Nicorette Fruit

Package Leaflet: Information for the Patient

Nicorette Fruit, 2 mg, lozenges

Nicorette Fruit, 4 mg, lozenges

Nicotine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 9 months you are still having trouble quitting smoking without the help of Nicorette Fruit, you should consult a doctor.

Table of Contents of the Leaflet

• 1. What is Nicorette Fruit and what is it used for
• 2. Important information before taking Nicorette Fruit
• 3. How to take Nicorette Fruit
• 4. Possible side effects
• 5. How to store Nicorette Fruit
• 6. Contents of the pack and other information

1. What is Nicorette Fruit and what is it used for

The medicine is used to alleviate withdrawal symptoms and reduce nicotine cravings that occur when trying to quit smoking or reduce the number of cigarettes smoked, in an attempt to quit smoking. This treatment is intended for adult smokers aged 18 and over.

Nicorette Fruit, 2 mg, lozenges are suitable for use by smokers with a low level of nicotine dependence, i.e., those who smoke their first cigarette of the day more than 30 minutes after waking up or who smoke 20 or fewer cigarettes per day.

Nicorette Fruit, 4 mg, lozenges are suitable for use by smokers with a high level of nicotine dependence, i.e., those who smoke their first cigarette of the day within 30 minutes of waking up or who smoke more than 20 cigarettes per day.

The medicine can help with immediate quitting or with reducing the number of cigarettes smoked before finally quitting. If the patient thinks they can quit immediately, they should do so. However, if they think it will be too difficult, they may want to reduce the number of cigarettes smoked as a first step before achieving complete abstinence. More detailed information is provided in section 3 "How to take Nicorette Fruit".

Nicorette Fruit alleviates withdrawal symptoms that occur after quitting smoking, including nicotine cravings. When nicotine from tobacco is suddenly stopped, various unpleasant feelings, called withdrawal symptoms, develop, such as irritability, feelings of anger or depression, anxiety, restlessness, decreased concentration, increased appetite or weight gain, strong desire to smoke (cravings), insomnia or sleep disturbances. The nicotine in Nicorette Fruit can prevent these unpleasant feelings or reduce their severity and reduce the desire to smoke.

To increase the chances of a successful quit attempt, it is also recommended to use counseling and behavioral support.

2. Important information before taking Nicorette Fruit

When not to take Nicorette Fruit:

• if the patient is allergicto nicotine or any of the other ingredients of this medicine (listed in section 6).
• if the patient is under 12 years old.
• if the patient has never smoked.

Warnings and precautions

Consult a doctor if the patient has any of the following conditions. It may be possible for the patient to use Nicorette Fruit, but they must first consult a doctor in the case of:

• recently having had a heart attackor stroke;
• chest pain(unstable angina) or angina at rest;
• heart diseaseaffecting the heart rate or rhythm (arrhythmias);
• high blood pressurethat is not controlled by medication;
• having ever had allergic reactions, such as swelling of the lips, face, and throat (angioedema) or itchy rash (hives); using NRT may occasionally provoke this type of reaction;
• severe or moderate liver disease;
• severe kidney disease;
• diabetes;
• hyperthyroidism;
• pheochromocytoma(a tumor of the adrenal gland);
• peptic ulcer disease or esophagitis;
• having had epilepsyor seizuresin the past.

Non-smokers should not use this medicine.

Lozenges may pose a choking hazard. The medicine should be used with caution if the patient has problems swallowing solids or liquids, or if they frequently cough while swallowing or after swallowing.

Children

An appropriate dose for adults, given to children, can cause serious poisoning, and even lead to death. It is essential, therefore, to keep Nicorette Fruit out of sight and out of reach of children.

Other medicines and Nicorette Fruit

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take. This is especially important if you are taking medicines containing:

• theophyllinefor asthma,
• tacrinefor Alzheimer's disease,
• clozapinefor schizophrenia,
• ropinirolefor Parkinson's disease.

Nicorette Fruit with food and drink

Do not eat or drink while taking the lozenges.

Pregnancy, breastfeeding, and fertility

It is very important to quit smoking during pregnancy, as it can lead to fetal growth restriction. It can also cause miscarriage or stillbirth. It is best for pregnant women to quit smoking without using nicotine-containing medicines. However, if they are unable to do so, they may use Nicorette Fruit, but only after consulting their doctor, primary care physician, or a doctor specializing in smoking cessation treatment.

