What is Nicotinell Patch and when is it used?

Nicotinell Patch is recommended as a support if you want to quit smoking. Nicotinell Patch is a nicotine patch that slowly releases nicotine and absorbs it through the skin.

Nicotine is the addictive component in tobacco smoke and is responsible for the various withdrawal symptoms associated with smoking cessation. The controlled delivery of nicotine through the skin using the patch reduces these withdrawal symptoms and makes it easier for the smoker to abstain from cigarette nicotine.

Once you have acquired new habits (substitute actions for smoking) over a period of time, experience has shown that you will find it easier to gradually reduce the amount of nicotine from Nicotinell patches and later to give up completely.

Health damage caused by the tar and carbon monoxide content in tobacco smoke is avoided.

What should be considered?

Your motivation and willpower are decisive for the success of the treatment. If you use Nicotinell patches, you must give up smoking altogether, otherwise there is a risk of nicotine overdose. It is therefore important that you are strongly motivated to quit smoking before starting Nicotinell treatment. Professional smoking advice increases the chances of quitting successfully.

When should Nicotinell Patch not be used?

Nicotinell Patch should not be used in the following cases:

• with known hypersensitivity to nicotine or one of the excipients according to the composition,
• with chronic skin diseases, psoriasis,
• with serious cardiovascular diseases, recent stroke or recent heart attack,
• during pregnancy and breastfeeding.
• Nicotinell plasters may not be used by non-smokers, children under the age of 12 and, in principle, by young people! For young people under the age of 18 and over the age of 12, the preparation should only be used if they are heavily dependent on nicotine and only after consultation with the doctor.

When is Do you need to be careful when using Nicotinell patches?

If you have any health problems, skin conditions or any of the following conditions, you should discuss the benefits and risks with your doctor before starting treatment with Nicotinell. Discuss carefully with your health care professional:

• Diabetes mellitus: when you start nicotine replacement therapy, you should check your blood sugar levels more frequently than usual, as blood sugar levels can fluctuate more widely. Drug therapy may need to be adjusted.
• Stable angina pectoris, recent heart attack, cardiac arrhythmia, cardiac insufficiency (heart failure), circulatory disorders in the arms and legs (e.g. smoker's leg), vascular diseases, stroke,
• Kidney and liver diseases,
• Hyperthyroidism, pheochromocytoma (adrenaline-producing tumor of the adrenal gland),
• Inflammation of the gastric mucosa or acute gastric and intestinal ulcers, inflamed esophagus. Nicotine replacement therapy may worsen symptoms.
• Epilepsy if you have ever had seizures.

The use of the preparation should only be considered in these cases if smoking cessation is being attempted is not possible without medical support. If new cardiovascular symptoms develop or existing symptoms worsen (chest pain, irregular pulse, shortness of breath), a doctor should be consulted.

Stopping smoking with or without a nicotine replacement such as Nicotinell patches may change the response to concomitant medicines for asthma, cardiac arrhythmia, severe pain, mood disorders, Alzheimer's disease, stomach and intestinal ulcers or diabetes (insulin). If necessary, your doctor will prescribe a dose adjustment of the medicines concerned.

Nicotinell patches contain aluminium:

The patch should be removed during MRI, electrical defibrillation and diathermy treatment.

Inform your doctor, pharmacist or druggist if you suffer from other illnesses, have allergies or use other medicines (even those you bought yourself!).

There is no evidence of any risk to driving or using machines as long as the recommended dosage is followed. However, be aware that behavioral changes may occur when you quit smoking.

Can Nicotinell patches be used while pregnant or breastfeeding?

It is very important that you completely stop smoking during pregnancy, as this will lead to a reduction in smoking growth of your child.

If you are pregnant, you should try to quit smoking without using any medication. Nicotine in any form can harm the unborn child.

No form of nicotine should be administered during pregnancy or breastfeeding, including through the Nicotinell patch. Nicotine passes into breast milk.

Talk to your doctor about how to quit smoking during this time.

How do you use Nicotinell patches?

Once you start treatment with Nicotinell patches, you should stop smoking completely.

Nicotinell patches are intended for adults over the age of 18.

Young people under the age of 18 and over the age of 12 should only use the preparation if they are heavily dependent on nicotine and only after consulting a doctor (See also «When shouldn't Nicotinell patch be used?».

