Nicorette Classic Gum Medicinal chewing gum 2 mg 105 pcs.

Use one chewing gum at the onset of nicotine craving. Usually 8-12 gums per day are used. Do not use more than 24 gums per day.
Storage: Store at ambient temperature
Packaging: box

One gum contains as active substance 2 mg nicotine, in the form of nicotine resin complex 20%, Contains sorbitol and butylated hydroxytoluene

Johnson & Johnson Sp. z o.o.

McNeil AB,
SE-251 09 Helsingborg,
Sweden

Manufacturer:
McNeil AB,
SE-251 09 Helsingborg,
Sweden

Number of units: 105

Read the leaflet carefully before using the drug, as it contains information important to the patient.
Always use this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- Ask your pharmacist if you need advice or additional information.
- If there is no improvement or the patient feels worse, contact your doctor.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If, after 9 months, you continue to have difficulty relapsing from 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 drug and what is it used for?
2. important information before using Nicorette Classic Gum drug
3 How to use the drug Nicorette Classic Gum
4. possible side effects
5. 5 How to store the drug Nicorette Classic Gum
6. package contents and other information

1 What is the drug Nicorette Classic Gum and for what purpose it is used.
Description of action
When a patient stops smoking cigarettes and nicotine is no longer regularly supplied to the body, various symptoms resulting from nicotine withdrawal begin to appear, including irritability, anxiety, mood disorders, dizziness and headaches, and sleep disorders. With the help of Nicorette Classic Gum, they can be prevented or lessened by supplying the body with small doses of nicotine.
The nicotine contained in Nicorette Classic Gum is in pure form. Unlike cigarettes, Nicorette Classic Gum does not emit harmful tar or carbon dioxide, which are produced in the combustion process.

Indications for use
Nicorette Classic Gum is indicated for the treatment of tobacco dependence in people determined to quit by reducing nicotine craving and withdrawal symptoms that occur after smoking cessation.

3 How to use the drug Nicorette Classic Gum
Children and adolescents
Do not use Nicorette Classic Gum in people under 18 years of age without a doctor's recommendation.
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 depending on the patient's nicotine dependence. Typically, 8 - 12 gums with the appropriate nicotine content per day are used. Smokers
with a low degree of dependence (smoking  20 cigarettes/day) should start treatment with a dose of
2 mg. Smokers with a high degree of addiction should start treatment with a dose of 4 mg. Do not
use more than 24 gums per day.
Smoking cessation
Gum should be used for at least 3 months. After that, a gradual discontinuation of the gum should be initiated. Treatment should be completed when the dose is reduced to 1 - 2 gums per day.
Reducing smoking
The drug Nicorette Classic Gum makes it easier to reduce the number of cigarettes smoked per day, to take the
first step in quitting smoking for people who are unwilling or unable to quit in an
abruptly.
To extend smoking intervals and to maximize the reduction of cigarettes smoked, the gum should be used in between cigarettes smoked when the
emergence of the desire to smoke a cigarette. If after 6 weeks a reduction in the number of
cigarettes smoked per day, consult a doctor.
Consider trying to stop smoking as soon as possible, but no later than 6 months after starting treatment. If it is not possible to make a
serious attempt to stop smoking, consult your doctor.
In general, regular use of gums for longer than 12 months is not recommended. Some former smokers may require longer treatment to avoid a return to smoking. Unused gums
should be saved in case nicotine cravings suddenly arise.
Seek the advice of support groups, as they can support the process of quitting smoking and help complete the therapy successfully.
Temporary abstinence
Use gum during breaks between cigarettes when the urge to light up arises, such as in places where smoking is prohibited or in other situations where you want to
avoid smoking.
Use of gums in combination with patches
Gum can be used alone or in combination with nicotine-containing patches. The use of more than one form of nicotine replacement therapy is beneficial for smokers who
have relapsed into smoking despite having used NTZ monotherapy in the past, or who have difficulty
in controlling the urge to light up a cigarette while on monotherapy. Therefore, if necessary,
Nicorette Invisipatch 15 mg/16 h patch and Nicorette Classic Gum 2 mg can be used together.
4
Nicorette Invisipatch 15 mg/16 h patch should be glued in the morning, after waking up, and peeled off after
16 hours, before going to bed. It should be used according to the dosage approved for monotherapy use. Nicorette Classic Gum 2 mg should be chewed when feeling a strong
desire to smoke a cigarette, not exceeding the maximum daily dose of 15 gums. The gum can be
used in this way for a period of 12 weeks, then the use of gum should be gradually reduced.
The maximum duration of gum use is 12 months.
How to chew Nicorette Classic Gum
The gum should be chewed when you feel the need to smoke a cigarette. 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 hiccups, for example. Nicorette Classic Gum should not be chewed like regular gum
continuously and vigorously, as the nicotine is released too intensively. Therefore, the gum
Nicorette Classic Gum should be chewed slowly, taking regular breaks.
Chewing technique
(1) Chew the gum slowly until you feel the taste.
(2) Then stop chewing and hold the gum between the gum and cheek.
(3) Start chewing again when the taste disappears.
4. this activity should be repeated for 30 minutes. This is the amount of time it takes for all the nicotine contained in the gum to be secreted.
Using more than the recommended dose of Nicorette Classic Gum
Abuse of nicotine, either from nicotine replacement products and/or as a result of smoking
cigarettes, can cause symptoms of overdose. The risk of poisoning from
ingestion of chewing gum is very low, as nicotine absorption in the absence of chewing is slow
and incomplete.
Symptoms of overdose are the same as after acute nicotine poisoning and include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headaches, dizziness,
hearing impairment and significant weakness. After large doses, these symptoms may be accompanied by hypotension, weak and irregular heart rate, difficulty breathing, exhaustion, circulatory collapse
and generalized convulsions.
Doses of nicotine tolerated by adults during treatment can cause symptoms of severe intoxication in young children and can be fatal.
Keep the drug out of the reach of children. If an overdose occurs, stop nicotine immediately and seek medical attention. The doctor will take
appropriate symptomatic treatment.
If excessive nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine.
If you use too much gum or chew or a child swallows gum, contact your doctor immediately or go to the nearest hospital, taking the gum pack and this leaflet with you.

