Nicorette 10 mg. / 16 hours. 7 patchs

What is a Nicoret Cleary transdermal patch and what is it used for

Nicorette Cleary transdermal patch is a medicine that helps you stop smoking.

Nicorette Cleary transdermal patch is used to treat tobacco addiction, to relieve smoking cravings (nicotine) and the symptoms of nicotine withdrawal, which helps motivated smokers to quit smoking.

When you stop smoking and provide tobacco with nicotine in your body, you may experience unpleasant sensations called withdrawal symptoms. By using the Nicoret Cleary transdermal patch, these unpleasant sensations can be prevented or reduced - with the help of the Nicoret Cleare patch, you continue to supply your body with a small amount of nicotine in its pure form, which does not carry any health risks associated with smoking.

The health risks associated with smoking are caused by toxins contained in tobacco.
Tips and support usually improve your chances of quitting smoking.
If possible, use the medicine as part of a smoking cessation program.

If used as recommended, the Nicorette Cleary Transdermal Patch helps you control the potential weight gain after stopping smoking.

2. What you need to know before using a Nicorette Cleary transdermal patch

Do not use the Nicoret Cleary transdermal patch

if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
if you are under 18 years old
if you are a non-smoker.
Take special care with the Nicoreth Cleary transdermal patch

Ask your doctor for advice before using Nicoreth Cleary transdermal patch if:

you have had a severe cardiovascular event or have been hospitalized within the last 4 weeks due to cardiovascular complaints (eg stroke, myocardial infarction, arrhythmia (heart rhythm disorder), unstable angina (angina)
have undergone cardiovascular surgery for bypass or angioplasty (artery surgery)
you suffer from high blood pressure that is not controlled by medication
you suffer from liver disease and / or severe kidney disease
you have diabetes as you may need to reduce your insulin dose when you stop smoking
you have increased thyroid function (hyperthyroidism) or adrenal tumor (pheochromocytoma)
you have ulcers of the stomach or duodenum
Children and adolescents
Nicorette Cleary transdermal patch should not be used in patients below 18 years of age.

Doses of nicotine given by adult smokers during treatment can lead to serious symptoms of child poisoning and can have a fatal outcome. Even if already used, the patch contains enough residual nicotine to harm children. Keep used and unused patches out of the reach and sight of children.

Other medications and Nicorette Cleary transdermal patch
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you are taking medicines containing:

theophylline for the treatment of asthma
tacrine for the treatment of Alzheimer's disease
clozapine for schizophrenia
ropinirole for the treatment of Parkinson's disease
Nicorette Cleary transdermal patch with food and drink
The intake of food and drink does not affect the effect of this medicine.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using any medicine.

Because smoking can cause serious harm to the fetus or your child, you should stop smoking during pregnancy and breast-feeding, if possible, without the use of nicotine-containing medicines.

Nicotine is found in breast milk in amounts that can harm babies.
Do not use the Nicoret Cleary transdermal patch while breast-feeding.

If you cannot stop smoking without using nicotine-containing medicines, use Nicorette products only after consulting your doctor.

Driving and using machines
No effects on the ability to drive and use machines have been observed.

3. How to use a Nicoret Cleary transdermal patch

Always use this medicine as directed in this leaflet or as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist. The maximum dose should not be exceeded.
You should do everything possible to stop smoking completely during treatment with the Nicoret Cleary transdermal patch.

The Nicoret Cleary transdermal patch can be used alone or in combination with Nicoret Eysmint 2 mg chewing gum or Nicoret Freshmint 1 mg / injection oral mucosa spray.

Children and adolescents
Safety and efficacy in children and adolescents have not been evaluated. Nicorette Cleary transdermal patch should not be used in children and children
Smokers with high nicotine dependence (Fagerström test for nicotine dependence corresponding to 6 or more cigarettes or more than 20 cigarettes per day) are advised to initiate treatment with Nicoret Cleary 25 mg / 16 h transdermal patch (one patch per day). Table 1.
Initial treatment should last for 8 weeks.

After 8 weeks, the dose of nicotine contained in the patch should be reduced gradually. Therefore, a Nicoreth Cleary 15 mg / 16 h transdermal patch should be used for 2 weeks, followed by a Nicoreth Cleary 10 mg / 16 h transdermal patch also for 2 weeks (one patch per day).

Smokers with lower nicotine dependence (Fagerström test for nicotine dependence below 6, or smoking less than 20 cigarettes a day) are advised to start treatment with Nicorette Cleary 15 mg / 16 h (one patch per day) transdermal patch see. Table 2.
Initial treatment should last for 8 weeks.

