Nicorette Freshmint Gum

Package Leaflet: Information for the Patient

Nicorette FreshMint Gum, 2 mg, chewing gum, medicinal

Nicorette FreshMint Gum, 4 mg, chewing gum, medicinal

Nicotine

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This package 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 any not listed in this package leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 9 months the patient is still having trouble quitting smoking with the help of Nicorette FreshMint Gum, they should contact their doctor.

Package Leaflet Contents:

• 1. What Nicorette FreshMint Gum is and what it is used for
• 2. Important information before using Nicorette FreshMint Gum
• 3. How to use Nicorette FreshMint Gum
• 4. Possible side effects
• 5. How to store Nicorette FreshMint Gum
• 6. Package contents and other information

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

Mode of Action

When a patient stops smoking cigarettes 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 FreshMint Gum can help prevent or reduce these symptoms by delivering small amounts of nicotine to the body quickly.

The nicotine in Nicorette FreshMint Gum is administered in its pure form. Unlike cigarettes, Nicorette FreshMint Gum does not release harmful tar substances or carbon monoxide, which are produced during tobacco combustion.

Indications

Nicorette FreshMint Gum is indicated for the treatment of tobacco dependence by reducing nicotine craving and withdrawal symptoms that occur after quitting smoking.

2. Important information before using Nicorette FreshMint 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 to use Nicorette FreshMint 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,
• heart disease that affects the heart rate or rhythm,
• uncontrolled high blood pressure,
• stomach or duodenal ulcers,
• hyperthyroidism,
• insulin-dependent diabetes (lower doses of insulin may be required as a result of quitting smoking),
• pheochromocytoma,
• severe or moderate liver disease,
• severe kidney disease,
• esophagitis,
• a history of seizures or epilepsy.

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

Some patients may continue to use Nicorette FreshMint Gum for longer than the recommended treatment period, but the potential risk of long-term use is much lower than the risk of nicotine dependence associated with returning to smoking tobacco.

Nicorette FreshMint Gum and 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.

If the patient is taking imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (a medicine used to treat asthma, chronic obstructive pulmonary disease, and bronchitis), tacrine (a medicine used to treat Alzheimer's disease), ropinirole (a medicine used to treat Parkinson's disease), flecainide (a medicine used to treat arrhythmias), pentazocine (a pain reliever), or insulin, they should consult their doctor before using Nicorette FreshMint Gum.

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.

Use of Nicorette FreshMint Gum in a smoking pregnant woman can only be initiated after consulting a doctor.

If the patient is unable to quit smoking, use of Nicorette FreshMint Gum by a breastfeeding woman can only be initiated after consulting a doctor. To minimize exposure to the baby, 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.

Nicorette FreshMint Gum contains xylitol (E967)

The medicine may have a laxative effect. The energy value is 2.4 kcal/g xylitol.

Nicorette FreshMint Gum contains butylhydroxytoluene (E321)

The medicine may cause irritation of the mucous membranes.

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 FreshMint Gum

Children and adolescents

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

Adults and elderly

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

Do not use more than 15 pieces of gum per day.

Quitting smoking

Nicorette FreshMint Gum helps people who are determined to quit 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 FreshMint Gum helps people who do not want to or cannot quit smoking to reduce their smoking.

To prolong the intervals between smoking and to 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 there is no reduction in the number of cigarettes smoked per day, the patient should consult their doctor.

Consider trying to quit smoking as soon as possible, but no later than 6 months after starting treatment. If after 9 months of treatment, it is not possible to make a serious attempt to quit smoking, the patient should consult their doctor.

Regular use of the gum for a period longer than 12 months is not recommended. Some former smokers may require longer treatment to avoid returning to smoking. Unused gum should be kept in case of sudden nicotine craving.

Use support groups, as they can improve the smoking cessation process and help complete therapy successfully.

Temporary abstinence

Nicorette FreshMint Gum helps smokers to temporarily abstain from smoking.

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 the patient wants to avoid smoking.

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 during monotherapy.

Therefore, if necessary, Nicorette Invisipatch 15 mg/16 h and Nicorette FreshMint 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 according to the approved dosing for monotherapy.

Nicorette FreshMint Gum 2 mg should be chewed when a strong urge to smoke occurs, not exceeding the maximum daily dose of 15 pieces of gum.

The gum can be used in this way for up to 12 weeks, after which the use of the gum should be gradually reduced. The maximum duration of gum use is 12 months.

How to chew Nicorette FreshMint Gum

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

Nicotine swallowed with saliva does not have a beneficial effect and can irritate the throat or stomach, causing hiccups, for example. Nicorette FreshMint Gum should not be chewed like regular gum continuously and energetically, as the nicotine is released too intensely.

Therefore, Nicorette FreshMint Gum should be chewed slowly, with regular breaks.

• 1. Chew the gum slowly until the taste is felt.
• 2. Then stop chewing and park 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 of Nicorette FreshMint Gum

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 chewing gum is very low, as the absorption of nicotine without chewing is slow and incomplete.

Symptoms of nicotine overdose include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing disturbances, and significant weakness.

After high 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 in small children and can be fatal.

The medicine should be kept out of the reach of children. In case of overdose, nicotine administration should be stopped immediately, and medical help should be sought. 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 pieces of gum are used or if a child chews or swallows the gum, immediate medical attention should be sought, taking the gum packaging and this package leaflet to the hospital or doctor.

4. Possible side effects

Like all medicines, Nicorette FreshMint Gum 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 side effects reported by patients 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 may stick to and, in rare cases, damage dental prostheses.

Rarely, allergic reactions (including severe allergic reactions) may occur during treatment with Nicorette FreshMint Gum.

Side effects reported in at least 1% of patients treated with nicotine in clinical trials and after marketing are presented in the following table. The frequency of occurrence is defined according to the following scheme:

Very common (may affect 1 to 10 in 10 people)

Common (may affect 1 to 10 in 100 people)

Uncommon (may affect 1 to 10 in 1,000 people)

Rare (may affect 1 to 10 in 10,000 people)

Unknown (frequency cannot be estimated from the available data)

Reporting of side effects

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

Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, more information can be collected on the safety of the medicine.

5. How to store Nicorette FreshMint Gum

The medicine should be stored out of sight and reach of children.

Store in a temperature below 25°C in the original packaging.

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. This will help protect the environment.

6. Package contents and other information

What Nicorette FreshMint Gum contains

• The active substance is nicotine. One piece of chewing gum contains 2 mg or 4 mg of nicotine, in the form of nicotine with cation exchange resin.
• The other ingredients are: core - chewing gum base, xylitol (E967), peppermint oil, sodium carbonate anhydrous, sodium bicarbonate (only 2 mg dose), quinoline yellow (E104) (only 4 mg dose), acesulfame potassium (E950), levomenthol, magnesium oxide; coating - xylitol (E967), peppermint oil, gum arabic (E414), titanium dioxide (E171), carnauba wax, quinoline yellow (E104) (only 4 mg dose).

Nicorette FreshMint Gum does not contain sugar (sucrose) or ingredients of animal origin.

What Nicorette FreshMint Gum looks like and contents of the pack

2 mg chewing gum:

A square-shaped chewing gum with dimensions of 15 x 15 x 6 mm in a white coating.

4 mg chewing gum:

A square-shaped chewing gum with dimensions of 15 x 15 x 6 mm in a cream-colored coating.

The packaging contains 15, 30, 90, 105, or 210 pieces of gum in blisters placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:McNeil AB, SE-251 09 Helsingborg, Sweden.

Manufacturer:McNeil AB, Norrbroplasten 2, SE-251 09 Helsingborg, Sweden.