Niquitin Pzhezrohisti

Package Leaflet: Information for the User

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

NiQuitin Transparent (NiQuitin)

114 mg; 21 mg/24 hours, transdermal system, patch
Nicotinum
NiQuitin Transparent and NiQuitin are different trade names for the same medicinal product authorized in Poland and Lithuania, in the country of export.

Before using the medicinal product, the patient should carefully read the package leaflet, as it contains important information for the patient.

This medicinal product should always be used exactly as described in the package leaflet for the patient or as directed by the doctor, pharmacist, or nurse.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

Package Leaflet Contents:

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

NiQuitin Transparent is a medicinal product in the form of transparent, square patches that are stuck to the skin, helping 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, providing 21 mg of nicotine over 24 hours;
• 78 mg, providing 14 mg of nicotine over 24 hours;
• 36 mg, providing 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 caused by nicotine cessation, such as nicotine craving, nervousness, anxiety, irritability, mood disturbances, sleep disturbances, concentration disturbances, increased appetite, mild somatic disturbances (headaches, muscle aches, constipation, fatigue), associated with quitting smoking.
If possible, during smoking cessation, 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 the patient is hypersensitive to nicotine or any of the other ingredients of this medicinal product (listed in section 6),
• in children,
• in non-smokers or occasional smokers.

Warnings and precautions

Before using, the patient 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 ischemia, cerebral circulation 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.
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.
Patient hospitalized due to myocardial infarction, severe arrhythmia, 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 who have ever had seizures should consult a doctor, pharmacist, or nurse before using the medicinal product.
Patient with diabetes using NiQuitin Transparent patches should measure their blood sugar levels more frequently than usual. Recommendations for insulin or oral hypoglycemic medications may need to be changed.
NiQuitin Transparent may cause contact irritation. The medicinal product should be used with caution and especially avoid contact with the eyes and nose. After using the patch, the 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 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 medicinal product should be stored in a place inaccessible to children and used patches should be disposed of carefully.
In patient with skin inflammation, undesirable 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) lasting more than 4 days, the patch should be discontinued and a doctor consulted.
The medicinal product should be used with caution in patient 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.
During the use of this medicinal product, there is a risk of dependence.

NiQuitin Transparent and other medicinal products

The patient should inform the doctor about all medicinal products taken recently, including those that are available without a prescription.
Both during smoking cessation and during the use of nicotine replacement therapy, the nicotine concentration in the body decreases, which may affect the action of other medicinal products.
Particular caution is advised when using nicotine and adenosine concomitantly, as nicotine may potentially enhance the hemodynamic effects of adenosine, i.e., increased blood pressure and heart rate, as well as increased pain response (angina pectoris-type pain) caused by adenosine administration.

Pregnancy, breastfeeding, and fertility

Quitting smoking is the most effective single intervention to improve the health of both the 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 therapy. If quitting smoking in this way is unsuccessful, 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 concentrations in the blood and the absence of additional exposure to polycyclic aromatic hydrocarbons and carbon monoxide.
However, since nicotine passes into 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 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, to which it would otherwise be exposed.
Compared to patches, the use of nicotine replacement therapy products with intermittent dosing may minimize the amount of nicotine in human milk, as the time between nicotine replacement therapy administration and breastfeeding can be maximized. Women should try to breastfeed 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 patches have no or negligible influence on the ability to drive and use machines.

3. How to use NiQuitin Transparent

This medicinal product should always be used exactly as described in the package leaflet for the patient or as directed by the doctor, pharmacist, or nurse. In case of doubt, the doctor, pharmacist, or nurse should be consulted.

Use in adults

Before starting treatment, the patient should stop smoking. Smoking even a small amount of tobacco during the attempt to quit may lead to relapse. During therapy, the patient 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 cravings.

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

For patients smoking 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, the patient should complete the full 10-week or 8-week treatment, as withdrawal symptoms may persist for several weeks.
The medicinal product 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), the doctor should be consulted to discuss further treatment.
Patient using patches for more than 12 months should consult a doctor.

