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

You should carefully read the contents of the package leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this package leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 9 months of treatment the patient has not been able to stop smoking, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is NiQuitin Extra Fresh and what is it used for
• 2. Important information 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 package and other information

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

NiQuitin Extra Fresh chewing gum helps to quit 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 Extra Fresh chewing gum helps to quit smoking by replacing some of the nicotine that the patient gets from cigarettes.
• The nicotine it provides relieves some of the unpleasant symptoms caused by stopping smoking, including feeling ill or irritable.
• The nicotine it provides also relieves the craving for a cigarette and helps to stop the urge to smoke.

NiQuitin Extra Fresh chewing gum is free from the dangers of smoking tobacco, as it does not contain tar, carbon monoxide, and other poisons found in tobacco smoke. Some patients may be concerned about becoming dependent on nicotine gum after stopping smoking. This dependence is very rare and even if it occurs, it is less harmful to health and easier to overcome than smoking tobacco.
The chances of quitting smoking can be increased by participating in a psychological support program to help quit smoking. To get information about a psychological support program to help quit smoking, you should contact your doctor, pharmacist, or nurse.
Smoking tobacco has no health benefits. Therefore, it is definitely better to quit smoking. Using Nicotine Replacement Therapy (NRT), such as NiQuitin Extra Fresh chewing gum, can help. Remember that the risks associated with smoking tobacco are greater than the side effects that may occur when using NRT.

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 other ingredients of this medicine (listed in section 6),
• in children under 12 years of age.

Warnings and precautions

Before starting to use NiQuitin Extra Fresh, you should ask your doctor, pharmacist, or nurse:

• if the patient has recently had a heart attack or stroke, has severe heart rhythm disturbances, has unstable or worsening angina (chest pain), has uncontrolled high blood pressure or nocturnal angina, they should try to quit smoking without using NRT, unless their doctor advises them to use NRT.
• if the patient has diabetes, they should monitor their blood sugar levels more often when using NiQuitin Extra Fresh gum. The recommendations for taking insulin or oral hypoglycemic agents may need to be changed.
• if the patient has ever had an allergic reaction, such as swelling of the lips, face, and throat (angioedema) or itchy rash on the skin (urticaria), they should be cautious. NRT can sometimes cause such reactions.
• if the patient wears dentures, as there may be problems with chewing.
• chewing nicotine gum can cause loosening of dental fillings or implants.
• NRT should not be used in children under 12 years of age. Nicotine is more toxic to children than to adults and can cause severe poisoning in children, which can be fatal.

When trying to quit smoking, you should not switch between NiQuitin Extra Fresh chewing gum and nicotine lozenges.

You should consult your doctor, pharmacist, or nurse if:

• you have severe liver or kidney problems, as this may increase the risk of side effects,
• you have uncontrolled hyperthyroidism or a pheochromocytoma (a tumor of the adrenal gland that affects blood pressure), as this may worsen the symptoms of the disease, which your doctor will inform you about,
• you have stomach or duodenal ulcers, or esophagitis (inflammation of the esophagus), as swallowed nicotine can exacerbate the symptoms of the disease and may cause oral ulcers. If the symptoms of the disease worsen, you should 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 Extra Fresh out of sight and out of reach of children.

NiQuitin Extra Fresh and other medicines

You should tell your doctor, pharmacist, or nurse about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Quitting smoking can affect the action of other medicines you are taking.
If you have any questions or concerns, you should consult 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 Extra Fresh with food and drink

While chewing NiQuitin Extra Fresh gum, you should not eat or drink.
Acidic drinks (such as fruit juices, coffee, or fizzy drinks) can affect the absorption of nicotine in the mouth. To get the best effect from the medicine, you should not consume these types of drinks within 15 minutes before taking NiQuitin Extra Fresh.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before using this medicine.
Smoking during pregnancy is dangerous for the baby. It can cause growth retardation, premature birth, or stillbirth. Quitting smoking is the only effective way to improve the health of both the pregnant woman and the baby. The sooner you quit smoking, the better.
Pregnant women should quit smoking without using NRT. However, if this is not possible, their doctor, pharmacist, or nurse may recommend using NRT to help them quit smoking, as it will be more beneficial for the baby's development than continuing to smoke. The decision to use NRT during pregnancy should be made as early as possible. It is recommended to use the treatment for only 2 to 3 months. Remember that the most important thing is to quit smoking. Medicines like chewing gum may be more beneficial than patches, which release nicotine throughout the day. Patches may be more suitable if you experience nausea or vomiting.
Secondhand smoke can cause breathing difficulties and other health problems in infants. Breastfeeding women should quit smoking without using NRT. However, if this is not possible, their 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 and much less harmful than passive smoking, which the baby would be exposed to if the mother continued to smoke.
The best option is to use NRT that provides a single dose of nicotine during the day (such as 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 Extra Fresh on the ability to drive or use machines. However, remember that quitting smoking can cause changes in behavior that can affect the ability to drive or use machines.

NiQuitin Extra Fresh contains:

• Sodium - The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".
• Sorbitol (E420) - If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
• Butylhydroxytoluene (E321) - The medicine may cause irritation to the mucous membranes.

