Nicorette classic gum

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Nicorette Classic Gum (Nicorette 4 mg Sans Sucre), 4 mg, chewing gum, medicinal
Nicotinum
Nicorette Classic Gum and Nicorette 4 mg Sans Sucre are different brand 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 so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If after 9 months you still have difficulties refraining from smoking without the help of Nicorette Classic Gum, you should consult your doctor.

Table of contents of the leaflet:

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 contained in Nicorette Classic Gum is administered in a 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 occurring 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
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,
• 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 cause damage to, dental prostheses.
Some patients may continue to use Nicorette Classic Gum for longer than the recommended treatment period; however, the potential risk of long-term use is considerably lower than the risk associated with returning to smoking.

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 medications.
If taking medications such as imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (a medicine used to treat bronchial asthma, chronic obstructive pulmonary disease and bronchial inflammation), tacrine (a medicine used in Alzheimer's disease), ropinirole (a medicine used in Parkinson's disease), flecainide (a medicine used, among others, in tachycardia, paroxysmal atrial fibrillation, cardiac arrhythmias), or pentazocine (an analgesic), consult a doctor before using Nicorette Classic Gum.

Use of 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 to have a baby, she should consult a doctor before using this medicine.
Use of Nicorette Classic Gum in a pregnant woman who smokes should only begin after consultation with a doctor.
If smoking cannot be stopped, use of Nicorette Classic Gum by a breastfeeding woman should only begin after consultation with a doctor. To reduce infant exposure, the medicine should be used immediately after breastfeeding.

Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery.

Nicorette Classic Gum contains 178.97 mg of sorbitol (E 420) per chewing gum. Sorbitol is a source of fructose.
If the patient (or the patient's 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.

Nicorette Classic Gum contains butylated hydroxytoluene (E 321). This medicine may cause irritation of mucous membranes.

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

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.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning 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
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 determined individually according to the degree of nicotine dependence. Typically, 8–12 pieces of gum containing the appropriate amount of nicotine per day are used. Individuals with low dependence (smoking ≤ 20 cigarettes/day) should start treatment with the 2 mg dose. Individuals with high dependence should start treatment with the 4 mg dose. Do not use more than 15 pieces of gum per day.
Smoking cessation
The gum should be used for at least 3 months. After this period, gradual discontinuation should be initiated. Treatment should be completed when the dose has been reduced to 1–2 pieces per day.
Smoking reduction
Nicorette Classic Gum helps reduce the number of cigarettes smoked daily and enables individuals who do not wish or are unable to quit smoking abruptly to take the first step towards quitting.
To extend the intervals between cigarettes and maximally reduce cigarette consumption, the gum should be used during periods between smoking, when the urge to smoke arises. If no reduction in daily cigarette consumption is achieved within 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.
Regular use of the gum for longer than 12 months is generally not recommended. However, some former smokers may require longer treatment to prevent relapse. Unused gum should be kept for sudden nicotine cravings.
Seek support from counseling or support groups, as they may assist in the smoking cessation process 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.
How to chew Nicorette Classic Gum
Chew the gum whenever you feel the need to smoke a cigarette. Chew the gum slowly to release nicotine, then stop chewing and place it between your gum and cheek to allow nicotine to be absorbed through the oral mucosa. Swallowing nicotine with saliva does not produce a beneficial effect and may irritate the throat or stomach, potentially causing hiccups. Nicorette Classic Gum should not be chewed continuously and vigorously like regular chewing gum, as this releases nicotine too intensely. Therefore, chew Nicorette Classic Gum slowly, taking regular breaks.
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 about 30 minutes—the time required 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 cause symptoms of overdose. The risk of poisoning following ingestion of 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, diarrhea, profuse 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.
Nicotine doses tolerated by adults during treatment may cause severe poisoning in young children and may be fatal. Keep the medicine out of reach of children. In case of overdose, immediately stop administering nicotine and seek medical help. The doctor will provide appropriate symptomatic treatment.
In cases of excessive nicotine ingestion, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many pieces of gum have been used, or if a child has chewed or swallowed the gum, contact a doctor immediately or go to the nearest hospital, taking 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.
Some symptoms may occur as a result of stopping smoking. These include mood deterioration,
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-syncope symptoms, cough, constipation, gum bleeding, aphthous
ulcers or nasopharyngitis, and nicotine craving associated with the desire to smoke.
Most of the reported adverse reactions occur during the first weeks of treatment. Irritation of the
oral cavity and throat may occur; however, most patients become accustomed to this during
treatment.
The chewing gum may adhere to, and in rare cases cause damage to, dental prostheses.
Allergic reactions (including severe allergic reactions) may rarely occur during treatment with
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. 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)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring 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.
Reporting of adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Nicorette Classic Gum

Keep the medicine out of sight and reach of children.
Do not store 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 stated month.
Medicines must not be disposed of via wastewater 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 packaging and other information

What Nicorette Classic Gum contains

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

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.
Marketing Authorisation 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in France, the country of export: 34009 376 307 5 7
Parallel Import Licence Number: 432/24