Niko-lek mint

Package leaflet: Information for the patient

NIKO-LEK MINT, 2 mg, chewing gum, medicinal
NIKO-LEK MINT, 4 mg, chewing gum, medicinal
nicotinum
For use in adults.
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Niko-Lek Mint is and what it is 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 pack and other information

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

Niko-Lek Mint is a chewing gum containing an active substance that helps in quitting smoking.
Niko-Lek Mint is used for the treatment of nicotine dependence and works by reducing
withdrawal symptoms, thereby supporting smoking cessation.
Even smokers who are currently unable to completely stop smoking may initially use Niko-Lek Mint to reduce cigarette consumption (smoking reduction) as a step towards quitting smoking.
Niko-Lek Mint 2 mg is intended for smokers who smoked up to 20 cigarettes per day before starting treatment.
Niko-Lek Mint 4 mg is intended for heavily dependent smokers who smoked more than 20
cigarettes per day before starting treatment.
The effectiveness of treatment can be increased by combining it with appropriate counseling and other supportive measures.

2. Important information before using Niko-Lek Mint

When not to use Niko-Lek Mint

• if the patient is allergic to nicotine, levomenthol, maltitol (E965), or butylhydroxytoluene (E321), or any of the other ingredients of this medicine (listed in section 6);
• if the patient does not smoke tobacco, or if the patient smokes occasionally and smokes one cigarette or fewer per day.

Warnings and precautions
Before starting to use Niko-Lek Mint, discuss this with your doctor or pharmacist.
You may use Niko-Lek Mint gum on your own, but you should consult your doctor if:

• you have recently (within the last 3 months) had a myocardial infarction or stroke,
• you suffer from chest pain caused by unstable angina,
• you have a condition affecting heart rate and rhythm,
• you have high blood pressure that is not controlled by medication,
• you have previously experienced allergic reactions such as swelling of the lips, face, and throat (angioedema), or itchy skin reactions (urticaria); nicotine replacement therapy may sometimes cause such reactions,
• you have moderate or severe liver impairment,
• you have severe renal impairment,
• you have diabetes,
• you have hyperthyroidism,
• you have a pheochromocytoma,
• you have been diagnosed with oesophagitis,
• you have gastric or duodenal ulcer disease.

Your doctor will carefully weigh the risks of using nicotine replacement therapy against the benefits of quitting smoking.
Adverse effects related to high blood nicotine levels may occur if you smoke shortly after chewing Niko-Lek Mint. Please consider situations in which you are particularly likely to reach for a cigarette without thinking.
The pre-existing nicotine dependence caused by tobacco may persist during nicotine replacement therapy; however, 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, use of Niko-Lek Mint may not be possible. Dental fillings or inlays that are not properly secured may become further loosened during chewing of Niko-Lek Mint.

Risk to children:
Nicotine administered at doses appropriate for adults may cause severe, even fatal, poisoning in children. Therefore, Niko-Lek Mint must always be stored out of sight and out of reach of children (see section 3, "Use of a higher than recommended dose of Niko-Lek Mint").

Children and adolescents
Nicotine chewing gum should not be used in children under 12 years of age.
Individuals under 18 years of age should not use Niko-Lek Mint unless otherwise decided by a doctor.

Niko-Lek Mint and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
After quitting smoking, changes in the body may enhance the effect of insulin. Your doctor may need to reduce your insulin dose.
The effectiveness of the following medicines may also increase:

• theophylline (used in the treatment of asthma),
• tacrine (a medicine used in Alzheimer's disease),
• clozapine (a medicine for schizophrenia),
• ropinirole (a medicine used in 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 its effectiveness.
Beverages that lower the pH in the mouth, such as coffee, fruit juices, or carbonated drinks, may reduce the absorption of nicotine from the oral cavity. To achieve maximum nicotine absorption, a 15-minute interval should be maintained between consuming such a drink and using the medicinal chewing gum.

Pregnancy and breastfeeding and effect on fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

Pregnancy
Stopping smoking during pregnancy is extremely important, as smoking may negatively affect the child's development. It may also lead to premature birth or stillbirth. Ideally, a pregnant woman should stop smoking without using nicotine-containing medicines. However, if this is not possible, Niko-Lek Mint may be used only after consulting a doctor.

