Niquitin 2 mg menthol-flavored lozenges

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

NiQuitin 2 mg lozenges with mint flavour

nicotine

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

Follow exactly the instructions for use provided in this leaflet or those given 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 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 you are unable to reduce your tobacco consumption or to stop smoking or using NiQuitin. See section 3.
• In this leaflet, NiQuitin 2 mg lozenges are referred to as NiQuitin.

Contents of the leaflet

1. What NiQuitin is and what it is used for
2. What you need to know before taking NiQuitin
3. How to take NiQuitin
4. Possible side effects
5. How to store NiQuitin
6. Contents of the pack and other information

1. What NiQuitin is and what it is used for

NiQuitin is used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy (NRT). NiQuitin is indicated for use in adults and adolescents (12–17 years, following advice from a healthcare professional).

NiQuitin 2 mg is suitable for smokers of 20 cigarettes or fewer per day.

Permanently stopping smoking is the ultimate goal. NiQuitin can also be used for gradually quitting smoking among those who do not wish or are unable to stop smoking abruptly. NiQuitin should preferably be used in conjunction with a behavioural support programme. See section 3, “How to take NiQuitin”, for further details.

The nicotine in cigarettes is what can make you physically addicted to them.

• NiQuitin helps you quit smoking by replacing part of the nicotine provided by cigarettes.
• This nicotine relieves some of the unpleasant symptoms smokers may experience when trying to quit. These symptoms include feeling unwell or irritable.
• Nicotine may also reduce your craving for a cigarette and help you resist the urge to smoke.

NiQuitin does not pose the same health risks as tobacco. NiQuitin does not contain tar, carbon monoxide, or other toxins found in cigarette smoke. Some people are concerned that after quitting smoking, they might become dependent on NiQuitin. This is very rare, and if it does occur, it is less harmful than continuing to smoke. In any case, it is an easier habit to break.

Your chances of successfully quitting smoking will improve if you participate in support programmes. For information about such programmes, please consult a healthcare professional.

Smoking has no health benefits. It is always better to quit smoking. The use of NRT, such as NiQuitin, can help you quit. In general, any potential side effects associated with NRT are outweighed by the dangers of smoking.

2. What you need to know before starting to take NiQuitin

Do not take NiQuitin:

• if you are allergic to nicotine or to any of the components of this medicine (see section 6)
• if you are under 12 years of age
• if you are a non-smoker

Warnings and precautions

Consult your doctor or pharmacist before starting to take NiQuitin:

• if you have recently had a heart attack or stroke, or you suffer from serious heart rhythm problems, unstable angina, worsening angina pectoris (chest pain), or angina at rest, you should try to quit smoking without using any nicotine replacement therapy (NRT) unless your doctor advises you to use it.
• If you are pregnant or breastfeeding.

Do not switch between NiQuitin and nicotine medicinal chewing gum during any attempt to quit smoking.

Seek help and advice from a healthcare professional if you have:

• heart or circulatory problems including heart failure, stable angina, high blood pressure, or occlusive peripheral arterial disease
• diabetes, as you should monitor your blood sugar levels more frequently than usual when starting NiQuitin. The amount of insulin or medication you require may change.
• if you have ever had allergic reactions including swelling of the lips, face and throat (angioedema) or skin itching (urticaria). The use of NRT can sometimes trigger such reactions.
• severe or moderate liver problems or serious kidney problems – because you may be more likely to experience side effects.
• uncontrolled hyperactivity of the thyroid gland or phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) – your doctor will have advised you that nicotine may worsen symptoms of your condition.
• stomach or duodenal ulcer or inflammation of the oesophagus or glottis (the passage between the mouth and stomach), as swallowed nicotine may worsen your symptoms. This treatment may also cause mouth ulcers. If your symptoms worsen, consult your doctor. You may wish to use a non-oral form of NRT, such as patches.
• a history of epilepsy (seizures)
• any concerns about becoming dependent on this product or if you believe you are already dependent on it.

Children and adolescents

This medicine must not be used by children under 12 years of age. A normal dose for an adult smoker could severely poison or even kill a child. It is therefore essential to keep NiQuitin out of the sight and reach of children. Adolescents (12–17 years) should only use NiQuitin on the advice of a healthcare professional. Adolescents should not quit smoking using combination NRT.

Other medicines and NiQuitin

Inform a healthcare professional if you are taking or have recently taken any other medicines. Nicotine may possibly enhance some effects of medications used for irregular or rapid heart rhythm (adenosine), for example increasing blood pressure and heart rate, as well as causing a painful response.

Stopping smoking may alter the effects of other medicines you are taking. If you have questions or concerns, speak with a healthcare professional. The following may require dose adjustment when quitting smoking: asthma medication (theophylline), painkillers (pentazocine), medicines to restore normal heart rhythm (flecainide), antipsychotics (clozapina, olanzapine), dopamine agonists (ropinirol), and caffeine.

