Nicorette Classic Gum

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nicorette Classic Gum (Nicorette 4 mg Sans Sucre), 4 mg, chewing gum, medicinal

Nicotine
Nicorette Classic Gum and Nicorette 4 mg Sans Sucre are different trade names for the same medicine.

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 directed by your doctor or pharmacist.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 9 months you are still having trouble quitting smoking without the help of Nicorette Classic Gum, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Nicorette Classic Gum and what is it 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 packaging and other information

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

Description of action

When a patient stops smoking cigarettes and nicotine is no longer regularly delivered to the body, various symptoms resulting from nicotine withdrawal begin to appear, including irritability, anxiety, mood disturbances, dizziness, and headaches, as well as sleep disturbances. With the help of Nicorette Classic Gum, you can prevent or alleviate these symptoms by delivering small doses of nicotine to the body over a short period.
Nicotine in Nicorette Classic Gum is administered in its pure form. Unlike cigarettes, Nicorette Classic Gum does not release harmful tar substances or carbon dioxide, which are produced during the combustion process.

Indications for use

Nicorette Classic Gum is indicated for the treatment of tobacco dependence in individuals who have decided 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 you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Nicorette Classic Gum, you should discuss it with your doctor if you have:

• recently had a stroke or heart attack,
• chest pain or symptoms of angina pectoris,
• heart disease that affects the speed or regularity of the heart rhythm,
• uncontrolled high blood pressure,
• peptic ulcer disease or duodenal ulcer,
• hyperthyroidism,
• insulin-dependent diabetes (you may need lower doses of insulin as a result of quitting smoking),
• proven pheochromocytoma,
• severe or moderate liver disease,
• severe kidney disease,
• esophagitis,
• a history of epilepsy or seizures.

Chewing gum may stick to dental work, and in rare cases, may cause damage to dental prostheses.
Some patients may continue to use Nicorette Classic Gum for longer than the recommended treatment period, but the potential risk of long-term use is much lower than the risk of addiction associated with returning to tobacco smoking.

Nicorette Classic Gum and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Quitting smoking may require modification of their dosing.
In the case of taking medicines such as imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (a medicine used to treat asthma, chronic obstructive pulmonary disease, and bronchitis), tacrine (a medicine used to treat Alzheimer's disease), ropinirole (a medicine used to treat Parkinson's disease), flecainide (a medicine used to treat arrhythmias, paroxysmal atrial fibrillation, and heart rhythm disorders), pentazocine (a pain reliever), you should consult your doctor before using Nicorette Classic Gum.

Using Nicorette Classic Gum with food and drink

You should not use it at the same time as eating and drinking.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Using Nicorette Classic Gum in a smoking pregnant woman can only be started after consulting a doctor.
If you are unable to quit smoking, using Nicorette Classic Gum while breastfeeding can only be started after consulting a doctor. To minimize exposure to the child, the medicine should be used immediately after breastfeeding.

Driving and operating machinery

The medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
The medicine contains 178.97 mg of sorbitol (E 420) per piece of chewing gum. Sorbitol is a source of fructose.
If you have previously been diagnosed with intolerance to some sugars or have previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking the medicine.
Nicorette Classic Gum contains butylhydroxytoluene (E 321). The medicine may cause irritation to the mucous membranes.
The medicine contains a flavoring with cinnamaldehyde, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeguenol, d-limonene, and linalool. These substances may cause allergic reactions.
The medicine contains 0.616 mg of alcohol (ethanol) per piece of 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 have noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Nicorette Classic Gum

