Leaflet: information for the user

NiQuitin 2 mg chewing tablets, peppermint flavour

nicotina

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

Follow exactly the administration instructions contained 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 more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you are unable to reduce your tobacco consumption or stop smoking or using NiQuitin. See section 3.
• In this leaflet, NiQuitin 2 mg chewing tablets are referred to as NiQuitin.

NiQuitin is used to help quit smoking. This type of treatment is called Nicotine Replacement Therapy or NRT. NiQuitin is indicated for adults and adolescents (12-17 years, with the advice of a healthcare professional).

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

The permanent abandonment of the smoking habit is the ultimate goal. NiQuitin can also be used to quit smoking gradually for those who do not want or cannot quit smoking abruptly. Preferably, NiQuitin should be used in conjunction with a behavioral support program. See section 3 “How to take NiQuitin” for more details.

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

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

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

The chances of quitting smoking will improve if you participate in support programs. For more information, please consult with a healthcare professional.

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

Do not take NiQuitin:

Warnings and precautions

Consult your doctor or pharmacist before starting to take NiQuitin:

Do not interchange the use of NiQuitin with nicotine chewing gum during any attempt to quit smoking.

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

Children and adolescents

This medicine should not be used by children under 12 years old. A normal dose for an adult smoker could severely poison or even cause death in 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 under the advice of a healthcare professional. Adolescents should not quit smoking with combined TSN therapy.

Other medicines and NiQuitin

Inform a healthcare professional if you are using or have recently used any other medication. Nicotine may possibly increase some effects of medications for irregular or rapid heart rhythm (adenosine), for example, increased blood pressure and heart rate and also a painful response.

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

Use ofNiQuitinwith food and drinks

You should not eat or drink while you have NiQuitinin your mouth.

Acidic drinks, such as coffee, fruit juice or non-alcoholic drinks, may make nicotine less effective. You should avoid such drinks approximately 15 minutes before using NiQuitin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

This therapy is not recommended during pregnancy or breastfeeding unless a healthcare professional considers it necessary.

Pregnancy

Smoking duringpregnancyposes risks to the baby. Including fetal growth delay, premature birth or fetal death. Quitting smoking is the best way to improve both your health and your baby's health. The sooner you quit smoking, the better.

Ideally, if you are pregnant, you should quit smoking without using nicotine replacement therapy (NRT). If you have tried and it has not worked, NRT may be recommended by a healthcare professional, as it is better for your baby than if you continue to smoke.

Breastfeeding

Tobacco smoke causes respiratory difficulties and other problems in the baby and children. Nicotine from tobacco and NRT passes into breast milk. You should quit smoking without using NRT. If you have tried and it has not worked, NRT may be recommended by a healthcare professional. If you need NRT to quit smoking, the amount of nicotine that can reach your baby is small but this is much less harmful than breathing tobacco smoke. Also, it is better to breastfeed just before taking NRT so that your baby receives the smallest amount of nicotine possible.

Driving and operating machinery

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

NiQuitin contains sodium

This medication contains less than 1 mmol (23 mg) per lozenge, which is essentially "sodium-free".

Use NiQuitin exactly as indicated in this leaflet or as directed by a healthcare professional. Consult a healthcare professional if unsure how to use it.

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

Insert a NiQuitin lozenge into the mouth and occasionally 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.

NiQuitin usage instructions depend on whether you want to:

(a) quit smoking abruptly

(b) quit smoking gradually

Adults (18 years and older)

Monotherapy

1. Quit smoking abruptly
   • Take a lozenge whenever you feel the urge to smoke (taking 8-12 lozenges per day) for a maximum of 6 weeks. Then gradually reduce the number of lozenges taken per day.
   • When taking 1 or 2 lozenges per day, stop taking them completely.

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

1. Quit smoking gradually

When you feel a strong urge to smoke, take a NiQuitin lozenge instead of smoking a cigarette. Reduce the number of cigarettes smoked per day as much as possible. If you cannot reduce the number of cigarettes smoked per day after 6 weeks, consult a healthcare professional.

As soon as you feel able, stop smoking completely. Follow the instructions “(a) Quit smoking abruptly” above as soon as possible. If you do not stop smoking completely within 6 months of starting NiQuitin, consult a healthcare professional.

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

If you need to take NiQuitinfor more than 9 months consecutively, consult a healthcare professional.

