NIQUITIN MINI

NiQuitin MINI
(Nicotinum)
4 mg, buccal tablets
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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 buccal tablets help you stop smoking. Using this type of treatment is called nicotine replacement therapy (NRT). NiQuitin MINI 4 mg buccal tablets are suitable for individuals who smoke 20 or more cigarettes per day.
Nicotine in tobacco causes physical dependence on cigarette smoking.

• NiQuitin MINI buccal tablets help you quit smoking by replacing part of the nicotine previously obtained from cigarettes.
• The supplied nicotine reduces unpleasant withdrawal symptoms, including low mood and irritability.
• The supplied nicotine also reduces nicotine cravings and helps resist the urge to smoke.

NiQuitin MINI buccal tablets eliminate the risks associated with smoking tobacco, as they do not contain tar, carbon monoxide, or other toxins found in tobacco smoke. Some patients may be concerned about becoming dependent on nicotine tablets after stopping smoking. Such dependence is very rare, and even if it occurs, it is less harmful to health and easier to overcome than continued smoking.
The chances of successfully quitting smoking can be improved by participating in a psychological support program. For information about psychological support programs to help quit smoking, please consult your doctor or pharmacist.
Smoking tobacco provides no health benefits. Therefore, quitting smoking is strongly recommended. Using nicotine replacement therapy, such as NiQuitin MINI buccal tablets, can help achieve this. Remember that the health risks of smoking tobacco are far greater than any possible side effects associated with nicotine replacement therapy.

2. Important information before using NiQuitin MINI

When not to use NiQuitin MINI:

• if the patient is allergic (hypersensitive) to nicotine or to any of the other ingredients of this medicine (listed in section 6),
• the medicine should not be used by non-smokers or by children under 12 years of age.

Warnings and precautions
Before starting to use NiQuitin MINI, discuss this with your doctor, pharmacist, or
nurse:

• Smokers who have recently suffered a heart attack or stroke, or who have unstable or worsening angina pectoris (chest pain), or nocturnal angina pectoris, or severe heart rhythm disorders should try to quit smoking without using nicotine replacement therapy, unless a doctor authorizes its use.
• Patients with diabetes using NiQuitin MINI tablets should monitor their blood sugar levels more frequently than usual. Dosage recommendations for insulin or antidiabetic medications may need to be adjusted.
• Patients who have experienced epileptic seizures
• Patients who have ever had an allergic reaction involving swelling of the lips, face, and throat (angioedema) or itchy skin rash (urticaria) should use caution. Nicotine replacement therapy may occasionally cause such reactions.

When attempting to quit smoking, do not interchange NiQuitin MINI tablets with nicotine-containing chewing gum.
Consult your doctor or pharmacist if you have:

• severe or moderate liver or kidney impairment, due to an increased risk of adverse effects,
• uncontrolled hyperthyroidism or a phaeochromocytoma (an adrenal gland tumor affecting blood pressure), due to the risk of worsening symptoms, as advised by your doctor,
• peptic ulcer of the stomach or duodenum or oesophagitis (inflammation of the oesophagus, the part of the digestive tract between the mouth and stomach), because swallowed nicotine may worsen symptoms and may also cause oral ulcers. If symptoms worsen, consult your doctor. It may be necessary to switch from oral nicotine replacement therapy to transdermal patches.
• any doubts regarding dependence on this medicinal product, or if you believe you have become dependent on this medicine.

Children and adolescents
This medicine should not be used in children under 12 years of age. A normal dose of nicotine used in adults may cause severe or fatal poisoning in a child. Therefore, NiQuitin MINI should be stored out of sight and out of reach of children.

NiQuitin MINI and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, including those obtained without a prescription.
Stopping smoking may alter the effects of other medicines you are taking. If in doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Smoking during pregnancy is dangerous for the unborn child. It may cause delayed fetal growth, premature birth, or stillbirth. Quitting smoking is the only effective way to improve the health of both the mother and the child. The sooner smoking is stopped, the better.
Pregnant women should try to quit smoking without using nicotine replacement therapy. However, if this is not successful, your doctor or pharmacist may recommend using nicotine replacement therapy to support your attempt to quit, as this would be less harmful to the child's development than continuing to smoke. The decision to use nicotine replacement therapy during pregnancy should be made as early as possible. It is recommended to use treatment for only 2–3 months. It is important to remember that the most crucial goal is to stop smoking. Medicines such as lozenges may be preferable to patches, which release nicotine continuously throughout the day and night. Patches may be used if lozenges cause nausea or vomiting.

Tobacco smoke to which breastfed infants are exposed causes breathing difficulties and other health problems. Women who are breastfeeding should try to quit smoking without using nicotine replacement therapy. However, if this is not successful, your doctor or pharmacist may recommend using nicotine replacement therapy. When a breastfeeding woman uses nicotine replacement therapy, the amount of nicotine passed to the infant through breast milk is small and significantly less harmful than passive smoking, to which the infant would otherwise be exposed if the mother continued smoking.
It is best to use nicotine replacement therapy that delivers single doses of nicotine during the day (e.g. lozenges or chewing gum) rather than patches. It is advisable to breastfeed the baby just before taking a lozenge, as the infant will then receive the lowest possible dose of nicotine.