5 How to store the drug Nicorette Classic Gum
Store the drug out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiration date on the package.
The expiration date means the last day of the stated month.
Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist what to do with medicines you no longer need. Doing so will help protect
environment.

4 Possible side effects
Like any drug, this medication may cause side effects, although they will not occur in everyone.
Some symptoms may occur in connection with smoking cessation. These include worsened mood, insomnia, irritability, frustration, anger, anxiety, trouble concentrating, nervousness or impatience. Physical symptoms such as decreased heart rate, increased appetite or weight gain, dizziness or pre-fainting symptoms, cough, constipation, bleeding gums, aphthous ulcers or nasopharyngitis, and nicotine craving combined with the desire to smoke may also occur.

Most of the reported side effects occur during the first weeks after starting treatment. Irritation of the mouth and throat can occur, but most patients become accustomed to this during the course of the drug.

The chewing gum may stick and, in rare cases, cause damage to dental prostheses.

Allergic reactions (including severe allergic reactions) may occur during the use of Nicorette Classic Gum.

Adverse reactions reported in at least 1% of nicotine-treated patients in clinical trials during and after marketing are shown in the table below. The incidence was determined according to the following scheme:
Very common (may occur in 1 to 10 out of 10 people)
Frequent (may occur in 1 to 10 out of 100 people)
Uncommon (may occur in 1 to 10 per 1,000 people)
Rare (may occur in 1 to 10 in 10,000 people)
Unknown (frequency cannot be determined from available data)

Classification of systems and organs
Frequency - Adverse effect

Cardiac disorders
Uncommon - Palpitations (palpitations)
Uncommon - Tachycardia (acceleration of heart rate)

Eye disorders
Unknown - Blurred vision
Unknown - Increased tearing

Gastrointestinal disorders
Common - Abdominal pain
Common - Dry mouth
Common - Indigestion
Frequent - Flatulence
Very common - Nausea
Frequent - Excessive salivation
Frequently - Oral inflammation
Frequently - Vomiting
Frequent - Diarrhea
Unknown - Dryness of the mucous membranes of the throat
Rare - Dysphagia (difficult swallowing)
Uncommon - Rebounding
Unknown - Gastrointestinal discomfort
Uncommon - Inflammation of the tongue
Rare - Oral dysphagia
Uncommon - Blistering and peeling of the oral mucosa
Unknown - Lip pain
Uncommon - Tingling sensation/ numbness of the mouth
Rare - Vomiting reflex

General disorders and conditions at the site of administration
Common - Burning sensation
Frequent - Fatigue
Uncommon - Weakness
Uncommon - Chest discomfort and pain
Uncommon - Malaise

