Niko-lek Mint

Leaflet accompanying the packaging: patient information

NIKO-LEK MINT, 2 mg, chewing gum, medicinal

NIKO-LEK MINT, 4 mg, chewing gum, medicinal

Nicotine
For use in adults.

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Niko-lek Mint and what is it used for
• 2. Important information before using Niko-lek Mint
• 3. How to use Niko-lek Mint
• 4. Possible side effects
• 5. How to store Niko-lek Mint
• 6. Contents of the packaging and other information

1. What is Niko-lek Mint and what is it used for

Niko-lek Mint is a chewing gum containing an active substance that helps to quit smoking..
Niko-lek Mint is used to treat nicotine addiction, it works by relieving withdrawal symptoms, thereby helping to quit smoking.
Even smokers who are currently unable to quit completely can first use Niko-lek Mint to reduce cigarette smoking (smoking reduction) in order to quit smoking later.
Niko-lek Mint 2 mg is intended for smokers who smoked a maximum of 20 cigarettes per day before starting treatment.
Niko-lek Mint 4 mg is intended for heavily addicted smokers who smoked more than 20 cigarettes per day before starting treatment.
The effectiveness of the treatment can be increased with appropriate counseling and the use of other supportive measures.

2. Important information before using Niko-lek Mint

When not to use Niko-lek Mint

• if you are allergic to nicotine, levomenthol, maltitol (E965) and butylhydroxytoluene (E321) or any of the other ingredients of this medicine (listed in section 6);
• if you do not smoke tobacco, if you smoke occasionally and smoke one cigarette a day or less.

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Warnings and precautions

Before starting to use Niko-lek Mint, you should discuss it with your doctor or pharmacist.
You can use Niko-lek Mint chewing gum on your own, but you should consult a doctor if:

• you have had a heart attack or stroke in the last 3 months,
• you have chest pain caused by unstable angina,
• you have a disease that affects heart rate and rhythm,
• you have high blood pressure that is not controlled with medication,
• you have ever had allergic reactions, such as swelling of the lips, face, and throat (angioedema), itchy skin reactions (hives); the use of nicotine replacement therapy may sometimes cause such reactions,
• you have moderate or severe liver failure,
• you have severe kidney failure,
• you have diabetes,
• you have hyperthyroidism,
• you have a pheochromocytoma,
• you have esophagitis,
• if you have stomach or duodenal ulcers.

Your doctor will carefully weigh the risks of using nicotine replacement therapy against the benefits of quitting smoking.
Side effects related to high blood nicotine levels may occur if you smoke soon after chewing Niko-lek Mint. Please consider situations where you are particularly prone to reaching for a cigarette without thinking.
Existing nicotine addiction caused by tobacco may persist during nicotine replacement therapy, but using nicotine alone is less harmful than smoking tobacco.
People wearing dentures may have difficulty chewing the product due to the stickiness of Niko-lek Mint; in some cases, it may not be possible to use Niko-lek Mint in them. Dental fillings or implants that are not properly secured may become even more loose when chewing Niko-lek Mint.

Risk to children:

Nicotine used in a dose suitable for adults may cause serious, even fatal, poisoning in children. For this reason, the Niko-lek Mint product must be kept out of sight and out of reach of children at all times (see section 3 "Using a higher dose of Niko-lek Mint than recommended").

Children and adolescents

Nicotine chewing gums should not be used in children under 12 years of age.
Persons under 18 years of ageshould not use the Niko-lek Mint product unless a doctor decides otherwise.

Niko-lek Mint and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
After quitting smoking, changes in the body may increase the effect of insulin. Your doctor may reduce the dose of insulin.
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The effectiveness of the following medicines may also increase:

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

Niko-lek Mint with food and drink

While chewing Niko-lek Mint gum, you should not eat or drink, as this may reduce the effectiveness of the gum.
Drinks that lower the pH in the mouth, such as coffee, fruit juices, or carbonated drinks, may reduce the absorption of nicotine from the mouth. To achieve maximum nicotine absorption, you should wait 15 minutes after consuming such a drink before taking the medicinal chewing gum.

Pregnancy and breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Quitting smoking during pregnancy is extremely important, as smoking can have a negative effect on the development of the child. It can also lead to premature birth or stillbirth.
In an ideal situation, a pregnant woman should stop smoking without the help of nicotine-containing medicines. However, if this is not possible, the Niko-lek Mint product can be used only after consulting a doctor.
Breastfeeding
You should avoid using Niko-lek Mint while breastfeeding, as nicotine passes into breast milk and may affect the baby. If your doctor has recommended using Niko-lek Mint during breastfeeding, you should take the gum immediately after breastfeeding, and not during or before breastfeeding.
Fertility
Smoking may have an adverse effect on fertility in both men and women. The specific effect of nicotine on these processes is not known. If possible, women planning a pregnancy should not smoke or use nicotine replacement therapy.

