Niquitin Mini

PATIENT INFORMATION LEAFLET: USER INFORMATION

NiQuitin MINI
(Nicotinum)
1.5 mg, lozenges

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as advised by your doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

NiQuitin MINI lozenges help you stop smoking. The use of this type of medicine is called nicotine replacement therapy. NiQuitin MINI 1.5 mg lozenges are suitable for people who smoke 20 or fewer cigarettes a day.
Nicotine in tobacco causes physical dependence on smoking.

• NiQuitin MINI lozenges help you quit smoking by replacing some of the nicotine you get from cigarettes.
• The nicotine provided relieves some of the unpleasant symptoms of nicotine withdrawal, including headache and irritability.
• The nicotine also relieves cravings for nicotine and helps you resist the urge to smoke.

NiQuitin MINI lozenges do not have the risks associated with smoking tobacco, as they do not contain tar, carbon monoxide, and other poisons from tobacco smoke. Some patients may worry about becoming dependent on nicotine lozenges after quitting 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 smoking can be increased by participating in a psychological program to support smoking cessation. To get information about a psychological program to support smoking cessation, you should contact your doctor or pharmacist.
Smoking has no health benefits. Therefore, it is definitely better to quit smoking. Using nicotine replacement therapy, such as NiQuitin MINI lozenges, can help. You should remember that the risks associated with smoking are 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),
• the medicine should not be used by non-smokers and children under 12 years of age.

Warnings and precautions

Before starting to use NiQuitin MINI, you should discuss it with your doctor, pharmacist, or nurse:

• People who are dependent on smoking and have recently had a heart attack or stroke, or have unstable or worsening angina (chest pain), or nocturnal angina, or severe arrhythmiasshould try to quit smoking without using nicotine replacement therapy, unless your doctor advises you to use it.
• People with diabetesusing 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.
• People who have had seizures
• People who have had an allergic reactioninvolving swelling of the lips, face, and throat (angioedema) or itchy skin rash (urticaria) should be cautious. Nicotine replacement therapy may sometimes cause such reactions.

When trying to quit smoking, you should not switch between NiQuitin MINI lozenges and nicotine chewing gum.

You should consult your doctor or pharmacist:

• in case of severe or moderate liver or kidney failuredue to the increased risk of side effects,
• in case of uncontrolled hyperthyroidism or pheochromocytoma(a tumor of the adrenal gland that affects blood pressure) due to the possibility of worsening symptoms of the disease, which your doctor will inform you about,
• in case of stomach or duodenal ulcers or esophagitis(inflammation of the esophagus) because swallowed nicotine may worsen symptoms of the disease, and may also cause oral ulcers. If symptoms of the disease worsen, you should consult your doctor. It may be necessary to replace oral nicotine replacement therapy with patches.
• in case of any doubts about dependence on this medicinal product or 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 normal dose of nicotine used in an adult can cause severe or fatal poisoning in a child. Therefore, you should keep NiQuitin MINI out of sight and reach of children.

NiQuitin MINI and other medicines

You should inform your doctor or pharmacist about all the medicines you have taken recently, including those obtained without a prescription.
Quitting smoking may change the effect of other medicines you are taking. In case of doubts, you should consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before using this medicine.
Smoking during pregnancyis dangerous for your baby. It may cause growth retardation, premature birth, or stillbirth. Quitting smoking is the only effective way to improve the health of both the pregnant woman and the baby. The sooner you quit smoking, the better.
Pregnant women should quit smoking without using nicotine replacement therapy. However, if this is not possible, your doctor or pharmacist may recommend using nicotine replacement therapy to support a quit attempt, as it will be more beneficial for the baby'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 the treatment for only 2-3 months. You should remember that the most important thing is to quit smoking. Medicines like lozenges may be more beneficial than patches, which release nicotine throughout the day. Patches can be used if lozenges cause nausea or vomiting.
Tobacco smoke, to which breastfeeding babies are exposed, causes them breathing difficulties and other health problems. Breastfeeding women should quit smoking without using nicotine replacement therapy. However, if this is not possible, your doctor or pharmacist may recommend using nicotine replacement therapy. When a breastfeeding woman uses nicotine replacement therapy, the amount of nicotine the baby gets from breast milk is small and much less harmful than passive smoking, to which the baby would be exposed if the mother continued to smoke.
It is best to use nicotine replacement therapy that provides single doses of nicotine throughout the day (e.g., lozenges or chewing gum, and not patches). It is best to breastfeed your baby just before taking a lozenge, as the baby will then get the smallest possible dose of nicotine.