Breastfeeding
Niko-Lek Mint should be avoided during breastfeeding, as nicotine passes into breast milk and may affect the infant. If your doctor has advised using Niko-Lek Mint during breastfeeding, the chewing gum should be taken immediately after breastfeeding, not during or before feeding.

Fertility
Smoking may have an adverse effect on fertility in both women and men. The specific effect of nicotine on these processes is unknown. If possible, women planning pregnancy should neither smoke nor use nicotine replacement therapy.

Driving and operating machinery
Niko-Lek Mint has no effect or a negligible effect on the ability to drive and operate machinery.

Niko-Lek Mint contains maltitol (E965), butylhydroxytoluene (E321), and sodium
If your doctor has informed you that you are intolerant to certain sugars, consult your doctor before starting to use Niko-Lek Mint medicinal product.
Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of mucous membranes.
The medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, meaning the medicine is considered "sodium-free".

3. How to use Niko-Lek Mint

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Unless otherwise prescribed by a doctor, the recommended dosage is as follows:

Smoking cessation

Adults and elderly patients
[For 2 mg gum only]

1 piece of Niko-Lek Mint 2 mg per hour, up to a maximum of 24 pieces daily, although typically 8 to 12 pieces are used

• in smokers who are not heavily dependent on 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 nicotine cravings occur. To increase the chances of successfully quitting smoking and to prevent relapse, it is important to chew an adequate number of Niko-Lek Mint 2 mg pieces daily. Experience shows that smokers trying to quit require fewer pieces of Niko-Lek Mint than the number of cigarettes previously smoked per day.

For heavily dependent smokers (more than 20 cigarettes per day), a 4 mg nicotine chewing gum product is available. Ask your pharmacist.

[For 4 mg gum only]

1 piece of Niko-Lek Mint 4 mg per hour, up to a maximum of 16 pieces daily, although typically 8 to 12 pieces are used

• in smokers who are heavily dependent on tobacco (a smoker is considered more dependent if they smoke their first cigarette within 20 minutes of waking and smoke more than 20 cigarettes per day),
• in smokers who were unable to quit using the 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 nicotine cravings occur. To increase the chances of successfully quitting smoking and to prevent relapse, it is important to chew an adequate number of Niko-Lek Mint 4 mg pieces daily. Experience shows that smokers trying to quit require fewer pieces of Niko-Lek Mint than the number of cigarettes previously smoked per day.

Smoking reduction with subsequent smoking cessation:

Niko-Lek Mint 2 mg should be used between cigarettes to reduce tobacco cravings and thereby extend the time without smoking. The goal is to reduce smoking as much as possible.

Niko-Lek Mint 4 mg should be used between cigarettes to reduce tobacco cravings and thereby extend the time without smoking. The goal is to reduce smoking as much as possible.

Children and adolescents

Nicotine chewing gums must not be used in children under 12 years of age.

Adolescents (aged 12 years and older but under 18 years) should only use nicotine chewing gums if recommended by a doctor. Experience with the use of nicotine chewing gums in children and adolescents under 18 years of age is limited.

Instructions for use

One piece of Niko-Lek Mint chewing gum should be chewed intermittently for about 30 minutes to release all available nicotine from the gum base. It is important to chew the gum slowly. Avoid chewing too quickly or vigorously, as this may cause nicotine to be released too rapidly from the gum.

To achieve this, chew the gum until a strong taste is noticeable. Then it is important to place and hold the gum between the gum and the cheek until the taste fades. Chewing can then be resumed. To increase the chances of success, it is important to avoid using too low a dose. Therefore, an adequate number of Niko-Lek Mint pieces should be chewed daily.

Duration of treatment

Smoking cessation

[For 2 mg gum only]
Niko-Lek Mint 2 mg should be used for at least 3 months.

• 1 piece of Niko-Lek Lemon 2 mg per hour, up to a maximum of 24 pieces daily, although typically 8 to 12 pieces are used.
• 4 to 6 weeks after starting treatment, gradually reduce the dose 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 past week has been 1 to 2 pieces of chewing gum.

[For 4 mg gum only]
Niko-Lek Mint 4 mg should be used for at least 3 months.

