Niquitin mini citrus
Poland
Table of Contents
Patient Information Leaflet
NiQuitin MINI Citrus, 2 mg, lozenges
Nicotinum
Please read this leaflet carefully before taking this medicine, as 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 side effects, including any not listed in this leaflet, tell your 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.
Table of contents
- What NiQuitin MINI Citrus is and what it is used for
- Important information before using NiQuitin MINI Citrus
- How to use NiQuitin MINI Citrus
- Possible side effects
- How to store NiQuitin MINI Citrus
- Contents of the pack and other information
1. What NiQuitin MINI Citrus is and what it is used for
NiQuitin MINI Citrus lozenges help people stop smoking. 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 seeking advice from a healthcare professional).
The 2 mg NiQuitin MINI Citrus lozenges are suitable for individuals who smoke 20 or fewer cigarettes per day.
The ultimate goal of treatment is permanent smoking cessation. NiQuitin MINI Citrus lozenges may also be used during a gradual smoking cessation programme for individuals who do not wish or are unable to stop smoking abruptly. NiQuitin MINI Citrus lozenges 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 lozenges help people quit smoking by replacing some of the nicotine obtained from cigarettes. The nicotine delivered helps relieve some of the unpleasant symptoms associated with smoking withdrawal, such as low mood and irritability. The nicotine also reduces nicotine cravings and helps resist the urge to smoke a cigarette.
NiQuitin MINI Citrus lozenges are much less harmful than smoking tobacco, because they do not contain tar, carbon monoxide, or other toxins found in tobacco smoke. Some patients may be concerned about becoming addicted to 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 cigarette smoking.
Your chances of quitting successfully are increased 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 smoking is strongly recommended. Using NRT, such as NiQuitin MINI Citrus lozenges, can help achieve this. Remember that the health risks associated with smoking tobacco are far greater than any possible side effects of 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, consult 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 attempt to quit smoking without using NRT, unless a doctor authorizes its use.
- If the patient is pregnant or breastfeeding.
When trying 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.
- history of 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 pheochromocytoma (a tumour of the adrenal gland affecting blood pressure), as symptoms of the disease may worsen, as advised by a physician,
- peptic ulcer of the stomach or duodenum or oesophagitis (inflammation of the oesophagus, the part of the digestive tract between the mouth and stomach), as swallowed nicotine may worsen symptoms and may also cause oral ulceration. If symptoms worsen, consult a doctor. It may be necessary to switch from oral NRT to transdermal patches.
- history of seizures (epilepsy)
- 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. A typical adult dose of nicotine may cause severe or fatal poisoning in a child. 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. Adolescents should not use combination NRT when quitting smoking.
NiQuitin MINI Citrus and other medicines
Inform your healthcare professional about all medicines currently or recently taken. Nicotine may potentially enhance certain effects of medications used for irregular or rapid heartbeat (adenosine), such as increased blood pressure, heart rate, and heightened pain response.
Stopping smoking may alter the effects of other medications. In case of doubt, consult a healthcare professional.
The following medicinal products may require dose adjustment when smoking is stopped: asthma medications (theophylline), painkillers (pentazocine), medications restoring normal heart rhythm (flecainide), antipsychotics (clozapine, olanzapine), dopamine agonists (ropinirole), and caffeine.
Taking 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 fluids for 15 minutes before taking a NiQuitin MINI Citrus lozenge.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. Combination NRT is not recommended during pregnancy or breastfeeding unless otherwise advised by a healthcare professional.
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 mother and the baby. The sooner smoking is stopped, the better.
Pregnant women should try to quit smoking without using NRT. However, if this is unsuccessful, a healthcare professional may recommend using NRT, as it is less harmful to the baby 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 from NRT passes into breast milk. Breastfeeding women should try to quit smoking without using NRT. However, if this attempt fails, 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 to minimize the infant's exposure to nicotine.
Driving and using machines
There is no data available on the effects of NiQuitin MINI Citrus lozenges on the ability to drive or operate machinery. However, it should be noted that quitting smoking may cause behavioural changes that may 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, meaning it is considered "sodium-free".
3. How to use NiQuitin MINI Citrus
This medicine should always be used exactly as described in this patient 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 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 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 (from 18 years of age)
Monotherapy:
a) Immediate smoking cessation
- For up to 6 weeks, take one lozenge (using 8 to 12 lozenges per day) each time a strong urge to smoke occurs. Gradually reduce the number of lozenges taken per day thereafter.
- When daily use decreases to 1 or 2 lozenges, completely discontinue use.
After quitting smoking, occasional sudden urges to smoke may still occur. In such cases, the lozenges may be used again.
b) Gradual smoking reduction
Whenever a strong urge to smoke occurs, take a NiQuitin MINI Citrus lozenge instead of a cigarette. Make every effort to reduce the number of cigarettes smoked per day.
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 to do so. 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.
Combination therapy:
Intended for individuals who have resumed smoking after using NRT (nicotine replacement therapy), for those in whom use of lozenges alone is insufficient to control nicotine cravings, or as first-line treatment for smokers with high levels of dependence.