3. How to use NiQuitin Extra Fresh

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor, pharmacist, or nurse. If you are in doubt, you should consult your doctor, pharmacist, or nurse.
During the treatment with NiQuitin Extra Fresh, you should stop smoking tobacco. However, if you do smoke a cigarette, do not stop the treatment.
If you still have trouble quitting smoking, you should consult your doctor, pharmacist, or nurse.
NiQuitin Extra Fresh 2 mg chewing gum is recommended for people who smoke less than 20 cigarettes a day.
NiQuitin Extra Fresh 4 mg chewing gum is recommended for people who smoke 20 or more cigarettes a day.
NiQuitin Extra Fresh gum should not be chewed like normal gum, quickly and continuously, as the nicotine is released too intensely. This can cause discomfort (such as heartburn or hiccups).
NiQuitin Extra Fresh should be used after removing the paper wrapper and taking the gum out of the blister pack.
The gum should be placed in the mouth, chewed slowly until the taste is felt (about 1 minute), then stopped and placed between the cheek and gum. You should start chewing again when the taste has gone. This should be repeated several times for 30 minutes, until the gum has lost its taste. While chewing the gum, you should not eat or drink, as this can reduce the absorption of nicotine. Do not use more than 15 pieces of gum per day. If you feel the need to use the medicine for longer than 9 months, you should consult your doctor, pharmacist, or nurse.
NiQuitin Extra Fresh should be taken 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).
• Treatment should be stopped when the number of pieces of gum used has decreased to 1 to 2 per day.

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 a higher dose than recommended. During treatment, do not smoke cigarettes or take nicotine in any other form. Use the medicine as directed and do not take more than 15 pieces of gum per day.

Children (under 12 years of age)

NiQuitin Extra Fresh should not be used in children under 12 years of age.

If you are concerned about relapse

If you are concerned about relapse or have trouble quitting smoking, you should 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 Extra Fresh

If you use more than the recommended dose of NiQuitin Extra Fresh, you may experience nausea, dizziness, and feeling unwell. You should then stop using the medicine and consult your doctor or go to the emergency room immediately. You should take the package leaflet or the packaging of the medicine with you so that you can show it.
The medicine is not suitable for children under 12 years of age or non-smokers. If a child or non-smoker takes the medicine, they may experience symptoms of nicotine overdose, such as headache, vomiting, stomach pain, and diarrhea. If a child uses or swallows the medicine, you should take them to the emergency room or consult a doctor immediately. If possible, you should show the doctor the package leaflet or the packaging of the medicine.
If you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, NiQuitin Extra Fresh can cause side effects, although not everybody gets them.
No serious side effects have been reported with the recommended use of NiQuitin Extra Fresh.
Quitting 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 quitting smoking.
You should consult your doctor and stop using NiQuitin Extra Fresh if you experience any of the following symptoms of an allergic reaction:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing,
• heart rhythm disturbances.

Other side effects are listed below in groups based on their frequency.

Common: may affect up to 1 in 10 people

• nausea, feeling unwell in the stomach,
• sore throat, pain and/or dryness in the mouth, irritation or ulcers in the mouth, sore throat, coughing,
• sleep disturbances, headaches, irritability, dizziness,
• vomiting, hiccups, indigestion, bloating, diarrhea, constipation,
• jaw pain.

These side effects are usually mild and often disappear on their own after a few days of treatment.
Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 10,000 people

• Severe allergic reactions with symptoms such as wheezing, feeling of tightness in the chest, skin rash, or feeling of impending fainting.

If you experience any side effects, including any possible side effects not listed in the package leaflet, you should consult your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including any side effects not listed in the package leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Extra Fresh

• The medicine should be kept out of sight and out of reach of children.
• Do not use this medicine after the expiry date stated on the blister pack and the outer packaging. The expiry date refers to the last day of the month.
• Do not store above 25°C.
• Store in the original packaging.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What NiQuitin Extra Fresh contains

• The active substance of the medicine is nicotine. Each piece of gum contains 2 mg or 4 mg of nicotine (in the form of nicotine with a cation exchange resin).
• The other ingredients of the medicine 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, Eukamentol, and Lewomentol.

What NiQuitin Extra Fresh looks like and what the package contains

The medicine is in the form of white or almost white rectangular chewing gum.
Each blister pack contains 4 or 10 pieces of chewing gum.
The package contains 4, 10, 30, 100, or 200 pieces of chewing gum. Not all packages may be marketed.

Marketing authorization holder:

Omega Pharma 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 marketing in the Member States of the European Union under the following trade names:

Austria
NiQuitin Minze 2 mg & 4mg wirkstoffhaltiges Kaugummi
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 2 mg & 4mg léčivá žvýkací guma
Denmark
NiQuitgum Mint medicinsk tyggegummi 2 mg & 4mg
Estonia
NiQuitin Mint
Finland
NiQuitin Mint 2 mg & 4mg lääkepurukumi
Germany
NiQuitin Minze 2 mg & 4mg wirkstoffhaltiges Kaugummi
Greece
NiQuitin Extra Fresh Mint
Hungary
NiQuitin Menthol Fresh 2 mg & 4mg gyógyszeres rágógumi
Ireland
NiQuitin Fresh Mint 2mg & 4mg Medicated Chewing Gum
Italy
NIQUITINACT 2 & 4 mg gomme da masticare medicate
Latvia
NiQuitin Mint 2 mg & 4mg Medicated Chewing Gum
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
Norway
Nicabate
Poland
NiQuitin Extra Fresh
Portugal
NiQuitin Menta Fresca 2mg & 4 mg gomas para mascar medicamentosas
Romania
NIQUITIN FRESH MINT 2 mg & 4 mg, gumă masticabilă medicamentoasă
Slovakia
NiQuitin Freshmint 2 mg & 4 mg mg liečivé žuvačky
Spain
NiQuitin Extra Fresh Mint 2 mg & 4 mg chicles medicamentosos
Sweden
NiQuitin Mint 2 mg & 4 mg medicinskt tuggummi
United Kingdom
Nicabate Extra Fresh Mint 2 mg Medicated Chewing Gum

Date of last revision of the package leaflet: July 2018

Other sources of information

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