Use of NiQuitin with food and drink

You must not eat or drink while NiQuitin is in your mouth.

Acidic drinks, such as coffee, fruit juice, or soft drinks, may reduce the effectiveness of nicotine. You should avoid such drinks for approximately 15 minutes before using NiQuitin.

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.

Combination NRT is not recommended during pregnancy or breastfeeding unless considered necessary by a healthcare professional.

Pregnancy

Smoking during pregnancy poses risks to the baby, including fetal growth restriction, premature birth, or fetal death. Quitting smoking is the best way to improve both your health and your baby's. The earlier you stop smoking, the better.

Ideally, if you are pregnant, you should stop smoking without using nicotine replacement therapy (NRT). If you have tried and failed, NRT may be recommended by a healthcare professional, as it is better for your baby than continuing to smoke.

Breastfeeding

Tobacco smoke causes breathing difficulties and other problems in babies and children. Nicotine from tobacco and from NRT passes into breast milk. You should stop smoking without using NRT. If you have already tried and failed, NRT may be recommended by a healthcare professional. If you need NRT to stop smoking, the amount of nicotine that reaches your baby is small, but this is far less harmful than exposure to tobacco smoke. It is also advisable to breastfeed just before taking NRT to ensure your baby receives the lowest possible amount of nicotine.

Driving and using machines

There are no known effects of NiQuitin on your ability to drive or operate machinery. However, quitting smoking may cause behavioural changes that could affect your ability to drive or use machines.

NiQuitin contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per lozenge, i.e. is essentially "sodium-free".

3. How to take NiQuitin

Always use NiQuitin exactly as described in this leaflet or as your healthcare professional has instructed you. Consult a healthcare professional if you are unsure about how to use it.

This medicine is for oral use. This means that the nicotine in the lozenge is slowly released into the mouth, from where it is absorbed into the body.

Place one NiQuitin lozenge in your mouth and from time to time move it from one side of the mouth to the other, until it dissolves completely. This may take about 10 minutes.

Do not chew the lozenge or swallow it whole.

The instructions for using NiQuitin depend on whether you wish to:

(a) stop smoking abruptly

(b) stop smoking gradually

Adults (over 18 years of age)

Monotherapy

1. Stopping smoking abruptly
   • Take one lozenge whenever you feel the urge to smoke (taking 8–12 lozenges per day), up to a maximum of 6 weeks. Then gradually reduce the number of lozenges you take each day.
   • When you are taking only 1 or 2 lozenges per day, stop taking them completely.

After successfully quitting smoking, you may suddenly feel the desire to smoke again. If this happens, you may take another lozenge.

2. Stopping smoking gradually

When you feel a strong need to smoke, take a NiQuitin lozenge instead of smoking a cigarette. Reduce the number of cigarettes you smoke each day as much as possible. If you have not been able to reduce the number of cigarettes you smoke per day after 6 weeks, speak with a healthcare professional.

As soon as you feel ready, stop smoking completely. Follow the instructions under “a) Stopping smoking abruptly” above as soon as possible. If you have not completely stopped smoking within 6 months of starting NiQuitin, speak with a healthcare professional.

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

If you need to use NiQuitin for more than 9 consecutive months, you must consult a healthcare professional.

Combination therapy

For smokers who have relapsed after nicotine replacement therapy (NRT), or when lozenges alone are not sufficient to control smoking cravings, or as first-line treatment for smokers with a high level of dependence.

Smokers may combine patches and oral NRT (medicated chewing gum, lozenges, etc.). Combination therapy provides greater efficacy than using patches alone.

Initial treatment should begin by determining the patch dose, which depends on the patient's previous smoking habits, in combination with NiQuitin. It is recommended that daily use of NiQuitin 2 mg lozenges in combination with patches be 5 to 6 units. The maximum daily dose for all oral forms is 15 units. Only one type of NiQuitin oral product (either lozenges or medicated chewing gum) should be used in combination with patches.

You should continue using NiQuitin orally for 2 to 3 months, then gradually begin reducing use as you experience less nicotine craving. When daily use is reduced to 1–2 doses, stop using it completely.

For more information, read the NiQuitin patches package leaflet.

Consult your doctor if symptoms persist.

Use in children and adolescents

Adolescents (12 to 17 years inclusive)

NiQuitin may only be used under the advice of a healthcare professional.

Children under 12 years

Children under 12 years must not use NiQuitin.

• Talk to a healthcare professional if: you are concerned about starting to smoke again
• you have difficulty completely stopping the use of nicotine lozenges.

If you start smoking again, you can be advised on how to achieve better results with additional NRT treatments.

