Niquitin Mini

Leaflet accompanying the packaging: information for the user

NiQuitin MINI, 2 mg, lozenges
Nicotinum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as advised by healthcare professionals.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a healthcare professional, such as a doctor, nurse, smoking cessation advisor, or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should tell your healthcare professional. See section 4.
• If you are unable to reduce or stop smoking or using NiQuitin, you should speak to your doctor. See section 3.

Table of contents of the leaflet

• 1. What NiQuitin MINI is and what it is used for
• 2. Important information before using NiQuitin MINI
• 3. How to use NiQuitin MINI
• 4. Possible side effects
• 5. How to store NiQuitin MINI
• 6. Contents of the pack and other information

1. What NiQuitin MINI is and what it is used for

NiQuitin MINI lozenges help you stop smoking. The use of this type of medicine is called Nicotine Replacement Therapy or NRT. NiQuitin MINI is indicated for use in adults and adolescents (12-17 years, after consulting a healthcare professional).
2 mg lozenges are suitable for those who smoke 20 or fewer cigarettes per day.
The ultimate goal of therapy is to permanently stop smoking. NiQuitin MINI lozenges can also be used during gradual smoking cessation in people who do not want or are unable to stop smoking abruptly. NiQuitin MINI lozenges should be used in combination with a behavioral support program. See section 3: "How to use NiQuitin MINI".

• Nicotine in tobacco causes physical dependence on smoking cigarettes. NiQuitin MINI lozenges help you quit smoking by replacing some of the nicotine you get from cigarettes. The nicotine it contains helps to alleviate some of the unpleasant symptoms caused by stopping smoking, such as feeling ill or irritable. The nicotine it contains also helps to alleviate nicotine cravings and helps to prevent the urge to light a cigarette.

NiQuitin MINI lozenges do not carry the health risks associated with smoking tobacco, as they do not contain tar, carbon monoxide, and other toxins found in tobacco smoke. Some patients may be concerned about becoming dependent on nicotine lozenges after stopping smoking. Such dependence is very rare and even if it occurs, it is less harmful to health and easier to overcome than smoking tobacco.
The chances of quitting will increase if you take part in a support program. For more information on these programs, you should speak to a healthcare professional.
Smoking tobacco has no health benefits. Therefore, it is definitely better to quit. Using Nicotine Replacement Therapy, such as NiQuitin MINI lozenges, can help. You should remember that the risk associated with smoking tobacco is greater than the side effects that may occur when using Nicotine Replacement Therapy.

2. Important information before using NiQuitin MINI

When not to use NiQuitin MINI

• if you are allergic (hypersensitive) to nicotine or any of the other ingredients of this medicine (listed in section 6),
• in children under 12 years of age,
• in non-smokers.

Warnings and precautions

Before starting to use NiQuitin MINI, you should discuss it with a healthcare professional:

• People who are dependent on tobacco and have recently had a heart attack or stroke, or who have unstable or worsening angina (chest pain), or who have resting angina, or severe heart rhythm disturbancesshould try to stop smoking without using Nicotine Replacement Therapy, unless their doctor advises them to use it.
• If you are pregnant or breastfeeding.

When trying to stop smoking, you should not use NiQuitin MINI lozenges interchangeably with nicotine chewing gum.

You should consult a healthcare professional in the following cases:

• heart problemsor circulatory problemsand in cases of heart failure, stable angina, high blood pressureor peripheral arterial disease
• diabetes: people with diabetes who use NiQuitin MINI lozenges should measure their blood sugar levels more often than usual. The recommendations for taking insulin or oral hypoglycemic agents may need to be changed.
• if you have ever had an allergic reaction, with swelling of the lips, face, and throat (angioedema) or itchy skin rash (urticaria). NRT may occasionally cause such a reaction.
• severe or moderate liver or kidney impairmentdue to the increased risk of side effects,
• uncontrolled hyperthyroidism or pheochromocytoma(an adrenal gland tumor that affects blood pressure) due to the possibility of worsening symptoms of the disease, which the doctor will inform you about,
• stomach or duodenal ulcers or esophagitis(inflammation of the esophagus) because swallowed nicotine can exacerbate symptoms of the disease, and may also cause oral ulcers. If symptoms of the disease worsen, you should consult a doctor. It may be necessary to replace the oral form of Nicotine Replacement Therapy with patches.
• if you have ever had seizures
• if you have any doubts about your dependence on this medicinal productor if you think you have become dependent on this medicine.

Children and adolescents

This medicine should not be used in children under 12 years of age. The typical nicotine dose used in an adult can cause severe or fatal poisoning in a child. Therefore, NiQuitin MINI should be kept out of sight and out of reach of children.
Adolescents (12-17 years old) should use NiQuitin MINI lozenges only after consulting a healthcare professional. During smoking cessation, adolescents should not use combined NRT therapy.