After 8 weeks, the dose of nicotine contained in the patch should be reduced gradually. Therefore, the Nicodoret Cleary 10 mg / 16 h transdermal patch should be used for 4 weeks (one patch per day - step 3, see Table 2).

Table 1. Dosage regimen for smokers with high nicotine dependence
Dosage
Treatment period

first 8 weeks - initial phase
for the next 2 weeks
last 2 weeks

Step 1 Nicorette Cleary 25 mg / 16 h one patch per day
Step 2 Nicorette Cleary 15 mg / 16 h one patch per day
Step 3 Nicoreth Cleary 10 mg / 16 h one patch per day

Table 2. Dosage regimen for smokers with lower nicotine dependence
Dosage
Treatment period

first 8 weeks - initial phase
the last 4 weeks

Step 1 Nicoreth Cleary 15 mg / 16 h one patch per day
Step 2 Nicoreth Cleary 10 mg / 16 h one patch per day
The use of patches for more than 6 months is generally not recommended. If you need to use the product for longer than recommended to prevent smoking resumption, consult your doctor.

Treatment with a patch in combination with Nicoret Eismint 2 mg chewing gum or Nicoret Freshmouth oral 1 mg / spray.
If you feel a desire for nicotine despite the use of nicotine-containing medicines, you can use the Nicorette patch in combination with the Nicorette Eismint 2 mg chewing gum or the Nicorette Freshmouth oral 1 mg / spray.

Read the package leaflet of the selected Nicoret product that you use with the patch before removing it. The package leaflet is included in each pack.

Smokers with high levels of nicotine dependence (Fagerström test for nicotine dependence corresponding to or higher than grade 6 or smoking more than 20 cigarettes per day) are advised to start their treatment with Nicorette Cleary 25 mg / 16 h ( one patch per day) in combination with Nicoret Eismint 2 mg chewing gum or Nicoret Freshmouth oral 1 mg / injection oral spray as described in Table 3.
Initial treatment should last for 8 weeks.

After 8 weeks, the dose of nicotine contained in the patches should be gradually reduced. Therefore, a Nicoreth Cleary 15 mg / 16 h transdermal patch should be used for 2 weeks (one patch per day), followed by a Nicoreth Cleary 10 mg / 16 h transdermal patch also used for 2 weeks (one patch per day) ). The dose of Nicoret Eysmint 2 mg chewing gum or Nicorette Freshmint oral mucosa spray 1 mg / injection in combination with patches is described in Table 3.

Smokers with lower nicotine dependence (Fagerström test for nicotine dependence at grade 6 or smoking less than 20 cigarettes per day) are advised to start their treatment with Nicorette Cleary 15 mg / 16 h (one patch of day) in combination with Nicoret Aysmint 2 mg chewing gum or Nicoret Freshmouth oral 1 mg / injection oral spray as described in Table 4.
Initial treatment should last for 8 weeks.

After 8 weeks, the dose of nicotine contained in the patches should be gradually reduced. Therefore, Nicoreth Cleary 10 mg / 16 h transdermal patch should be used for 4 weeks (one patch per day), see Table 4. Dose of Nicoret Eismint 2 mg chewing gum or Nicoret Freshmint oral mucosa spray 1 mg / injection in combination with patches is described in Table 4.

Table 3. Dosage regimen for combination therapy in smokers with high nicotine dependence
Treatment period
A dose of Nicorette Cleary

Adaptive application

One of the following products can be used simultaneously

Daily dosage of the formulation for adaptive administration in combination with the patch

Step 1: first 8 weeks - start phase

Nicorette Cleary 25 mg / 16 h one patch per day

Nicoret Eysmint 2mg Chewing Gum As needed. Usually 5 to 6 chewing gum per day (max .: 16 chewing gum per day)
Nicoret Freshmint Oral Mucosa Spray 1 mg / Injection As needed. Apply one spray first, and if your craving does not go away within a few minutes, spray a second time. If necessary
Apply one patch daily to clean, dry, hairless skin (eg, thigh, shoulder, chest, etc.) so that you can change the placement site each day and therefore prevent possible skin irritation. For perfect bonding, avoid using cosmetics, lotions and powders at application sites. At best, the patch should be applied immediately after waking up in the morning and removed before bedtime so as to provide an action of 16 hours that meets the needs of smokers and does not disturb sleep.

1. Wash your hands before placing the patch.
2. Use scissors to open the envelope and cut as directed. Glue the patch to clean, dry, hairless skin (eg thigh, shoulder, chest, etc.).
3. Remove as much of the silver aluminum layer as possible, but avoid touching the adhesive portion of the patch with your fingers!
4. Apply the adhesive of the patch to your skin and remove the rest of the silver aluminum layer.
5. Press the patch firmly against the skin with your fingers or palm.
6. Smooth the patch with your fingertips to ensure perfect adhesion.