Nicorette Fruit should not be taken during breastfeeding, as nicotine passes into breast milk and may affect the baby. If a doctor recommends using Nicorette Fruit, the lozenge should be taken immediately after breastfeeding and no sooner than 2 hours before starting breastfeeding.

Smoking increases the risk of infertility in women and men. The effect of nicotine on fertility is unknown.

Driving and using machines

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

Nicorette Fruitcontains less than 1 mmol of sodium (23 mg) per lozenge, which means the medicine is essentially "sodium-free". The medicine also contains small amounts of sulfites from the flavor, which can rarely cause severe hypersensitivity reactions and bronchospasm. Nicorette Fruit contains polysorbate, which can cause allergic reactions.

3. How to take Nicorette Fruit

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

The way to take Nicorette Fruit depends on whether the patient:

• (a) quits smoking immediately
• (b) quits smoking gradually

Adults (18 years and over)

• (a)Immediate quittingThis involves quitting smoking immediately and using lozenges to reduce cigarette cravings.
• Start treatment with 8 to 12 lozenges per day. Whenever the urge to smoke occurs, place one lozenge in the mouth and wait for it to dissolve.
• Use the lozenges in this way for up to 6 weeks, then gradually reduce the number of lozenges used per day.
• When using only 1 or 2 lozenges per day, stop them altogether. After quitting smoking, the patient may sometimes feel a strong desire to smoke. In such cases, a lozenge can be used again.
• (b) Gradual quittingThis involves gradually replacing some cigarettes with a lozenge. After achieving this goal, the patient stops smoking cigarettes altogether, using lozenges. Finally, the patient also stops using lozenges. If the patient feels a strong desire to smoke, they should use a Nicorette Fruit lozenge instead of a cigarette to control nicotine cravings. The patient should reduce the number of cigarettes smoked per day to as few as possible. If the patient is unable to reduce the number of cigarettes smoked per day after 6 weeks, they should consult a healthcare professional.

If the patient feels they can do so, they should quit smoking altogether. They should then follow the instructions for immediate quitting, described above. The patient should do this as soon as possible. If the attempt to quit smoking altogether is not successful within 6 months of starting treatment, the patient should consult a healthcare professional.

Do not exceed the recommended dose. Follow the instructions carefully and do not use more than 15 lozengesin 24 hours. If the patient needs to use the medicine for more than 9 months in total, they should consult a doctor.

Children and adolescents

Adolescents aged 12-17 years

Nicorette Fruit should only be used on the advice of a doctor.

Children under 12 years

The medicine should not be given to children under 12 years old.

Instructions for use

[Polypropylene container]

OPENING
CLOSING
[Cardboard box]
Opening:

• 1- Gently press the latch with the words "Press here"
• 2- At the same time, firmly pull the top part of the box

Closing: press the top part of the box.

The medicine is intended for administration to the oral mucosa. It should be placed in the mouth and allowed to dissolve, releasing nicotine to be absorbed into the body through the lining of the mouth.

Place one lozenge in the mouth and move it from time to time from one side of the mouth to the other until it is completely dissolved. This should take less than 20 minutes. The lozenges should not be chewed or swallowed whole. Do not eat or drink while a lozenge is in the mouth.

What to do if you feel like going back to smoking

If the patient:

• is worried that they might start smoking again,
• is having trouble quitting lozenges altogether, they should consult a healthcare professional. If the patient starts smoking again despite this, the healthcare professional may advise them on how to get the best results from further courses of nicotine replacement therapy (NRT).

Overdose of Nicorette Fruit

If the patient smokes while taking Nicorette Fruit, nicotine overdose may occur.

If the medicine is taken by a child or if the patient uses more Nicorette Fruit than recommended, they should immediatelyconsult a doctor or go to the nearest hospital.

Doses of nicotine tolerated during treatment by adult smokers can cause severe poisoning symptoms and may be fatal to children.

Overdose symptoms include: nausea (vomiting), vomiting, increased salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, and significant weakness. After these symptoms, large doses may cause low blood pressure, weak and irregular pulse, breathing difficulties, exhaustion, vascular collapse, and generalized seizures.

In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Withdrawal symptoms (nicotine withdrawal)

Some of the side effects that occur when quitting smoking may be withdrawal symptoms caused by reducing the dose of nicotine. Possible symptoms include:

• irritability, aggression, frustration, or impatience,
• feeling anxious, restless, or having trouble concentrating,
• waking up at night or sleep disturbances,
• increased appetite or weight gain,
• feeling unwell,
• desire to smoke (nicotine cravings),
• decreased heart rate,
• gum bleeding or mouth ulcers,
• dizziness or feeling empty-headed,
• cough, sore throat, stuffy nose, or runny nose,
• constipation.

