Nicorette Invisipatch Plaster 15 mg 7 sztuk

Skin administration.
Nicorette Invisipatch is indicated for the treatment of tobacco dependence in people determined to quit by relieving nicotine craving and withdrawal symptoms that occur after smoking cessation.

Read the leaflet before taking the drug.
Storage: Store at ambient temperature
Package: Box

1 Nicorette Invisipatch 15 mg/ 16 h patch (13.5 cm2) contains 23.62 mg of nicotine (applied to the skin once daily releases15.5 mg of nicotine for 16 hours) and excipients - carrier layer: medium chain triglycerides, alkali butyl methacrylate copolymer, protective outer layer: polyethylene terephthalate (PET) 19 μm, acrylic layer, adhesion: acrylic adhesion solution Durotak 387-2051, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate, protective layer, removed before placing the patch on the skin: polyethylene terephthalate (PET) 100 μm

Johnson & Johnson Poland Sp. z o.o.

Responsible party:
McNeil AB,
SE-251 09 Helsingborg,
Sweden

Manufacturer:
LTS Lohmann Therapie-Systeme AG,
Lohmannstrasse 2,
D-56626 Andernach,
Germany

Keep the drug out of sight and reach of children.

Read the leaflet carefully before using the drug, as it contains important information for the patient.
Always use this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so you can read it again if needed.
- Ask your pharmacist if you need advice or additional information.
- If there is no improvement or the patient feels worse, contact your doctor.
- If you experience any side effects, including any possible side effects not listed in the leaflet, 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 the drug Nicorette Invisipatch
4 Possible side effects
5 How to store the drug Nicorette Invisipatch
6. package contents and other information

1 What is the drug Nicorette Invisipatch and for what purpose it is used.
Description of action
When a patient stops smoking cigarettes and nicotine is no longer regularly supplied to the body, various symptoms resulting from nicotine withdrawal begin to appear, including irritability, anxiety, mood disorders, dizziness and headaches, and sleep disorders. With the help of Nicorette Invisipatch patches, they can be prevented or diminished by delivering adequate doses of nicotine to the body. Nicotine contained in Nicorette Invisipatch patches is administered in pure form. Unlike cigarettes, Nicorette Invisipatch patches do not emit harmful tar or carbon dioxide, which are produced in the combustion process. Nicotine is slowly released from the Nicorette Invisipatch patch and absorbed through the skin at a constant rate. The steady release of nicotine is made possible by its even distribution in the patch.
Nicorette patches are designed to be used during the daytime activity period, i.e. for about 16 hours, as they are meant to mimic the nicotine delivery period of smoking. The maximum concentration is reached in the afternoon/evening, when the risk of relapse is greatest.

Indications for use
The drug is indicated for the treatment of tobacco dependence in individuals determined to quit by relieving nicotine craving and withdrawal symptoms that occur after smoking cessation.

3 How to use the drug Nicorette Invisipatch
Children and adolescents
Do not use Nicorette Invisipatch in people under 18 years of age without a doctor's recommendation. Data on the treatment of people in this age group with Nicorette Invisipatch are limited.

Adults and the elderly
The patch should be applied in the morning, after waking up, on an intact area of the skin, and removed before going to bed. Treatment with the patch (transdermal system) mimics the fluctuation of nicotine concentration in smokers during the day and without nicotine intake during sleep. Use of the patch during the day does not cause the sleep disturbances observed with nicotine use at bedtime.

Monotherapy
In highly dependent individuals, it is recommended to start treatment with Step 1, i.e. a 25 mg/16 h patch used once daily for eight weeks. Then start gradually weaning off the patch (transdermal system). Use a 15 mg/16 h patch once daily for two weeks and then 10 mg/16 h once daily for another two weeks.
For those with a low degree of dependence, it is recommended to start treatment with Step 2, i.e., the 15 mg/16 h patch used once daily for eight weeks and then continue treatment with the 10 mg/ 16 h patch (Step 3) used for another four weeks.

