Niquitin Pzhezrohisti

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

NiQuitin Transparent (NiQuitin)

114 mg; 21 mg/24 hours, transdermal system, patch
Nicotine
NiQuitin Transparent and NiQuitin are different trade names for the same medicine.

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 more information, you should ask your 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 you do not improve or 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 pack 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.
The NiQuitin Transparent medicine 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 used to alleviate symptoms resulting from nicotine withdrawal, such as: nicotine craving, nervousness, anxiety, irritability, mood disturbances, sleep disturbances, concentration disorders, increased appetite, mild somatic disorders (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 medicine (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.

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), after a recent myocardial infarction or stroke, in cases of cerebrovascular disorders, diseases with vascular 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.
Patients hospitalized due to a recent myocardial infarction, severe arrhythmias, or stroke should try to quit smoking without using nicotine replacement therapy, unless a doctor allows its use. 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.
Diabetic patients using 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, you should wash your hands thoroughly with only water, without soap, as it may increase nicotine absorption.
Smoking during NiQuitin Transparent patch therapy poses a potential risk of side effects due to the accumulation of nicotine from tobacco and nicotine released from the patch.
The nicotine dose 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 cases of severe, persistent local reactions at the patch application site (e.g., severe redness, itching, or swelling) or generalized skin reactions (hives, general rash), you should stop using the patch and consult a doctor.
You should use with caution in patients with stomach or duodenal ulcers, esophagitis (connection between the mouth and stomach), oral or pharyngeal inflammation, as nicotine replacement therapy may exacerbate their symptoms.
There is a risk of dependence when using 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 nicotine level in the body decreases, which may affect the action of other medicines.

Pregnancy, breastfeeding, and fertility

Pregnant 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.
Breastfeeding women may use nicotine patches, as the amount of nicotine passing into breast milk is small and poses a smaller risk than smoking cigarettes.

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 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 the attempt to quit can lead to a relapse. During therapy, you should not smoke cigarettes, as this may 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 strong cravings for cigarettes.

For people smoking more than 10 cigarettes per day, the nicotine dose is reduced in three stages according to the following dosing scheme:

For people smoking 10 cigarettes or less per day, the nicotine dose is reduced in 2 stages according to the following dosing scheme:

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.

Using patches in combination with other oral forms

If a patient experiences strong cravings 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 scheme is recommended as for patch therapy alone. If a patient feels a strong need to smoke, they should take a lozenge or tablet or chew gum - on average 5-6 pieces per day. You should not use more than 15 pieces in 24 hours.
The patient should use oral forms of NiQuitin for 2-3 months, then gradually reduce the amount of medicine taken. Treatment should be stopped when the patient is taking 1 to 2 oral forms per day.
Stage Patches* Oral NiQuitin forms Stage 1: 6 weeks NiQuitin Transparent 21mg/24 hours On average: 5 to 6 pieces/24 hours ** Stage 2: 2 weeks NiQuitin Transparent 14mg/24 hours Continue using lozenges/tablets/chewing gum if necessary. Stage 3: 2 weeks NiQuitin Transparent 7mg/24 hours Continue using lozenges/tablets/chewing gum if necessary. After 8-10 weeks Stop using NiQuitin Transparent Gradually reduce the amount of oral forms taken. Treatment should be stopped 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. If a patient needs more information, they should read the patient leaflet for NiQuitin in the form of lozenges/tablets/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 after a doctor's recommendation. Children under 12 years You should not use NiQuitin Transparent 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. You should avoid areas where the skin folds (e.g., joints) or where creases form during movement. You should not place the patch on skin that is red, damaged, or irritated.
The NiQuitin Transparent patch should be applied immediately after removal from the sachet.

• To open the sachet, you should cut it along the dotted line, being careful 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 film.
• Remove half of the protective film, starting from the center, and then hold the patch so that you touch the adhesive part as little as possible, and remove the other half of the film. After removing the protective film, apply the patch to the skin with the adhesive side. You should press the patch firmly onto the skin with your hand for at least 10 seconds. You should 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 bathe during treatment.
NiQuitin Transparent patches should be changed once a day, always at the same time and as soon as possible after waking up.
You should not leave the patch on the skin for more than 24 hours. You should not apply a new patch to the same area before 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, you should stick a new one 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 more than the recommended dose of NiQuitin Transparent

In case of using a higher dose than recommended or accidental ingestion of the medicine, 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 disorders may occur.
After symptoms of overdose appear, the NiQuitin Transparent patch should be removed immediately. The skin surface 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. In case of suspected poisoning, you should immediately contact a doctor.
In case of accidental ingestion of a patch, a doctor may recommend administering activated charcoal.
After nicotine poisoning, a 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 immediately apply a new one and continue treatment as before. You should not use a double dose to make up for the missed dose.

Stopping use of NiQuitin Transparent

In case of any further doubts about using 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 may cause symptoms such as weakness, dizziness, headaches, cough, and flu-like symptoms. Symptoms such as mood swings, insomnia, depression, irritability, anxiety, drowsiness, restlessness, nervousness, and concentration disorders, sleep disturbances may also be caused by quitting smoking.
Other side effects are listed below in groups based on their frequency of occurrence:

• 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
• cough
• pharyngitis
• indigestion
• abdominal pain
• diarrhea
• constipation
• increased sweating
• dry mouth
• joint, muscle, chest, or limb pain
• fatigue/bad condition 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
• hypersensitivity to sunlight
• severe allergic reactions characterized by sudden onset of wheezing or feeling of chest tightness, skin rash, or feeling of possible fainting

Side effects with unknown frequency:

• seizures

In the patch application area, transient rash, itching, burning, and tingling of the skin may occur, as well as swelling and pain. 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.
In case of worsening of the listed symptoms or occurrence of other side effects not mentioned in this leaflet, 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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NiQuitin Transparent

Store in a temperature below 30°C.
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.
Do not use NiQuitin Transparent patches if you notice damaged or opened sachets. In case of questions and 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 no longer required. This will help protect the environment.

6. Contents of the pack 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, and ethylene-vinyl acetate, high-density polyethylene film, polyisobutylene laminate, polyester film, white ink.

What NiQuitin Transparent looks like and contents of the pack

The medicine is in the form of transparent, square patches, placed in individual sachets.
A cardboard box contains 7 patches.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Richard Bittner AG
Reisnerstraße 55-57
A-1030 Vienna
Austria

Manufacturer:

FAMAR A.V.E AVLON PLANT
48 km National Road Athens-Lamia
Avlona Attiki, 19011, Greece
LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2
56626 Andernach
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, export country marketing authorization number:LT/1/99/0366/005
LT/1/99/0366/006

Parallel import authorization number: 228/23

Date of leaflet approval: 11.10.2023

[Information about the trademark]