Driving and using machines

There are no data on the effect of NiQuitin MINI on the ability to drive and use machines. However, you should remember that quitting smoking may cause changes in behavior that affect the ability to drive and use machines.

NiQuitin MINI contains sodium

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

3. How to use NiQuitin MINI

You should use NiQuitin MINI as described in the leaflet. In case of doubts, you should consult your doctor or pharmacist.
One NiQuitin MINI lozenge should be placed in the mouth, from time to time moving it from one side of the mouth to the other, until it is completely dissolved (about 10 minutes). The lozenges should not be chewed or swallowed whole. Do not use more than 15 lozenges per day. If you feel the need to use the medicine for longer than 9 months, you should consult your doctor or pharmacist.

Adults (over 18 years)

• Initially, use 8 to 12 lozenges per day. Suck a lozenge when you feel the urge to smoke.
• After no more than 6 weeks, you should gradually reduce the number of lozenges used.
• Treatment should be stopped when the number of lozenges used is reduced to 1-2 per day.

Even after treatment is stopped, you may still feel the urge to smoke, and you can also use the medicine then.

Use in children and adolescents

Adolescents 12-17 years

The medicine can be given to adolescents 12-17 years only if recommended by a doctor or pharmacist.

Do not exceed the recommended dose. Use the medicine as recommended and do not take more than 15 lozenges in 24 hours.

Children under 12 years should not use the medicine.

The medicine is intended for use on the mouth mucosa. The nicotine in the lozenges is released in the mouth and absorbed into the body.

In case of urge to smoke again

If you are afraid of relapsing into smoking or having trouble quitting the medicine, you should consult your doctor or pharmacist.
In case of relapse into smoking, your doctor or pharmacist will advise you on how to use the next nicotine replacement therapy most effectively.

Using more than the recommended dose of NiQuitin MINI

In case of taking too many NiQuitin MINI lozenges, you may experience nausea, dizziness, and malaise. You should then stop using the medicine and immediately consult your doctor or pharmacist. You should take the leaflet or packaging of the medicine with you to show them.
The medicine is not intended for children under 12 years of age or non-smokers. In case of ingestion of the medicine by a child or non-smoker, symptoms of nicotine overdose may occur, such as headache, vomiting, abdominal pain, and diarrhea. A child who has used or swallowed the medicine should be taken to the hospital emergency department or consulted by a doctor immediately. If possible, you should show the doctor the leaflet or packaging of the medicine.
In case of additional questions about using this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No serious side effects have been reported with the recommended use of NiQuitin MINI.
Quitting smoking itselfmay 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 caused by quitting smoking.
Other side effectsare listed below in groups based on their frequency:

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

Frequent (may affect up to 1 in 10 people)

• Sore throat
• Nausea
• Discomfort in the stomach
• Diarrhea
• Indigestion/heartburn
• Bloating with gas
• Hiccups
• Pharyngitis

Uncommon (may affect up to 1 in 100 people)

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

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

• severe allergic reactions with symptoms such as wheezing, chest tightness, skin rash, or feeling of impending faint

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

• seizures
• dysphagia (difficulty swallowing)
• belching (eructation)
• excessive salivation
• flu-like symptoms
• hypersensitivity reaction
• tremors, taste disturbances, paresthesia in the mouth (tingling or numbness of the mouth)
• shortness of breath
• itching or rash, swelling of the skin or mucous membranes, redness of the skin, excessive sweating

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store NiQuitin MINI

Do not use this medicine after the expiry date stated on the tube and outer packaging after: EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use the packaging containing the medicine for other purposes due to the remaining powder from the lozenges.
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 is nicotine. Each lozenge contains 1.5 mg of nicotine (as nicotine bitartrate).
• The other ingredients are: mannitol, sodium alginate, xanthan gum, potassium bicarbonate, calcium polycarbophil, anhydrous sodium carbonate, acesulfame potassium, magnesium stearate, peppermint flavor 020184, spearmint flavor 022173, flavor corrective 031431

What NiQuitin MINI looks like and contents of the pack

The medicine is in the form of white or almost white oval lozenges, biconvex. The 1.5 mg lozenge has the letter L embossed on one side.
Each container contains 20 lozenges. The pack contains 1 or 3 containers.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Omega Pharma Poland Sp. z o.o.
Al. Niepodległości 18
02-653 Warsaw
Tel +48 22 489 54 51
Fax +48 22 489 54 52

Manufacturer:

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

Importer:

Omega Pharma International NV
Venecoweg 26
Nazareth, 9810
Belgium
This medicine has been authorized for marketing in the Member States of the European Union under the following trade names:

Date of last revision of the leaflet:March 2019