Nicotinell patches are available in three strengths:

Nicotinell patch 1 strong (21 mg/24h, 52.5 mg nicotine)

Nicotinell Patch 2 medium (14 mg/24h, 35 mg nicotine)

Nicotinell Patch 3 light (7 mg/24h, 17.5 mg nicotine)

The strength that applies to you is determined by the number of cigarettes you smoke per day or by the Fagerstrom test. This test measures the level of your nicotine dependency. Based on your score on this test, you will be able to choose the most suitable patch strength for you.

In order to assess the degree of your nicotine dependency, please use the Fagerstrom test.

Fagerstrom test

Evaluation of the Fagerström test

• Score from 0 to 2: You are not addicted to nicotine. You can quit smoking without nicotine replacement therapy. However, if you are concerned about quitting smoking or are unsure about how to choose the patch strength, consult your doctor, pharmacist or druggist.
• Score from 3 to 4: You are slightly addicted to nicotine.
• Score from 5 to 6: You are moderately addicted to nicotine. Nicotine replacement therapy increases your chances of success.
  Let your doctor, pharmacist or druggist advise you on the choice of the most suitable treatment for you.
• Score from 7 to 10: You are heavily or very heavily dependent on nicotine. To overcome your nicotine addiction, nicotine replacement therapy is recommended. It must be used in a sufficient and appropriate dose.
  Ask your doctor, pharmacist or druggist for advice, if possible as part of a special consultation on smoking cessation.

The degree of nicotine dependence must be estimated by the number of cigarettes smoked per day or by the Fagerstrom test for nicotine dependence.

	1. month	2. month	3. month
More than 20 cigarettes a day (5 or more points on the Fagerstrom test)	Strength 1 (strong)	Strength 2 (medium)	Strength 3 (light)
Less than 20 cigarettes a day (less than 5 points on the Fagerstrom test)	Strength 2 (medium)	Strength 2 (medium)	Strength 3 (light)

The overall treatment with Nicotinell patches should last a maximum of 3 months!

Type of application:



Each Nicotinell patch is individually sealed in an airtight child-resistant sachet. Use scissors to cut open the child-resistant pouch along the outer edge and remove the patch (Fig. 1). After removing the cut edge of the aluminium-colored protective film (Fig. 2), hold the patch by the protruding edge and slowly peel off the aluminium-colored protective film from the cut point without touching the adhesive layer (Fig. 3).

Apply a Nicotinell patch daily, preferably when you get up, and leave it on the skin for 24 hours.

Place the patch on a healthy, hairless, dry and clean area of ​​skin (no lotion, alcohol, ointment residue, etc.), preferably on the trunk or upper arm (inside or outside) (Fig. 4-6). The plaster should be pressed with the heel of the hand for about 10-20 seconds over its entire surface. It should not be applied to a red, bruised or irritated area of ​​skin. Wash your hands carefully afterwards so that no nicotine can get from your fingers into your eyes.

The Nicotinell patch will now stay on the skin for 24 hours.

Then peel off the patch and fold it with the sticky side inwards. Since the plasters still contain nicotine after use, they must be disposed of in such a way that they cannot get into the hands of children.

Now stick a new patch on a different area of ​​skin. To avoid local skin irritation, the same area of ​​skin should be used again after 7 days at the earliest. Nicotinell Patch adheres well to the skin and remains functional even when bathing, showering or exercising.

If you ever forget to change Nicotinell patches at the allotted time, don't worry. Make up for the patch change as soon as possible and apply the next patch at the usual time.

If you start smoking again while you are being treated with Nicotinell patches, the treatment should be interrupted. You can try to stop using Nicotinell patches at a later time.

Dosage adjustment cannot be made by cutting a patch. Never use more than one Nicotinell patch at a time.

Follow the dosage given in this leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Nicotinell patch have?

Stop using Nicotinell (remove the patch) and tell your doctor immediately if one or more you experience the following symptoms, which may be signs of a rare serious allergic reaction:

• Allergic reactions such as skin swelling,
• swelling of the face, lips, tongue or throat,
• low blood pressure and difficulty breathing.

Certain symptoms such as irritability, nervousness, restlessness, mood swings, depressive mood, anxiety, drowsiness, difficulty concentrating, insomnia and sleep disorders can be attributed to withdrawal symptoms associated with smoking cessation. Individuals who quit smoking by any means may experience headaches, drowsiness, coughing, or flu-like symptoms.