Driving and using machines

The Niko-lek Mint product has no or negligible influence on the ability to drive and use machines.

Niko-lek Mint contains maltitol (E965), butylhydroxytoluene (E321), and sodium

If your doctor has told you that you do not tolerate some sugars, you should consult your doctor before using the Niko-lek Mint medicinal product.
Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or irritation of the mucous membranes.
The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is essentially 'sodium-free'.

3. How to use Niko-lek Mint

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This medicine should always be used exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If you are in any doubt, you should ask your doctor or pharmacist.
If your doctor has not prescribed a different dosage, the recommended doses are as follows:
Quitting smoking

Adults and the elderly [Only for 2 mg gum]

1 piece of Niko-lek Mint 2 mg per hour, maximum 24 pieces per day, usually 8 to 12 pieces are used

• for smokers who are not heavily addicted to tobacco (less than 20 cigarettes per day).

Niko-lek Mint 2 mg should be used whenever you would normally reach for a cigarette or when you feel the urge for nicotine. To increase the chances of success in quitting smoking and avoiding relapse, it is essential to chew the right amount of Niko-lek Mint 2 mg every day.
Experience has shown that smokers who want to quit smoking need less Niko-lek Mint than the number of cigarettes they used to smoke during the day. For heavily addicted smokers (more than 20 cigarettes per day), there is a product in the form of a 4 mg nicotine gum. Ask your pharmacist about it.
[Only for 4 mg gum]
1 piece of Niko-lek Mint 4 mg per hour, maximum 16 pieces per day, usually 8 to 12 pieces are used

• for smokers who are heavily addicted to tobacco (it is considered that a smoker is more addicted to tobacco if they smoke their first cigarette within 20 minutes of waking up and smoke more than 20 cigarettes per day),
• for smokers who have not been able to quit smoking with a lower dose of Niko-lek Mint 2 mg.

Niko-lek Mint 4 mg should be used whenever you would normally reach for a cigarette or when you feel the urge for nicotine. To increase the chances of success in quitting smoking and avoiding relapse, it is essential to chew the right amount of Niko-lek Mint 4 mg every day.
Experience has shown that smokers who want to quit smoking need less Niko-lek Mint than the number of cigarettes they used to smoke during the day.
Reducing smoking with subsequent cessation:
The Niko-lek Mint 2 mg product should be used between cigarettes to reduce the craving for tobacco and thus extend the time without smoking. The goal of use is to limit smoking as much as possible.
The Niko-lek Mint 4 mg product should be used between cigarettes to reduce the craving for tobacco and thus extend the time without smoking. The goal of use is to limit smoking as much as possible.

Children and adolescents

Nicotine chewing gums should not be used in children under 12 years of age.
Adolescents (12 years and older and under 18 years) should use nicotine chewing gums only if advised by a doctor. Experience with the use of nicotine chewing gums in children and adolescents under 18 years is limited.
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Method of use

1 Niko-lek Mint chewing gum is chewed for about 30 minutes with breaks to release all the available nicotine from the gum base. It is essential to chew the Niko-lek Mint gum slowly. You should avoid fast and/or intense chewing of the gum, so that the nicotine is not released too quickly from the gum base.

In order to do this, the chewing gum should be chewed until an intense taste is felt. Then, it is essential to place and keep the chewing gum between the gum and the cheek until the taste disappears. Then you can resume chewing. To increase the chances of success, it is essential to

avoid giving too small a dose. Therefore, you should chew the right amount of Niko-lek Mint every day.

Duration of treatment

Quitting smoking
[Only for 2 mg gum]
Niko-lek Mint 2 mg should be used for at least 3 months.

• 1 piece of Niko-lek Lemon 2 mg per hour, maximum 24 pieces per day, usually 8 to 12 pieces are used
• 4 to 6 weeks after starting treatment, the dose should be gradually reduced by chewing Niko-lek Mint 2 mg at intervals longer than 1 hour.
• The first attempt to stop using Niko-lek Mint 2 mg should be made when the average daily consumption over the last week was 1 to 2 pieces of gum.

[Only for 4 mg gum]
Niko-lek Mint 4 mg should be used for at least 3 months.