Immunologic system disorders
Common - Hypersensitivity
Unknown - Anaphylactic reaction (sudden severe allergic reaction that may manifest as hives, itching, flushing, shortness of breath, decreased blood pressure, abdominal pain, diarrhea, or vomiting)

Nervous system disorders
Very common - Headache
Frequent - Change in sensation of taste
Frequent - Cold, warm and tingling sensations on the skin

Musculoskeletal disorders
Unknown - Stiffness of the jaw muscles
Uncommon - Jaw pain

Psychiatric disorders
Uncommon - Unusual dreams

Respiratory, thoracic and mediastinal disorders
Common - Cough
Very common - Hiccups
Uncommon - Throat irritation
Uncommon - Bronchospasm
Uncommon - Voice disorders
Uncommon - Nasal mucosal congestion
Uncommon - Pain in the mouth and throat
Uncommon - Sneezing
Uncommon - Pressure in the throat

Skin and subcutaneous tissue disorders
Unknown - Angioedema (a disease of the skin and mucous membranes characterized by limited swelling)
Unknown - Erythema
Uncommon - Excessive sweating
Uncommon - Pruritus
Uncommon - Rash
Uncommon - Urticaria

Vascular disorders
Uncommon - Facial redness
Uncommon - Hypertension

Reporting of side effects
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: + 48 22 49 21 301,
fax: + 48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.

6 Package contents and other information
What the drug Nicorette Classic Gum contains
- The active substance of the drug is nicotine. One chewing gum contains 2 mg or 4 mg of nicotine - in the form of a 20% nicotine resin complex.
- The other ingredients are: sodium bicarbonate (2 mg dose only), anhydrous sodium carbonate, base gum, sorbitol powder, sorbitol (solution), flavor ZD-49284 (Haverstroo), flavor 84.6422, glycerin 85%, quinoline yellow (4 mg dose only).
The package contains 15, 30 or 105 gums in blisters of 15 pieces in a cardboard box.

2 Information important before using Nicorette Classic Gum
When not to use the drug Nicorette Classic Gum
- If you are allergic to nicotine or any of the other ingredients of this drug (listed in section 6).

Warnings and precautions
Before taking Nicorette Classic Gum, discuss with your doctor if:
- a recent history of stroke or myocardial infarction,
- chest pain or symptoms of angina pectoris,
- heart disease affecting the speed or regularity of your heartbeat,
- failure of hypertension,
- gastric or duodenal ulcer disease;
- hyperthyroidism;
- insulin-dependent diabetes (lower insulin doses may be required as a result of smoking cessation);
- established pheochromocytoma of the adrenal glands;
- severe or moderate liver disease;
- severe kidney disease;
- esophagitis.

Chewing gum can stick and, in rare cases, cause damage to dental prostheses.

Some patients may continue using Nicorette Classic Gum for longer than the recommended treatment period, but the potential risks of long-term Nicorette use are far less than the risk of addiction associated with a return to smoking.

Nicorette Classic Gum and other medications
Tell your doctor about all medications you are currently or recently taking, as well as medications you plan to take. Smoking cessation may require modification of their dosage.
If you are taking medications such as imipramine, clomipramine, fluvoxamine (drugs used to treat depression), clozapine, olanzapine (drugs used to treat schizophrenia), theophylline (a drug used to treat bronchial asthma, chronic obstructive pulmonary disease and bronchial inflammation), tacrine (a drug used for Alzheimer's disease), ropinirole (a drug used for Parkinson's disease), flecainide (a drug used for, among other things.among others in tachycardia, paroxysmal atrial fibrillation, arrhythmia), pentazocine (painkiller), insulin, you should consult your doctor before using Nicorette Classic Gum.

Use of Nicorette with food and drink
Do not use at the same time with food and drink.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor before using this drug.
To reduce the exposure of the child, the drug should be used immediately after breastfeeding.

Driving and operating machinery
No effect on the ability to drive and operate machinery has been found.

The drug contains 190.25 mg of sorbitol (2 mg gum) or 178.97 mg of sorbitol (4 mg gum) in each chewing gum. Sorbitol is a source of fructose. If you (or your child) have been previously diagnosed with
intolerance to certain sugars, or you have previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should
consult a doctor before taking the drug.

The drug Nicorette Classic Gum contains butylhydroxytoluene (E 321). The drug may cause irritation of the mucous membranes.

The drug contains less than 1 mmol (23 mg) of sodium per dose, that is, the drug is considered "sodium free."

Nicorette Classic Gum, 2 mg, chewing gum, medicinal
Nicorette Classic Gum, 4 mg, chewing gum, medicinal

Nicotinum