High degree of dependence
Dose size Step 1 / Nicorette Invisipatch, 25 mg/16 h / Duration of therapy first 8 weeks
Dose size Step 2 / Nicorette Invisipatch, 15 mg/16 h / Therapy time the next 2 weeks
Dose size Step 3 / Nicorette Invisipatch, 10 mg/16 h / Therapy time last 2 weeks

Low level of addiction
Dose size Step 2 / Nicorette Invisipatch, 15 mg/16 h / Therapy time first 8 weeks
Dose size Step 3 / Nicorette Invisipatch, 10 mg/16 h / Therapy time last 4 weeks

It is not recommended to use the patch for more than 6 months. However, some ex-smokers may require a longer treatment period to avoid relapse.

Combination therapy
The patch 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 for heavy smokers, smokers who have relapsed despite taking NTZ monotherapy, or who have difficulty controlling the urge to light up a cigarette while taking monotherapy. If necessary to quickly control the desire to light up a cigarette, the Nicorette Invisipatch patch can be used together with the following products
Nicorette: chewing gums 2 mg, lozenges 2 mg or oral spray 1 mg/dose.

Smokers using combination therapy should follow the dosage recommended in monotherapy for the patch and the selected Nicorette oral product.

It is recommended that patients using combination therapy, use only one selected Nicorette product per day along with the patch.

The patch should be stuck on in the morning, after waking up, and removed after 16 hours before going to bed according to the dosage schedule recommended for monotherapy (see above).

Nicorette 2 mg gumor Nicorette 2 mg lozenge tablet should be used as needed when a smoker feels a strong desire to light up, not exceeding the maximum daily dose of 15 gums or tablets.
The gum can be used as needed for a period of 12 weeks, then the use of gum should be gradually reduced. The maximum duration of use of gums is 12 months.
Tablet can be used as needed for a period of 6 weeks, then gradually reduce the use of tablets. The maximum duration of tablet use is 9 months.
Nicorette aerosol 1 mg/dose should be used as needed, not exceeding 2 doses at a time and 64 doses (4 doses per hour for 16 hours) per day. Usually, regular use of the aerosol is not recommended for longer than 6 months.
Some ex-smokers may require longer use of gums, tablets or aerosol to prevent relapse. Keep the remaining product for use in case nicotine cravings suddenly arise.

Withdrawal regimen: Start by gradually discontinuing the patch according to the dosage regimen recommended for monotherapy (see above). If further treatment is necessary, the chosen Nicorette product should be used according to the dosage recommended in monotherapy.

The recommended dosage of the patch in combination with chewing gums 2 mg/ lozenges 2 mg/ oral spray 1 mg/dose:

Highly addictive
Dose Step 1 / Nicorette Invisipatch, 25 mg/16 h / Duration of therapy First 8 weeks / Gum 2 mg Use as needed, but no more than 15 gums/day. The recommended dose is 5-6 gums/day. / Tablets 2 mg / Use as needed, but not more than 15 tablets/day. The recommended dose is 5-6 tablets/day. / Aerosol 1 mg/dose / Use as needed, but not more than 64 doses/day (4 doses/hour for 16 hours). The recommended dose is 1-2 doses every 30 minutes to 1 hour. Begin reducing the number of doses from week 7.
Dose Step 2 / Nicorette Invisipatch, 15 mg/16 h / Duration of therapy Another 2 weeks / Gum 2 mg Use as needed, but no more than 15 gums/day. / Tablets 2 mg / Use as needed, but no more than 15 tablets/day. / Aerosol 1 mg/dose / Use as needed, but not more than 64 doses/day (4 doses/hour for 16 hours). Continue to reduce the number of doses per day. Before the end of week 9, the patient should use half the average number of doses used up to week 6.
Dose Step 3 / Nicorette Invisipatch, 10 mg/16 h / Duration of therapy Last 2 weeks / Gum 2 mg Use as needed, but no more than 15 gums/day. Begin gradually reducing the number of gums. / Tablets 2 mg / Use as needed, but not more than 15 tablets/day. Begin gradual reduction in the number of tablets. / Aerosol 1 mg/dose / Continue to reduce the number of doses used per day, so that by week 12 no more than 4 doses/day are used. When the number of doses per day is reduced to 2-4, stop using the aerosol. Do not use more than 64 doses/day (4 doses/hour for 16 hours).
Dose Beyond Step 3 / Duration of therapy After 12 weeks / Gum 2 mg Use as needed, up to a maximum of 12 months. / Tablets 2 mg / Use as needed, up to a maximum of 9 months. / Aerosol 1 mg/dose / Use as needed, up to a maximum of 6 months.