NiQuitin MINI and other medicines

You should tell your healthcare professional about all the medicines you are taking or have recently taken. Nicotine may increase the effects of some medicines used for irregular or fast heartbeat (adenosine), i.e., increased blood pressure and heart rate, and may also increase the response to pain.
Stopping smoking tobacco may change the effect of other medicines you are taking. If you are in doubt, you should consult a healthcare professional.
The following medicines may require a dose adjustment when stopping smoking: asthma medicines (theophylline), painkillers (pentazocine), medicines that restore a normal heart rhythm (flecainide), antipsychotic medicines (clozapine, olanzapine), dopamine agonists (ropinirole), and caffeine.

NiQuitin MINI with food or drink

While sucking a NiQuitin MINI lozenge, you should not eat or drink.
Drinks such as coffee, juices, and soft drinks may reduce the effectiveness of nicotine.
You should avoid these fluids for 15 minutes before taking a NiQuitin MINI lozenge.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. Combined therapy is not recommended during pregnancy or breastfeeding unless your healthcare professional advises you to do so.
Pregnancy
Smoking tobacco during pregnancyis dangerous for your baby. It may cause growth restriction, premature birth, or stillbirth. Stopping smoking is the only effective way to improve the health of both you and your baby. The sooner you stop smoking, the better.
Pregnant women should stop smoking without using Nicotine Replacement Therapy. However, if this is not possible, a healthcare professional may recommend using Nicotine Replacement Therapy because it will be more beneficial for your baby than continuing to smoke.
Breastfeeding
Tobacco smoke exposure in infants and children causes breathing difficulties and other health problems. Nicotine from smoking and NRT is found in breast milk. Breastfeeding women should stop smoking without using Nicotine Replacement Therapy. However, if this is not possible after trying, a healthcare professional may recommend using Nicotine Replacement Therapy. When a breastfeeding woman needs to use Nicotine Replacement Therapy to stop smoking, the amount of nicotine the baby is exposed to is small and much less harmful than passive smoking, which the baby would be exposed to if the mother continued to smoke. It is also better to breastfeed your baby before using Nicotine Replacement Therapy, so your baby gets as little nicotine as possible.

Driving and using machines

There is no data on the effect of NiQuitin MINI lozenges on the ability to drive or use machines. However, you should remember that stopping smoking can cause changes in behavior that affect the ability to drive or use machines.

NiQuitin MINI contains sodium

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

3. How to use NiQuitin MINI

This medicine should always be used exactly as advised by your healthcare professional. If you are in doubt, you should consult a healthcare professional.
The product is intended for sublingual use. This means that the nicotine contained in the lozenge is released slowly into the mouth and then absorbed into the body.
One NiQuitin MINI lozenge should be placed in the mouth, occasionally moving it from one side of the mouth to the other, until it is completely dissolved (about 10 minutes).
Lozenges should not be chewed or swallowed whole.
Further dosage recommendations depend on whether:
a) you intend to stop smoking immediately,
b) you intend to gradually reduce smoking before stopping completely.

Adults (from 18 years)

Monotherapy:
a) Immediate smoking cessation

• For up to 6 weeks, take one lozenge (using 8-12 lozenges per day) whenever you feel the urge to smoke. Then gradually reduce the number of lozenges taken per day.
• When the number of lozenges used per day is reduced to 1 or 2, you should completely stop using them.

After stopping smoking, you may sometimes feel the urge to smoke. In such cases, you can use NiQuitin MINI lozenges again.
b) Gradual smoking cessation
When you feel the urge to smoke, take a NiQuitin MINI lozenge instead of a cigarette. You should try to reduce the number of cigarettes smoked per day as much as possible. If you are unable to reduce the number of cigarettes smoked per day after 6 weeks, you should consult a healthcare professional.
You should completely stop smoking cigarettes as soon as you feel you can. Then follow the instructions above in the "a) Immediate smoking cessation" section. You should do this as soon as possible. If you are unable to completely stop smoking within 6 months of starting to use NiQuitin MINI lozenges, you should consult a healthcare professional.
Do not exceed the recommended dose. You should follow the instructions carefully and not use more than 15 lozenges in 24 hours.
If you need to use NiQuitin MINI lozenges for more than 9 months, you should consult a healthcare professional.
Combined therapy:
Intended for people who have returned to smoking after using NRT or for those who find that using only lozenges is not enough to control their nicotine cravings or as a first-line treatment for smokers with a high level of dependence.
Patients can combine a transdermal system (patches) with oral NRT forms (such as chewing gum, lozenges, or tablets, etc.). Combined use is more effective than using patches alone.
Combined therapy should start with determining the patch dose, which depends on the patient's previous smoking habits. The recommended number of NiQuitin MINI 2 mg lozenges used in combination with patches is 5-6 lozenges per day.
The maximum daily dose is 15 lozenges. You should only use one type of oral NiQuitin form (lozenges or chewing gum) in combination with a transdermal system (patches).
You should continue to use the NiQuitin product orally for 2-3 months, then start to gradually reduce its use as the number of nicotine cravings decreases. When daily use is reduced to 1-2 lozenges, treatment should be stopped.