• 1 piece of Niko-lek Lemon 4 mg per hour, maximum 16 pieces per day, usually 8 to 12 pieces are used
• 4 to 6 weeks after starting treatment, the dose should be gradually reduced by chewing Niko-lek Mint 4 mg at intervals longer than 1 hour.
• The first attempt to stop using Niko-lek Mint 4 mg should be made when the average daily consumption over the last week was 1 to 2 pieces of gum.

However, the medicinal product should always be kept on hand for some time after stopping treatment to counteract the desire to smoke again.
It is not recommended to use Niko-lek Mint for more than 6 months. In some cases, longer treatment may be necessary to prevent relapse into smoking addiction.
Reducing smoking with subsequent cessation:
You should completely quit smoking as soon as you feel ready, but no later than 6 months after starting to use Niko-lek Mint. If this is not achieved within 9 months of starting to use Niko-lek Mint, you should consult a doctor.
You should read the relevant instructions for quitting smoking. For example, do the following:

1. Step 1 – 0-6 weeks: reduce the number of cigarettes smoked by 50%

You should chew Niko-lek Mint gum whenever you feel the urge to light a cigarette. Try to reduce your cigarette consumption by half by the end of the sixth week – or even earlier if possible.

2. Step 2 – within 6 months

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Continue to reduce cigarette smoking until you completely quit smoking. To avoid relapse, you should chew Niko-lek Mint whenever you feel the urge to smoke. Try to quit smoking within 4 months or earlier if you can.

3. Step 3 – within 9 months: Quit smoking!

Using a higher dose of Niko-lek Mint than recommended

Overdose symptoms may occur due to excessive use of Niko-lek Mint and/or smoking cigarettes. The risk of poisoning due to swallowing the gum is very low, as absorption of nicotine is slow and incomplete without chewing. The symptoms of Niko-lek Mint overdose are similar to those of acute nicotine poisoning: nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing disturbances, and significant weakness. At high doses, these symptoms may be accompanied by low blood pressure, weak and irregular pulse, breathing difficulties, extreme exhaustion, circulatory collapse (collapse caused by very low blood pressure), and convulsions.
Doses of nicotine tolerated by adult smokers during treatment can cause severe poisoning symptoms in small children and can be fatal. Suspected nicotine poisoning in a child should be treated as a medical emergency - you should contact a doctor or a hospital emergency department, providing information about the poisoning.

In the event of overdose, you should temporarily stop taking nicotine. Then, you should reduce nicotine intake by reducing the frequency of use or using a lower strength.
In the event of nicotine poisoning symptoms, you should immediately stop taking nicotine. Contact your doctor or a hospital emergency department. If necessary, you will be given symptomatic treatment. In the case of oral ingestion of excessive amounts of nicotine, activated charcoal may reduce the absorption of nicotine from the gastrointestinal tract.

If you miss a dose of Niko-lek Mint

You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Niko-lek Lemon may cause side effects similar to those that occur when using nicotine in another form. Most side effects occur in the early stages of treatment and are usually dose-dependent.
Effects related to quitting smoking (nicotine withdrawal)
Some side effects that may occur after quitting smoking may be withdrawal symptoms resulting from reduced nicotine intake.

• Irritability, frustration, impatience, or anger
• Anxiety, nervousness, or concentration problems
• Insomnia or sleep disturbances
• Increased appetite or weight gain, constipation

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• Feeling depressed
• Cravings for cigarettes
• Decreased heart rate
• Bleeding in the mouth
• Dizziness or fainting
• Cough, sore throat, stuffy nose, or runny nose

You should stop using Niko-lek Lemon and immediately contact your doctor if you experience any symptoms of an allergic reaction, which can be severe (such as angioedema).
These are rare side effects (may affect up to 1 in 1000 people using the medicine):

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and breathing difficulties.

After quitting smoking, mouth ulcers may appear. The cause of this is unclear. However, it can be assumed that the side effects during treatment with Niko-lek Lemon are less severe than those that occur when smoking, due to the lower maximum blood nicotine levels. In addition to the effects of nicotine, smoking poses an additional risk to smokers and passive smokers due to the known harmful effects of carbon monoxide, tar, and other toxic substances.
Throat irritation, increased salivation, and occasional damage to the oral mucosa may occur. Hiccups may also occur at the beginning of treatment due to frequent swallowing of nicotine-containing saliva. If you have a tendency to stomach hypersensitivity, Niko-lek Lemon may cause mild stomach upset or heartburn. Slow chewing with longer breaks may help to alleviate this.

