Niquitin transparent patch

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is 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 medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as advised by
your doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If your condition does not improve or worsens, contact your doctor.

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 medicine in the form of transparent, square patches applied to the
skin, which helps in quitting smoking.
NiQuitin Transparent delivers a constant dose of nicotine to the body over 24 hours. During
a 10- or 8-week treatment period (see section How to use NiQuitin Transparent), the body's
need for nicotine gradually decreases. NiQuitin Transparent patches are available in three strengths:

• 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 gradual reduction of nicotine doses during treatment, leading to progressive freedom from nicotine dependence.

NiQuitin Transparent is indicated to relieve symptoms associated with nicotine withdrawal, such as:
nicotine craving, nervousness, restlessness, irritability, mood disturbances, sleep disturbances,
difficulty concentrating, increased appetite, mild somatic symptoms (headache, muscle aches,
constipation, fatigue), related to stopping smoking.
If possible, NiQuitin Transparent should be used together with a psychological support program
when quitting smoking.
NiQuitin Transparent patches may 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 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
Consult a doctor before use in the following cases: cardiovascular diseases (e.g. unstable angina pectoris, Prinzmetal's angina, heart failure, uncontrolled hypertension, severe arrhythmia), recent myocardial infarction or ischemic stroke, cerebral circulatory disorders, diseases associated with vasoconstriction, severe peripheral vascular disease, atopic dermatitis or eczema (due to local skin hypersensitivity to the patch), moderate to severe kidney or liver disease, gastric or duodenal ulcer, hyperthyroidism, diabetes, or pheochromocytoma.
Combination therapy (using NiQuitin Transparent patch together with other oral forms of NiQuitin (1.5 mg/2 mg/4 mg)) should not be used in patients with diagnosed cardiovascular disease without prior risk/benefit assessment by a healthcare professional.
Patients hospitalized due to recent myocardial infarction, severe cardiac arrhythmias, or stroke should attempt to quit smoking without using nicotine replacement therapy, unless a physician approves its use. After hospital discharge, normal use of nicotine replacement therapy may be resumed.
Patients who have ever experienced seizures should consult a doctor, pharmacist, or nurse before using this medicine.
Diabetic patients using NiQuitin Transparent patches should monitor their blood glucose levels more frequently than usual. Insulin or antidiabetic medication requirements may need adjustment.
NiQuitin Transparent may cause contact irritation. The product should be used carefully, avoiding contact of the patch with eyes and nose. After applying the patch, hands should be washed thoroughly with water only, without soap, as soap may increase nicotine absorption.
Smoking during treatment with NiQuitin Transparent patches poses a potential risk of adverse effects due to additive nicotine exposure from both tobacco and the patch.
The nicotine dose present in both used and new patches may be harmful to children. Therefore, the medicine should be stored out of children's reach, and used patches should be disposed of carefully.
Adverse skin reactions may occur in patients with skin inflammation after patch application. If severe local reactions at the application site persist for more than 4 days (e.g. severe erythema, itching, or swelling) or generalized skin reactions occur (e.g. urticaria, generalized rash), patch use should be discontinued and a doctor should be consulted.
Use with caution in patients with gastric ulcer or peptic ulcer, esophagitis (inflammation of the esophagus connecting the mouth and stomach), stomatitis, pharyngitis, or gastritis, as nicotine replacement therapy may exacerbate these conditions.
There is a risk of dependence during treatment with this medicine.

NiQuitin Transparent and other medicines
Inform your doctor about all medicines you are currently taking, including those available without a prescription.
Both quitting smoking and using nicotine replacement products reduce nicotine levels in the body, which may affect the action of other medicines.
Particular caution is required when using nicotine together with adenosine, as nicotine may potentially enhance the hemodynamic effects of adenosine, including increased blood pressure and heart rate, and may increase the incidence of pain (angina-like chest pain) induced by adenosine administration.

