Niquitin transparent patch

Package leaflet: Information for the user

Warning! Keep this leaflet! 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 medicine.
Please read the entire leaflet carefully 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
advised by the 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 adverse reactions, including any possible adverse reactions 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
a ten- or eight-week treatment period (see section How to use NiQuitin Transparent), the
body's need for nicotine is gradually reduced. 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 dependence.

NiQuitin Transparent is indicated to relieve symptoms associated with nicotine withdrawal, such as: nicotine craving, nervousness, anxiety, irritability, mood disturbances, sleep disturbances, difficulty concentrating, increased appetite, mild somatic symptoms (headaches, 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.

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 arterial hypertension, severe arrhythmia), recent myocardial infarction or ischaemic stroke, cerebral circulation 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, gastric or duodenal ulcer, hyperthyroidism, diabetes, phaeochromocytoma.
Patients hospitalised due to recent myocardial infarction, severe cardiac arrhythmias or stroke should attempt to quit smoking without using nicotine replacement therapy, unless their doctor authorises its use. After discharge from hospital, normal use of nicotine replacement therapy is possible.
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 with caution, and contact of the patch with eyes and nose should be especially avoided. After applying the patch, hands should be thoroughly washed with water only (without soap), as soap may increase nicotine absorption.
Smoking during therapy 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 reach of children, and used patches should be disposed of carefully.
Unwanted reactions may occur in patients with skin inflammation after application of the patch.
If severe local reactions at the application site persist for more than 4 days (e.g. severe erythema, itching or swelling) or generalised skin reactions occur (urticaria, generalised rash), use of the patch should be discontinued and medical advice sought.
Use with caution in patients with gastric ulcer, peptic ulcer, oesophagitis (inflammation of the oesophagus connecting the mouth and stomach), stomatitis, pharyngitis or gastritis, as nicotine replacement therapy may worsen symptoms of these conditions.
There is a risk of dependence during treatment with this medicine.

NiQuitin Transparent with other medicines
Inform your doctor about all medicines currently taken, including those obtained without a prescription.
Both quitting smoking and using nicotine replacement therapy reduce nicotine levels in the body, which may affect the action of other medicines.

Pregnancy, breastfeeding and fertility
Pregnant women should try to stop smoking without using nicotine replacement therapy.
If quitting smoking in this way is unsuccessful, patients should consult their doctor, who may recommend using NiQuitin Transparent.
Breastfeeding women may use nicotine patches, as the amount of nicotine transferred into breast milk is small and poses less risk than cigarette smoking.

Driving and operating machinery
The effect of this medicine on the ability to drive and operate machinery is unknown.

3. How to use NiQuitin Transparent

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a 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 is not recommended, as it may result in nicotine overdose. In some cases, it may be beneficial to use an oral form 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, a full 10-week or 8-week treatment course should be completed, 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), the patient should consult a doctor to discuss further treatment options.

Use of 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 using patches alone.
The same dosing regimen as for patch monotherapy 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 day. No more than 15 units should be used within 24 hours.
The patient should use oral forms of NiQuitin for 2–3 months, after which the dose should be gradually reduced. Treatment should be discontinued when the patient is taking 1 to 2 oral units per day.

| Phase | Patches* | Oral forms of NiQuitin |
|-------|-----------|------------------------|
| Phase 1: 6 weeks | NiQuitin Transparent 21mg/24 hours | Average: 5 to 6 units/24 hours ** |
| Phase 2: 2 weeks | NiQuitin Transparent 14mg/24 hours | Continue using lozenges/oromucosal tablets/chewing gum as needed |
| Phase 3: 2 weeks | NiQuitin Transparent 7mg/24 hours | Continue using lozenges/oromucosal tablets/chewing gum as needed |
| After 8–10 weeks | Discontinue NiQuitin Transparent | Gradually reduce the number of oral forms used. Discontinue treatment when the patient takes 1 to 2 oral units per day. |

*Depending on the number of cigarettes smoked per day (see recommendations for monotherapy).
**Patients who smoke more than 20 cigarettes per day should use the 4 mg dose in oral form for the first 6 weeks, then reduce the dose.
If the patient requires 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
This 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 proper adhesion of the patch, it should be applied to a non-hairy, clean, and dry area of skin. Avoid areas where the skin folds (e.g. joints) or areas that develop creases during movement. Do not apply the patch to red, damaged, or irritated skin.
The NiQuitin Transparent 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 its 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 minimize contact with the adhesive surface while peeling off 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 the patch adheres well to the skin, especially at the edges. After applying the NiQuitin Transparent patch, avoid touching the eyes or nose. Hands should be washed with water (without 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.
The patch should not be left on the skin for longer than 24 hours. A new patch should not be applied to the same site until at least 7 days have passed.
Do not use two patches simultaneously, as excessive nicotine doses may be harmful.
If the patch detaches, apply a new one to a different, non-hairy, clean, and dry area of skin. Continue treatment as previously planned.
Used patches should be folded in half with the adhesive sides together, stuck together, and placed in the empty patch packaging that the patient intends to use next, 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 medicine is accidentally ingested, 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, 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 absorption of nicotine, which continues to be delivered into the circulation for several hours after patch removal.
Even a small dose of nicotine may be dangerous for children. If poisoning is suspected, 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 should be provided, and in arterial hypotension and cardiovascular collapse, fluid administration is indicated.

Missed 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. Do not use a double dose to make up for a missed dose.

Discontinuation of NiQuitin Transparent
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
No serious side effects have been observed with the use of NiQuitin Transparent at the recommended dosage.

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 side effects are listed below, grouped according to their likelihood of occurrence:

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

• 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 people)

• 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 people)

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

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

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

Side effects of unknown frequency:

• seizures

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 pronounced reactions at the application site may rarely occur. In such cases, discontinue use of the medicine and consult a doctor.

If any of the listed symptoms worsen or if other side effects not mentioned in this leaflet occur, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 side effects helps provide more information on the safety of the medicine.

5. How to store NiQuitin Transparent patch

Store below 30°C.
Keep the medicine 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 stated month.
Do not use NiQuitin Transparent patches if the sachets are damaged or opened. If in doubt, 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. Such measures help 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 laminate, polyester film, white ink.

What NiQuitin Transparent looks like and contents of the pack
NiQuitin Transparent is a transparent, square patch contained in individual sachets.
The cardboard pack contains 7 patches.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Lithuania, the country of export: LT/1/99/0366/005
LT/1/99/0366/006
Parallel Import Authorisation Number: 228/23