Side effects that occur very frequently (may affect more than 1 in 10 people using the medicine)

• headache
• cough
• hiccups
• nausea
• irritation of the mouth or throat

Side effects that occur frequently (may affect up to 1 in 10 people using the medicine)

• hypersensitivity
• dizziness,
• taste disturbances
• tingling
• diarrhea
• indigestion
• dry mouth
• increased salivation
• oral inflammation
• vomiting (nausea)
• burning sensation
• bloating
• fatigue, exhaustion
• abdominal pain

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Side effects that occur uncommonly (may affect up to 1 in 100 people using the medicine)

• unusual dreams
• hives
• palpitations (rapid heartbeat)
• hot flashes
• high blood pressure
• sudden constriction of small airways in the lungs
• loss or damage to the voice
• shortness of breath
• nasal congestion
• mouth and throat pain
• coughing
• feeling of pressure in the throat
• belching
• tongue inflammation
• ulceration and inflammation of the oral mucosa
• numbness of the mouth
• weakness
• discomfort and chest pain
• malaise
• excessive sweating
• itching
• rash
• jaw muscle pain

Side effects that occur rarely (may affect up to 1 in 1000 people using the medicine):

• difficulty swallowing
• decreased sensitivity in the mouth
• nausea

Side effects of unknown frequency:

• allergic reactions (anaphylaxis)
• blurred vision
• increased tear production
• dry throat
• gastrointestinal disorders
• lip pain
• facial, tongue, or throat swelling (angioedema)
• skin redness
• muscle tension

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
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Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.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 Niko-lek Mint

The medicine should be stored out of sight and out of reach of children.
Store in a temperature below 25 °C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
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 packaging and other information

What Niko-lek Mint contains

[Only for 2 mg]
The active substance of the medicine is nicotine. One piece of chewing gum contains 2 mg of nicotine (in the form of 13.2 mg of nicotine bitartrate).

• The other ingredients are: gum base:gum base (contains butylhydroxytoluene [E321]), xylitol, calcium carbonate, sodium carbonate anhydrous, peppermint flavor, sodium bicarbonate, Coolmix flavor, levomenthol, acesulfame potassium, sucralose; coating:maltitol (E965), liquid maltitol, peppermint flavor, titanium dioxide (E171), Coolmix flavor, levomenthol, sucralose.

[Only for 4 mg]
The active substance of the medicine is nicotine. One piece of chewing gum contains 4 mg of nicotine (in the form of 26.5 mg of nicotine bitartrate).

• The other ingredients are: gum base:gum base (contains butylhydroxytoluene [E321]), xylitol, calcium carbonate, sodium carbonate anhydrous, peppermint flavor, Coolmix flavor, levomenthol, acesulfame potassium, sucralose; coating:maltitol (E965), liquid maltitol, peppermint flavor, titanium dioxide (E171), Coolmix flavor, levomenthol, sucralose.

What Niko-lek Mint looks like and contents of the pack

Niko-lek Mint is a white or almost white, slightly convex, rectangular chewing gum with approximate dimensions of 19 x 12 mm.
The Niko-lek Mint packaging contains 12, 20, 24, 30, 36, 48, 50, 80, 96, or 108 medicinal chewing gums in blisters placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

US Pharmacia Sp. z o.o.
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Ziębicka Street 40, 50-507 Wrocław
To obtain more detailed information, you should contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
phone +48 (22) 543 60 00

Manufacturer

Fertin Pharma A/S
Dandyvej 19, DK-7100 Vejle
Denmark

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

[Only for 2 mg]
Germany
Voye Mint 2 mg wirkstoffhaltiges Kaugummi
France
NICOTINE EUROGENERICS MENTHE 2 mg SANS SUCRE, gomme à mâcher médicamenteuse édulcorée au xylitol, à l'acésulfame potassium, au sucralose et au maltitol
Spain
Quitt 2 mg chicle medicamentoso sabor menta
Poland
NIKO-LEK MINT
[Only for 4 mg]
Germany
Voye Mint 4 mg wirkstoffhaltiges Kaugummi
France
NICOTINE EUROGENERICS MENTHE 4 mg SANS SUCRE, gomme à mâcher médicamenteuse édulcorée au xylitol, à l'acésulfame potassium, au sucralose et au maltitol
Spain
Quitt 4 mg chicle medicamentoso sabor menta
Poland
NIKO-LEK MINT
Date of last revision of the leaflet:July 2024
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