Pregnancy, breastfeeding, and fertility
Stopping smoking is the single most effective intervention to improve health for both a pregnant woman and her unborn child. The earlier abstinence is achieved, the better.
Pregnant and breastfeeding women should first attempt to quit smoking without using nicotine replacement products. If this approach fails, patients should consult their doctor, who may recommend using NiQuitin Transparent.
For the fetus, the risk associated with using NRT is lower than the risk expected from continued smoking, due to lower maximum plasma nicotine concentrations and absence of additional exposure to polycyclic aromatic hydrocarbons and carbon monoxide.
However, since nicotine crosses the placenta and affects fetal breathing movements and has a dose-dependent effect on placental/fetal circulation, the decision to use NRT should be made as early as possible in pregnancy. NRT use should generally be limited to a period of 2–3 months. Products with intermittent dosing may be preferred, as they usually provide a lower daily nicotine dose compared to patches. However, patches may be suitable if the woman experiences nausea during pregnancy.
Nicotine from both smoking and NRT passes into breast milk. However, the amount of nicotine to which an infant is exposed during NRT is relatively small and less dangerous than exposure to passive smoking, which would otherwise occur.
Compared to patches, using intermittently dosed NRT products may minimize nicotine levels in human milk, as the interval between NRT administration and breastfeeding can be maximized. Women should try to breastfeed just before taking the NRT product.
Due to lack of specific studies, combination therapy with patches and oral NRT forms is not recommended during pregnancy and lactation, unless a healthcare professional determines it necessary to ensure abstinence.

Driving and operating machinery
NiQuitin Transparent has no effect or negligible effect on the ability to drive and operate machinery.

3. How to use NiQuitin Transparent

This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Use in adults

Before starting treatment, stop smoking completely. Smoking even a small amount of tobacco during an attempt to quit may lead to relapse. Smoking cigarettes during therapy should be avoided, as it may result in nicotine overdose. In some cases, it may be beneficial to use oral forms of nicotine replacement therapy (such as lozenges, tablets for sucking, or chewing gum) in combination with NiQuitin Transparent, to use when a strong urge to smoke occurs.

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

For individuals smoking no more than 10 cigarettes per day, the nicotine dose should be reduced in 2 stages according to the following dosing schedule:

For best results, complete the full 10-week or 8-week treatment, as withdrawal symptoms may persist for several weeks.
The product should not be used for longer than 10 weeks. If the treatment has not achieved the desired outcome (e.g. the patient has not stopped smoking or has resumed smoking), consult a doctor to agree on further treatment.
Patients using patches for longer than 12 months should consult their doctor.

Using patches in combination with other oral forms
If a patient experiences strong cravings to smoke, combining patches with oral forms of nicotine-containing medicines may provide a greater chance of successfully quitting smoking than patch therapy alone.

The same dosing regimen as for patch-only therapy is recommended. If the patient feels a strong urge to smoke, they should take a lozenge, a soluble tablet, or chewing gum NiQuitin—on average, 5–6 units per day. When using combination therapy, the maximum daily dose for all oral forms is 10 units for 4 mg and 15 units for 1.5 mg/2 mg.

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 only 1 to 2 oral units per day.

*Depending on the number of cigarettes smoked (see recommendations for monotherapy).
**Patients who smoke more than 20 cigarettes per day should use the 4 mg dose orally for the first 6 weeks, then reduce the dose. The maximum daily dose for all oral forms is 10 units for 4 mg tablets/pastilles and 15 units for 1.5 mg/2 mg tablets/pastilles.
If the patient requires further information, they should consult the patient leaflet included with NiQuitin lozenges/sucking 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 medical advice.

Children under 12 years of age
NiQuitin Przezroczysty should not be used in children under 12 years of age.

Method of administration:
To ensure proper adhesion of the patch to the skin, it should be applied to a non-hairy, clean and dry area of skin. Avoid areas where the skin folds (e.g. joints) or where creases form during movement. Do not apply the patch to red, damaged or irritated skin.

The NiQuitin Przezroczysty patch should be applied immediately after removal from the sachet.

• To open the sachet, cut along the dotted line, taking care not to damage the patch inside.
• Carefully remove the patch. The patch should be applied with the adhesive side, which is covered by a transparent protective film.
• Peel off half of the protective film starting from the center, then hold the patch so as to touch the adhesive surface as little as possible, and remove the second half of the film.
• After removing the protective film, apply the patch to the skin with the adhesive side down. Press firmly with the palm of the hand for at least 10 seconds. Ensure that the patch adheres well to the skin, especially at the edges.
• After applying the NiQuitin Przezroczysty patch, avoid touching the eyes or nose. Wash hands with water without using soap.