Driving and using machines
There are no data on the influence of NiQuitin MINI on the ability to drive or operate machinery. However, it should be remembered that quitting smoking may cause behavioral changes that may affect the ability to drive or operate machinery.

NiQuitin MINI contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use NiQuitin MINI

Use NiQuitin MINI according to the instructions provided in the package leaflet. If in doubt,
consult your doctor or pharmacist.
Place one NiQuitin MINI tablet in the mouth and move it occasionally from one side of the mouth
to the other until it dissolves completely (approximately 10 minutes). Do not chew or swallow the
tablet whole. Do not use more than 15 tablets per day. If you feel the need to use the medicine for
longer than 9 months, consult your doctor or pharmacist.
Adults (over 18 years of age)

• At the beginning of treatment, use 8 to 12 tablets per day. Suck a tablet whenever you feel the urge to smoke a cigarette.
• Within no more than 6 weeks, gradually reduce the number of tablets used.
• Complete treatment when the number of tablets used decreases to 1-2 per day.

Even after completing therapy, the urge to smoke may still occur; in such cases, the medicine may
also be used.
Use in children and adolescents
Adolescents aged 12–17 years
NiQuitin MINI may be used by adolescents aged 12–17 years only upon recommendation by a
doctor or pharmacist.
Do not exceed the recommended dosage. Use the medicine as directed and do not take more than 15 tablets per day.
Children under 12 years of age must not use this medicine.
This medicine is intended for oral mucosal use. The nicotine contained in the tablets is released in
the mouth and absorbed into the body.
In case of craving to smoke again
If the patient fears a relapse into smoking or has difficulties discontinuing treatment, they should
consult their doctor or pharmacist.
In case of relapse into smoking, your doctor or pharmacist will advise on how best to use the next
nicotine replacement therapy.
Use of a higher than recommended dose of NiQuitin MINI
If too many NiQuitin MINI tablets are taken, nausea, dizziness, and general malaise may occur.
In such cases, stop using the medicine immediately and consult your doctor or pharmacist without delay.
Take the package leaflet or medicine packaging with you to show to the doctor.
This medicine is not intended for children under 12 years of age or for non-smokers. If a child or a
non-smoker accidentally takes the medicine, symptoms of nicotine overdose may occur, such as
headache, vomiting, abdominal pain, and diarrhoea. A child who has used or ingested the medicine
must be taken immediately to the nearest hospital emergency department or a doctor must be contacted.
If possible, show the doctor the package leaflet or medicine packaging.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No serious side effects have been observed with the use of NiQuitin MINI tablets at the recommended dosage.

Stopping smoking itself may cause symptoms such as dizziness, headache, sleep disturbances, cough, and flu-like symptoms. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be due to stopping smoking.

Other side effects listed below are grouped according to the likelihood of their occurrence:

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

• The lozenges may cause mild irritation or soreness of the tongue or mouth. Nausea may occur.

Common (may affect up to 1 in 10 people)

• Sore throat
• Nausea
• Feeling of stomach discomfort
• Diarrhea
• Indigestion/heartburn
• Bloating with passing wind
• Hiccups
• Sore throat (pharyngitis)

Uncommon (may affect up to 1 in 100 people)

• Nervousness
• Depression
• Palpitations (awareness of heartbeat)
• Increased heart rate
• Chest pain
• Rash
• Fatigue and general malaise

Very rare (may affect up to 1 in 10,000 people)

• severe allergic reactions characterised by sudden onset of wheezing or tightness in the chest, skin rash, or feeling faint

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

• seizures
• dysphagia (difficulty swallowing)
• belching with regurgitation of gas from the stomach through the mouth (loud belching)
• excessive salivation
• flu-like illnesses (flu-like symptoms)
• hypersensitivity reaction
• tremor, taste disturbances, oral paraesthesia (tingling or numbness in the mouth)
• shortness of breath
• itching or rash, swelling of the skin or mucous membranes, redness of the skin, excessive sweating

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store NiQuitin MINI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and outer packaging following: EXP. The expiry date refers to the last day of the month.
Do not store above 25 °C.
Store in the original packaging to protect from moisture.
Do not reuse the medicine container for other purposes due to residual tablet powder.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What NiQuitin MINI contains

• The active substance is nicotine. Each tablet contains 4 mg of nicotine (as nicotine polacrilex).
• The other ingredients are: mannitol, sodium alginate, xanthan gum, potassium bicarbonate, calcium polycarbophil, anhydrous sodium carbonate, acesulfame potassium, peppermint flavour, magnesium stearate, sucralose.

What NiQuitin MINI looks like and contents of the pack
NiQuitin MINI is a white or almost white, oval, biconvex tablet. The 4 mg tablet has the letter "NIC4" embossed on one side.
Each container contains 20 tablets. The pack contains 1 or 3 containers.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
Tel +48 (22) 852 55 51

Manufacturer:
Wrafton Laboratories Limited,
Exeter Road, Wrafton, Braunton
EX33 2DL
United Kingdom

Importer:
Perrigo Supply Chain International DAC
The Sharp Building
Hogan Place
Dublin 2
Dublin, D02 TY74
Ireland

This medicine has been authorised in the European Union Member States under the following trade names: