Nicotinell 7 mg/24 hours transdermal patches

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nicotinell 7 mg/24 hours transdermal patch

Nicotine

Read the entire leaflet carefully because it contains important information for you.

This medicine is available without a prescription. However, to achieve the best results,
it must be used carefully.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If symptoms worsen or persist beyond 6 months, you must consult your doctor.
• If you consider any of the adverse effects to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Nicotinell transdermal patch is and what it is used for
2. Before using Nicotinell transdermal patch
3. How to use Nicotinell transdermal patch
4. Possible adverse effects
5. Storage of Nicotinell transdermal patch
6. Further information

1. What NICOTINELL TRANSDERMAL PATCH is and what it is used for

Nicotinell belongs to a group of medicines used to help you stop smoking.

Nicotinell is a transdermal patch and is similar to a plaster, containing the medicine in the part that adheres to the skin.

This medicine is indicated for the relief of nicotine withdrawal symptoms in nicotine dependence, as an aid to smoking cessation.

2. BEFORE USING NICOTINELL TRANSDERMAL PATCH

Do not use Nicotinell transdermal patch

• if you are an occasional smoker or a non-smoker.
• if you are allergic (hypersensitive) to nicotine or to any of the other components of this medicine.

If you are unsure whether you should use Nicotinell, consult your doctor or pharmacist.

Take special care with Nicotinell transdermal patch

If you are in the immediate recovery period after a heart attack, stroke, or have serious heart rhythm disorders or uncontrolled hypertension, you must consult your doctor before starting treatment with Nicotinell.

You should consult your doctor or a healthcare professional before using Nicotinell:

• if you have stable cardiovascular disorders, severe hypertension, or heart failure,
• if you have had cerebrovascular or arterial occlusion problems,
• if you have diabetes, you should monitor your blood sugar levels more frequently than usual when starting to use the nicotine patch. You may need to adjust your insulin or antidiabetic treatment.
• if you have stomach or duodenal ulcers, or inflammation of the esophagus or throat (the passage between the mouth and the stomach), as nicotine replacement therapy may worsen your symptoms.
• if you have severe hepatic and/or renal impairment,
• if you have a skin disorder,
• if you have ever experienced seizures (fits).

Stop using the patch and consult a healthcare professional

• if you develop redness, swelling, or a rash on the skin. If you have a history of dermatitis, you are more likely to experience these reactions.

Used nicotine patches contain enough residual nicotine to be harmful to children. Keep all medicines out of the reach and sight of children.

After use, fold the patch in half before carefully disposing of it, and keep it out of the reach and sight of children.

Using Nicotinell patches with other medicines

Stopping smoking may alter the effect of other medicines you may be taking. If you have any questions or concerns about this, consult a healthcare professional.

Pregnancy

If you are pregnant, you should stop smoking without using nicotine replacement therapy. Quitting completely is by far the best option. However, if you have tried and failed, nicotine replacement therapy should only be used to help you stop smoking upon the advice of a healthcare professional.

Breast-feeding

If you are breast-feeding, you should first try to stop smoking without using nicotine replacement therapy. However, if you have tried and failed, nicotine replacement therapy should only be used upon the advice of a healthcare professional, as nicotine may pass into breast milk.

Driving and using machines

Although no effects on the ability to drive or use machines are known at the recommended doses, it should be noted that stopping smoking may cause changes in behavior.

Important information about some components of Nicotinell transdermal patch

Nicotinell transdermal patch contains aluminium: you must not wear the Nicotinell patch during Magnetic Resonance Imaging (MRI) procedures.

3. HOW TO USE NICOTINELL TRANSDERMAL PATCH

You must completely stop smoking with this treatment in order to successfully quit the smoking habit.

You should not use Nicotinell simultaneously with another nicotine-containing product such as chewing gum or
lozenges, unless under strict medical supervision.

Smokers under 18 years of age should not use Nicotinell without the explicit recommendation of a healthcare professional.

Three dosage strengths of this medicine are available: Nicotinell 7 mg/24 h, Nicotinell 14 mg/24 h, and
Nicotinell 21 mg/24 h.

The appropriate dose for each individual is determined based on the number of cigarettes smoked per day or on the results of the Fagerström test. This test measures the degree of nicotine dependence. Based on the result of this test, the most suitable patch dose can be selected for each person.

Use the Fagerström test to assess the degree of nicotine dependence.