Water does not adversely affect the patch if it is properly applied; therefore, bathing is permitted during treatment.
NiQuitin Przezroczysty patches should be changed once daily, always at the same time and as soon as possible after waking up.
The patch should not be left on the skin for longer than 24 hours. Do not reapply a new patch to the same site until at least 7 days have passed.
Do not use two patches simultaneously, as excessive doses of nicotine may be harmful.
If the patch detaches, apply a new one to another non-hairy, clean and dry area of skin. Continue treatment as before.
Used patches should be folded in half with the adhesive side inward, stuck together, and placed in the empty patch packaging intended for disposal. The packaging should then be discarded in a place inaccessible to children and pets.

Use of a higher than recommended dose of NiQuitin Przezroczysty
If a higher than recommended dose is used or if the patch is accidentally swallowed, contact a doctor immediately.
Symptoms similar to acute nicotine poisoning may occur, such as: pallor, sweating, nausea, hypersalivation, vomiting, stomach pain, diarrhoea, headache, dizziness, hearing and vision disturbances, tremor, confusion (disorientation), and weakness. In cases of significant overdose, cardiovascular collapse and respiratory disturbances may occur.
If symptoms of overdose occur, the NiQuitin Przezroczysty patch should be removed immediately.
The skin surface may be washed with water and dried. Do not use soap, as this may increase the absorption of nicotine, which may continue to be delivered into the circulation for several hours after patch removal.
Even a small dose of nicotine may be dangerous for children and may be fatal. In case of suspected poisoning, contact a doctor immediately.
In case of accidental ingestion of the patch, the doctor may recommend administration of activated charcoal.
In nicotine poisoning, the doctor may administer atropine, diazepam or barbiturates (for seizure control).
In respiratory failure, respiratory support should be provided; in arterial hypotension and cardiovascular collapse, fluid administration is indicated.

Missed dose of NiQuitin Przezroczysty
If the patient forgets to change the patch, a new one should be applied immediately and treatment continued as before. Do not use a double dose to make up for a missed dose.

Discontinuation of NiQuitin Przezroczysty
If you have any further questions about the use of this medicinal product, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone will experience them.
No serious adverse reactions have been observed with the recommended dosage of NiQuitin Transparent.
Simply stopping smoking may cause symptoms such as weakness, dizziness, headache, cough, and flu-like symptoms. Symptoms such as mood changes, insomnia, depression, irritability, anxiety, drowsiness, restlessness, nervousness, and difficulty concentrating, as well as sleep disturbances, may also result from stopping smoking.

Other adverse reactions listed below are grouped according to their frequency of occurrence:

Very common (occurring in more than 1 in 10 patients)

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

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

• nervousness
• tremor
• shortness of breath
• cough
• sore throat
• indigestion
• abdominal pain
• diarrhoea
• constipation
• increased sweating
• dry mouth
• joint, muscle, chest or limb pain
• fatigue/malaise or weakness

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

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

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

• skin reactions
• photosensitivity (increased sensitivity to sunlight)
• severe allergic reactions manifesting as sudden onset of wheezing or feeling of chest tightness, skin rash, or sensation of possible fainting

Adverse reactions with unknown frequency:

• seizures (in patients receiving anticonvulsant treatment or with a history of epilepsy)

At the site of patch application, transient rash, itching, burning, tingling, swelling and pain may occur. These symptoms usually resolve quickly after removing the patch. More severe reactions at the application site may rarely occur. In such cases, discontinue use of the product and consult a doctor.
If any of the listed symptoms worsen or if other adverse reactions not mentioned in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse reactions helps to increase the knowledge about the safety of the medicine.

5. How to store NiQuitin Transparent

Do not store at temperatures above 30°C.
Keep the medicine out of the 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 stated month.
Do not use NiQuitin Transparent patches if the sachets appear damaged or opened. If in doubt or if you have questions, consult your doctor or pharmacist.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What NiQuitin Transparent contains

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

What NiQuitin Transparent looks like and contents of the pack
NiQuitin Transparent is in the form of transparent, square patches contained in individual sachets.
The cardboard box contains 7 patches.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in France, the country of export:
Laboratoire Perrigo France
200 Avenue de Paris
92320 Chatillon
France
Manufacturer:
LTS Lohmann Therapie-system AG
Lohmannstr. 2
55626 Andernach, Rheinland-Pfalz
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in France, the country of export: 3400930260432
Parallel import authorisation number: 11/26