Nicotinell TTS 14 mg/24 H, Transdermal Device Box Of 28

Box Please read this leaflet carefully before using this medicine. It contains important information for your treatment. If you have any further questions or in doubt, ask your doctor or pharmacist for more information. · Keep this notice, you may need to read it again. · If you need more information and advice, ask your pharmacist. · If symptoms worsen or persist, consult your doctor. · If you notice any side effects not listed in this leaflet, or if you experience any of the side effects listed as serious, please inform your doctor or pharmacist.

Summary notice

In this leaflet: 1. WHAT IS NICOTINELL TTS 14 mg/24 H, transdermal patch AND IN WHAT CASES IS IT USED? 2. WHAT INFORMATION SHOULD YOU KNOW BEFORE USING NICOTINELL TTS 14 mg/24 H, transdermal patch? 3. HOW TO USE NICOTINELL TTS 14 mg/24 H, transdermal patch? 4. WHAT ARE THE POSSIBLE SIDE EFFECTS? 5. HOW TO STORE NICOTINELL TTS 14 mg/24 H, transdermal patch? 6. ADDITIONAL INFORMATION

1. WHAT IS NICOTINELL TTS 14 mg/24 H, transdermal patch AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic class DRUGS USED IN NICOTINE DEPENDENCE.

Therapeutic indications

This medication is indicated in the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects wishing to stop their tobacco consumption.

2. WHAT INFORMATION SHOULD YOU KNOW BEFORE USING NICOTINELL TTS 14 mg/24 H, transdermal patch?

List of information necessary before taking the medication Not applicable. Contraindications Never use NICOTINELL TTS 14 mg/24 h, transdermal patch · if you do not smoke or if you are an occasional smoker, · if you are allergic (hypersensitive) to nicotine or to one of the components contained in this medicine, mentioned in section 6. · in the event of a skin condition which may interfere with the use of a transdermal system. If in doubt, do not hesitate to seek the advice of your doctor or pharmacist. Precautions for use; special warningsIn order to successfully quit smoking, completely stopping smoking is essential. Read the health education tips carefully. Take care with NICOTINELL TTS 14 mg/24 h, transdermal patch Warnings You must consult a doctor before using NICOTINELL TTS 14 mg/24 h, transdermal patch in case of recent myocardial infarction (heart attack), unstable or worsening angina including Prinzmetal's angina, severe heart rhythm disorder, uncontrolled high blood pressure, recent stroke. You must seek the advice of your doctor or a healthcare professional before using NICOTINELL TTS, transdermal patch:

· in the event of stable cardiovascular disease, severe high blood pressure or heart failure, · in the event of cerebrovascular disorder or arteritis of the lower limbs, · in case of diabetes, · in case of hyperthyroidism or pheochromocytoma (adrenal gland disease leading to severe high blood pressure), · in case of severe liver and kidney disease, · in the event of an evolving stomach or duodenal ulcer, · in the event of a skin condition. The therapeutic dose intended for adults could cause serious or even fatal poisoning in children. This is why you should always keep the transdermal patch before and after use, out of the reach and sight of children. After use, it is recommended to fold the transdermal patch on itself before disposing of it. IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR PHARMACIST. Interactions with other medicines Other medicines and NICOTINELL TTS 14 mg/24 h, transdermal patch: Inform your doctor or pharmacist if you are using, have recently used or might use any other medicine. Interactions with food and drinks Not applicable. Interactions with phytotherapy products or alternative therapies Not applicable.

Use during pregnancy and breastfeeding Pregnancy  It is very important to stop smoking during your pregnancy for you and your child. Stopping smoking during pregnancy requires medical advice and monitoring. You must therefore consult the doctor who is following your pregnancy or your usual doctor or even a doctor in a center specializing in smoking cessation. Breastfeeding If you smoke a lot and you are not planning to quit smoking, you should not breastfeed your child, but resort to artificial breastfeeding. The use of this medication is not recommended during breastfeeding. However, if you want to stop smoking and breastfeed your child, seek advice from your doctor or a doctor at a center specializing in smoking cessation. Athletes Not applicable. Effects on the ability to drive or use machines Not applicable.