Combined therapy

For smokers who have relapsed after TSN, or when lozenges alone are not sufficient to control smoking cravings, or as first-line treatment for smokers with high nicotine dependence.

Smokers can combine patches and oral TSN (medicated chewing gum, lozenges, etc.). The combination provides greater efficacy than using patches alone.

The initial treatment should start by determining the patch dose, which depends on the patient's previous smoking habit, in combination with NiQuitin. It is recommended that the daily intake 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 oral NiQuitin product (either lozenges or medicated chewing gum) should be used in combination with patches.

Continue using NiQuitin orally for 2 to 3 months, then start reducing usage gradually as you experience less nicotine craving. When daily usage is reduced to 1-2 doses, stop using.

For more information, see the NiQuitin patches leaflet.

Consult a doctor if symptoms persist.

Use in children and adolescents

Adolescents (12 to 17 years inclusive)

NiQuitin can only be used with the advice of a healthcare professional.

Children under 12 years

Children under 12 yearsshould not use NiQuitin.

• Consult a healthcare professional if:you are concerned about relapsing to smoking
• you have difficulty quitting completely.

If you start smoking again, you may be advised on how to get better results with additional TSN treatments.

If you take more NiQuitin than you should:

If you take more NiQuitin than you should, you may start to feel unwell, dizzy, or

indisposed. Stop using lozenges and consult a doctorimmediatelyor go to the emergency department of a hospital. If possible, bring the medication package or this leaflet.

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

Lozenges are not suitable for children under 12 years or non-smokers. If children or non-smokers use them, they may show signs of nicotine overdose. These include headaches, nausea, stomach pain, and diarrhea. If a child has used or eaten a lozenge, consult a doctor or go to the emergency department of the nearest hospitalimmediately.If possible, show them the medication or this leaflet.

Like all medicines, NiQuitin can cause side effects, although not everyone will experience them.

Stopping smokingmay cause symptoms such as dizziness, headache, sleep disturbances, cough, and symptoms similar to a cold. Other symptoms (withdrawal symptoms) such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be related.

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

- Severe allergic reaction, symptoms of which include sudden wheezing or chest tightness, skin rash, and feeling of fainting (very rare).

- Swelling of the skin or mucous membranes, face, tongue, and throat that cause breathing difficulties (frequency unknown).

Other side effects that may occur are:

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

Frequent (may affect up to 1 in 10 people)

Rarely frequent (may affect up to 1 in 100 people)

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

Frequency unknown (the frequency cannot be estimated with the available data)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use NiQuitin after the expiration date that appears on the packaging and on the box. The expiration date refers to the last day of the month indicated.
• Do not store above 25°C.
• Keep in the original packaging to protect it from moisture.
• Do not re-use the packaging for any purpose due to the possibility of it containing powder from the tablet.
• Dispose of the packaging responsibly. Medications should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. Please ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of NiQuitin

Each lozenge contains nicotine resinate equivalent to 2 mg of nicotine.

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

Appearance of NiQuitin and contents of the package

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

White to off-white oval-shaped lozenges with convex surfaces. The 2 mg lozenges have "NIC2" printed on one side.

The presentations may contain 1 (including a total of 20 lozenges), 3 (including a total of 60 lozenges) or 5 (including a total of 100 lozenges) packs of lozenges.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Perrigo España, S.A.

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

Spain

Perrigo Supply Chain International DAC

The Sharp Building

10-12 Hogan Place

Dublin 2

Ireland

Manufacturer responsible:

Omega Pharma International NV

Venecoweg 26

Nazareth

9810 Belgium

This medicine is authorized in some Member States of the European Economic Area with the following names:

Sweden: NiQuitin 2mg compressed lozenge

Belgium: NiQuitin Minilozenge 2 mg zuigtabletten – comprimés à sucer – Lutschtabletten, gepresst

Luxembourg: NiQuitin Minilozenge 2 mg

Netherlands: NiQuitin minizuigtablet 2 mg, zuigtabletten

Poland: NiQuitin MINI

Portugal: Niquitin Menta 2mg compressed lozenge

Ireland: Niquitin Mini 2 mg Mint Lozenges

Czech Republic: Nicotine Omega

Estonia: NiQuitin Mini Mint

Hungary: NiQuitin Minitab 2 mg préselt szopogató tabletta

Slovakia: NiQuitin mini mint 2 mg

This leaflet was revised in:February 2022.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/