Nicorette Invisipath

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

NICORETTE INVISIPATCH

10 mg/16 h transdermal system, patch
Nicotine

NICORETTE INVISIPATCH

15 mg/16 h transdermal system, patch
Nicotine

NICORETTE INVISIPATCH

25 mg/16 h transdermal system, patch
Nicotine

You should carefully read the contents of the leaflet 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 directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult your pharmacist if you need advice or more information.
• If you do not feel better or if you feel worse, you should contact your doctor.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Nicorette Invisipatch and what is it used for
• 2. Important information before using Nicorette Invisipatch
• 3. How to use Nicorette Invisipatch
• 4. Possible side effects
• 5. How to store Nicorette Invisipatch
• 6. Contents of the package and other information

1. What is Nicorette Invisipatch and what is it used for

Description of action

When a patient stops smoking and nicotine is no longer regularly delivered to the body, various symptoms resulting from nicotine withdrawal begin to appear, including irritability, anxiety, mood disturbances, dizziness, and headaches, as well as sleep disturbances. With the help of Nicorette Invisipatch patches, these can be prevented or alleviated by delivering the appropriate doses of nicotine to the body.
Nicotine contained in Nicorette Invisipatch patches is administered in its pure form. Unlike cigarettes, Nicorette Invisipatch patches do not release harmful tar substances or carbon dioxide, which are produced during the combustion process.
Nicotine is slowly released from the Nicorette Invisipatch patch and absorbed through the skin at a constant rate. The constant release of nicotine is possible due to its uniform distribution in the patch.
Nicorette patches are intended for use during periods of activity during the day, i.e., for about 16 hours, as they mimic the period of nicotine delivery during smoking. The maximum concentration is reached in the afternoon/evening, when the risk of relapse is highest.

Indications for use

The medicine is indicated for the treatment of tobacco dependence in individuals who have decided to quit the habit by alleviating nicotine craving and withdrawal symptoms that occur after stopping smoking.

2. Important information before using Nicorette Invisipatch

When not to use Nicorette Invisipatch

• If the patient is allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

You should consult your doctor before using Nicorette Invisipatch patches in the following cases:

• if you have recently had a stroke or heart attack;
• if you have chest pain or symptoms of angina pectoris;
• if you have uncontrolled high blood pressure;
• if you have stomach or duodenal ulcers;
• if you have hyperthyroidism;
• if you have insulin-dependent diabetes (you may need lower doses of insulin as a result of quitting smoking);
• if you have a diagnosed pheochromocytoma;
• if you have severe or moderate liver disease;
• if you have severe kidney disease;
• if you have esophagitis,
• if you have a history of epilepsy or seizures.

The Nicorette Invisipatch patch should be removed before undergoing magnetic resonance imaging (MRI) to prevent burns.
Some patients may continue to use Nicorette Invisipatch after the recommended treatment period, but the potential risk of long-term use of Nicorette Invisipatch is much lower than the risk of dependence associated with returning to tobacco smoking.

Combination therapy

Warnings and precautions for combination therapy are the same as for Nicorette Invisipatch and the chosen Nicorette product for oral use in monotherapy. You should read the leaflet included in the package of the chosen Nicorette product to learn about the warnings and precautions for its use.

Nicorette Invisipatch and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Quitting smoking may require modification of the dosage of these medicines.
If you are taking medicines such as imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (a medicine used to treat asthma, chronic obstructive pulmonary disease, and inflammatory bronchial conditions), tacrine (a medicine used to treat Alzheimer's disease), ropinirole (a medicine used to treat Parkinson's disease), flecainide (a medicine used to treat arrhythmias), pentazocine (a pain reliever), or insulin, you should consult your doctor before using Nicorette Invisipatch patches.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Nicotine passes into breast milk in amounts that may affect the baby, even when used in therapeutic doses.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

