Niquitin pzhezrohisti

Leaflet accompanying the packaging: information for the user

NiQuitin Transparent
114 mg; 21 mg/24 hours, transdermal system
Nicotine
NiQuitin Transparent
78 mg; 14 mg/24 hours, transdermal system
Nicotine
NiQuitin Transparent
36 mg; 7 mg/24 hours, transdermal system
Nicotine

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 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 additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is NiQuitin Transparent and what is it used for

NiQuitin Transparent is a medicine in the form of transparent, square patches that are stuck to the skin, making it easier to quit smoking.
NiQuitin Transparent provides a constant dose of nicotine to the body throughout the day. During the ten- or eight-week treatment (see section How to use NiQuitin Transparent), the body's need for nicotine gradually decreases. NiQuitin Transparent patches come in three doses:

• 114 mg, delivering 21 mg of nicotine over 24 hours;
• 78 mg, delivering 14 mg of nicotine over 24 hours;
• 36 mg, delivering 7 mg of nicotine over 24 hours. This allows for a reduction in nicotine doses during treatment, leading to gradual liberation from addiction.

NiQuitin Transparent is indicated for the relief of withdrawal symptoms, such as nicotine craving, nervousness, anxiety, irritability, mood disturbances, sleep disturbances, concentration disturbances, increased appetite, mild somatic symptoms (headaches, muscle aches, constipation, fatigue), associated with quitting smoking.
If possible, when quitting smoking, NiQuitin Transparent should be used in conjunction with a psychological support program to help quit smoking.
NiQuitin Transparent patches can be used alone or in combination with other oral forms of NiQuitin (see section How to use NiQuitin Transparent).

2. Important information before using NiQuitin Transparent

When not to use NiQuitin Transparent

• if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6),
• in children
• in non-smokers or occasional smokers

Warnings and precautions

Before using, you should consult a doctor in cases of: cardiovascular diseases (e.g. unstable angina, Prinzmetal's angina, heart failure, uncontrolled hypertension, severe arrhythmia), recent myocardial infarction or cerebral ischemic stroke, cerebral circulation disorders, diseases with vessel spasm, severe peripheral vascular disease, atopic dermatitis or eczema (due to local hypersensitivity to the patch), moderate to severe kidney or liver disease, peptic ulcer disease, hyperthyroidism, diabetes, pheochromocytoma.
Combination therapy (using NiQuitin Transparent in combination with other oral forms of NiQuitin (1.5 mg/2 mg/4 mg)) should not be used in patients with diagnosed cardiovascular disease without assessing the risk/benefit by medical personnel.
Patients hospitalized due to myocardial infarction, severe arrhythmias, or stroke should try to quit smoking without using nicotine replacement therapy, unless a doctor allows it. After discharge from the hospital, normal use of nicotine replacement therapy is possible.
Patients who have ever had seizures should consult a doctor, pharmacist, or nurse before using the medicine.
Patients with diabetes who use NiQuitin Transparent patches should measure their blood sugar levels more frequently than usual. Insulin or oral hypoglycemic medication dosage may need to be adjusted.
NiQuitin Transparent may cause contact irritation. The medicine should be used with caution and especially avoid contact between the patch and the eyes and nose. After using the patch, hands should be washed with water only, without soap, as it may increase nicotine absorption.
Smoking during NiQuitin Transparent patch therapy poses a potential risk of side effects due to the cumulative effect of nicotine in tobacco and nicotine released from the patch.
The dose of nicotine present in used and new patches can be harmful to children. Therefore, the medicine should be stored in a place inaccessible to children and used patches should be disposed of carefully.
In patients with skin inflammation, adverse reactions may occur after using the patch.
In case of severe, persistent local reactions at the patch application site (e.g. severe redness, itching, or swelling) or generalized skin reactions (hives, rash), the patch should be discontinued and a doctor consulted.
Caution should be exercised in patients with stomach or duodenal ulcers, esophagitis (connection between the mouth and stomach), oral and pharyngeal inflammation, and gastritis, as nicotine replacement therapy may exacerbate their symptoms.
There is a risk of dependence during the use of this medicine.

NiQuitin Transparent and other medicines

You should tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.
Both when quitting smoking and when using nicotine replacement products, the level of nicotine in the body decreases, which may affect the action of other medicines.
Particular caution is advised when using nicotine and adenosine together, as nicotine may increase the hemodynamic effects of adenosine, i.e. increased blood pressure and heart rate, as well as increased reaction to pain (chest pain of angina pectoris type) caused by adenosine administration.