Patients may combine patches with oral forms of NRT (such as chewing gum, pastilles, or lozenges, etc.). Combination therapy is more effective than using patches alone.
Combination therapy should begin with selecting a patch dose based on the individual's previous smoking habits, in combination with NiQuitin MINI Citrus. The recommended number of NiQuitin MINI Citrus 2 mg lozenges to be used alongside patches is 5 to 6 per day.
The maximum daily dose is 15 lozenges. Only one type of oral NiQuitin product (either lozenges or chewing gum) should be used in combination with patches.
Continue using the NiQuitin oral product for 2–3 months, then gradually reduce usage as nicotine cravings decrease. When daily use decreases to 1–2 lozenges, discontinue treatment.
| Smokers smoking more than 10 cigarettes per day | ||
| Stage | Transdermal system (patches) | NiQuitin MINI Citrus 2 mg, lozenges. |
| First 6 weeks | Step 1, NiQuitin Clear 21 mg / 24 hours | 5 to 6 lozenges per day |
| Week 7 and 8 | Step 2, NiQuitin Clear 14 mg / 24 hours | Lozenges should continue to be used as needed |
| Week 9 and 10 | Step 3, NiQuitin Clear 7 mg / 24 hours | |
| After 10 weeks | Discontinue NiQuitin Clear patches | Gradually reduce the number of lozenges. Treatment should be stopped when the patient takes 1 to 2 lozenges per day. |
| Smokers smoking fewer than 10 cigarettes per day | ||
| Period | Transdermal system (patches) | NiQuitin MINI Citrus 2 mg, lozenges. |
| First 6 weeks | Step 2, NiQuitin Clear 14 mg / 24 hours | 5 to 6 lozenges per day |
| Week 7 and 8 | Step 3, NiQuitin Clear 7 mg / 24 hours | Lozenges should continue to be used as needed |
| After 8 weeks | Discontinue NiQuitin Clear patches | Gradually reduce the number of lozenges. Treatment should be stopped when the patient takes 1 to 2 lozenges per day. |
For additional information, please refer to the package leaflet included with
the NiQuitin Transparent product.
If symptoms persist, consult a doctor.
Use in children and adolescents
Adolescents aged 12–17 years
This medicine may be used by adolescents aged 12–17 years only under the recommendation 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 relapsing into tobacco addiction,
- or has difficulties discontinuing the use of the medicine.
If relapse into tobacco use occurs, a healthcare professional will advise on the most effective way to use the next NRT.
Use of a higher than recommended dose of NiQuitin MINI Citrus
If too many NiQuitin MINI Citrus tablets are taken, nausea, dizziness, and general malaise may occur. In such a case, stop using the medicine immediately and seek medical advice without delay from a doctor or go to a hospital emergency department. If possible, show the doctor the package leaflet or the medicine packaging.
This medicine is not intended for children under 12 years of age or for non-smokers. If accidentally ingested 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 swallowed the medicine must be taken immediately to a hospital emergency department or medical advice must be sought. If possible, show the doctor the package leaflet or the medicine packaging.
4. Possible adverse reactions
Like all medicines, this product may cause adverse reactions, although not everybody experiences them.
Stopping smoking itself may cause symptoms such as dizziness, headache,
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 stopping smoking.
If any of the following serious adverse reactions occur, you must stop using NiQuitin product and immediately contact a doctor, as they may be signs of a severe allergic reaction:
- Severe allergic reaction, symptoms of which include 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 breathing difficulties (frequency: unknown)
Other possible adverse reactions 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
- Diarrhoea
- Tremor
- Constipation
- Indigestion/heartburn
- Bloating
- 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
- Unusual dreams, depression, irritability, anxiety, taste disturbances/distortion, rash
- Itching
- Skin redness
- Increased sweating
- Urticaria
- Tingling in the mouth, belching
- Excessive salivation
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a healthcare professional. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store NiQuitin MINI Citrus
Keep the medicine out of 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 powder from the tablets may deposit on its walls.
Medicines must not be disposed of via the sewage system 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 2 mg of nicotine.
- Other ingredients (excipients): 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 "CIT2" on one side.
Outer packaging may contain 1 (total 20 lozenges), 3 (total 60 lozenges), or 5 (total 100 lozenges) containers for lozenges.
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 countries under the following names:
Sweden: NiQuitin Citrus 2 mg
Belgium: NiQutin Minilozenge Citrus 2 mg zuigtabletten – comprimés à sucer – Lutschtabletten gepresst
Luxembourg: NiQuitin Minilozenge Citrus 2 mg zuigtabletten – comprimés à sucer Lutschtabletten, gepresst
Netherlands: NiQuitin Citrus minizugtablet 2 mg, zuigtabletten
Poland: NiQuitin MINI Citrus
Portugal: Niquitin Citrus 2 mg
Spain: Niquitin 2 mg comprimidos para chupar sabor limón
Ireland: Niquitin Mini 2 mg Citrus Lozenges
Czech Republic: NiQuitin Mini Citrus
Estonia: NiQuitin Mini Citrus
Hungary: NiQuitin Minitab citrusízű 2 mg préselt szopogató tabletta
Slovakia: NiQuitin Mini Citrus 2 mg lisované pastilky