Niquitin transparent

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
NiQuitin Transparent (NiQuitin)
78 mg; 14 mg/24 hours, transdermal system, patch
Nicotinum
NiQuitin Transparent and NiQuitin are different brand 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 so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If your condition does not improve or if you feel worse, contact your doctor.

Contents of the leaflet:

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 ten- or eight-week treatment (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 a gradual reduction of nicotine doses during treatment, leading to a progressive release from dependence.

NiQuitin Transparent is indicated to relieve symptoms associated with nicotine withdrawal, such as: craving for nicotine, nervousness, restlessness, irritability, mood disturbances, sleep disturbances, difficulty concentrating, increased appetite, and mild somatic symptoms (headache, muscle aches, constipation, fatigue) related to stopping smoking.
If possible, when quitting smoking, NiQuitin Transparent should be used in conjunction with a psychological support program to help stop 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 to 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, cerebrovascular disorders, diseases associated with vasoconstriction, severe peripheral vascular disease, atopic dermatitis or eczema (due to local hypersensitivity to the patch), moderate to severe kidney or liver disease, peptic ulcer of the stomach or duodenum, hyperthyroidism, diabetes, or pheochromocytoma.
Combination therapy (using NiQuitin Transparent 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. Dosage recommendations for insulin or antidiabetic medications may need adjustment.
NiQuitin Transparent may cause contact irritation. The medicine should be used carefully, and contact of the patch with eyes and nose should be particularly avoided. 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 amount of nicotine present in used and unused 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), the patch should be discontinued and a doctor should be consulted.
Use with caution in patients with gastric ulcer, 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 when using this medicine.

NiQuitin Transparent and other medicines
Inform your doctor about all medicines you are currently taking, including those obtained 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 concomitantly with adenosine, as nicotine may potentially enhance the hemodynamic effects of adenosine, i.e. increased blood pressure and heart rate, and may also increase the pain response (chest pain typical of angina) induced by adenosine administration.

Pregnancy, breastfeeding, and fertility
Stopping smoking is the single most effective intervention to improve health for both the pregnant woman and her unborn child. The earlier abstinence is achieved, the better.
Pregnant and breastfeeding women should attempt to quit smoking without using nicotine replacement therapy. If this approach fails, patients should consult their doctor, who may recommend using NiQuitin Transparent.
The risk associated with using NRT during pregnancy 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 dose of nicotine compared to patches. However, patches may be suitable if the woman experiences nausea during pregnancy.
Nicotine from smoking and NRT passes into breast milk. However, the amount of nicotine to which an infant is exposed due to NRT is relatively small and less hazardous than passive smoking, to which the infant would otherwise be exposed.
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 has a 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 the patient information leaflet or as
advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor,
pharmacist, or nurse.
The following products are available in the market: NiQuitin Transparent 114 mg; 21 mg/24 hours,
NiQuitin Transparent 78 mg; 14 mg/24 hours, NiQuitin Transparent 36 mg; 7 mg/24 hours.
Use in adults
Before starting treatment, you must stop smoking completely. Smoking even a small amount of
tobacco during an attempt to quit may lead to relapse. Smoking cigarettes during therapy is not
recommended, 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 who smoke 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:

To achieve the 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 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 a doctor.

Using patches in combination with other oral forms
If a patient experiences a strong urge 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 monotherapy with patches is recommended. If the patient feels a strong urge to smoke, they should take a lozenge, oromucosal tablet, or chewing gum NiQuitin – on average 5–6 units per 24 hours. 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.
Patients 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 takes only 1 to 2 oral units per day.