FAGERSTRÖM TEST

How long after waking up do you smoke your first cigarette? within 5 minutes : 3 6 to 30 minutes : 2 31 to 60 minutes : 1 more than 60 minutes : 0	Score
Is it difficult for you not to smoke in places where smoking is forbidden? yes : 1 no : 0
Which cigarette of the day is hardest for you to give up? the first one in the morning : 1 any other : 0
How many cigarettes do you smoke per day? 10 or fewer : 0 between 11 and 20 : 1 between 21 and 30 : 2 more than 30 : 3
Do you smoke more in the morning than during the rest of the day? yes : 1 no : 0
Do you smoke even if you are so ill that you must stay in bed most of the day? Yes : 1 no : 0
TOTAL SCORE

• Score of 0 to 2: not dependent on nicotine.

You can stop smoking without needing nicotine replacement therapy.

However, if you are concerned about quitting smoking or are unsure which patch dose to use, consult your doctor or pharmacist.

• Score of 3 to 4: low dependence on nicotine.
• Score of 5 to 6: moderate dependence on nicotine.

Using nicotine replacement therapy will increase your chances of success.

Consult your doctor or pharmacist to help you choose the most appropriate treatment for you.

• Score of 7 to 10: high or very high dependence on nicotine.

Nicotine replacement therapy is recommended to assist you with your dependence.
The treatment should be used at a sufficient and appropriate dose.

Consult your doctor or pharmacist, preferably within a specialized smoking cessation support program.

The dose of Nicotinell transdermal patch may need to be adjusted during treatment, as nicotine dependence can vary. Sometimes the nicotine dose from the Nicotinell patch may be too low, and sometimes too high.

You should increase the dose if you experience withdrawal symptoms such as:

• if you still feel a strong urge to smoke
• if you are irritable
• if you have difficulty sleeping
• if you feel nervous or impatient
• if you have difficulty concentrating

Consult your doctor or pharmacist; the dose may need to be adjusted.

You should reduce the dose if you experience signs of overdose, such as:

• if you have nausea (feel sick), vomiting, stomach pain, or diarrhea
• if you produce excessive saliva
• if you sweat excessively
• if you have headache, dizziness, hearing loss, or visual disturbances
• if you experience general weakness (lack of energy)

It is essential to adjust the treatment with the help of your doctor or pharmacist.

The usual treatment consists of 3 phases:

Initial phase: this will help you stop smoking.

Continuation phase: this phase consolidates tobacco abstinence and begins nicotine weaning.

Weaning phase: this phase helps you complete the treatment.

Normally, treatment should last for 3 months, although the duration may vary depending on the individual.

Do not use Nicotinell for longer than 6 months.

	Initial Phase 3 to 4 weeks	Follow-up Treatment 3 to 4 weeks	Tapering Treatment 3 to 4 weeks
Fagerström Test score greater than or equal to 5, or smoking 20 or more cigarettes/day	Nicotinell 21 mg/24 h	Nicotinell 14 mg/24h or Nicotinell 21 mg/24h*	Nicotinell 7 mg/24 h or Nicotinell 14 mg/24h then Nicotinell 7 mg/24 h*
Fagerström Test score less than 5 or smoking fewer than 20 cigarettes/day	Nicotinell 14 mg/24h or increase to Nicotinell 21 mg/24 h*	Nicotinell 7mg/24h** or Nicotinell 14 mg/24h	Discontinuation of treatment ** or Nicotinell 7 mg/24 h

• depending on the results obtained regarding withdrawal symptoms.

** if results are satisfactory.

Form and route of administration

Transdermal route (through the skin).

Open the sachet using scissors and remove the transdermal patch. Do not cut the Nicotinell transdermal patch.

Remove the pre-cut disposable protective liner located on the side of the transdermal patch. This is the side containing the medication and must be in contact with the skin.

Immediately after removing the protective liner, apply the Nicotinell transdermal patch to a dry, intact area of skin (without cuts, scratches, or bruises) and with minimal hair, such as the shoulder, waist, or upper outer arm. Avoid mobile areas of the body subject to friction with clothing. Apply the entire patch without cutting it.

To ensure perfect adhesion, press firmly with the palm of your hand over the entire outer surface of the patch for at least 10–20 seconds.

Keep the patch in place for 24 hours. If you have difficulty sleeping, consult your doctor or pharmacist.

Replace the Nicotinell transdermal patch every 24 hours. Use a different area of skin for each new patch, allowing several days to pass before reapplying to the same site.

When removing the patch from your skin, fold it in half with the medicated side inward before disposing of it safely, and keep it out of sight and reach of children.

During handling, avoid contact with the eyes and nose, and wash your hands after application.

If taking prolonged baths in the sea or swimming pool, you have two options:

• before bathing, remove the transdermal patch and immediately place it back into its container. You may reapply it later onto dry skin.
• cover the transdermal patch with a waterproof adhesive dressing (plaster) throughout the bath.

During showering, the transdermal patch may remain in place, avoiding directing the water stream directly at it.

Frequency of administration

Use one patch every 24 hours.

Duration of treatment

The duration of treatment is restricted to 6 months.

