Nicorette Classic Gum

Leaflet accompanying the packaging: patient information

Nicorette Classic Gum, 2 mg, chewing gum, medicinal

Nicorette Classic Gum, 4 mg, chewing gum, medicinal

Nicotine

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 you can read it again if you need to.
• If you need advice or additional information, you should ask your 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 withdrawal symptoms begin to appear, including irritability, anxiety, mood disturbances, dizziness, and headaches, as well as sleep disturbances. Nicorette Classic Gum chewing gum can help prevent or alleviate these symptoms by delivering small amounts of nicotine to the body over a short period.

Indications for use

Nicorette Classic Gum is indicated for the treatment of tobacco dependence in individuals who want to quit smoking by reducing nicotine craving and withdrawal symptoms that occur after quitting 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 angina pectoris, heart disease that affects heart rate or rhythm, uncontrolled high blood pressure, stomach or duodenal ulcers, hyperthyroidism, insulin-dependent diabetes (you may need lower insulin doses as a result of quitting smoking), diagnosed pheochromocytoma, severe liver disease, severe kidney disease, esophagitis, or a history of epilepsy or seizures.

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. The use of Nicorette Classic Gum in a smoking pregnant woman can only be started after consulting a doctor. If you are unable to quit smoking, the use of Nicorette Classic Gum by a breastfeeding woman can only be started after consulting a doctor. To minimize exposure to the child, the medicine should be used immediately after breastfeeding.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

The medicine contains 190.25 mg of sorbitol (E420) (2 mg gum) or 178.97 mg of sorbitol (E420) (4 mg gum)

in each 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 (E321).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) in each 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

Children and adolescents
Without a doctor's recommendation, Nicorette Classic Gum chewing gum should not be used 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, depending on the degree of nicotine dependence. Usually, 8-12 gums of 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 gums per day.
Quitting smoking
The gum should be used for at least 3 months. Then, you should start gradually reducing the gum use. Treatment should be completed when the dose is reduced to 1-2 gums per day.
Reducing smoking
Nicorette Classic Gum helps reduce the number of cigarettes smoked per day, taking the first step in quitting smoking for people who do not want or are not able to quit immediately. To prolong the intervals between smoking and 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. Generally, regular use of gum for a period longer than 12 months is not recommended. Some former smokers may require longer treatment to avoid returning to smoking. Unused gums should be kept in case of sudden nicotine cravings. You should take advantage of 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.
Using gum in combination with patches
Gums can be used alone or in combination with nicotine patches. Using more than one form of nicotine replacement therapy is beneficial in the case of smokers who have returned to smoking despite previously using monotherapy or who have difficulty controlling the urge to smoke during monotherapy. Therefore, if necessary, Nicorette Invisipatch 15 mg/16 h and Nicorette Classic Gum 2 mg can be used together. Nicorette Invisipatch 15 mg/16 h should be applied in the morning after waking up and removed after 16 hours, before going to bed. It should be used in accordance with the approved dosage for monotherapy. Nicorette Classic Gum 2 mg should be chewed when you feel a strong urge to smoke, not exceeding the maximum daily dose of 15 gums. The gum can be used in this way for a period of 12 weeks, then you should gradually reduce the use of gum. 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. The gum is chewed to release nicotine, and then you should stop chewing to allow the nicotine to be absorbed through the mucous membrane of the mouth. 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 way, as nicotine is released too intensely. Therefore, Nicorette Classic Gum should be chewed slowly, making 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 more than the recommended dose of Nicorette Classic Gum

Overuse of nicotine, both from nicotine replacement products and (or) as a result of smoking cigarettes, 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, and hearing disturbances, as well as significant 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 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 taking 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 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 mood worsening, 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 craving associated with 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 can stick to dental work and, in rare cases, cause damage to dental prostheses. During the use of Nicorette Classic Gum, allergic reactions (including severe allergic reactions) may rarely occur. 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 determined 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), Not known (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 Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide 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. Store in a temperature 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 month. Medicines should not be disposed of via wastewater or household waste. 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 2 mg or 4 mg of nicotine - in the form of a 20% nicotine resin complex.
• The other ingredients are: sodium bicarbonate (E500) (only 2 mg dose), anhydrous sodium carbonate (E500), base gum, sorbitol powder (E420), sorbitol (solution) (E420), flavoring ZD-49284 (Haverstroo), flavoring 84-6422 (contains ethanol and trace amounts of cinnamaldehyde, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeguenol, d-limonene, and linalool), glycerin 85% (E422), quinoline yellow (only 4 mg dose).

What Nicorette Classic Gum looks like and what the packaging contains

The packaging contains 15, 30, or 105 gums in blisters of 15 pieces in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:McNeil AB, SE-251 09 Helsingborg, Sweden.
Manufacturer:McNeil AB, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden.
To obtain more detailed information, you should contact:
email: [email protected]

Date of last revision of the leaflet: