Niquitin Pzhezrohisti

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

NiQuitin Clear (NiQuitin Transparent)

114 mg; 21 mg/24 hours, transdermal system, patch
Nicotine
NiQuitin Transparent and NiQuitin Clear 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 according to the recommendations of a doctor, pharmacist, or nurse.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their 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 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 (see section How to use NiQuitin Transparent).

2. Important information before using NiQuitin Transparent

When not to use NiQuitin Transparent

• 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), recent myocardial infarction or cerebral stroke, cerebral circulation disorders, diseases with vasospasm, 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.
Patient's hospitalized due to myocardial infarction, severe arrhythmias or stroke, should try to quit smoking without using nicotine replacement therapy, unless the doctor allows it. After discharge from the hospital, normal use of nicotine replacement therapy is possible.
Patient's who have ever had seizures should consult a doctor, pharmacist, or nurse before using the medicine.
Patient's with diabetes using NiQuitin Transparent patches should measure their blood sugar levels more often than usual. The recommendations for taking insulin or oral hypoglycemic agents may change.
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 thoroughly 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 accumulation of nicotine from 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 patient's 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, general rash), the patch should be discontinued and a doctor consulted.
The medicine should be used with caution in patient's 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 during the use of nicotine replacement products, the level of nicotine 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, patient's should consult a doctor, who may recommend the use of NiQuitin Transparent.
Breastfeeding women may use nicotine patches, as the amount of nicotine that passes 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 according to the recommendations of a 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 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 increase the chances of successfully quitting smoking.

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

For smokers of 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 the patient experiences a strong desire to smoke, the combined use of patches and oral forms of nicotine replacement therapy may provide a greater chance of successfully quitting smoking than therapy with patches alone.
The same dosing scheme is recommended as for therapy with patches 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. 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. The treatment should be discontinued when the patient takes 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 in the oral form, then reduce the dose.
If the 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 on the recommendation 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. 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.
NiQuitin Transparent patch should be applied directly after removing it from the sachet.

• To open the sachet, you should cut it 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 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 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.
The patch should not be left on the skin for more than 24 hours. A new patch should not be applied to the same site before 7 days have passed.
You should not use two patches at the same time, as excessive doses of nicotine 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 packaging, then thrown away 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 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 the onset of overdose symptoms, 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 circulation 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 the patch, the doctor may recommend the administration of 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 the patient forgets to change the patch, they 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 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 changes, 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 the likelihood of their occurrence:
Very common (occurring in more than 1 in 10 patients)

• 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/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 compression in the chest, skin rash, or feeling of possible fainting

Side effects with unknown frequency:

• seizures

In the patch application site, a transient rash, itching, burning, and tingling of the skin, swelling, and pain may occur. Such symptoms usually disappear quickly after the patch is removed. Rarely, more severe reactions may occur at the patch application site. In such a case, 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, pharmacist, or nurse.

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 Adverse Reaction Monitoring 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store NiQuitin Transparent

Store at 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 open sachets.
In case of questions and doubts, you should consult a doctor, pharmacist, or nurse.
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. 1 patch with an area of 22 cm² for transdermal use, containing 114 mg of nicotine as the active substance, delivers 21 mg of nicotine over 24 hours.
• The other ingredients are: ethylene-vinyl acetate copolymer, polyethylene terephthalate/ethylene-vinyl acetate, high-density polyethylene film, pressure-sensitive polyisobutylene laminate, polyester film, white ink (3015Z-009L).

What NiQuitin Transparent looks like and what the packaging contains

The medicine is in the form of transparent, square patches, placed in individual laminated 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 Portugal, the country of export:

Perrigo Portugal, Lda.
Lagoas Park, Edifício 15, 3° piso, 2740-262 Porto Salvo
Portugal

Manufacturer:

FAMAR A.V.E. AVLON PLANT (48th)
48th km National Road Athens-Lamia
Avlona Attiki, 19011, Greece

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portuguese marketing authorization number: 4944880
4944781
4944989
4945085
4945184

Parallel import authorization number: 15/23 Date of leaflet approval: 03.02.2023

[Information about the trademark]