Niquitin transparent

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
NiQuitin Clear (NiQuitin Clear)
114 mg; 21 mg/24 hours, transdermal system, patch
Nicotinum
NiQuitin Przezroczysty and NiQuitin Clear 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 a
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 Clear is and what it is used for
2. Important information before using NiQuitin Clear
3. How to use NiQuitin Clear
4. Possible side effects
5. How to store NiQuitin Clear
6. Contents of the pack and other information

1. What NiQuitin Clear is and what it is used for

NiQuitin Clear is a medicine in the form of transparent, square patches applied to the skin, which helps in quitting smoking.
NiQuitin Clear continuously 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 Clear), the body's need for nicotine is gradually reduced. NiQuitin Clear 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 Clear 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 (headaches, muscle aches, constipation, fatigue), occurring when quitting smoking.
Whenever possible, NiQuitin Clear should be used together with a psychological support program when quitting smoking.
NiQuitin Clear patches may be used alone or in combination with other oral forms of NiQuitin (see section How to use NiQuitin Clear).

2. Important information before using NiQuitin Przezroczysty

When not to use NiQuitin Przezroczysty

• 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 hypertension, severe arrhythmia), after a recent myocardial infarction or ischemic stroke, in cases of cerebral circulatory disorders, diseases involving 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, pheochromocytoma.
Patients hospitalized due to recent myocardial infarction, severe cardiac arrhythmias, or stroke should attempt to quit smoking without using nicotine replacement therapy, unless their doctor approves 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 Przezroczysty patches should monitor their blood glucose levels more frequently than usual. Insulin or antidiabetic medication requirements may change.
NiQuitin Przezroczysty 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 while using NiQuitin Przezroczysty 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.
In patients with skin inflammation, undesirable reactions may occur 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 (urticaria, generalized rash) occur, the use of 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 symptoms of these conditions.
There is a risk of dependence during treatment with this medicine.

NiQuitin Przezroczysty 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 therapies reduce nicotine levels in the body, 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 unsuccessful, patients should consult their doctor, who may recommend using NiQuitin Przezroczysty.
Breastfeeding women may use nicotine patches, as the amount of nicotine passing 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 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 tobacco completely. Smoking even a small amount of tobacco during the attempt to quit may lead to relapse. Smoking cigarettes during treatment 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 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 course, as withdrawal symptoms may persist for several weeks.
The medication 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 physician to determine further management.
Use of patches in combination with other oral forms
If a patient experiences strong cravings to smoke, combining the patch with oral nicotine replacement therapies may provide a greater chance of successfully quitting smoking compared to using patches 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, an oral tablet, or a chewing gum containing NiQuitin—on average, 5–6 units per day. Do not use more than 15 units within 24 hours.
The patient should use oral forms of NiQuitin for 2–3 months, after which the dosage should be gradually reduced. 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.
If the patient requires further information, they should consult the patient leaflet included with NiQuitin in the form of 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 Transparent should not be used in children under 12 years of age.

Instructions for use:
To ensure proper adhesion of the patch to the skin, it should be applied to clean, dry, and non-hairy skin. Avoid areas where the skin folds (e.g. joints) or where creases form during movement. Do not apply the patch to reddened, 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 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 in such a way as to minimize contact with the adhesive surface, and remove 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 hand for at least 10 seconds to ensure good adhesion, especially at the edges.
• After applying the NiQuitin Transparent 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 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 doses of nicotine may be harmful.

If the patch becomes detached, apply a new one to another clean, dry, non-hairy 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, then discarded 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 medicinal 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, diarrhea, 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 the absorption of nicotine, which will continue to be delivered into the circulation for several hours after removal of the patch.

Even a small dose of nicotine may be dangerous for children. In case of suspected poisoning, contact a doctor immediately.

In case of accidental ingestion of the 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; in arterial hypotension and cardiovascular collapse, fluid administration is indicated.

Missed dose of NiQuitin Transparent
If the patient forgets to change the patch, 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 medicinal product, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
No serious adverse reactions have been observed with NiQuitin Transparent when used at the recommended dosage.

Stopping smoking itself 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 be caused by stopping smoking.

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

Very common (affects 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 (affects 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
• dry mouth
• joint, muscle, chest or limb pain
• fatigue/malaise or weakness

Uncommon (affects less than 1 in 100 but more than 1 in 1,000 people)

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

Rare (affects 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

Adverse reactions with 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 severe reactions at the application site may rarely occur. In such cases, use of the product 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 a doctor, pharmacist or nurse.

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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store NiQuitin Transparent

Store below 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 are damaged or open.
If you have any questions or doubts, consult your doctor, pharmacist, or nurse.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What NiQuitin Transparent contains

• The active substance is nicotine. One 22 cm² transdermal patch containing 114 mg of nicotine as the active substance delivers 21 mg of nicotine over 24 hours.
• Other components: ethylene vinyl acetate copolymer, polyethylene terephthalate/ethylene vinyl acetate, high-density polyethylene film, polyisobutylene adhesive laminate, polyester film, white ink (3015Z-009L).

What NiQuitin Transparent looks like and contents of the pack
The medicine is in the form of transparent, square patches, individually placed in laminated sachets. The cardboard box contains 7 patches.
For more detailed information, please contact the responsible entity or the parallel importer.
Responsible entity in Portugal, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portugal, country of export, marketing authorization number: 4944880
Parallel import authorization number: 15/23