Niquitin

Package Leaflet: Information for the User

NiQuitin

(Nicotinum)
lozenges, 2 mg

NiQuitin (Nicotinum)lozenges, 4 mg

You should carefully read the contents of this 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 your doctor, pharmacist, or nurse.

• 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 pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If you do not improve or feel worse, you should contact your 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 cation exchange resin, from which nicotine is slowly released and absorbed into the body.
NiQuitin lozenges are indicated for the relief of nicotine withdrawal symptoms, including the desire to smoke, in patients giving up smoking.
The use of this type of medicine is called Nicotine Replacement Therapy (NRT). NiQuitin is indicated for use in adults (18 years and over).
NiQuitin lozenges, 2 mg, are suitable for smokers who smoke 20 or fewer cigarettes per day.
NiQuitin lozenges, 4 mg, are suitable for smokers who smoke more than 20 cigarettes per day.

2. Important information before using NiQuitin

When not to use NiQuitin

• the medicine contains soya oil. Do not use if you are allergic to peanuts or soya
• the medicine should not be used by non-smokers, children, and adolescents under 18 years.

Warnings and precautions

Special care should be taken in the following cases:

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

There is a risk of dependence on this medicine.
Diabetic patientsshould monitor their blood sugar levels more frequently when using this medicine as the need for insulin or oral hypoglycaemic drugs may change.
Phenylketonuric patients: NiQuitin lozenges contain a source of phenylalanine and may be harmful to people with phenylketonuria.
If you have previously been diagnosed with an intolerance to some sugars, you should consult your 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 patients on a low-sodium diet

1 NiQuitin lozenge contains 15 mg of sodium, which should be taken into account in patients on a controlled sodium diet.

NiQuitin with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

Pregnant or breastfeeding women, or those planning to become pregnant, should try to stop smoking without using 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 your doctor, pharmacist, or nurse. If you are unsure, you should consult your doctor, pharmacist, or nurse.
NiQuitin lozenges, 2 mg, are suitable for smokers who smoke 20 or fewer cigarettes per day.
NiQuitin lozenges, 4 mg, are suitable for smokers who smoke more than 20 cigarettes per day.

Adults (18 years and over):

Monotherapy:
a) Immediate cessation of smoking
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, the 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 use more than 15 lozenges per day.
Treatment with nicotine lozenges may last longer than 24 weeks if necessary to avoid smoking cigarettes.
b) Gradual cessation of smoking
In case of strong craving for cigarettes, 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, you should consult a healthcare professional.
The user should stop smoking completely as soon as they feel able to do so. Then, follow the instructions above in the "a) Immediate cessation of smoking" section. This should be done as soon as possible. If complete cessation of smoking is not achieved within 6 months of starting NiQuitin lozenges, you should consult a healthcare professional.
Do not use a higher dose than recommended. Follow the instructions carefully and do not use more than 15 lozenges per day (24 hours).
If you need to use NiQuitin lozenges for more than 9 months, you should consult a healthcare professional.
Temporary abstinence (when smoking is prohibited or when you want to avoid smoking a cigarette):
Take lozenges every 1-2 hours to control troublesome withdrawal symptoms, including the desire to smoke.
Do not take more than 30 lozenges per day.
It is recommended that you stop smoking completely as soon as possible.
If, after 6 months of treatment, users of the lozenges still feel the need to use them regularly and are still unable to make a serious attempt to stop smoking, it is recommended that they consult a healthcare professional.
Combination therapy:
Intended for people who have relapsed after using NRT or for whom the use of lozenges alone is not sufficient to control their desire to smoke 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 sublingual tablets). Combination therapy is more effective than using patches alone.
Combination therapy should start with the determination of 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).
NiQuitin should be continued in oral form for 2-3 months, and then gradually reduced as the number of cravings decreases. When the daily need decreases to 1-2 lozenges, treatment should be stopped.

* The maximum daily dose for oral 2 mg forms is 15 lozenges. The maximum daily dose for oral 4 mg forms is 10 lozenges.
For further information, you should read the leaflet of NiQuitin Transparent.

Method of administration

Place one lozenge in the mouth and occasionally move it from one side of the mouth to the other until it is completely dissolved (about 20-30 minutes). The lozenge should not be chewed or swallowed 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, you should consult your doctor.

Using more than the recommended dose of NiQuitin

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

Missing a dose of NiQuitin

If you miss a dose, you should take the next lozenge. However, you should 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:

• 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, oral discomfort, heartburn, and oral mucosal irritation
• headache, dizziness
• insomnia, anxiety, increased appetite
• pharyngitis, cough, sore throat and larynx.

Uncommon (affecting less than 1 in 100 people)

• peptic ulcer, gastro-oesophageal reflux disease, hiatus hernia, oesophagitis, dry throat, toothache
• local anaesthesia, taste disturbance
• ill humour, increased anxiety, nightmares, hunger, mood swings
• laryngospasm, asthma, lower respiratory tract infections, nasal or throat irritation, nasal congestion
• coagulation disorders and related bleeding (gingival and nose bleeding)
• flushing
• rash, itching, urticaria, local skin reactions, increased sweating
• jaw pain
• nocturnal enuresis
• overdose effect, leg pain, peripheral oedema.

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

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

Side effects of unknown frequency

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

How to store NiQuitin

Store in a temperature below 25°C, in the original packaging. The medicine should be kept 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, you should consult your doctor or pharmacist.
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 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 flavour (contains maltodextrin and modified starch).

What NiQuitin looks like and contents of the pack

The medicine is in the form of white or almost white, round lozenges, which are packaged in blisters. The 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
phone: +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