Pregnancy, breastfeeding, and fertility

Quitting smoking is the most effective single intervention to improve the health of both a smoking pregnant woman and her child. The earlier abstinence is achieved, the better.
Pregnant and breastfeeding women should try to quit smoking without using nicotine replacement products. If quitting smoking in this way is not successful, patients should consult a doctor, who may recommend using NiQuitin Transparent.
For the fetus, the risk of nicotine replacement therapy is lower than the risk predicted in the case of smoking, due to lower maximum nicotine levels in the blood and the absence of additional exposure to polycyclic aromatic hydrocarbons and carbon monoxide.
However, since nicotine passes through to the fetus, affecting breathing movements and showing a dose-dependent effect on placental/fetal circulation, the decision to use nicotine replacement therapy should be made as early as possible in pregnancy. Nicotine replacement therapy should only be used for a period of 2-3 months.
Products with intermittent dosing may be preferred, as they usually provide a lower daily dose of nicotine than patches. However, patches may be suitable if the woman experiences nausea during pregnancy.
Nicotine from smoking and nicotine replacement therapy is present in breast milk. However, the amount of nicotine to which the infant is exposed due to nicotine replacement therapy is relatively small and less dangerous than passive smoking, which it would otherwise be exposed to.
Compared to patches, using nicotine replacement products with intermittent dosing may minimize the amount of nicotine in human milk, as the time between nicotine replacement product administration and breastfeeding can be maximized. Women should try to breastfeed immediately before taking the product.
Due to the lack of specific studies, combination therapy with patches and oral forms is not recommended during pregnancy and lactation, unless medical personnel consider it necessary to ensure abstinence.

Driving and using machines

NiQuitin Transparent does not have a significant effect on the ability to drive and use machines.

3. How to use NiQuitin Transparent

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor, pharmacist, or nurse. In case of doubt, you should consult a doctor, pharmacist, or nurse.

Use in adults

Before starting treatment, you should stop smoking. Smoking even a small amount of tobacco during a quit attempt can lead to relapse. During therapy, you should not smoke cigarettes, as this can cause nicotine overdose. In some cases, it may be beneficial to use oral forms of nicotine replacement therapy (such as lozenges, tablets, or chewing gum) in combination with NiQuitin Transparent to help manage cravings for cigarettes.

For smokers of more than 10 cigarettes per day, the nicotine dose is reduced in three stages according to the following dosing schedule:

For smokers of 10 cigarettes or less per day, the nicotine dose is reduced in two stages according to the following dosing schedule:

To achieve the best results, you should complete the full 10-week or 8-week treatment, as withdrawal symptoms may persist for several weeks.
The medicine should not be used for more than 10 weeks. If the treatment does not produce the expected result (e.g. the patient does not quit smoking or starts again), you should consult a doctor to discuss further treatment.
Patients using patches for more than 12 months should consult a doctor.

Using patches in combination with other oral forms

If a patient experiences a strong craving for cigarettes, combined use of patches and oral forms of nicotine replacement therapy may provide a greater chance of successfully quitting smoking than patch therapy alone.
The same dosing schedule is recommended as for patch therapy alone. If the patient feels a strong need to smoke, they should take a lozenge or tablet or chew gum - on average 5-6 pieces per day. In the case of combination therapy, the maximum daily dose for all oral forms for 4 mg is 10 pieces, and for 1.5 mg/2 mg is 15 pieces.
The patient should use oral forms of NiQuitin for 2-3 months, then gradually reduce the amount of medicine taken. Treatment should be discontinued when the patient is taking 1 to 2 oral forms per day.

*Depending on the number of cigarettes smoked (see monotherapy recommendations).
**Patients smoking more than 20 cigarettes per day should use a 4 mg dose for the first 6 weeks, then reduce the dose. The maximum daily dose for all oral forms for 4 mg is 10 pieces, and for 1.5 mg/2 mg is 15 pieces.
If the patient needs more information, they should read the patient leaflet accompanying the NiQuitin lozenge/tablet/chewing gum.

Use in children and adolescents

Adolescents aged 12 to 17 years

The medicine may be used in adolescents aged 12 to 17 years only on the advice of a doctor.

Children under 12 years

NiQuitin Transparent should not be used in children under 12 years.

Method of use:

To ensure the patch adheres properly to the skin, it should be applied to non-hairy, clean, and dry skin. Areas where the skin folds (e.g. joints) or where creases form during movement should be avoided. The patch should not be placed on skin that is red, damaged, or irritated.
NiQuitin Transparent should be applied directly after removal from the sachet.

• To open the sachet, it should be cut along the dotted line, taking care not to damage the patch inside.
• Remove the patch carefully. The patch should be stuck to the skin with the adhesive side, which is covered with a transparent protective foil.
• Remove half of the protective foil, starting from the center, then hold the patch so that you touch the adhesive part as little as possible and remove the other half of the foil.
• After removing the protective foil, apply the patch to the skin with the adhesive side. Press the patch firmly onto the skin with your hand for at least 10 seconds. Make sure the patch is well stuck to the skin, especially at the edges.
• After applying the NiQuitin Transparent patch, do not touch the area around your eyes or nose, and wash your hands with water without using soap.

