Nicorette Classic Gum

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nicorette Classic Gum (Nicorette Classic 2 mg)

2 mg, chewing gum, medicinal

Nicotine
Nicorette Classic Gum and Nicorette Classic 2 mg are different trade names for the same medicine.

Read the 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 9 months the patient still has trouble 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 pack and other information

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

Mode of Action

When a patient stops smoking and nicotine is no longer regularly delivered to the body, various withdrawal symptoms occur, including irritability, anxiety, mood disturbances, dizziness, and headaches, as well as sleep disturbances. Nicorette Classic Gum can help prevent or reduce these symptoms by delivering small amounts of nicotine to the body over a short period.

Indications

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 stopping smoking.

2. Important information before using Nicorette Classic Gum

Contraindications

• 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 treatment with Nicorette Classic Gum, the patient should discuss it with their doctor if they have:

• recently had a heart attack or stroke,
• chest pain or angina,
• heart disease that affects the heart rate or rhythm,
• uncontrolled high blood pressure,
• stomach or duodenal ulcers,
• hyperthyroidism,
• insulin-dependent diabetes (may require lower insulin doses as a result of quitting smoking),
• pheochromocytoma,
• severe or moderate liver disease,
• severe kidney disease,
• esophagitis,
• a history of seizures or epilepsy.

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

Interactions 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 dosages.

Using Nicorette Classic Gum with Food and Drink

Nicorette Classic Gum should not be used while eating or drinking.

Pregnancy and Breastfeeding

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

Driving and Using Machines

No effects on the ability to drive or use machines have been observed.

Nicorette Classic Gum Contains Sorbitol

The medicine contains 190.25 mg of sorbitol per 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 called hereditary fructose intolerance, they should consult their doctor before taking the medicine.

The Medicine Contains Aroma Flavor 84.6422 with Cinnamaldehyde, Cinnamyl Alcohol, Citral, Citronellol, Eugenol, Geraniol, Isoeugenol, D-Limonene, and Linalool

These substances may cause allergic reactions.

The Medicine Contains Ethanol

The medicine contains 0.616 mg of ethanol per piece of chewing gum. The amount of ethanol in one dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of ethanol in this medicine will not produce noticeable effects.

Nicorette Classic Gum Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to Use Nicorette Classic Gum

Nicorette Classic Gum is available in 2 mg and 4 mg strengths.

Children and Adolescents

Nicorette Classic Gum should not be used in individuals under 18 years of age without a doctor's recommendation. Data on the treatment of individuals in this age group with Nicorette Classic Gum are limited.

Adults and Elderly

The initial dose should be determined individually based on the patient's degree of nicotine dependence. Typically, 8-12 pieces of gum per day are used, with the appropriate nicotine content. Patients with low nicotine dependence (smoking ≤ 20 cigarettes/day) should start treatment with the 2 mg dose. Patients with high nicotine dependence should start treatment with the 4 mg dose. No more than 24 pieces of gum should be used per day.

Quitting Smoking

The gum should be used for at least 3 months. Then, gradual reduction of the gum should be started. 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, taking the first step towards quitting smoking for those who do not want or are not able to quit immediately.

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 smoking is to be avoided.

Using Gum in Combination with Patches

Gum 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 while using monotherapy.

How to Chew the Gum

The gum should be chewed when the urge to smoke is felt. The gum is chewed to release nicotine, and then chewing is stopped to allow nicotine to be absorbed through the mouth mucosa.

Chewing Technique

• 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.

Overdose

Overuse of nicotine, both from nicotine replacement products and (or) due to smoking, can cause overdose symptoms. The risk of poisoning due to swallowing the gum is very low, as absorption of nicotine without chewing is slow and incomplete.

4. Possible Side Effects

Like all medicines, Nicorette Classic Gum can cause side effects, although not everybody gets them.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

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 Nicorette Classic Gum 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. This will help protect the environment.

6. Contents of the Pack and Other Information

What Nicorette Classic Gum Contains

• The active substance is nicotine. One piece of chewing gum contains 2 mg of nicotine - in the form of a 20% nicotine resin complex.
• The other ingredients are: sodium bicarbonate, sodium carbonate, gum base, sorbitol, powder (E420), sorbitol 70% solution, Haverstroo flavor, flavor 84.6422 (contains ethanol and trace amounts of cinnamaldehyde, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, iso-eugenol, d-limonene, and linalool), glycerol 85%.

What Nicorette Classic Gum Looks Like and Contents of the Pack

The pack contains 15, 30, or 105 pieces of gum in blisters of 15 pieces in a cardboard box.

Marketing Authorisation Holder in Greece, Country of Export:

Johnson & Johnson Hellas Consumer ΑΕ, Aigialeias & Epidavrou 4, 151 25, Marousi, Athens, Greece

Manufacturer:

McNeil AB, Norrbroplatsen 2, Helsingborg, Sweden

Parallel Importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation Number in Greece, Country of Export: 71142/1-11-07

Parallel Import Authorisation Number: 146/24

Date of Revision of the Leaflet: 11.04.2024

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