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 contains reduces some of the unpleasant symptoms that occur when you stop smoking, such as feeling ill or irritable.
• The nicotine it contains also reduces the craving for a cigarette and helps you resist the urge to smoke.

NiQuitin Fruit chewing gum does not have the dangers of smoking tobacco because it does not contain tar, carbon monoxide, and 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.
The chances of quitting can be increased by taking part in a support program to help you stop smoking. To find out about support programs, ask your doctor, pharmacist, or nurse.
Smoking tobacco has no health benefits. Therefore, it is best to quit smoking. Using Nicotine Replacement Therapy (NRT), such as NiQuitin Fruit chewing gum, can help. Remember, the risk from smoking tobacco is 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 a severe heart rhythm disturbance, 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.
• do not use NRT in children under 12 years of age. Nicotine is more toxic to children than adults and can cause serious 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:

• if you have severe liver or kidney problems, as you may be more likely to experience side effects,
• if you have uncontrolled hyperthyroidism or a pheochromocytoma (a tumor of the adrenal gland that affects blood pressure), as your symptoms may get worse,
• if you have stomach or duodenal ulcers, or inflammation of the esophagus, as swallowed nicotine can make your symptoms worse and may cause mouth ulcers. If your symptoms get worse, ask your doctor for advice.

Children (under 12 years of age)

Even a dose suitable for adults can cause serious 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, have recently taken, or might 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 beverages (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 are planning to have a baby, 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 both your health and your baby's health. The sooner you stop smoking, the better.
Pregnant women should try to 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 better than patches, which release nicotine all day. Patches may be more suitable if you experience nausea or vomiting.
Second-hand smoke can cause breathing difficulties and other health problems in babies. Breastfeeding mothers should try to stop smoking without using NRT. However, if this is not possible, your doctor, pharmacist, or nurse may recommend using NRT. When a breastfeeding mother uses NRT, the amount of nicotine that the baby gets from the breast milk is small.
The best option is to use NRT that gives a single dose of nicotine during the day (e.g., chewing gum or lozenges, not patches). It is best to breastfeed your baby just before using the 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 told by your doctor that you have an intolerance to some sugars, or if you have previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should talk to your doctor before taking this 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 treatment, you must stop smoking. If you do smoke a cigarette, do not stop treatment.
If you still have trouble stopping smoking, consult your doctor, pharmacist, or nurse.
NiQuitin Fruit 2 mg gum is suitable for people who smoke less than 20 cigarettes a day.
NiQuitin Fruit 4 mg gum is suitable for people who smoke 20 or more cigarettes a day.
Do not chew NiQuitin Fruit gum like normal chewing gum, as the nicotine will be released too quickly. 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 for about 30 minutes until the gum has lost 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 used (see the table below).
• Stop treatment when the number of pieces used per day has been reduced to 1 to 2.

Even after stopping treatment, you may still feel the urge to smoke. You can use the gum 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 worried about relapse or have trouble stopping smoking

If you are worried about relapse or have trouble stopping smoking, talk to your doctor, pharmacist, or nurse. If you start smoking again, your doctor, pharmacist, or nurse will advise you on the best way to use NRT next time.

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 accidentally ingests the medicine, they may experience nicotine poisoning symptoms, such as headache, vomiting, stomach pain, and diarrhea.
Take the child to the hospital emergency department 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. 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 wheezing, tightness in the chest, skin rash, or feeling faint.

Other side effects are listed below by frequency:

Very common: may affect more than 1 in 10 people

• nausea

Common: may affect up to 1 in 10 people

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

These side effects are usually mild and often go away after a few days of treatment.
Uncommon: may affect up to 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, 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 any medicines via wastewater or household waste. Ask your pharmacist how to throw away 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) and 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

NiQuitin Fruit is a white or almost white rectangular chewing gum.
Each blister pack contains 4 or 10 pieces of gum.
The pack contains 4, 10, 30, 100, or 200 pieces of 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:

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

Luxembourg

NiQuitin Tropisch Fruit – Fruits tropicaux - Tropische Früchte 2 mg/4 mg Gomme à mâcher médicamenteuse

Netherlands

NiQuitin Fruit en Mint 2 mg & 4 mg kauwgom

Norway

Nicabate, 2 mg/4 mg medisinsk tyggegummi Tropisk frukt

Poland

NiQuitin Fruit

Portugal

NiQuitin Tropical 2mg & 4mg gomas para mascar medicamentosas

Slovakia

NiQuitin Tropické ovocie 2mg & 4mg liečivé žuvačky

Spain

NiQuitin Fruit 2mg & 4mg chicles medicamentosos

Sweden

NiQuitin Tropisk frukt 2mg & 4mg medicinskt tuggummi

United Kingdom

Nicabate Tropical Flavour 2mg & 4mg Medicated Chewing Gum

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.