Consult your doctor if withdrawal symptoms worsen or do not improve, if anxiety persists, or if you have difficulty discontinuing treatment.

If you use more Nicotinell transdermal patch than you should:

In case of accidental overdose or if a child sucks on or applies a transdermal patch to the skin, remove the patch immediately, wash the skin with water only (do not use soap), consult a doctor or go to a hospital emergency department, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the name of the product and the amount used.

In children, even small amounts of nicotine can be dangerous and potentially fatal. If nicotine poisoning is suspected in a child, seek immediate medical attention.

In addition to signs of overdose that only require dose reduction (see the list before the dosage table), severe poisoning may occur with the following symptoms:

• Pale skin
• Increased sweating
• Involuntary muscle contractions
• Sensory disturbances
• And confusion may occur

With high overdose:

• Exhaustion
• Seizures
• Low blood pressure that may lead to circulatory collapse or respiratory failure

If you forget to apply the Nicotinell transdermal patch:

Apply the patch as soon as you remember, then continue your treatment as before. Do not use two patches at the same time.

If you have further questions about the use of this medicine, consult a healthcare professional.

4. Possible adverse effects

Like all medicines, Nicotinell can have adverse effects, although not everyone experiences them.

Some adverse effects may be serious

Allergic reactions such as skin inflammation, swelling of the face and mouth, low blood pressure, and difficulty breathing.

If you experience any of these, remove the patch immediately and contact your doctor without delay.

Some adverse effects are very common (affect more than 1 in 10 patients):
Reactions at the application site such as itching, redness, oedema (swelling), and burning sensation (on the area of skin where the Nicotinell transdermal patch has been applied). If you develop a severe skin reaction that does not resolve, you should stop treatment and consult your doctor or pharmacist to find an alternative nicotine replacement therapy to help you quit smoking.

These reactions are often caused by failure to change the application site daily. Changing the application site daily will allow skin irritation to resolve naturally, causing only mild discomfort.

Sleep disturbances including insomnia and abnormal dreams. Headache, nausea, dizziness, malaise, vomiting.

Some adverse effects are common (affect between 1 and 10 in 100 patients):
Palpitations (awareness of heartbeats), breathing difficulty, nervousness, tremors, malaise, stomach pain, diarrhoea, sore throat, cough, dry mouth, fatigue or weakness, constipation, joint and muscle pain.

These effects are often mild and will usually resolve quickly and naturally once the patch has been removed.

Some adverse effects are uncommon (affect between 1 and 10 in 1,000 patients):
Rapid heartbeat, general malaise.

Some adverse effects are rare (affect between 1 and 10 in 10,000 patients):
Irregular heartbeats.

Some adverse effects are very rare (affect fewer than 1 in 10,000 patients):
Tremors, increased skin sensitivity to sunlight.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. STORAGE OF NICOTINELL TRANSDERMAL PATCH

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the foil and packaging following "EXP". The expiry date refers to the last day of the month indicated.

• Do not store above 25°C

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Nicotinell transdermal patch:

• The active substance is nicotine. Each transdermal patch contains 17.5 mg of nicotine in a 10 cm² patch, which delivers a nominal amount of 7 mg of nicotine over 24 hours.
• The other components (excipients) are: Butyl methacrylate basic copolymer (Eudragit E100), aluminum-coated polyester film, acrylate-vinyl acetate copolymer (Duro Tak 387-2516), medium-chain triglycerides (Miglyol), 26 g/m² paper, silicone-coated aluminum polyester film, brown ink.

Appearance of Nicotinell transdermal patch and contents of the pack:

Nicotinell 7 mg/24 h: yellowish-brown round transdermal patch (10 cm² in size, marked CWC), sealed in a protective pouch.

Nicotinell 7 mg/24 h is available in packs of: 7, 14, 21 and 28 patches. Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Dr. Reddy’s Netherlands B.V.

Claude Debussylaan 10

1082 MD Amsterdam

The Netherlands

Manufacturer

LTS Lohmann Therapie-Systeme AG

Lohmannstrasse 2

56626 Andernach

Germany

or

Haleon - Gebro Consumer Health GmbH

Bahnhofbichl 13

6391 Fieberbrunn

Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona (Spain)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Nicotinell TTS Depot-Pflaster 10 (7 mg/24 h)

Belgium Nicotinell 7 mg/24 h, pleister voor transdermaal gebruik

Spain Nicotinell 7 mg/24 hours transdermal patch

Greece Nicotinell TTS® NCH

Luxembourg Nicotinell 7 mg/24 h, dispositif transdermique

Netherlands Nicotinell 7 mg/24 h, pleister voor transdermaal gebruik

Portugal Nicotinell 7 mg/24 hours

This leaflet was approved in May 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es