Nicorette Supermint 4 mg lozenges EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette Supermint 4 mg lozenges for sucking

Nicotine

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if, after 6 months of treatment, you still have difficulty abstaining from smoking without the help of Nicorette Supermint.

Leaflet contents:

1. What Nicorette Supermint is and what it is used for
2. What you need to know before using Nicorette Supermint
3. How to use Nicorette Supermint
4. Possible adverse effects
5. How to store Nicorette Supermint

Pack contents and additional information

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

Nicorette Supermint is used to relieve withdrawal symptoms and reduce nicotine cravings that occur when trying to quit smoking. This treatment is indicated for adult smokers over 18 years of age who smoke more than 20 cigarettes per day or who have high nicotine dependence.

Nicorette Supermint 4 mg tablets for sucking are suitable for those smokers who have a high dependence on nicotine, for example, those who smoke their first cigarette of the day within 30 minutes of waking up or those who smoke more than 20 cigarettes per day.

Nicorette Supermint relieves nicotine withdrawal symptoms, including craving, associated with stopping tobacco use. When you suddenly stop providing nicotine from tobacco to your body, you experience various unpleasant sensations, known as withdrawal symptoms, such as irritability or aggression, depression, anxiety, restlessness, difficulty concentrating, increased appetite or weight gain, craving for cigarettes (craving), nocturnal awakenings or sleep disturbances. The nicotine in Nicorette Supermint can help you prevent or reduce these unpleasant symptoms as well as your urge to smoke.

To improve your chances of successfully quitting smoking, it is advisable to seek medical advice and support.

2. What you need to know before using Nicorette Supermint

Do not take Nicorette Supermint

• If you are allergic to nicotine or to any of the other ingredients of this medicine (listed in section 6).
• If you are under 18 years of age.
• If you are a non-smoker.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Nicorette Supermint.

Inform your doctor before taking this medicine if you have any of the following conditions, as although you may be able to use Nicorette Supermint, you should first discuss it with your doctor:

• If you have recently had a heart attack or stroke.
• If you suffer from chest pain (unstable angina) or angina at rest.
• If you have a heart disease affecting your heart rhythm or rate (arrhythmia).
• If you have high blood pressure that is not controlled with medication.
• If you have heart failure or circulation problems.
• If you have had an allergic reaction with swelling of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may sometimes cause such reactions.
• If you have severe or moderate liver disease.
• If you have severe kidney disease.
• If you have diabetes.
• If you have hyperactivity of the thyroid gland.
• If you have a tumor of the adrenal gland (pheochromocytoma).
• If you have duodenal or stomach ulcer.
• If you have oesophagitis.
• If you have a history of epilepsy or seizures.

The lozenges may pose a choking hazard. Use with caution if you have difficulty swallowing solids or liquids or if you cough frequently during or after swallowing.

Children and adolescents

Do not give this medicine to children or adolescents.

Use of Nicorette Supermint with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is considered especially important if you are taking medicines containing:

Theophylline for the treatment of asthma

Tacrine for Alzheimer's disease

Clozapine for schizophrenia

Ropinirole for the treatment of Parkinson's disease.

Use of Nicorette Supermint with food and drinks

Do not eat or drink while using the lozenges. Acidic drinks, such as coffee, juice, or soft drinks, may reduce the absorption of nicotine. To achieve maximum nicotine absorption, avoid consuming these drinks at least 15 minutes before using the lozenge.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is very important to stop smoking during pregnancy, as smoking may cause intrauterine growth retardation, premature birth, or stillbirth. It is advisable to stop smoking without using nicotine-containing medicines. If you are unable to do so, you may use Nicorette Supermint only after consulting your doctor.

Since nicotine passes into breast milk and may affect the infant, this product should only be used during breastfeeding after consulting with your doctor. If your doctor recommends using Nicorette Supermint, the lozenges should be used immediately after breastfeeding and never within the 2 hours preceding breastfeeding.

Driving and using machines

This medicine does not affect your ability to drive or operate machinery.

Nicorette Supermint contains less than 23 mg of sodium (1 mmol) per lozenge, i.e., essentially “sodium-free”.

Nicorette Supermint contains polysorbate, which may cause allergic reactions.

3. How to use Nicorette Supermint

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

This medicine must not be used by individuals under 18 years of age.

This medicine is for oral use. Place the tablet in the mouth and allow it to dissolve, releasing nicotine which is absorbed through the oral mucosa into the rest of the body.

In all cases, place one lozenge in the mouth and periodically move it from one side of the mouth to the other until completely dissolved. This usually takes less than 20 minutes. Do not chew or swallow the tablet whole. Do not use more than 15 lozenges per day. If you feel the need to continue using Nicorette Supermint after 6 months of treatment, you should seek advice from your doctor.

The goal is to stop smoking completely and immediately, using Nicorette Supermint lozenges to relieve cravings.

Adults over 18 years of age

• Begin by using between 8 and 12 lozenges per day. Each time you feel a craving to smoke, use one lozenge, place it in your mouth and allow it to dissolve completely.
• Follow this regimen for up to 6 weeks, then gradually reduce the number of lozenges used each day.
• Once you have reached 1 or 2 lozenges per day, stop using Nicorette Supermint. After stopping, you may still experience sudden cravings to smoke. In such cases, you may use one lozenge.

Do not exceed the recommended dose. Follow the instructions carefully and do not use more than 15 lozenges per day (24 hours).

Do not eat or drink while the lozenge is in your mouth (see section Nicorette Supermint with food and drink).

For plastic container:

For cardboard box:

TO OPEN:

1.- Gently press the tab marked "press here".

2.- At the same time, pull the top of the box upwards firmly.