• 1 piece of Niko-Lek Lemon 4 mg per hour, up to a maximum of 16 pieces daily, although typically 8 to 12 pieces are used.
• 4 to 6 weeks after starting treatment, gradually reduce the dose 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 past week has been 1 to 2 pieces of chewing gum.

However, the medicinal product should remain readily available for some time after stopping treatment to help resist the urge to smoke again.

Use of Niko-Lek Mint for longer than 6 months is not recommended. However, in some former smokers, longer treatment may be necessary to prevent relapse.

Smoking reduction with subsequent smoking cessation:

Smoking should be completely stopped as soon as you feel ready, but no later than 6 months after starting Niko-Lek Mint. If this goal has not been achieved within 9 months of starting Niko-Lek Mint, consult your doctor.

Please follow the appropriate instructions for quitting smoking. For example, follow these steps:

1. Step 1 – 0-6 weeks: Reduce cigarette consumption by 50%
Chew Niko-Lek Mint whenever you feel the urge to smoke. Try to reduce cigarette consumption by half by the end of the sixth week—or even earlier, if possible.

2. Step 2 – Within 6 months
Continue reducing cigarette smoking until you stop completely. To prevent relapse, chew Niko-Lek Mint every time you feel the urge to smoke. Try to quit smoking within 4 months or earlier, if possible.

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

Use of a higher than recommended dose of Niko-Lek Mint

Symptoms of overdose may occur due to excessive use of Niko-Lek Mint and/or continued smoking. The risk of poisoning from swallowing the gum is very low, as nicotine absorption is slow and incomplete without chewing. Symptoms of Niko-Lek Mint overdose are similar to those of acute nicotine poisoning: nausea, vomiting, excessive salivation, abdominal pain, diarrhoea, excessive sweating, headache, dizziness, hearing disturbances, and marked weakness. With large doses, these symptoms may be accompanied by low blood pressure, weak and irregular pulse, breathing difficulties, severe exhaustion, circulatory collapse (due to very low blood pressure), and seizures.

Nicotine doses tolerated by adult smokers during treatment may cause severe poisoning symptoms in young children and may be fatal. Suspected nicotine poisoning in a child should be treated as a medical emergency—contact a doctor or an emergency hospital department immediately.

Management in case of overdose

If symptoms of nicotine overdose occur, temporarily discontinue nicotine use. Then reduce nicotine intake by decreasing the frequency of use or by switching to a lower strength.

If symptoms of nicotine poisoning occur, stop using nicotine immediately. Contact your doctor or emergency department. If necessary, symptomatic treatment will be provided. In cases of oral ingestion of excessive amounts of nicotine, activated charcoal may reduce nicotine absorption from the gastrointestinal tract.

If a dose of Niko-Lek Mint is missed

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everyone will experience them.
Niko-Lek Lemon may cause adverse effects similar to those occurring during the use of nicotine in other forms. Most adverse effects occur early in treatment and are usually dose-dependent.

Withdrawal symptoms associated with quitting smoking (nicotine withdrawal)
Some adverse effects that may occur after quitting smoking may be withdrawal symptoms resulting from reduced nicotine intake.
These include:

• Irritability, frustration, impatience or anger
• Anxiety, nervousness or difficulty concentrating
• Nighttime awakenings or sleep disturbances
• Increased appetite or weight gain, constipation
• Feeling depressed
• Cravings to smoke (urges)
• Decreased heart rate
• Bleeding in the oral cavity
• Dizziness or fainting
• Cough, sore throat, nasal congestion or runny nose

Treatment with Niko-Lek Lemon should be discontinued and medical advice sought immediately if the patient experiences any symptoms of an allergic reaction, which may be severe (such as angioedema).
The following are rare adverse effects (may occur in 1 out of 1,000 patients using the medicine):

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Urticaria and breathing difficulties

Oral ulcers may appear after quitting smoking. The cause is unclear. However, it can be assumed that adverse effects during treatment with Niko-Lek Lemon are less severe than those associated with smoking, due to lower maximum blood nicotine concentrations. In addition to the effects of nicotine, smoking poses additional risks for smokers and passive smokers due to the well-known harmful effects of carbon monoxide, tar, and other toxic substances.