Some side effects are very common (may affect more than 1 in 10 people):

Reactions at the application site, such as itching, redness, edema and burning sensation. If you experience a serious skin reaction that does not go away, you should stop use and consult your doctor, pharmacist or druggist to find you another form of nicotine replacement therapy.

Application site reactions are partly caused by not changing the patch application site every day. Rotating the application site daily allows for a natural decrease in irritation and should cause less discomfort.

Some side effects are common (may affect up to 1 in 10 people in 100):

Headache, nausea, dizziness, trouble sleeping including abnormal dreams, insomnia, nervousness, cough , sore throat, abdominal pain, upset stomach, muscle pain.

These side effects are usually mild and resolve quickly on their own once you remove the patch.

Some side effects are uncommon (may affect up to 1 in 10 people in 1,000):

Tingling sensation, palpitations, vomiting, constipation, diarrhoea , flatulence, dry mouth, excessive sweating, joint pain, weakness, pain at the application site, malaise, flu-like symptoms.

Some side effects are rare (may affect up to 1 in 10,000 people):

tremor, shortness of breath, abnormal heart rhythm.

Some side effects are very rare (less than 1 in 10,000 people):

Allergic inflammatory skin disease, contact dermatitis, photosensitivity.

Aphthous ulcers can occur when smoking cessation, the reason is unknown.

If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

Overdose:

An overdose and thus nicotine poisoning can also occur in adults if, for example, several patches are used together or if nicotine from tobacco is consumed at the same time. In the event of an overdose, the signs correspond to those of acute nicotine poisoning. The following occur: nausea, salivation, abdominal pain, low temperature, diarrhea, sweating, headache, dizziness, hearing disorders, confusion, paleness and pronounced weakness. In extreme cases, the following can follow: cramps, drop in blood pressure, weak, irregular pulse, respiratory failure and fainting, circulatory collapse.

In the event of an overdose or suspected overdose, the nicotine patch must be removed immediately and the application site rinsed with water and dried (do not use soap). Consult a doctor immediately. Even small amounts of nicotine are dangerous for children and can lead to severe symptoms of poisoning, which can be fatal. If you suspect nicotine poisoning in children, you must seek emergency medical help.

What else needs to be considered?

Special warning for children

Keep medicines out of the reach of children. Nicotine is a highly toxic substance. Even the dose tolerated by adults in the treatment can lead to severe poisoning in small children, i. Sticking on Nicotinell patches while playing can be fatal to children if not noticed in time. Therefore, the Nicotinell patches must be kept out of the reach of children at all times.

The patches still contain nicotine after use! Therefore, fold the removed plasters together with the adhesive layer on the inside and dispose of them in such a way that they cannot get into the hands of children.

Storage instructions

Store at 15-30 °C.

Keep out of the reach of children.

The medicinal product may only be used up to the date marked «EXP» on the container.

Further information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Nicotinell patch contain?

Active ingredient

Nicotine.

Excipients

Nicotinell patch is a Ttransdermal Ttherapeutic S >system (TTS).

1 Nicotinell Patch 1 (strong) contains 52.5 mg nicotine. TTS 30 with 30 cm² absorption area.

Average active ingredient release on the skin 21 mg/24 hours.

Round, yellow-ochre transdermal patch, protective liner marked with the code «EME».

1 Nicotinell Patch 2 (medium) contains 35 mg nicotine. TTS 20 with 20 cm² absorption area.

Average active ingredient release on the skin 14 mg/24 hours.

Round, yellow-ochre transdermal patch, protective liner marked with the code «FEF».

1 Nicotinell Patch 3 (light) contains 17.5 mg nicotine. TTS 10 with 10 cm² absorption area.

Average active ingredient release on the skin 7 mg/24 hours.

Circular, yellow-ochre transdermal patch, protective liner marked with the code «CWC».

Approval number

50582 (Swissmedic).

Where can you get Nicotinell patches? What packs are available?

In pharmacies and drugstores, without a doctor's prescription.

Nicotinell Patch 1 (strong) 21 mg/24h: 7 and 21 depot patches.

Nicotinell Patch 2 (medium) 14 mg/24h: 7 and 21 depot patches.

Nicotinell patch 3 (light) 7 mg/24h: 7 and 21 depot patch.

Authorization holder

GSK Consumer Healthcare Schweiz AG, Risch.

This package leaflet was last checked by the Medicines Agency (Swissmedic) in June 2019.