Nicorette Classic Gum is available in the following doses: 2 mg, 4 mg.
Children and adolescents
Without a doctor's recommendation, you should not use Nicorette Classic Gum in people under 18 years of age. Data on the treatment of people in this age group with Nicorette Classic Gum are limited.
Adults and the elderly
The initial dose should be determined individually based on the degree of nicotine dependence. Usually, 8-12 pieces of gum with the appropriate nicotine content are used per day. People who smoke with a low degree of dependence (smoking ≤ 20 cigarettes/day) should start treatment with a 2 mg dose. People who smoke with a high degree of dependence should start treatment with a 4 mg dose. You should not use more than 15 pieces of gum per day.
Quitting smoking
The gum should be used for at least 3 months. Then you should start gradually reducing the gum. Treatment should be completed when the dose is reduced to 1-2 pieces of gum per day.
Reducing smoking
Nicorette Classic Gum helps to reduce the number of cigarettes smoked per day, taking the first step in quitting smoking for people who do not want to or are unable to quit immediately.
To prolong the intervals between smoking and to maximize the reduction in the number of cigarettes smoked, the gum should be used during the periods between cigarettes when the urge to smoke occurs. If after 6 weeks you do not achieve a reduction in the number of cigarettes smoked per day, you should consult your doctor.
You should consider trying to quit smoking as soon as possible, but no later than 6 months after starting treatment. If within 9 months of starting treatment, you are unable to make a serious attempt to quit smoking, you should consult your doctor.
Regular use of gum for a period longer than 12 months is not usually recommended. Some former smokers may require longer treatment to avoid returning to smoking. Unused gum should be kept in case of sudden nicotine cravings.
You should use support groups, as they can support the smoking cessation process and help complete therapy successfully.
Temporary abstinence
The gum should be used during breaks between cigarettes when the urge to smoke occurs, for example, in places where smoking is prohibited or in other situations where you want to avoid smoking.
How to chew Nicorette Classic Gum
The gum should be chewed when you feel the need to smoke. The gum is chewed to release nicotine, and then chewing is stopped to allow the nicotine to be absorbed through the oral mucosa. Nicotine swallowed with saliva has no beneficial effect and in excess can irritate the throat or stomach, causing, for example, hiccups. Nicorette Classic Gum should not be chewed like regular gum in a continuous and energetic manner, as nicotine is released too intensely.
Therefore, Nicorette Classic Gum should be chewed slowly, with regular breaks.

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

Using a higher than recommended dose of Nicorette Classic Gum

Overuse of nicotine, both from nicotine replacement products and (or) due to smoking, can cause overdose symptoms. The risk of poisoning as a result of swallowing chewing gum is very low, as absorption of nicotine without chewing is slow and incomplete.
Overdose symptoms are the same as those of acute nicotine poisoning and include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headaches, dizziness, hearing disturbances, and significant weakness. After high 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 can cause severe poisoning symptoms in small children and can be fatal. The medicine should be stored in a place inaccessible to children. In case of overdose, you should immediately stop administering nicotine and seek medical help. The doctor will provide appropriate symptomatic treatment.
In case of swallowing an excessive amount of nicotine, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many gums are used or if a child chews or swallows gum, you should immediately contact a doctor or go to the nearest hospital, taking the gum packaging and this leaflet with you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms may occur in connection with quitting smoking. These include worsening mood, insomnia, irritability, frustration, anger, anxiety, concentration problems, nervousness, or impatience. Physical symptoms may also occur, such as decreased heart rate, increased appetite or weight gain, dizziness or hyperventilation symptoms, cough, constipation, gum bleeding, aphthous ulcers, or pharyngitis, as well as nicotine cravings accompanied by the desire to smoke.
Most reported side effects occur within the first few weeks of starting treatment. Mouth and throat irritation may occur, but most patients get used to it during treatment.
Chewing gum may stick to dental work, and in rare cases, may cause damage to dental prostheses.
Rarely, allergic reactions may occur during treatment with Nicorette Classic Gum (including severe allergic reactions).
Side effects reported in at least 1% of patients treated with nicotine in clinical trials and after marketing are presented in the table below. The frequency of occurrence is defined according to the following scheme:
Very common (may occur in 1 to 10 out of 10 people)
Common (may occur in 1 to 10 out of 100 people)
Uncommon (may occur in 1 to 10 out of 1,000 people)
Rare (may occur in 1 to 10 out of 10,000 people)
Unknown (frequency cannot be estimated from available data)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Nicorette Classic Gum

The medicine should be stored in a place out of sight and reach of children.
Do not store in a temperature above 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. 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 Nicorette Classic Gum contains

• The active substance of the medicine is nicotine. One piece of chewing gum contains 4 mg of nicotine - in the form of a 20% nicotine resin complex.
• Other ingredients are: sodium carbonate (E 500), Dreyco gum, sorbitol (E 420), liquid sorbitol, crystallizing (E 420), Haverstroo flavor, flavor (contains ethanol and trace amounts of cinnamaldehyde, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeguenol, d-limonene, and linalool), glycerol 85% (E 422), quinoline yellow.

What Nicorette Classic Gum looks like and what the packaging contains

The packaging contains 15, 30, or 105 pieces of gum in blisters of 15 pieces in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Johnson & Johnson Santé Beauté France
43 rue Camille Desmoulins
92130 Issy-les-Moulineaux, France

Manufacturer:

McNeil AB, Norrbroplatsen 2, 251 09 Helsingborg, Sweden

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:34009 376 307 5 7

Parallel import authorization number: 432/24

Date of leaflet approval: 06.12.2024

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