| Phase | Patches* | Oral forms of NiQuitin | |-------|-----------|------------------------| | Phase 1: 6 weeks | NiQuitin Transparent 21 mg/24 hours | Average: 5 to 6 units/24 hours ** | | Phase 2: 2 weeks | NiQuitin Transparent 14 mg/24 hours | Continue using lozenges/oromucosal tablets/chewing gum if necessary | | Phase 3: 2 weeks | NiQuitin Transparent 7 mg/24 hours | Continue using lozenges/oromucosal tablets/chewing gum if necessary | | After 8–10 weeks | Discontinue use of NiQuitin Transparent | Gradually reduce the number of oral forms taken. Discontinue treatment when the patient takes 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 oral dose for the first 6 weeks, then reduce the dose. The maximum daily dose for all oral forms is 10 units for 4 mg, and 15 units for 1.5 mg/2 mg.
If patients require further information, they should read the patient leaflet included with NiQuitin lozenges/oromucosal 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 medical advice.

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

Instructions for use:
To ensure the patch adheres properly to the skin, apply it to a hairless, 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.
Apply the NiQuitin Transparent patch immediately after removing it 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, 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 peel off the second half of the protective film.
• After removing the protective film, apply the patch to the skin with the adhesive side. Press firmly with the palm of the hand for at least 10 seconds. Ensure the patch adheres well to the skin, especially at the edges.
• After applying the NiQuitin Transparent patch, do not touch the eyes or nose; wash hands with water without using soap.

Water does not adversely affect the patch if it is properly applied, so bathing is permitted during treatment.
NiQuitin Transparent patches should be changed once daily, always at the same time and as soon as possible after waking up.
Do not leave the patch 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 becomes detached, apply a new one to another hairless, clean, and dry area of skin. Continue treatment as before.
Used patches should be folded in half with the adhesive sides together, stuck together, and placed in the empty patch packaging intended for the next patch, then disposed of in a place inaccessible to children and pets.

Use of a higher than recommended dose of NiQuitin Transparent
If a higher than recommended dose is used or if the product is accidentally ingested, contact a doctor immediately.
Symptoms similar to acute nicotine poisoning may occur, such as: pallor, sweating, nausea, salivation, 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 Transparent 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 will 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 cause death. In case of suspected poisoning, contact a doctor immediately.
In case of accidental ingestion of a patch, a doctor may recommend administration of activated charcoal.
In nicotine poisoning, a doctor may administer atropine, diazepam, or barbiturates (for seizure treatment). In respiratory failure, respiratory support is used; in arterial hypotension and cardiovascular collapse, fluid administration is indicated.

Missed dose of NiQuitin Transparent
If a patient forgets to change the patch, they should apply a new one immediately and continue treatment as before. Do not use a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
No serious adverse reactions have been observed with the recommended dosage of NiQuitin Transparent following the use of the medicine.
Simply stopping smoking may cause symptoms such as feeling weak, 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 likelihood 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 more than 1 in 100 patients)

• nervousness
• tremor
• shortness of breath
• cough
• sore throat
• indigestion
• abdominal pain
• diarrhoea
• constipation
• increased sweating
• dryness of the 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 (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 chest tightness, skin rash, or feeling faint

Adverse reactions with unknown frequency:

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

At the site where the patch is applied, transient rash, itching, burning, tingling, swelling and pain may occur. These symptoms usually resolve quickly after removal of the patch. More severe reactions at the site of patch application may rarely occur. In such cases, use of the medicine should be discontinued and a doctor should be consulted.

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 any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store NiQuitin Transparent

Do not store above 30°C.
Keep the medicine in a place invisible and out of 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. In case of questions or doubts, consult your doctor or pharmacist.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What NiQuitin Transparent contains

• The active substance is nicotine. One 15 cm² transdermal patch containing 78 mg of nicotine as the active substance delivers 14 mg of nicotine over 24 hours.
• Other ingredients are: ethylene vinyl acetate copolymer, polyethylene terephthalate/ethylene vinyl acetate, high-density polyethylene film, polyisobutylene adhesive 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 (PET/PE/Aluminium/EVOH). The cardboard box contains 7 patches.
For more detailed information, please contact the responsible entity 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: 3400930260401
Parallel import licence number: 49/26