If you take more NiQuitin than you should:

If you take more NiQuitin than you should, you may begin to feel unwell, dizzy or nauseous. Stop using the lozenges immediately and consult a doctor immediately or go to a hospital emergency department. If possible, take the medicine pack or this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

The lozenges are not suitable for children under 12 years of age or for non-smokers. If used by children or non-smokers, signs of nicotine overdose may occur. These include headache, nausea, stomach pain and diarrhoea. If a child has used or swallowed any lozenges, consult your doctor or go to the nearest hospital emergency department immediately. If possible, show them the medicine or this leaflet.

4. Possible adverse effects

Like all medicines, NiQuitin can cause adverse effects, although not everyone experiences them.

Stopping smoking can cause symptoms such as dizziness, headache, sleep disturbances, cough, cold-like symptoms. Other symptoms (withdrawal symptoms) such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also occur.

If you notice any of the following serious side effects, stop taking NiQuitin and contact a doctor immediately, as they may be signs of a severe allergic reaction:

• Severe allergic reaction, with symptoms including sudden wheezing or tightness in the chest, skin rash, and feeling faint (very rare frequency).
• Swelling of the skin or mucous membranes, face, tongue, and throat causing breathing difficulties (frequency not known).

Other adverse effects that may occur are:

Very common (may affect more than 1 in 10 people)

• Nausea, vomiting
• Sleep disturbances

Common (may affect up to 1 in 10 people)

• Nervousness, dizziness, headache
• Diarrhea
• Tremor
• Constipation
• Indigestion/heartburn
• Flatulence
• Hiccups
• Sore throat
• Cough
• Difficulty breathing, shortness of breath
• Upper abdominal pain
• Dry mouth
• Mouth ulcers
• Mouth discomfort
• Fatigue (tiredness)
• General malaise
• Flu-like symptoms
• Lack of energy

Uncommon (may affect up to 1 in 100 people)

• Difficulty swallowing
• Palpitations (awareness of heartbeat)
• Increased heart rate

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

• Hypersensitivity

Frequency not known (frequency cannot be estimated from the available data)

• Seizures (fits)
• Abnormal dreams, depression, irritability, anxiety, taste disturbance/distortion, rash
• Itching
• Skin redness
• Increased sweating
• Urticaria
• Tingling in the mouth, burping
• Increased salivation
• Fast and irregular heartbeat (Atrial fibrillation)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NiQuitin

• Keep this medicine out of the sight and reach of children.
• Do not use NiQuitin after the expiry date stated on the packaging and carton. The expiry date refers to the last day of the month indicated.
• Do not store above 25°C.
• Store in the original packaging to protect it from moisture.
• Do not reuse the container due to the possibility that it may contain residual tablet powder.
• Dispose of the container responsibly. Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of NiQuitin

Each lozenge contains nicotine resin complex equivalent to 2 mg of nicotine.

The other components are: mannitol (E421), sodium alginate (E401), xanthan gum (E415), potassium bicarbonate (E501), polycarbophil calcium, anhydrous sodium carbonate (E500), acesulfame potassium (E950), peppermint flavour (racemic menthol, peppermint oil, acacia), magnesium stearate (E470b), sucralose.

Appearance of NiQuitin and contents of the pack

The size of the lozenges (to the nearest mm) is: L: 10 mm x W: 5 mm.

White to off-white, oval-shaped lozenges with convex surfaces. The 2 mg lozenges are printed with “NIC2” on one side.

Pack sizes may contain 1 (containing a total of 20 lozenges), 3 (containing a total of 60 lozenges) or 5 (containing a total of 100 lozenges) blister packs of lozenges.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Perrigo España, S.A.

Pza. Xavier Cugat, 2 Edif. D Pl. 1ª 08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer:

Perrigo Supply Chain International DAC

The Sharp Building

Hogan Place

Dublin 2

Dublin, D02 TY74 Ireland

This medicinal product is authorised in certain Member States of the European Economic Area under the following names:

Sweden: NiQuitin 2mg komprimerad sugtablett

Belgium: NiQuitin Minilozenge 2 mg

Luxembourg: NiQuitin Minilozenge 2 mg

Ireland: NiQuitin Mini 2 mg Mint Lozenges

Luxembourg: Niquitin Minilozenge 2 mg

Netherlands: NiQuitin minizuigtablet 2 mg, zuigtabletten

Poland: NiQuitin 2 mg, tabletki do ssania

Portugal: Niquitin Menta 2mg comprimido para chupar

Czech Republic: Nicotine Omega 2 mg lisované pastilky

Slovakia: NiQuitin mini mint 2 mg pas. Cmp, nicotine

Estonia: NiQuitin Mini Mint 2 mg pressitud losengid

Hungary: NiQuitin Minitab 2 mg préselt szopogató tabletta

This leaflet was last revised in: November 2025.

Detailed 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/