Niquitin

Leaflet accompanying the packaging: information for the user

NiQuitin

(Nicotine)
lozenges, 2 mg

NiQuitin (Nicotine)lozenges, 4 mg

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 the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is NiQuitin and what is it used for

NiQuitin lozenges are a medicine that helps you stop smoking. They contain a nicotine complex with a cationic exchange resin, from which nicotine is slowly released and absorbed into the body.
NiQuitin lozenges are indicated for the relief of withdrawal symptoms, including nicotine craving, associated with smoking cessation.
The use of this type of medicine is called Nicotine Replacement Therapy or NRT. NiQuitin is indicated for use in adults (aged 18 and over).
NiQuitin lozenges, 2 mg, are suitable for smokers who smoke 20 or fewer cigarettes a day.
NiQuitin lozenges, 4 mg, are suitable for smokers who smoke more than 20 cigarettes a day.

2. Important information before using NiQuitin

When not to use NiQuitin

• if the patient is allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
• the medicine contains soybean oil. Do not use if you have a known hypersensitivity to peanuts or soy
• the medicine should not be used by non-smokers, children, and adolescents under 18 years of age.

Warnings and precautions

Particular caution should be exercised in cases of:

• uncontrolled hypertension,
• renal or hepatic impairment,
• pheochromocytoma,
• hyperthyroidism,
• cardiovascular disease (e.g., stable angina, heart failure, cerebrovascular disease, peripheral vascular disease),
• patients who have ever had seizures should consult their doctor, pharmacist, or nurse before using the medicine.
• gastric or duodenal ulcers or esophagitisas swallowed nicotine may exacerbate symptoms of the disease,
• hospitalization for myocardial infarction, severe arrhythmia, or strokeshould try to stop smoking without using nicotine replacement therapy unless a doctor advises otherwise. After discharge from the hospital, nicotine replacement therapy can be used as before. If there is a clinically significant increase in blood pressure or other nicotine-related effects, the dose of NiQuitin should be reduced or discontinued.

There is a risk of dependence when using this medicine.
Diabetic patientsshould monitor their blood sugar levels more frequently when using this medicine as the requirements for insulin or other diabetes medications may change.
Patients with phenylketonuria: NiQuitin lozenges contain a source of phenylalanine and may be harmful to people with phenylketonuria.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Keep out of sight and reach of children.

NiQuitin with food and drink

Do not eat or drink while sucking a lozenge.

Important information for people on a low-sodium diet

1 NiQuitin lozenge contains 15 mg of sodium, which should be taken into account for patients controlling their sodium intake.

NiQuitin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

Pregnancy, breastfeeding, and fertility

Pregnant or breastfeeding women, or those planning to become pregnant, should try to stop smoking without taking NiQuitin lozenges. If they are unable to stop smoking, they should consult their doctor.

Driving and using machines

The effect of the medicine on the ability to drive and use machines is not known.

3. How to use NiQuitin

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If you are in doubt, consult your doctor, pharmacist, or nurse.
NiQuitin lozenges, 2 mg, are suitable for smokers who smoke 20 or fewer cigarettes a day.
NiQuitin lozenges, 4 mg, are suitable for smokers who smoke more than 20 cigarettes a day.

Adults (from 18 years):

Monotherapy:
a) Immediate smoking cessation
During treatment, the following treatment schedule should be followed:

As the dose is reduced, the body gradually becomes less dependent on nicotine. Therefore, to achieve a good treatment outcome, a full, three-stage treatment should be used.
During the first 6 weeks of therapy (stage 1), it is recommended to take at least 9 lozenges per day.
Do not suck more than 1 lozenge at a time.
Do not take more than 15 lozenges per day.
Treatment with nicotine lozenges may last longer than 24 weeks if necessary to avoid smoking cigarettes.
b) Gradual smoking cessation
In case of strong craving for a cigarette, take a NiQuitin lozenge instead of a cigarette.
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, consult a healthcare professional.
The user should completely stop smoking as soon as they feel it is possible. Then, follow the instructions above in the "a) Immediate smoking cessation" section. This should be done as soon as possible. If complete smoking cessation is not achieved within 6 months of starting NiQuitin lozenge treatment, consult a healthcare professional.
Do not take a higher dose than recommended. Follow the instructions carefully and do not take more than 15 lozenges per day (24 hours).
If you feel the need to use NiQuitin lozenges for more than 9 months, consult a healthcare professional.
Temporary abstinence (when smoking is prohibited or when a person wants to avoid smoking a cigarette):
Take lozenges every 1-2 hours to control annoying withdrawal symptoms, including nicotine craving.
Do not take more than 30 lozenges per day.
It is recommended to stop smoking as soon as possible.
If, after 6 months of treatment, people using the lozenges still feel the need to use them regularly and are still unable to make a serious attempt to quit smoking, it is recommended to consult a healthcare professional.
Combination therapy:
Intended for people who have returned to smoking after using NRT or for whom the use of lozenges alone is not sufficient to control nicotine craving 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 (in the form of chewing gum, lozenges, or sublingual tablets, etc.). Combination therapy is more effective than using patches alone.
Combination therapy should start with determining the patch dose, which depends on the user's previous smoking habits, in combination with NiQuitin lozenges.
The recommended number of NiQuitin lozenges used in combination with patches is 5 to 6 lozenges per day.
The maximum daily dose of 2 mg lozenges is 15 lozenges. The maximum daily dose of 4 mg lozenges is 10 lozenges. Only one type of oral NiQuitin form (lozenges or chewing gum) should be used in combination with a transdermal system (patches).
Continue using the NiQuitin oral form for 2-3 months, then start gradually reducing its use as the number of nicotine cravings decreases. When the daily need decreases to 1-2 lozenges, the treatment should be stopped.

