Niquitin mini citrus

Package leaflet: Information for the user

NiQuitin MINI Citrus, 4 mg, chewing tablets
Nicotinum
Please read this leaflet carefully before using this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a healthcare professional.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact a healthcare professional, such as your doctor, nurse, smoking cessation advisor, or pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, tell a healthcare professional. See section 4.
• If you are unable to reduce or stop smoking or using NiQuitin MINI Citrus, please consult your doctor. See section 3.

Leaflet contents

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

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

NiQuitin MINI Citrus chewing tablets help you stop smoking tobacco. The use of this type of medicine is called Nicotine Replacement Therapy (NRT). NiQuitin MINI Citrus is indicated for use in adults and adolescents (aged 12–17 years, after consulting a healthcare professional).
The 4 mg NiQuitin MINI Citrus chewing tablets are suitable for people who smoke more than 20 cigarettes per day.
The ultimate goal of treatment is permanent cessation of smoking. NiQuitin MINI Citrus chewing tablets may also be used during a gradual smoking cessation in individuals who do not wish or are unable to quit smoking abruptly. NiQuitin MINI Citrus chewing tablets should be used in conjunction with a behavioural support programme. See section 3: "How to use NiQuitin MINI Citrus".

• Nicotine in tobacco causes physical dependence on cigarette smoking. NiQuitin MINI Citrus chewing tablets help you quit smoking by replacing part of the nicotine obtained from cigarettes. The supplied nicotine relieves some of the unpleasant symptoms associated with cigarette withdrawal, such as low mood and irritability. The supplied nicotine also reduces nicotine cravings and helps resist the urge to smoke.

NiQuitin MINI Citrus chewing tablets eliminate the health 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 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.
Your chances of breaking the habit will increase if you participate in a support programme. For more information about such programmes, please contact a healthcare professional.
Smoking tobacco provides no health benefits. Therefore, quitting is strongly recommended. Using NRT, such as NiQuitin MINI Citrus chewing tablets, can help achieve this. Remember that the risks of smoking tobacco are greater than any possible adverse effects associated with using NRT.

2. Information before using NiQuitin MINI Citrus

When not to use NiQuitin MINI Citrus

• if the patient is allergic to nicotine or to 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 Citrus, discuss this with a healthcare professional:

• Smoking-dependent individuals who have recently suffered a myocardial infarction or stroke, or who have unstable or worsening angina pectoris (chest pain), resting angina, or severe cardiac arrhythmias should try to quit smoking without using NRT, unless a doctor authorizes its use.
• If the patient is pregnant or breastfeeding.

When attempting to quit smoking, do not interchangeably use NiQuitin MINI Citrus lozenges with nicotine-containing chewing gum.
Consult a healthcare professional in the following cases:

• heart or circulatory problems, including heart failure, stable angina pectoris, high blood pressure, or peripheral arterial occlusive disease,
• diabetes: diabetic patients using NiQuitin MINI Citrus lozenges should monitor their blood glucose levels more frequently than usual. Dosage recommendations for insulin or antidiabetic medications may need adjustment.
• previous allergic reactions, including swelling of the lips, face, and throat (angioedema) or itchy skin rash (urticaria). NRT may occasionally cause such reactions.
• severe or moderate liver or kidney impairment, due to an increased risk of adverse effects,
• uncontrolled hyperthyroidism or phaeochromocytoma (an adrenal gland tumor affecting blood pressure), as symptoms of the disease may worsen; inform your doctor,
• peptic ulcer of the stomach or duodenum or esophagitis (inflammation of the esophagus, the part of the digestive tract between the mouth and stomach), as swallowed nicotine may worsen symptoms and may also cause oral ulcers. If symptoms worsen, consult a doctor. It may be necessary to switch from oral NRT to transdermal patches.
• history of epileptic seizures,
• any doubts regarding dependence on this medicinal product or if the patient believes they have become dependent on this medicine.

Children and adolescents
This medicine must not be used in children under 12 years of age. The typical dose of nicotine used in adults may cause severe or fatal poisoning in children. Always store NiQuitin MINI Citrus out of sight and reach of children.
Adolescents (aged 12–17 years) should use NiQuitin MINI Citrus lozenges only after consulting a healthcare professional.