Take advice from support groups, as they can support the process of quitting smoking and complete the therapy successfully.

Instructions for use
Nicorette Invisipatch patch should be applied to clean, dry, undamaged, hairless skin, for example, on the buttocks, upper arm or chest. Change the spot where the patch is applied each day, the same spot should not be applied for consecutive days.
You can bathe and shower as usual.
1 Wash your hands before sticking the patch.
2 Cut the package lengthwise with scissors according to the labeling. Select an area of the body where the skin is clean, dry, undamaged and hairless, such as the buttocks, upper arm or chest.
3 Remove part of the silver aluminum protective film from the patch. Do not touch the sticky side of the patch with your fingers as much as possible.
4. adhere the patch carefully to the skin and peel off the remaining part of the silver aluminum protective foil.
5. press the patch firmly against the skin with your hand or fingers.
6. rub the edges of the patch with your fingers to make sure it is properly adhered.
After peeling off, discard used patches.

Using more than the recommended dose of Nicorette Invisipatch
Overuse of nicotine, whether in replacement therapy and/or smoking, can cause symptoms of overdose.
Symptoms of overdose are the same as after acute nicotine poisoning and include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing impairment and significant weakness. At high doses, these symptoms may be accompanied by hypotension, weak and irregular heart rate, difficulty breathing, exhaustion, circulatory collapse and generalized convulsions.
Doses of nicotine tolerated by adults during treatment can cause symptoms of severe intoxication in young children and can be fatal.

Management of overdose
Nicotine administration should be stopped immediately, the patient should be treated symptomatically. If excessive nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine.
Remove the patch and wash the application site with water.

Omission of Nicorette Invisipatch application.
Do not use a double dose to make up for a missed dose.

5 How to store the drug Nicorette Invisipatch
Store the drug out of reach and sight of children.
Store at a temperature below 25ºC.
Do not use Nicorette Invisipatch after the expiration date on the package. The expiration date means the last day of the given month.
Do not dispose of the medication down the drain or in household waste containers. Ask your pharmacist what to do with medicines you no longer need. Doing so will help protect the environment.

4 Possible side effects
Like any drug, this medication may cause side effects, although not everyone will experience them.

Some symptoms may occur in connection with smoking cessation. These include worsened mood, insomnia, irritability, frustration, anger, anxiety, trouble concentrating, nervousness or impatience. Physical symptoms such as decreased heart rate, increased appetite or weight gain, dizziness or pre-fainting symptoms, coughing, constipation, bleeding gums, aphthous ulcers or nasopharyngitis, and nicotine craving combined with the desire to smoke may also occur.

Nicorette Invisipatch may cause side effects similar to those that occur after nicotine absorption from cigarette smoking or the use of other forms of tobacco. These effects are mostly nicotine dose-dependent.

Approximately 20% of patients using Nicorette Invisipatch patches experience mild local skin reactions during the first weeks of treatment.

Allergic reactions (including severe allergic reactions) may rarely occur during the use of Nicorette Invisipatch.

Nicotine-related adverse reactions found in the post-marketing period are listed in the table below. The incidence was determined according to the following scheme:

Frequent (may occur in 1 to 10 out of 100 people)
Uncommon (may occur in 1 to 10 per 1,000 people)
Unknown (frequency cannot be determined from available data)

Classification of systems and organs
Frequency - Adverse effect

Cardiac disorders
Uncommon - Palpitations
Uncommon - Tachycardia

Gastrointestinal disorders
Unknown - Gastrointestinal discomfort*.