* The maximum daily dose for the 2 mg oral form is 15 lozenges. The maximum daily dose for the 4 mg oral form is 10 lozenges.
To obtain additional information, you should read the leaflet accompanying the NiQuitin Transparent product.

Method of administration

Place one lozenge in the mouth and from time to time move it from one side of the mouth to the other until it is completely dissolved (about 20-30 minutes). Do not chew or swallow the lozenge whole. Do not eat or drink while sucking a lozenge.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of NiQuitin than recommended

If you take too many NiQuitin lozenges, you may experience pallor, cold sweat, salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, hearing and vision disturbances, tremor, confusion, and weakness. Stop using the medicine and consult your doctor or pharmacist immediately.

Missing a dose of NiQuitin

If you miss a dose, take the next lozenge. However, do not take two lozenges at the same time to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been divided into groups based on their frequency:

Very common (affecting more than 1 in 10 people)

• nausea.

Common (affecting less than 1 in 10 but more than 1 in 100 people)

• vomiting, dyspepsia, abdominal pain, diarrhea, dry mouth, constipation, hiccups, stomatitis, flatulence, discomfort in the mouth, heartburn, oral mucosal irritation or ulcers
• headache, dizziness
• insomnia, restlessness, increased appetite
• pharyngitis, cough, sore throat and larynx.

Uncommon (affecting less than 1 in 100 people)

• peptic ulcer, gastroesophageal reflux disease, hiatus hernia, esophagitis, dry throat, toothache
• local anesthesia, taste disturbances
• bad mood, increased restlessness, nightmares, hunger, mood swings
• laryngospasm, asthma, lower respiratory tract infections, nasal or throat irritation, nasal congestion
• coagulation disorders and related bleeding (gum bleeding and nosebleeds)
• redness of the skin
• rash, itching, urticaria, local skin reactions, increased sweating
• jaw pain
• nocturnal enuresis
• overdose effect, leg pain, swelling of the legs.

Rare (affecting less than 1 in 10,000 people)

• severe allergic reactions such as sudden shortness of breath or tightness in the chest, skin rash, and feeling of impending faint

Side effects with unknown frequency

• palpitations, tachycardia (rapid heart rate)
• difficulty swallowing, regurgitation, gastroesophageal reflux, excessive salivation, oral mucosal ulcers
• weakness, fatigue, malaise, flu-like symptoms
• hypersensitivity, angioedema (difficulty breathing or swelling of the lips, tongue, throat, or face), urticaria
• tremor
• seizures
• nervousness
• dyspnea
• abnormal dreams

If you experience any side effects, including any possible side effects not listed in the leaflet, you should consult your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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.
Reporting side effects will help to gather more information on the safety of the medicine.

How to store NiQuitin

Store in a temperature below 25°C, in the original packaging. The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
If you have any questions or doubts, consult your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. 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 contains

The active substance of the medicine is nicotine.
The other ingredients are: mannitol (E421), sodium alginate (E401), xanthan gum (E415), potassium hydrogen carbonate (E501), anhydrous sodium carbonate, aspartame (E951), magnesium stearate, peppermint flavor (contains maltodextrin and modified starch).

What NiQuitin looks like and contents of the pack

The medicine is in the form of white or off-white round lozenges placed in blisters. A cardboard box contains 12, 24, 36, or 72 lozenges in blisters.

Marketing authorization holder and importer

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
Nazareth, 9810
Belgium
Perrigo Supply Chain International Designated Activity Company
The Sharp Building
Hogan Place
Dublin 2
Dublin, D02 TY74, Ireland

Date of last revision of the leaflet: August 2024