NiQuitin MINI Citrus and other medicines
Inform your healthcare professional about all medicines currently or recently taken. Nicotine may potentially intensify certain effects of medications used for irregular or rapid heartbeat (adenosine), such as increased blood pressure and heart rate, and may also enhance pain response.
Stopping smoking may alter the effects of other medications being used. If in doubt, consult a healthcare professional.
The following medicinal products may require dose adjustment when stopping smoking: asthma medications (theophylline), painkillers (pentazocine), medications restoring normal heart rhythm (flecainide), antipsychotics (clozapine, olanzapine), dopamine agonists (ropinirole), and caffeine.

Using NiQuitin MINI Citrus with food or drink
Do not eat or drink while sucking the NiQuitin MINI Citrus lozenge.
Beverages such as coffee, fruit juices, and soft drinks may reduce the effectiveness of nicotine. Avoid these liquids for 15 minutes before taking the NiQuitin MINI Citrus lozenge.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
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 pregnant woman and her child. The sooner smoking cessation occurs, the better.

Pregnant women should quit smoking without using NRT. However, if this is unsuccessful, a healthcare professional may recommend using NRT, as it is less harmful to the child than continuing to smoke.

Breastfeeding
During breastfeeding, exposure of infants and children to tobacco smoke causes breathing difficulties and other health problems. Nicotine from smoking and NRT passes into breast milk. Breastfeeding women should quit smoking without using NRT. However, if quitting fails despite attempts, a healthcare professional may recommend using NRT. When a breastfeeding woman needs to use NRT to quit smoking, the amount of nicotine to which the infant is exposed is small and significantly less harmful than exposure to tobacco smoke. Oral NRT may be preferred over patches, as nicotine is not delivered continuously. It is also advisable to breastfeed before using NRT, so that the infant receives the lowest possible amount of nicotine.

Driving and operating machinery
There is no data available on the effects of NiQuitin MINI Citrus lozenges on the ability to drive or operate machinery. However, bear in mind that quitting smoking may cause behavioral changes that could affect the ability to drive or operate machinery.

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

3. How to use NiQuitin MINI Citrus

This medicine should always be used exactly as described in this patient information leaflet or as directed by a healthcare professional. If in doubt, consult a healthcare professional.
This product is intended for oral mucosal administration. This means that the nicotine contained in the lozenge is slowly released into the mouth and absorbed into the body.
Place one NiQuitin MINI Citrus lozenge in the mouth and periodically move it from one side of the mouth to the other until completely dissolved (approximately 10 minutes).
Do not chew or swallow the lozenge whole.
Further dosage recommendations for NiQuitin MINI Citrus depend on whether:
a) the patient intends to stop smoking immediately,
b) the patient intends to gradually reduce smoking before completely stopping.

Adults (aged 18 years and over)
a) Immediate smoking cessation

• For a period of up to 6 weeks, take one lozenge (using 8 to 12 lozenges per day) each time a strong urge to smoke occurs. Then gradually reduce the number of lozenges taken per day.
• When the number of daily lozenges has decreased to 1 or 2, completely stop using them.

After quitting smoking, occasional sudden urges to smoke may still occur. In such cases, the lozenges may be used again.
b) Gradual smoking cessation
Whenever a strong urge to smoke occurs, take a NiQuitin MINI Citrus lozenge instead of a cigarette. Try to reduce the number of cigarettes smoked per day as much as possible.
If it is not possible to reduce the number of daily cigarettes after 6 weeks, consult a healthcare professional.
The user should completely stop smoking as soon as they feel able. Then follow the instructions above under section a) Immediate smoking cessation. This should be done as quickly as possible. If complete smoking cessation is not achieved within 6 months of starting NiQuitin MINI Citrus lozenges, consult a healthcare professional.
Do not exceed the recommended dose. Follow the instructions carefully and do not use more than 15 lozenges in 24 hours.
If you feel the need to use NiQuitin MINI Citrus lozenges for more than 9 months in total, seek advice from a healthcare professional.

Use in children and adolescents
Adolescents aged 12–17 years
This medicine may be given to adolescents aged 12–17 years only on the advice of a healthcare professional.

