Nicorette Supermint 2 mg lozenges EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette Supermint 2 mg lozenges for sucking

Nicotine

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use of this medicine as described in this leaflet or as advised by your doctor or pharmacist.

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

Contents of the leaflet:

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
6. Contents of the pack and other information

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

This medicine is used to relieve withdrawal symptoms and reduce nicotine cravings that occur when trying to quit smoking. This treatment is indicated for adult smokers aged 18 years or older.

Nicorette Supermint 2 mg lozenges is suitable for smokers with low nicotine dependence, for example, those who smoke their first cigarette of the day at least 30 minutes after waking up, or those who smoke 20 cigarettes or fewer per day.

Nicorette Supermint relieves nicotine withdrawal symptoms, including cravings, associated with stopping tobacco use. When you suddenly stop supplying nicotine to your body from tobacco, you experience various unpleasant sensations known as withdrawal symptoms, such as irritability or aggression, depression, anxiety, restlessness, difficulty concentrating, increased appetite or weight gain, cravings to smoke (cravings), nighttime awakenings, or sleep disturbances. The nicotine in Nicorette Supermint can help you prevent or reduce these unpleasant symptoms and 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 still be able to use Nicorette Supermint, you should consult your doctor first:

• If you have recently suffered a heart attack or heart-related episode.
• If you suffer from chest pain (unstable angina) or angina at rest.
• If you have a heart condition affecting heart rhythm or rate (arrhythmia).
• If you have high blood pressure that is not controlled by 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 overactivity of the thyroid gland.
• If you have a tumor of the adrenal gland (pheochromocytoma).
• If you suffer from 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 especially important if you are taking medicines containing:

Theophylline for asthma

Tacrine for Alzheimer's disease

Clozapine for schizophrenia

Ropinirole for the treatment of Parkinson's disease.

Use of Nicorette Supermint with food and drink

Do not eat or drink while using the lozenges. Acidic drinks that make the mouth acidic, such as coffee, juice, or soft drinks, may reduce the absorption of nicotine. To achieve maximum nicotine absorption, avoid consuming these drinks for 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 medications. 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, Nicorette Supermint should only be used during breastfeeding after consulting with your doctor. If your doctor has advised you to use Nicorette Supermint, the lozenges should be taken immediately after breastfeeding and never within the 2 hours prior.

Driving and operating machinery

The use of 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., it is essentially "sodium-free".

Nicorette Supermint contains polysorbate, which may cause allergic reactions.

3. How to use Nicorette Supermint

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed 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 side to side until it dissolves completely. 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 beyond 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 for cigarettes.

Adults over 18 years of age

• Begin by using between 8 and 12 lozenges per day. Each time you feel the urge 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 the point of using only 1 or 2 lozenges per day, stop using Nicorette Supermint. After stopping, you may still experience sudden urges 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 pack:

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 pack

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 symptoms of poisoning and even death in children.

Symptoms of overdose include discomfort (nausea), vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache and dizziness, hearing disturbances, and a feeling of 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 using 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 may produce adverse effects, although not everyone will experience them.

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects experienced when you stop 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 (frequency is very rare: may affect up to 1 in 10,000 people):**

• Hives (a skin condition characterized by itching and red patches).
• 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 few days of treatment, irritation of the mouth and throat may occur; however, most patients adapt with continued use.

Other possible adverse effects

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

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

Common: may affect up to 1 in 10 people:

• Effects at the application site such as burning sensation, mouth swelling, or changes in taste perception
• Dry mouth or increased salivation
• Dyspepsia
• 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
• Noisy breathing (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, mouth and throat pain, belching
• Palpitations (unusual awareness of heartbeat), increased heart rate, hypertension
• Skin rash and/or itching (pruritus, urticaria) or skin redness
• Depression, nervousness, abnormal dreams
• Chest discomfort and pain
• Feeling of weakness, feeling unwell

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

• Difficulty swallowing, 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)
• Dry 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 adverse 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 this medicine 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 opening the wrapper.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly 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 2 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 flavourings), anhydrous sodium carbonate (E500)(i), sucralose (E955), acesulfame potassium (E950), magnesium stearate (E470b).
  Coating: hypromellose (E464), winterfresh RDE4-149 flavour (mint, menthol and eucalyptus flavourings), titanium dioxide (E171), sucralose (E955), sepifilm gloss (hypromellose (E464), microcrystalline cellulose (E460), potassium aluminium silicate (E555), titanium dioxide (E171)), acesulfame potassium (E950), polysorbate 80 (E433).

Appearance of the product and contents of the pack

Nicorette Supermint are oval, white or almost white lozenges, printed with an “n” on one side and a “2” 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.

Cardboard pack containing 40 lozenges. Packaged in quantities of 1 or 2 packs.

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 obtained 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 this leaflet: January 2025

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