If the patient notices any of the following serious side effects, they should stop taking Nicorette Fruit and consult a doctor immediately, as they may be a sign of a severe allergic reaction (frequency not known: frequency cannot be estimated from the available data):

on the basis of available data):

• hives (a skin disorder characterized by the presence of itchy, raised, or red patches),
• swelling of the face, tongue, or throat,
• difficulty breathing,
• difficulty swallowing.

Most side effects occur in the early stages of treatment. During the first few days of treatment, mouth and throat irritation may occur, but most patients adapt to the treatment with the disappearance of this symptom during continued therapy.

Other possible side effects:

Very common: may affect more than 1 in 10 people:

• cough,
• headache,
• hiccups,
• nausea (vomiting),
• irritation of the throat, mouth, and tongue.

Common: may affect up to 1 in 10 people:

• local reactions, such as a burning sensation, mouth ulcers, changes in taste,
• feeling cold, heat, or tingling on the skin,
• dry mouth or increased salivation,
• feeling sick,
• abdominal pain or discomfort,
• vomiting, bloating, or diarrhea,
• heartburn,
• feeling tired,
• hypersensitivity (allergy).

Uncommon: may affect up to 1 in 100 people:

• nasal problems, such as congestion, sneezing,
• wheezing (bronchospasm) or feeling more breathless than usual (dyspnea), tightness in the throat,
• redness of the skin or increased sweating,
• reactions in the mouth, such as tingling in the mouth, tongue inflammation, mouth ulcers, damage to the mouth mucosa, or change in voice, mouth and throat pain, belching,
• palpitations, rapid heart rate, high blood pressure,
• fast and irregular heartbeat, which may require treatment,
• skin rash and (or) itching,
• unusual dreams,
• discomfort and pain in the chest,
• weakness, feeling unwell.

Rare: may affect up to 1 in 1,000 people:

• difficulty swallowing, decreased sensation in the mouth,
• gagging reflex.

Unknown: frequency cannot be estimated from the available data:

• blurred vision, increased tear production,
• dry throat, discomfort in the stomach, lip pain,
• redness of the skin,
• seizures.

Reporting side effects

If side effects occur, including any not listed in this leaflet, 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.: 22 49-21-301, fax: 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 this medicine.

5. How to store Nicorette Fruit

• Keep the medicine out of sight and out of reach of children.
• Do not use this medicine after the expiry date stated on the container and outer packaging. The expiry date refers to the last day of that month.
• Polypropylene container: store in the original packaging to protect from moisture.
• Cardboard box: store in the original packaging to protect from moisture. Use within 3 months of removing the protective foil.
• Do not use the container for storing anything else, as it may contain powder from the lozenges, which can coat other objects placed in the container.
• Medicines should not be disposed of via wastewater or household waste. Ask your 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 Fruit contains

The active substance is nicotine. One lozenge contains 2 mg or 4 mg of nicotine (as nicotine ion-exchange resin).

The other ingredients are:

• core: mannitol (E 421), xanthan gum, Tutti Frutti flavor (contains trace amounts of sulfites), arabic gum (E 414), sodium carbonate anhydrous (E 500)(i), sucralose (E 955), acesulfame potassium (E 950), magnesium stearate (E 470b);
• coating: hypromellose (E 464), Tutti Frutti flavor, titanium dioxide (E 171), sucralose (E 955), microcrystalline cellulose (E 460), silicon dioxide (E 551), acesulfame potassium (E 950), polysorbate 80 (E 433).

Nicorette Fruit lozenges do not contain sugar.

What Nicorette Fruit looks like and contents of the pack

Oval lozenge, white to almost white, marked with "n" on one side and "2" or "4" on the other, approximately 14 x 9 x 7 mm in size.

Pack sizes: each polypropylene container contains 20 lozenges. Packs may contain 1 container, 4 containers, or 8 containers.

Each cardboard box contains 40 lozenges. Packs may contain 1 box, 2 boxes, or 4 boxes.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

McNeil AB, PO Box 941, 251 09 Helsingborg, Sweden

Manufacturer

McNeil AB, Norrbroplatsen 2, 251 09 Helsingborg, Sweden

Johnson & Johnson Consumer NV/SA, Michel De Braeystraat 52, 2000 Antwerp, Belgium

Johnson & Johnson GmbH, Johnson & Johnson Platz 2, 41470 Neuss, Germany