3. How to use Nicorette Invisipatch

Children and adolescents
Nicorette Invisipatch should not be used in individuals under 18 years of age without a doctor's recommendation. Data on the treatment of this age group with Nicorette Invisipatch are limited.
Adults and the elderly
The patch should be applied in the morning, after waking up, to undamaged skin, and removed before going to bed. Treatment with patches (transdermal system) mimics the fluctuations in nicotine levels in smokers during the day and without taking nicotine during sleep. Using the patch during the day does not cause sleep disturbances observed during nicotine use during sleep.
Monotherapy
For individuals with a high degree of dependence, it is recommended to start treatment with Step 1, i.e., a 25 mg/16 h patch used once a day for eight weeks. Then, you should start gradual withdrawal of the patches (transdermal system). You should use a 15 mg/16 h patch once a day for two weeks, and then a 10 mg/16 h patch once a day for another two weeks.
For individuals with a low degree of dependence, it is recommended to start treatment with Step 2, i.e., a 15 mg/16 h patch used once a day for eight weeks, and then continue treatment with a 10 mg/16 h patch (Step 3) used for another four weeks.
Dosing schedule

High degree of dependence Low degree of dependence

Dose Duration of therapy Dose Duration of therapy

Step 1
Nicorette
Invisipatch,
25 mg/16 h
first
8 weeks
Step 2
Nicorette
Invisipatch,
15 mg/16 h
next
2 weeks
Step 2 Nicorette
first
8 weeks
Invisipatch,
15 mg/16 h
Step 3
Nicorette
Invisipatch,
10 mg/16 h
last
2 weeks
Step 3 Nicorette
last
4 weeks
Invisipatch,
10 mg/ 16 h
It is not recommended to use the patches for more than 6 months. However, some former smokers may require a longer treatment period to avoid relapse.
Combination therapy
The patches can be used alone or in combination with other Nicorette products containing nicotine. The use of more than one form of nicotine replacement therapy is beneficial in the case of heavy smokers, smokers who have returned to the smoking habit despite using monotherapy, or those who have difficulty controlling the urge to light a cigarette during monotherapy. If necessary, to quickly control the urge to light a cigarette, the Nicorette Invisipatch patch can be used in combination with the following Nicorette products: 2 mg chewing gum, 2 mg lozenges, or 1 mg/dose oral spray.
Smokers using combination therapy should follow the recommended dosing for monotherapy for patches and the chosen Nicorette product for oral use.
It is recommended that patients using combination therapy use only one chosen Nicorette product per day with the patch.
The patch should be applied in the morning, after waking up, and removed after 16 hours, before going to bed, according to the dosing schedule recommended for monotherapy (see above).
Nicorette 2 mg chewing gum or Nicorette 2 mg lozenges should be used as needed, when the smoker feels a strong urge to light a cigarette, not exceeding the maximum daily dose of 15 gums or lozenges.
The gum can be used as needed for up to 12 weeks, then the use of the gum should be gradually reduced. The maximum duration of gum use is 12 months.
The lozenge can be used as needed for up to 6 weeks, then the use of the lozenges should be gradually reduced. The maximum duration of lozenge use is 9 months.
Nicorette 1 mg/dose oral spray should be used as needed, not exceeding 2 doses at a time and 64 doses (4 doses/hour for 16 hours) per day. It is not recommended to use the spray regularly for more than 6 months.
Some former smokers may require longer use of gum, lozenges, or spray to avoid relapse. The remaining product should be kept for use in case of sudden nicotine craving.
Withdrawal schedule: You should start by gradually withdrawing the patches according to the recommended dosing schedule for monotherapy (see above). If further treatment is necessary, the chosen Nicorette product should be used according to the recommended dosing for monotherapy.

Recommended dosing of patches in combination with 2 mg chewing gum/2 mg lozenges/1 mg/dose oral spray:

High degree of dependence

Low degree of dependence

You should take advantage of support groups, as they can help you quit smoking and complete the therapy successfully.
Instructions for use
The Nicorette Invisipatch patch should be used on clean, dry, undamaged, and hairless skin, for example, on the buttocks, upper arm, or chest. You should change the patch application site every day; the same site should not be used on consecutive days.
You can bathe and shower as usual.