Children under 12 years of age
Children under 12 years of age must not use NiQuitin MINI Citrus.

Consult a healthcare professional if the patient:

• is concerned about relapse into tobacco addiction,
• or has difficulties stopping use of the medicine.

If relapse into tobacco smoking occurs, a healthcare professional will advise on the most effective way to use the next NRT (nicotine replacement therapy).

Overdose of NiQuitin MINI Citrus
If too many NiQuitin MINI Citrus lozenges are taken, symptoms such as nausea, dizziness, and general malaise may occur. In such cases, stop using the medicine immediately and seek urgent medical advice from a doctor or go to the nearest hospital emergency department. If possible, show the doctor the leaflet or the medicine packaging.

This medicine is not intended for children under 12 years of age or for non-smokers. If accidentally taken by a child or a non-smoker, symptoms of nicotine overdose may occur, such as headache, vomiting, abdominal pain, and diarrhoea. A child who has used or ingested this medicine must be taken immediately to the nearest hospital emergency department or a doctor must be contacted. If possible, show the doctor the leaflet or the medicine packaging.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everyone experiences them.
Stopping smoking itself may cause symptoms such as dizziness, headaches,
sleep disturbances, cough, and flu-like symptoms. Other symptoms (withdrawal symptoms), such as depression,
irritability, anxiety, restlessness, increased appetite, and insomnia, may also be
caused by quitting smoking.

If any of the following serious adverse effects occur, you must stop using NiQuitin MINI Citrus and contact your doctor immediately, as
they may be signs of a severe allergic reaction:

• Severe allergic reaction, with symptoms including sudden onset of wheezing or chest tightness, rash, and feeling faint (frequency: very rare)
• Swelling of the skin or mucous membranes, face, tongue, and throat causing difficulty in breathing (frequency: not known)

Other possible adverse effects include:
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, headache
• Diarrhea
• Tremor
• Constipation
• Indigestion/heartburn
• Flatulence
• Hiccups
• Sore throat
• Cough
• Breathing difficulties, shortness of breath
• Upper abdominal pain
• Dryness of the oral mucosa
• Oral ulcers
• Oral discomfort
• Fatigue (tiredness)
• Feeling of general discomfort
• 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 available data)

• Seizures
• Abnormal dreams, depression, irritability, anxiety, disturbances/ distortion of taste, rash
• Itching
• Skin redness
• Increased sweating
• Urticaria (hives)
• Tingling in the mouth, belching
• Excessive salivation

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

5. How to store NiQuitin MINI Citrus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, following "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original immediate packaging to protect from moisture.
The container should not be used for other purposes, as fine dust from the tablets may deposit on its walls.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What NiQuitin MINI Citrus contains

• Each lozenge contains nicotine in the form of nicotine cation-exchange resin equivalent to 4 mg of nicotine.
• 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), citrus flavour, magnesium stearate (E 470b), sucralose.

What NiQuitin MINI Citrus looks like and contents of the pack

Approximate size to the nearest 1 mm: length: 10 mm × width: 5 mm.
White or almost white, biconvex, oval lozenge with the imprint "CIT4" on one side.

Outer packaging may contain 1 (total 20 lozenges), 3 (total 60 lozenges), or 5 (total 100 lozenges) tablet containers.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the European Economic Area member states under the following names:
Sweden: NiQuitin Citrus 4 mg
Belgium: NiQutin Minilozenge Citrus 4 mg zuigtabletten – comprimés à sucer – Lutschtabletten gepresst
Luxembourg: NiQuitin Minilozenge Citrus 4 mg zuigtabletten – comprimés à sucer – Lutschtabletten, gepresst
Netherlands: NiQuitin Citrus minizugtablet 4 mg, zuigtabletten
Poland: NiQuitin MINI Citrus
Portugal: Niquitin Citrus 4 mg
Spain: Niquitin 4 mg comprimidos para chupar sabor limón
Ireland: Niquitin Mini 4 mg Citrus Lozenges
Czech Republic: NiQuitin Mini Citrus
Estonia: NiQuitin Mini Citrus
Hungary: NiQuitin Minitab citrusízű 4 mg préselt szopogató tabletta
Slovakia: NiQuitin Mini Citrus 4 mg lisované pastilky