If misplaced or peel off, use a new patch. Do not use the patch at night, ie. no more than 16 hours!
Used patches should be disposed of safely.

If you accidentally forget to remove the patch in the evening, you can remove it in the morning and continue your treatment as usual using a new patch.

If you have used more than the required Nicorette Cleary transdermal patch
Nicotine overdose can occur if you smoke and use the Nicorette Cleary transdermal patch at the same time and / or if you use other forms of nicotine replacement therapy, or if you have a low nicotine addiction.

If you have used more patches than recommended, or if your child accidentally uses or swallows a patch, consult your doctor or seek medical advice immediately. Doses of nicotine well tolerated by adult smokers during treatment can cause severe symptoms of child poisoning and can be fatal.

Symptoms of overdose include nausea, vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache, dizziness, changes in hearing and a feeling of weakness. At high doses, these symptoms can be followed by low blood pressure, low and irregular heartbeat, difficulty breathing, exhaustion, circulatory collapse and convulsions.
If you experience any symptoms of overdose, stop using the product and consult your doctor or pharmacist. The skin surface where the patch is applied should be washed with water and dried (no soap used).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, the Nicorette Cleary transdermal patch can cause side effects, although not everybody gets them.

Nicorette Cleary transdermal patch can cause the same side effects as other forms of nicotine. The side effects are usually dose dependent.

Smoking cessation reactions (nicotine withdrawal)
Some of the side effects you may experience from smoking cessation may be withdrawal symptoms due to a decrease in nicotine intake.

These reactions include:

Irritability, aggression, impatience or powerlessness
Feeling of anxiety, nervousness or difficulty concentrating
Awakening at night or sleep disturbances
Increased appetite or weight gain
Feeling depressed
Smoking desire
Heart rate reduction
Gingival bleeding or mouth ulcers
Dizziness or dizziness
Cough, sore throat, blocked or runny nose
Constipation
If you notice any of the following serious rare side effects, stop using the Nicorette Cleary transdermal patch and contact your doctor immediately (signs of angioedema):

Swelling of the face, tongue or throat
Swallowing difficulties
Hives and difficulty breathing
Very common: may affect more than 1 in 10 people

itchy skin
Common: Can affect up to 1 in 10 people

dizziness, headache, urticaria, stomach ache, nausea, nausea, skin rash
Uncommon: may affect up to 1 in 100 people

unusual dreams, application site reactions, chest discomfort and chest pain, tiredness (exhaustion), malaise, palpitations, hypersensitivity, hypertension, increased heart rate, increased sweating, muscle pain, pain in the arm or leg, redness skin, numbness, weakness, feeling that breathing requires more effort than usual (dyspnoea)
Very rare: Can affect up to 1 in 10,000 people

temporary irregular heartbeat.
Unknown frequency: frequency cannot be estimated from the available data

Allergic reactions, including
5. How to store Nicorette Cleary transdermal patch

Keep out of the reach and sight of children.

Keep below 25C, keep container tightly closed in order to protect from moisture.

Do not use the Nicorette Cleary transdermal patch after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.

Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Nicorette Cleary contains transdermal patch
The active substance is nicotine. One 10 mg patch of 9.0 cm2 contains 15.75 mg of nicotine, one 15 mg patch of 13.5 cm2 contains 23.62 mg of nicotine and one 25 mg patch of 22.5 cm2 contains 39, 37 mg nicotine.
The nicotine content of each patch is 1.75 mg / cm2.

The other ingredients are:
Nicotine layer: Polyethylene terephthalate film (PET), medium chain triglycerides, the major butylated methacrylate copolymer.
Acrylate layer: Acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate.
Release layer: Polyethylene terephthalate (PET) film, aluminized on one side, siliconized on both sides.

What Nicorette Cleary looks like in a transdermal patch and what the pack contains
Beige, translucent, rectangular patch with rounded edges and light brown "Nicorette" seal affixed to an easily removable layer, covered with aluminum and silicone and formed by a nicotine layer and an adhesive acrylic layer.

The patches are sealed in individual multilayer packages, packed in a box.

Packaging
Nicorette Cleary 25 mg / 16 h: 7, 14, 28 patches
Nicorette Cleary 15 mg / 16 h: 7, 14, 28 patches
Nicorette Cleary 10 mg / 16 h: 7, 14 patches

Not all pack sizes may be marketed.

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