Irritation of the throat, 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 saliva containing nicotine. In patients with a predisposition to gastric hypersensitivity, Niko-Lek Lemon may cause mild stomach upset or heartburn. Chewing slowly with longer breaks may help alleviate this.
In patients allergic to levomenthol, hypersensitivity reactions (including shortness of breath) may occur.

Very common adverse effects (may occur in more than 1 out of 10 patients using the medicine):

• Headache
• Cough
• Hiccups
• Nausea
• Irritation of the mouth or throat

Common adverse effects (may occur in 1 out of 10 patients using the medicine):

• Hypersensitivity
• Dizziness
• Taste disturbances
• Tingling
• Diarrhoea
• Indigestion
• Dry mouth
• Increased salivation
• Inflammation in the mouth
• Vomiting (nausea)
• Burning sensation
• Bloating
• Fatigue, tiredness
• Abdominal pain

Uncommon adverse effects (may occur in 1 out of 100 patients using the medicine):

• Unusual dreams
• Urticaria
• Palpitations (rapid heartbeat)
• Hot flushes
• High blood pressure
• Sudden constriction of the small airways in the lungs
• Loss or damage to voice
• Shortness of breath
• Nasal mucosal congestion
• Pain in the mouth and throat
• Sneezing
• Sensation of pressure in the throat
• Belching
• Inflammation of the tongue
• Ulceration and inflammation of the oral mucosa
• Numbness of the lips
• Weakness
• Discomfort and chest pain
• Malaise
• Excessive sweating
• Itching
• Rash
• Jaw muscle pain

Rare adverse effects (may occur in 1 out of 1,000 patients using the medicine):

• Difficulty swallowing
• Reduced sensitivity in the oral cavity
• Vomiting reflex

Adverse effects with unknown frequency:

• Allergic reactions (anaphylaxis)
• Blurred vision
• Increased tear production
• Dry throat
• Gastrointestinal disorders
• Lip pain
• Swelling of the face, tongue or throat (angioedema)
• Skin redness
• Muscle tension
• Rapid and irregular heartbeat (atrial fibrillation)

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
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 the medicine.

5. How to store Niko-Lek Mint

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Niko-Lek Mint contains
[for 2 mg only]

• The active substance is nicotine. One chewing gum contains 2 mg of nicotine (as 13.2 mg of nicotine polacrilex).
• Other ingredients are: gum core: gum base (contains butylated hydroxytoluene [E321]), xylitol, calcium carbonate, anhydrous sodium carbonate, peppermint flavour, sodium bicarbonate, Coolmix flavour, levomenthol, potassium acesulfame, sucralose; gum coating: maltitol (E965), liquid maltitol, peppermint flavour, titanium dioxide (E171), Coolmix flavour, levomenthol, sucralose.

[for 4 mg only]

• The active substance is nicotine. One chewing gum contains 4 mg of nicotine (as 26.5 mg of nicotine polacrilex).
• Other ingredients are: gum core: gum base (contains butylated hydroxytoluene [E321]), xylitol, calcium carbonate, anhydrous sodium carbonate, peppermint flavour, Coolmix flavour, levomenthol, potassium acesulfame, sucralose; gum coating: maltitol (E965), liquid maltitol, peppermint flavour, titanium dioxide (E171), Coolmix flavour, 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 pack 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 Authorisation Holder
Fertin Pharma A/S
Dandyvej 19, DK-7100 Vejle
Denmark

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

This medicinal product is authorised in the European Economic Area countries under the following names:
[for 2 mg only]
Germany: Nicotin AL 2 mg wirkstoffhaltiges Kaugummi mit Minzgeschmack
France: NICOTINE EUROGENERICS MENTHE 2 mg SANS SUCRE, gomme à mâcher médicamenteuse édulcorée au xylitol, à l'acésulfame potassique, au sucralose et au maltitol
Spain: Quitt 2 mg chicle medicamentoso sabor menta
Poland: NIKO-LEK MINT

[for 4 mg only]
Germany: Nicotin AL 4 mg wirkstoffhaltiges Kaugummi mit Minzgeschmack
France: NICOTINE EUROGENERICS MENTHE 4 mg SANS SUCRE, gomme à mâcher médicamenteuse édulcorée au xylitol, à l'acésulfame potassique, au sucralose et au maltitol
Spain: Quitt 4 mg chicle medicamentoso sabor menta
Poland: NIKO-LEK MINT