Nicorette Classic Gum

Leaflet attached to 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 a 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 consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 9 months the patient still has difficulty quitting smoking without the help of Nicorette Classic Gum, they should contact their 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. Nicorette Classic Gum chewing gum can prevent or alleviate these symptoms by delivering small doses 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 the patient is 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, the patient should discuss it with their doctor if they 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 heartbeat,
• uncontrolled high blood pressure,
• stomach or duodenal ulcers,
• hyperthyroidism,
• insulin-dependent diabetes (lower insulin doses may be required as a result of quitting smoking),
• confirmed 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 prosthetics.

Nicorette Classic Gum with other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Quitting smoking may require modification of their dosing.

Nicorette Classic Gum with food and drink

The patient should not use Nicorette Classic Gum while eating or drinking.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

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 the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder where their body does not break down fructose, they should consult their doctor before taking the medicine.

The medicine 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, iso-eugenol, 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

Therefore, the medicine is considered 'sodium-free'.

3. How to use Nicorette Classic Gum

Children and adolescents

Without a doctor's recommendation, Nicorette Classic Gum should not be used in individuals under 18 years of age.

Adults and the elderly

The initial dose should be determined individually based on the patient's degree of nicotine dependence. Typically, 8-12 pieces of gum with the appropriate nicotine content are used per day.

Quitting smoking

The gum should be used for at least 3 months. Then, the patient should start gradually reducing the gum use. Treatment should be completed when the dose is reduced to 1-2 pieces of gum per day.

Reducing smoking

Nicorette Classic Gum helps reduce the number of cigarettes smoked per day, allowing individuals who do not want or are not able to quit smoking immediately to take the first step towards quitting.

Temporary abstinence

The gum should be used during breaks between cigarettes, when the urge to smoke arises, for example, in places where smoking is prohibited or in other situations where the patient wants 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 for smokers who have returned to smoking despite previously using monotherapy or who have difficulty controlling the urge to smoke during monotherapy.

How to chew the gum

• 1. Chew the gum slowly until the taste is felt.
• 2. Then, stop chewing and place the gum between the 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) due to smoking, may cause overdose symptoms. The risk of poisoning from swallowing chewing gum is very low, as absorption of nicotine without chewing is slow and incomplete.

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, problems with concentration, 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 urge to smoke.

Most reported side effects occur within the first few weeks of starting treatment.

Irritation of the mouth and throat 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 prosthetics.

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

Side effects reported in at least 1% of patients treated with nicotine in clinical trials and after marketing are presented in the table below.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist.

5. How to store Nicorette Classic Gum

The medicine should be stored 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 stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required.

6. Contents of the packaging and other information

What Nicorette Classic Gum contains

• The active substance 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), flavor ZD-49284 (Haverstroo), flavor 84-6422 (contains ethanol and trace amounts of cinnamaldehyde, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, iso-eugenol, 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 pieces of gum 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.

For more information, please contact:

email: consumer-pl@kenvue.com

Date of last revision of the leaflet: