Nicorette classic gum

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Nicorette Classic Gum (Nicorette Classic 2 mg)
2 mg, medicated chewing gum
Nicotinum
Nicorette Classic Gum and Nicorette Classic 2 mg are different trade names for the same medicinal product.
Please read this leaflet carefully 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 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If after 9 months you still have difficulty refraining from smoking without the help of Nicorette Classic Gum, you should contact your doctor.

Table of contents:

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

1. What Nicorette Classic Gum is and what it is used for

Mechanism of action
When you stop smoking cigarettes and nicotine is no longer regularly supplied to the body, various withdrawal symptoms begin to appear, such as irritability, restlessness, mood disturbances, dizziness and headaches, and sleep disturbances. Nicorette Classic Gum can help prevent or reduce these symptoms by delivering small doses of nicotine to the body over a short period.
The nicotine in Nicorette Classic Gum is administered in pure form. Unlike cigarettes, Nicorette Classic Gum does not release harmful tar substances or carbon dioxide produced during combustion.

Indications
Nicorette Classic Gum is indicated for the treatment of tobacco dependence in individuals determined to quit smoking, by reducing nicotine cravings and withdrawal symptoms that occur after stopping smoking.

2. Important information before using Nicorette Classic Gum

When not to use Nicorette Classic Gum

• If the patient is allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
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Before starting to use Nicorette Classic Gum, consult a doctor if the patient has:

• recently suffered a stroke or heart attack,
• chest pain or symptoms of angina pectoris,
• heart disease affecting the heart rate or rhythm,
• uncontrolled high blood pressure,
• peptic ulcer of the stomach or duodenum,
• hyperthyroidism,
• insulin-dependent diabetes (lower insulin doses may be required as a result of stopping smoking),
• diagnosed phaeochromocytoma,
• severe or moderate liver disease,
• severe kidney disease,
• oesophagitis,
• a history of epilepsy or seizures.

The chewing gum may stick to, and in rare cases damage, dental prostheses.
Some patients may continue using Nicorette Classic Gum beyond the recommended treatment period. However, the potential risk of long-term use is significantly lower than the risk associated with returning to smoking tobacco.

Nicorette Classic Gum and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. Stopping smoking may require adjustment of dosages of other medicines.
If the patient is taking any of the following medicines, medical advice should be sought before using Nicorette Classic Gum: imipramine, clomipramine, fluvoxamine (used in the treatment of depression), clozapine, olanzapine (used in the treatment of schizophrenia), theophylline (used in the treatment of bronchial asthma, chronic obstructive pulmonary disease, and inflammatory airway conditions), tacrine (used in Alzheimer's disease), ropinirole (used in Parkinson's disease), flecainide (used, among others, in tachycardia, paroxysmal atrial fibrillation, and cardiac arrhythmias), pentazocine (a painkiller).

Using Nicorette Classic Gum with food and drink
Do not use simultaneously with food or drink.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult a doctor before using this medicine.
To reduce exposure to the infant, the medicine should be used immediately after breastfeeding. If smoking cannot be stopped, use of Nicorette Classic Gum by a breastfeeding woman should only begin after consultation with a doctor.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

Nicorette Classic Gum contains sorbitol
The medicine contains 190.25 mg of sorbitol per chewing gum. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—the patient should consult a doctor before taking this medicine.

The medicine contains flavouring 84.6422 with cinnamaldehyde, cinnamic alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, d-limonene, and linalool
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These substances may cause allergic reactions.

The medicine contains ethanol
The medicine contains 0.616 mg of alcohol (ethanol) per chewing gum. The amount of alcohol in one dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Nicorette Classic Gum contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use the medicine Nicorette Classic Gum