To obtain additional information, you should read the leaflet accompanying the NiQuitin Transparent product.

Use in children and adolescents

Adolescents (12-17 years old)

The medicine can be given to adolescents (12-17 years old) only after consulting a healthcare professional.

Children under 12 years old should not use NiQuitin MINI.

You should consult a healthcare professional if:

• you are concerned about returning to smoking
• or you are having trouble stopping the use of the medicine

If you return to smoking, a healthcare professional will advise you on how to use the next Nicotine Replacement Therapy most effectively.

Using more than the recommended dose of NiQuitin MINI

If you take too many NiQuitin MINI lozenges, you may experience nausea, dizziness, and malaise. You should then stop using the medicine and immediatelyconsult a doctor or go to the hospital emergency department. You should take the leaflet or packaging of the medicine with you to show it.
The medicine is not intended for children under 12 years of age or non-smokers. If a child or non-smoker takes the medicine, nicotine overdose symptoms may occur, such as headache, vomiting, abdominal pain, and diarrhea. A child who has used or swallowed the medicine should be immediatelytaken to the hospital emergency department or consulted with a doctor. If possible, you should show the doctor the leaflet or packaging of the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stopping smoking itself can cause symptomssuch as dizziness, headaches, sleep disturbances, coughing, and flu-like symptoms. Other symptoms (withdrawal symptoms), such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia, may also be caused by stopping smoking tobacco.
If you notice any of the following serious side effects, you should stop using NiQuitinand immediately consult a doctor, as they may be signs of a severe allergic reaction:

• Severe allergic reaction, with symptoms including sudden wheezing or tightness in the chest, rash, and feeling faint (frequency: very rare)
• Swelling of the skin or mucous membranes, face, tongue, and throat causing difficulty breathing (frequency: unknown)

Other side effects that may occur:
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, headaches
• Diarrhea
• Tremors
• Constipation
• Indigestion/heartburn
• Bloating
• Hiccups
• Sore throat
• Coughing
• Breathing difficulties, shortness of breath
• Pain in the upper abdomen
• Dryness of the mouth
• Oral ulcers
• Discomfort in the mouth
• Fatigue (tiredness)
• Feeling unwell
• 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 (cannot be estimated from the available data)

• Seizures
• Unusual dreams, depression, irritability, anxiety, taste disturbances/distortions, rash
• Itching
• Redness of the skin
• Increased sweating
• Hives
• Tingling in the mouth, belching
• Excessive salivation

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your healthcare professional. 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 NiQuitin MINI

The medicine should be stored out of sight and out of 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 stated.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
The container should not be used for other purposes, as a fine powder from the lozenges may settle on its walls.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What NiQuitin MINI contains

• The active substance of the medicine is nicotine in the form of nicotine cation exchange resin equivalent to 2 mg of nicotine
• The other ingredients (excipients) are: mannitol (E 421), sodium alginate (E 401), xanthan gum (E 415), potassium bicarbonate (E 501), calcium polycarbophil, sodium carbonate (E 500), acesulfame potassium (E 950), peppermint flavor (D,L-menthol, peppermint oil, gum arabic, peppermint flavor), magnesium stearate (E 470b), sucralose.

What NiQuitin MINI looks like and contents of the pack

Approximate size: length: 10 mm × width: 5 mm
White or off-white, biconvex, oval lozenge with "NIC2" embossed on one side.
Outer packaging may contain 1 (total 20 lozenges), 3 (total 60 lozenges), or 5 (total 100 lozenges) containers of lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder

Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
Tel +48 (22) 852 55 51

Importer

Omega Pharma International NV
Venecoweg 26
9810 Nazareth
Belgium
Perrigo Supply Chain International DAC
The Sharp Building
10-12 Hogan Place
Dublin 2
Ireland

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

Sweden:
NiQuitin 2 mg compressed lozenge
Belgium:
NiQutin Minilozenge 2 mg zuigtabletten – comprimés à sucer – Lutschtabletten geprést
Luxembourg:
NiQuitin Minilozenge 2 mg
Netherlands:
NiQuitin minizugtablet 2 mg, zuigtabletten
Poland:
NiQuitin MINI
Portugal:
Niquitin Menta 2 mg compressed lozenge
Spain:
Niquitin 2 mg comprimidos para chupar sabor menta
Ireland:
Niquitin Mini 2 mg Mint Lozenges
Czech Republic:
Nicotine Omega
Greece:
NiQuitim Mini Mint
Hungary:
NiQuitin Minitab 2 mg préselt szopogató tabletta
Date of last revision of the leaflet:August 2024