• 1. Wash your hands before applying the patch.
• 2. Cut the packaging with scissors along the marked line. Choose a body area where the skin is clean, dry, undamaged, and hairless, for example, on the buttocks, upper arm, or chest.
• 3. Remove the silver, aluminum protective foil from the patch. Avoid touching the adhesive side of the patch with your fingers as much as possible.
• 4. Apply the patch carefully to the skin and remove the remaining silver, aluminum protective foil.
• 5. Press the patch firmly to the skin with your hand or fingers.
• 6. Rub the edges of the patch with your fingers to ensure it is properly attached. After removing the used patches, dispose of them.

Using a higher than recommended dose of Nicorette Invisipatch

Nicotine overdose, both during replacement therapy and (or) smoking, can cause symptoms of overdose.
Symptoms of overdose are the same as those of acute nicotine poisoning and include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, and hearing disturbances, as well as significant weakness. At high doses, these symptoms may be accompanied by hypotension, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.
Doses of nicotine tolerated by adults during treatment can cause symptoms of severe poisoning in small children and can be fatal.
Procedure in case of overdose
Nicotine administration should be stopped immediately, and the patient should be treated symptomatically.
In case of swallowing an excessive amount of nicotine, activated charcoal reduces gastrointestinal absorption of nicotine.
The patch should be removed, and the application site should be rinsed with water.

Missing a dose of Nicorette Invisipatch

You should not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms may occur in connection with quitting smoking. These include worsening of mood, insomnia, irritability, frustration, anger, anxiety, concentration problems, nervousness, or impatience. Physical symptoms may also occur, such as decreased heart rate, increased appetite, or weight gain, dizziness, or hyperventilation symptoms, cough, constipation, gum bleeding, aphthous ulcers, or pharyngitis, as well as nicotine craving accompanied by the urge to light a cigarette.
Nicorette Invisipatch may cause side effects similar to those that occur with nicotine absorbed during smoking or using other tobacco products.
These effects are mostly dose-dependent.
In about 20% of patients using Nicorette Invisipatch patches during the first weeks of treatment, mild, local skin reactions occur.
Rarely, allergic reactions (including severe allergic reactions) may occur during the use of Nicorette Invisipatch.
Side effects of nicotine identified during the post-marketing period are presented in the following table. The frequency of occurrence is defined according to the following scheme:
Common
(may occur in 1 to 10 out of 100 people)
Uncommon
(may occur in 1 to 10 out of 1,000 people)
Unknown
(frequency cannot be estimated from available data)

in the patch area
Combination therapy
In the case of combination therapy, in addition to the side effects associated with the use of Nicorette Invisipatch patches, side effects resulting from the use of the chosen Nicorette product for oral use may also occur, including local side effects related to the specific pharmaceutical form. You should read the leaflet included in the package of the chosen Nicorette product to learn about the side effects related to its use.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Nicorette Invisipatch

The medicine should be stored in a place inaccessible and invisible to children.
Store at a temperature below 25°C.
Do not use Nicorette Invisipatch after the expiry date stated on the package. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Nicorette Invisipatch contains

• The active substance of the medicine is nicotine. 1 patch (transdermal system) 10 mg/16 h contains 15.75 mg of nicotine. 1 patch (transdermal system) 15 mg/16 h contains 23.62 mg of nicotine. 1 patch (transdermal system) 25 mg/16 h contains 39.37 mg of nicotine.
• Other ingredients are: carrier layer:medium-chain triglycerides, basic butyl methacrylate copolymer, outer protective layer:19 µm polyethylene terephthalate (PET), acrylic adhesive layer:adhesive acrylic solution Durotak 387-2051, potassium hydroxide, sodium croscarmellose, aluminum acetylacetonate, protective layer to be removed before applying the patch to the skin:100 µm polyethylene terephthalate (PET).

What Nicorette Invisipatch looks like and what the package contains

The medicine is in the form of patches packaged in individual sachets made of laminated foil (paper, PET, aluminum, or extruded cyclic polyolefin copolymer), placed in a cardboard box.
The package contains 7, 14, or 28 patches.

Marketing authorization holder and manufacturer

Marketing authorization holder: McNeil AB, SE-251 09 Helsingborg, Sweden.
Manufacturer:LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, D-56626 Andernach, Germany.
To obtain more detailed information, you should contact:
email: [email protected]
Date of the last revision of the leaflet: June 2023