The medicine Nicorette Classic Gum is available in the following doses: 2 mg, 4 mg.
Children and adolescents
Nicorette Classic Gum chewing gum should not be used in individuals under 18 years of age without medical advice. Data on treatment with Nicorette Classic Gum in this age group are limited.
Adults and elderly
The initial dose should be individually determined based on the patient's degree of nicotine dependence. Typically, 8–12 pieces of gum containing the appropriate amount of nicotine are used per day. Smokers with low dependence (smoking ≤ 20 cigarettes/day) should start treatment with the 2 mg dose. Smokers with high dependence should start treatment with the 4 mg dose. Do not use more than 24 pieces of gum per day.
Smoking cessation
The gum should be used for at least 3 months. Then, gradual discontinuation of the gum should be initiated. Treatment should be completed when the dose has been reduced to 1–2 pieces per day.
Smoking reduction
The medicine Nicorette Classic Gum helps reduce the number of cigarettes smoked daily and supports taking the first step towards quitting smoking in individuals who do not wish or are unable to quit abruptly.
To extend the intervals between cigarettes and maximally reduce cigarette consumption, the gum should be used between cigarettes when the urge to smoke arises. If no reduction in daily cigarette consumption is achieved after 6 weeks, consult a doctor. Consider attempting complete smoking cessation as soon as possible, but no later than 6 months after starting treatment. If a serious attempt to quit smoking is not possible within 9 months of starting treatment, consult a doctor.
Generally, regular use of the gum for longer than 12 months is not recommended. However, some former smokers may require longer treatment to prevent relapse. Unused gum should be kept in case of sudden nicotine cravings.
Seek support from support groups, as they may assist in the process of quitting smoking and help ensure successful completion of therapy.
Temporary abstinence
Use the gum during breaks between cigarettes when the urge to smoke arises, for example, in places where smoking is prohibited or in other situations where one wishes to avoid smoking.
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Use of gum in combination with patches
The gum can be used alone or in combination with nicotine-containing patches. Using more than one form of nicotine replacement therapy (NRT) may be beneficial for smokers who have relapsed despite previous monotherapy with NRT or who have difficulty controlling cigarette cravings during monotherapy. Therefore, if necessary, the Nicorette Invisipatch 15 mg/16 h patch and Nicorette Classic Gum 2 mg gum may be used together.
The Nicorette Invisipatch 15 mg/16 h patch should be applied in the morning upon waking and removed after 16 hours, before going to sleep. It should be used according to the dosing regimen approved for monotherapy. The Nicorette Classic Gum 2 mg gum should be chewed when experiencing a strong urge to smoke, without exceeding the maximum daily dose of 15 pieces. The gum may be used in this way for up to 12 weeks, after which gum use should be gradually reduced. The maximum duration of gum use is 12 months.
How to chew Nicorette Classic Gum
Chew the gum when you feel the need to smoke. The gum is chewed to release nicotine, then chewing is stopped to allow absorption of nicotine through the oral mucosa. Nicotine swallowed with saliva has no beneficial effect and, in excess, may irritate the throat or stomach, causing, for example, hiccups. Nicorette Classic Gum should not be chewed continuously and vigorously like regular chewing gum, as this causes too rapid release of nicotine. Therefore, Nicorette Classic Gum should be chewed slowly, with regular pauses.
Chewing technique

1. Chew the gum slowly until you notice the taste.
2. Then stop chewing and place the gum between your gum and cheek.
3. Start chewing again when the taste fades.
4. Repeat this process for 30 minutes. This is how long it takes for all the nicotine in the gum to be released.

Use of a higher than recommended dose of Nicorette Classic Gum
Abuse of nicotine, either from nicotine replacement products and/or continued cigarette smoking, may lead to symptoms of overdose. The risk of poisoning following ingestion of the chewing gum is very low, as absorption of nicotine without chewing is slow and incomplete.
Symptoms of overdose are the same as those of acute nicotine poisoning and include nausea, vomiting, excessive salivation, abdominal pain, diarrhoea, excessive sweating, headache, dizziness, hearing disturbances, and marked weakness. After large doses, these symptoms may be accompanied by hypotension, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.
Doses of nicotine tolerated by adults during treatment may cause severe poisoning in young children and may be fatal.
Keep the medicine out of the reach of children. In case of overdose, stop administering nicotine immediately and seek medical help. The doctor will provide appropriate symptomatic treatment.
In the event of excessive nicotine ingestion, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many pieces of gum are used, or if a child chews or swallows gum, contact a doctor immediately or go to the nearest hospital, bringing the gum packaging and this leaflet with you.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody gets them.
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Some symptoms may occur as a result of stopping smoking. These include low mood, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience. Physical symptoms may also occur, such as decreased heart rate, increased appetite or weight gain, dizziness or pre-syncopal symptoms, cough, gum bleeding, aphthous ulcers or nasopharyngitis, and nicotine craving associated with the urge to smoke.
Most of the reported adverse reactions occur during the first weeks of treatment. Oral and throat irritation may occur, but most patients become accustomed to this during treatment.
The chewing gum may stick to, and in rare cases cause damage to, dental prostheses.
Allergic reactions (including severe allergic reactions) have been reported rarely during use of Nicorette Classic Gum.
Adverse reactions reported in at least 1% of patients treated with nicotine in clinical trials and post-marketing experience are listed in the table below. The frequency of occurrence is defined according to the following classification:
Very common (may affect up to 1 in 10 people)
Common (may affect up to 1 in 100 people)
Uncommon (may affect up to 1 in 1,000 people)
Rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)

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Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables better assessment of the safety of the medicinal product.

5. How to store Nicorette Classic Gum

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Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use Nicorette Classic Gum 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Nicorette Classic Gum contains

• The active substance is nicotine. One chewing gum contains 2 mg of nicotine – in the form of 20% nicotine resin complex.
• Other ingredients are: sodium hydrogen carbonate, sodium carbonate, gum base, sorbitol powder (E 420), sorbitol 70% solution, flavour Haverstroo, flavour 84.6422 (containing ethanol and trace amounts of cinnamaldehyde, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, d-limonene and linalool), glycerol 85%.

What Nicorette Classic Gum looks like and contents of the pack
The pack contains 15, 30 or 105 chewing gums in blisters of 15 pieces in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Greece, country of export:
Johnson & Johnson Hellas Consumer ΑΕ, Aigialeias & Epidavrou 4, 151 25, Marousi, Athens, Greece
Manufacturer:
McNeil AB, Norrbroplatsen 2, Helsingborg, Sweden
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Greece, country of export, marketing authorisation number: 71142/1-11-07
Parallel import authorisation number: 146/24
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