General disorders and conditions at the site of administration
Uncommon - Reactions at the site of administration
Uncommon - Asthenia
Uncommon - Chest discomfort and pain
Uncommon - Malaise

Immunologic system disorders
Unknown - Anaphylactic reaction (sudden severe allergic reaction)

Musculoskeletal disorders
Uncommon - Myalgia*.
Unknown - Pain in the extremities

Mental disorders
Uncommon - Unusual dreams

Respiratory, thoracic and mediastinal disorders
Uncommon - Shortness of breath

Skin and subcutaneous tissue disorders
Unknown - Angioedema (a disease of the skin and mucous membranes characterized by limited swelling)
Unknown - Erythema
Uncommon - Excessive sweating
Common - Rash
Frequent - Urticaria

Vascular disorders
Uncommon - Facial redness
Uncommon - Hypertension

Combination therapy
When using combination therapy, in addition to adverse reactions associated with the use of Nicorette Invisipatch patches, adverse reactions resulting from the use of the selected Nicorette oral product may also occur, including, but not limited to, topical adverse reactions associated with the pharmaceutical formulation. Refer to the package insert of the selected Nicorette product to learn about adverse reactions related to its use.

Reporting of adverse reactions
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions may be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, tel: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the responsible party.
By reporting side effects, more information on the safety of the drug can be gathered.

6 Package contents and other information
What the drug Nicorette Invisipatch contains
- The active substance of the drug 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.

- The other ingredients are: carrier layer: medium chain triglycerides, alkali butyl methacrylate copolymer, outer, protective layer: polyethylene terephthalate (PET) 19 µm, acrylic adhesion layer: Durotak 387-2051 acrylic adhesion solution, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate, protective layer, removed before placing the patch on the skin: polyethylene terephthalate (PET) 100 µm.

What Nicorette Invisipatch looks like and what the packaging contains.
The drug comes in the form of patches packaged in separate sachets of laminated film (paper, PET film, aluminum, acrylonitrile copolymer or extruded cyclic polyolefin copolymer), placed in a cardboard box.
The package contains 7, 14 or 28 patches.

2 Important information before using Nicorette Invisipatch.
When not to use Nicorette Invisipatch
- If you are allergic to nicotine or any of the other ingredients of this drug (listed in section 6).

Warnings and precautions
Consult your doctor before using Nicorette Invisipatch patches if:
- a recent history of stroke or myocardial infarction;
- chest pain or symptoms of angina pectoris;
- uncompensated high blood pressure;
- peptic ulcer disease of the stomach or duodenum;
- hyperthyroidism;
- insulin-dependent diabetes mellitus (lower insulin doses may be required as a result of cessation of
smoking);
- established pheochromocytoma of the adrenal glands;
- severe or moderate liver disease;
- severe kidney disease;
- esophagitis.

The Nicorette Invisipatch patch should be removed before magnetic resonance imaging (MRI) is performed to prevent burns.
Some patients may continue using Nicorette Invisipatch after the recommended treatment period, but the potential risks of long-term use of Nicorette Invisipatch are much less than the risks of addiction associated with a return to smoking.

Combination therapy
The warnings and precautions for combination therapy are the same as for the use of Nicorette Invisipatch and the selected Nicorette oral product as monotherapy. Read the package insert of the selected Nicorette product to learn about the warnings and precautions for its use.

Nicorette Invisipatch and other medications
Tell your doctor about all medications you are currently or recently taking, as well as medications you plan to take. Smoking cessation may require modification of the dosage of these drugs.
If you are taking medications such as imipramine, clomipramine, fluvoxamine (drugs used to treat depression), clozapine, olanzapine (drugs used to treat schizophrenia), theophylline (a drug used to treat bronchial asthma, chronic obstructive pulmonary disease and bronchial inflammation), tacrine (a drug used for Alzheimer's disease), ropinirole (a drug used for Parkinson's disease), flecainide (a drug used for, among other things.among others in tachycardia, paroxysmal atrial fibrillation, arrhythmia), pentazocine (a painkiller), insulin, you should consult your doctor before using Nicorette Invisipatch patches.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or if you are planning to have a baby, you should consult your doctor before using this medication.
Nicotine passes into breast milk in amounts that may affect the baby, even when used in therapeutic doses.

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

NICORETTE INVISIPATCH
10 mg/ 16 h transdermal system, patch
Nicotinum

NICORETTE INVISIPATCH
15 mg/ 16 h transdermal system, patch
Nicotinum

NICORETTE INVISIPATCH
25 mg/ 16 h transdermal system, patch
Nicotinum