 100, or 200 pieces of chewing gum. Not all pack sizes may be marketed.

Marketing authorization holder:

Perrigo Poland Sp. z o.o.
Al. Niepodległości 18
02-653 Warsaw
tel. (22) 489 54 51

Manufacturer:

Fertin Pharma A/S
Dandyvej 19
7100 Vejle
Denmark

This medicine has been authorized for use in the Member States of the European Economic Area under the following names:

Marketing authorization numbers:

Belgium
NiQuitin Tropisch Fruit – Fruits tropicaux - Tropische Früchte 2mg/4 mg Gomme à mâcher médicamenteuse
Croatia
NiQuitin GUM Tropical Fruit 2 mg & 4mg ljekovita guma za žvakanje
Denmark
NiQuitgum Tropical
Estonia
NiQuitin Fruit
Finland
NiQuitin Tropical 2mg & 4mg lääkepurukumi
Hungary
NiQuitin trópusi gyümölcs 2mg & 4mg gyógyszeres rágógumi
Ireland
NiQuitin Tropical Fruit 2mg & 4mg medicated chewing gum
Latvia
NiQuitin Fruit 2mg & 4mg ārstnieciskā košļājamā gumija
Lithuania
NiQuitin Fruit 2mg & 4mg vaistinė kramtomoji guma
NiQuitin Tropisch Fruit – Fruits tropicaux - Tropische Früchte 2 mg/4 mg Gomme à mâcher médicamenteuse
NiQuitin Fruit en Mint 2 mg & 4 mg kauwgom
Nicabate, 2 mg/4 mg medisinsk tyggegummi Tropisk frukt
NiQuitin Fruit
NiQuitin Tropical 2mg & 4mg gomas para mascar medicamentosas
NiQuitin Tropické ovocie 2mg & 4mg liečivé žuvačky
NiQuitin Fruit 2mg & 4mg chicles medicamentosos
NiQuitin Tropisk frukt 2mg & 4mg medicinskt tuggummi
Nicabate Tropical Flavour 2mg & 4mg Medicated Chewing Gum
Luxembourg
Netherlands
Norway
Poland
Portugal
Slovakia
Spain
Sweden
United Kingdom

Date of revision of the leaflet:

Other sources of information

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