Water does not adversely affect the patch if it is applied correctly, so you can shower during treatment.
NiQuitin Transparent patches should be changed once a day, always at the same time and as soon as possible after waking up.
Patches should not be left on the skin for more than 24 hours. A new patch should not be applied to the same area until at least 7 days have passed.
You should not use two patches at the same time, as excessive nicotine doses can be harmful.
If the patch falls off, a new one should be applied to a different, non-hairy, clean, and dry area. Continue treatment as before.
Used patches should be folded in half with the adhesive side inward, stuck together, and placed in an empty patch package, then discarded in a place inaccessible to children and pets.

Using a higher dose of NiQuitin Transparent than recommended

In case of using a higher dose than recommended or accidental ingestion of the product, you should immediately contact a doctor.
It is possible to experience symptoms similar to those of acute nicotine poisoning, such as: paleness, sweating, nausea, salivation, vomiting, stomach pain, diarrhea, headache, dizziness, hearing and vision disturbances, tremors, confusion (disorientation) and weakness. In case of significant overdose, cardiovascular collapse and respiratory disturbances may occur.
After the symptoms of overdose appear, the NiQuitin Transparent patch should be removed immediately.
The skin area can be washed with water and dried. You should not use soap, as it may increase nicotine absorption, which will continue to be delivered into the bloodstream for several hours after the patch is removed.
Even a small dose of nicotine can be dangerous for children and may cause death. In case of suspected poisoning, you should immediately contact a doctor.
In case of accidental ingestion of the patch, the doctor may recommend activated charcoal.
After nicotine poisoning, the doctor may administer atropine, diazepam, or barbiturates (seizure treatment). In respiratory failure, respiratory support is used, and in hypotension and cardiovascular collapse, fluids are administered.

Missing a dose of NiQuitin Transparent

If you forget to change the patch, you should apply a new one as soon as possible and continue treatment as before. You should not use a double dose to make up for the missed dose.

Stopping the use of NiQuitin Transparent

In case of any further doubts about the use of this medicine, you should consult a doctor, pharmacist, or nurse.

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 Transparent.
Quitting smoking itself can cause symptoms such as weakness, dizziness, headaches, coughing, and flu-like symptoms. Symptoms such as mood swings, insomnia, depression, irritability, anxiety, drowsiness, restlessness, nervousness, and concentration difficulties, sleep disturbances may also be caused by quitting smoking.
Other side effects are listed below in groups based on their frequency:

• skin reactions at the patch application site
• sleep disturbances, including insomnia and nightmares
• nausea, vomiting
• headache
• dizziness
• palpitations

Common (occurring in less than 1 in 10, but more than 1 in 100 patients)

• nervousness
• tremors
• shortness of breath
• coughing
• pharyngitis
• indigestion
• abdominal pain
• diarrhea
• constipation
• increased sweating
• dry mouth
• joint, muscle, chest, or limb pain
• fatigue/malaise or weakness

Uncommon (occurring in less than 1 in 100, but more than 1 in 1,000 patients)

• allergic reactions (hypersensitivity)
• tachycardia (rapid heart rate)
• flu-like symptoms

Rare (occurring in more than 1 in 10,000 patients)

• skin reactions
• photosensitivity
• severe allergic reactions characterized by sudden onset of wheezing or feeling of chest tightness, skin rash, or feeling of potential fainting

Side effects with unknown frequency:

• seizures (in patients taking antiepileptic medication or with a history of epilepsy)

A transient rash, itching, burning, and tingling of the skin may occur at the patch application site. Such symptoms usually resolve quickly after the patch is removed.
Rarely, more severe reactions may occur at the patch application site. In such cases, you should stop using the medicine and consult a doctor.
If the listed symptoms worsen or other side effects not mentioned in this leaflet occur, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. 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 this medicine.

5. How to store NiQuitin Transparent

Store at a temperature below 30°C, in the original packaging.
The medicine should be stored in a place 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.
Do not use NiQuitin Transparent patches if you notice damaged or opened sachets.
If you have any questions or doubts, you should consult a 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 packaging and other information

What NiQuitin Transparent contains

• The active substance of the medicine is nicotine.
• The other ingredients are: ethylene-vinyl acetate copolymer, polyethylene terephthalate/ethylene-vinyl acetate, high-density polyethylene film, adhesive polyisobutylene laminate, polyester film, white ink

What NiQuitin Transparent looks like and what the packaging contains

The medicine is in the form of transparent, square patches, placed in individual sachets.
A cardboard box contains 7 patches.

Marketing authorization holder:

Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel. +48 (22) 852 55 51
www.niquitin.pl

Manufacturer:

LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2
56626 Andernach
Germany

Date of last revision of the leaflet: October 2024

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products