TO CLOSE: Press down on the top of the box.

Consult your doctor if you feel the urge to smoke again:

• If you are concerned that you might start smoking again.
• If you have difficulty stopping the use of Nicorette Supermint lozenges.

If you start smoking again, your doctor can advise you on how to achieve the best results in future attempts with nicotine replacement therapy (NRT).

If you use more Nicorette Supermint than you should

Nicotine overdose may occur if you smoke while using Nicorette Supermint.

. If a child takes Nicorette Supermint, contact your doctor immediately or go to the nearest hospital. Doses of nicotine tolerated by adult smokers during treatment may cause poisoning and even death in children.

Symptoms of overdose include discomfort (nausea), vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache, dizziness, hearing disturbances, and weakness. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme fatigue, circulatory collapse, and generalized seizures.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

In case of overdose or accidental poisoning, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects experienced when quitting smoking may be withdrawal symptoms due to reduced nicotine intake.

These effects include:

• Irritability, aggression, impatience, or frustration.
• Feelings of anxiety, restlessness, or difficulty concentrating.
• Night awakenings or sleep disturbances.
• Increased appetite or weight gain.
• Lethargy.
• Craving for cigarettes.
• Slowed heart rate.
• Bleeding gums or mouth ulcers.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or mucus production.
• Constipation.

If you experience any of the following serious adverse effects, stop using Nicorette Supermint and contact your doctor immediately, as they may be symptoms of a severe allergic reaction:

• Hives (a skin condition characterized by itching and red spots).
• Swelling of the face, tongue, or throat.
• Difficulty breathing.
• Difficulty swallowing.

Most of these adverse effects occur during the initial stages of treatment. During the first days of treatment, irritation in the mouth and throat may occur; however, in most cases, patients adapt with continued use.

Other possible adverse effects

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

• Cough
• Headache
• Hiccups
• Nausea (feeling of discomfort)
• Irritation of the throat, mouth, and tongue

Common: may affect up to 1 in 10 people:

• Effects at the site of administration such as burning sensation, mouth inflammation, or changes in taste perception
• Dry mouth or increased salivation
• Indigestion-like sensation
• Pain or discomfort in the stomach (abdomen)
• Vomiting, flatulence, or diarrhea
• Heartburn
• Feeling of tiredness (fatigue)
• Dizziness
• Hypersensitivity (allergy)
• Irritability and feelings of anxiety

Uncommon: may affect up to 1 in 100 people:

• Nasal effects such as nasal congestion, sneezing
• Wheezing (bronchospasm), or sensation of needing to breathe harder than normal (dyspnea), throat tightness
• Skin redness (flushing), tingling, or increased sweating
• Mouth effects such as tingling, tongue swelling, mouth ulcers, damage to the oral mucosa, changes in voice sound, mouth or throat pain, belching
• Palpitations (unusual awareness of heartbeat), increased heart rate, hypertension
• Skin rash and/or itching (pruritus, urticaria), or skin redness
• Depression, feeling of nervousness, abnormal dreams
• Chest discomfort or pain
• Feeling of weakness, malaise

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

• Difficulty swallowing, sensation of numbness in the mouth
• Rapid and irregular heartbeat, which may require appropriate medication
• Retching

Frequency not known: frequency cannot be estimated from available data:

• Blurred vision, increased tear production (lacrimation)
• Sore throat, stomach discomfort, lip pain
• Skin redness
• Seizures

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nicorette Supermint

Keep this medicine out of the sight and reach of children.

Do not use Nicorette Supermint after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

For the polypropylene container: Store in the original bottle to protect from moisture.

For the cardboard pack: Store in the original packaging to protect from moisture. Use within 3 months after removing from the wrapper.

Do not reuse the container to store any other substance, as residual powder from the tablets may remain in the container and could deposit onto items stored in it.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nicorette Supermint

• The active substance is Nicotine (as nicotine resin complex). Each lozenge contains 4 mg of nicotine.
• The other components are:
  Tablet core: mannitol (E421), xanthan gum, winterfresh RDE4-149 spray dried flavour (gum arabic (E414), mint, menthol and eucalyptus flavours), anhydrous sodium carbonate (E500)(i), sucralose (E955), potassium acesulfame (E950), magnesium stearate (E470b).
  Coating: hypromellose (E464), winterfresh RDE4-149 flavour (mint, menthol and eucalyptus flavours), titanium dioxide (E171), sucralose (E955), sepifilm gloss (hypromellose (E464), microcrystalline cellulose (E460), potassium aluminium silicate (E555), titanium dioxide (E171)), potassium acesulfame (E950), polysorbate 80 (E433).

Appearance of the product and contents of the pack

Nicorette Supermint are oval, white or almost white lozenges, printed with a "n" on one side and a "4" on the other. The size of each lozenge is approximately 14 x 9 x 7 mm.

Pack sizes:

Plastic container containing 20 lozenges. Packaged in quantities of 1 or 4 containers.

Carton pack containing 40 lozenges. Packaged in quantities of 1 or 2 cartons.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

JNTL Consumer Health (Spain), S.L.
C/ Vía de los Poblados 1, Edificio E, planta 3
28033-MADRID

Manufacturer

McNeil AB
Norrbroplatsen 2, SE-251 09
Sweden

Further information on this medicinal product can be requested from the local representative of the Marketing Authorisation Holder:

JNTL Consumer Health (Spain), S.L.
C/ Vía de los Poblados 1, Edificio E, planta 3
28033-MADRID

This medicinal product is authorised in other Member States under the following names:

Italy: Nicoretteicy
Spain: Nicorette Supermint

Date of the most recent revision of the summary of product characteristics: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/