Using patches in combination with other oral forms

If the patient experiences a strong craving for cigarettes, the combined use of patches and oral forms of nicotine replacement therapy may provide a greater chance of successful smoking cessation than patch therapy alone.
The same dosing schedule is recommended as for patch monotherapy. If the patient feels a strong need to smoke, they should take a lozenge, tablet, or chewing 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 medicinal product taken. Treatment should be discontinued when the patient is taking 1-2 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 package leaflet for NiQuitin lozenges/tablets/chewing gum.

Use in children and adolescents

Adolescents aged 12 to 17 years

The medicinal product 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 administration:

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.
The NiQuitin Transparent patch should be applied immediately 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 film.
• Remove half of the protective film, starting from the center, and then hold the patch so that the adhesive part is touched 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. Press the patch firmly onto the skin with your hand for at least 10 seconds. Make sure the patch is well adhered to the skin, especially at the edges.
• After applying the NiQuitin Transparent patch, do not touch the eyes or nose, and wash your hands with water only, without soap.

Water does not adversely affect the patch if it is applied correctly, so the patient 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.
The patch should not be left on the skin for more than 24 hours. A new patch should not be applied to the same area until 7 days have passed.
Two patches should not be used at the same time, as excessive nicotine doses may be harmful.
If the patch falls off, a new one should be applied to a different non-hairy, clean, and dry area. Treatment should be continued 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 medicinal product, the doctor should be contacted immediately.
It is possible to experience symptoms similar to those of acute nicotine poisoning, such as pallor, 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 appearance of overdose symptoms, the NiQuitin Transparent patch should be removed immediately. The skin area can be washed with water and dried. Soap should not be used, 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 and may cause death. In case of suspected poisoning, a doctor should be contacted immediately.
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 apply a new one as soon as possible and continue treatment as before. A double dose should not be used to make up for the missed dose.

Stopping the use of NiQuitin Transparent

In case of any further doubts about the use of this medicinal product, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicinal products, NiQuitin Transparent 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 changes, insomnia, depression, irritability, anxiety, restlessness, nervousness, and concentration difficulties, sleep disturbances may also be caused by quitting smoking.
Other side effects are listed below in groups based on the frequency 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
• cough
• 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, rash, or feeling of possible fainting

Side effects with unknown frequency:

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

At the patch application site, transient rash, itching, burning, and tingling of the skin, swelling, and pain may occur. Such symptoms usually resolve quickly after the patch is removed. Rarely, more severe reactions may occur at the patch application site. In such cases, the medicinal product should be discontinued and a doctor consulted.
In case of worsening of the listed symptoms or occurrence of other side effects not mentioned in this package leaflet, the doctor or pharmacist should be informed.

Reporting side effects

If side effects occur, including any side effects not listed in the package leaflet, the doctor, pharmacist, or nurse should be informed. 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.
Reporting side effects will help to gather more information on the safety of the medicinal product.

5. How to store NiQuitin Transparent

Store below 30°C.
The medicinal product should be stored in a place out of sight and reach of children.
Do not use this medicinal product 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 the sachets are damaged or open.
In case of questions or doubts, the doctor or pharmacist should be consulted.
Medicinal products should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What NiQuitin Transparent contains

• The active substance of the medicinal product 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, and ethylene-vinyl acetate, high-density polyethylene film, polyisobutylene laminate, white ink (3015Z).

What NiQuitin Transparent looks like and contents of the pack

The medicinal product is in the form of transparent, square patches, placed in individual sachets.
A carton box contains 7 patches.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Lithuania, in the country of export:

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

Manufacturer:

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

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
Lithuanian, in the country of export, marketing authorization number: LT/1/99/0366/005
LT/1/99/0366/006

Parallel import authorization number: 307/19

Date of package leaflet approval: 12.08.2024

[Information about the trademark]