List of excipients with known effects

Important information about the ingredients of Nicotinell TTS 14 mg/24 h, transdermal patch The NICOTINELL TTS transdermal patch contains aluminum. Therefore, you must remove it before any MRI (magnetic resonance imaging) examination.

3. HOW TO USE NICOTINELL TTS 14 mg/24 H, transdermal patch?

Instructions for proper use Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage Reserved for adults and adolescents over 15 years old. Three sizes of transdermal devices are available: 10, 20 and 30 cm2 corresponding to 3 different dosages: 7, 14 and 21 mg/24 hours. Your degree of nicotine dependence will be assessed by the Fagerström test (see Health education tips) or by the number of cigarettes consumed per day. It will allow you to choose the dosage that meets your needs. The dose will need to be increased if you experience “withdrawal” symptoms. It should be reduced if you experience signs of overdose: reread the chapter on precautions for use and do not hesitate to ask your pharmacist for advice. NICOTINELL TTS, transdermal patch can be used alone or in combination with the oral forms NICOTINELL 1 mg lozenge or NICOTINELL 2 mg, chewing gum. In the event of a combination, it is advisable to seek medical advice. · Treatment with NICOTINELL TTS, transdermal patch alone: ​​The treatment takes place in 3 periods: · Initial period: it lasts 3 to 4 weeks and will allow you to stop smoking. · Monitoring of treatment: this period consolidates the cessation of smoking and begins nicotine withdrawal · Therapeutic withdrawal: this period should allow you to stop the treatment. The entire treatment lasts on average 3 months. The duration of treatment may, however, vary depending on individual response. The total duration of treatment should not exceed 6 months. Initial phase 3 to 4 weeks Follow-up treatment 3 to 4 weeks Treatment withdrawal 3 to 4 weeks Score of 5 or more on the Fargerström test or Smokers of 20 or more cigarettes per day NICOTINELL TTS 21 mg/24 hours NICOTINELL TTS 14 mg/24 hours or NICOTINELL TTS 21 mg/24 h * NICOTINELL TTS 7 mg/24 hours or NICOTINELL TTS 14 mg/24 h then NICOTINELL TTS 7 mg/24 h * Score less than 5 on the Fagerström test or Smokers of less than 20 cigarettes per day NICOTINELL TTS 14 mg/24 hours or increase to NICOTINELL TTS 21 mg/24 hours * NICOTINELL TTS 14 mg/24 hours or NICOTINELL TTS 7 mg/24 hours ** NICOTINELL TTS 7 mg/24 hours or discontinuation of treatment ** *Depending on results on withdrawal symptoms. **In case of satisfactory results. · Treatment with NICOTINELL TTS, transdermal patch in combination with NICOTINELL 1 mg lozenge or NICOTINELL 2 mg, medicated chewing gum If your treatment with NICOTINELL TTS transdermal patch has failed, you can use it in combination with NICOTINELL 1 mg tablet. suck or NICOTINELL 2 mg, medicated chewing gum. Note: Read the instructions for NICOTINELL 1 mg lozenge or NICOTINELL 2 mg chewing gum before use. In order to increase your chances of quitting smoking, it is advisable to stop smoking completely when you start taking these lozenges or chewing gums in combination with NICOTINELL TTS, transdermal patch, and this for the entire duration. of treatment. Initial treatment: Start treatment with a transdermal patch of 21 mg / 24 hours in combination with NICOTINELL 1 mg, lozenge or NICOTINELL 2 mg, chewing gum. Use at least 4 lozenges (1 mg) or chewing gum (2 mg) per day. In most cases, 5 to 6 tablets or chewing gums per day are sufficient. Do not use more than 15 1 mg lozenges or 2 mg chewing gums per day. Under normal circumstances, treatment should not last more than 6 to 12 weeks. Thereafter, you must reduce the dose of nicotine gradually. Reducing the nicotine dose after the initial 6 to 12 weeks: This can be done in 2 ways. Option 1: Use of transdermal patches at a lower dose i.e. NICOTINELL TTS 14 mg/24 hours, transdermal patch for 3-6 weeks followed by NICOTINELL TTS 7 mg/24 hours, transdermal patch for again 3 to 6 weeks without reducing the number of gums or tablets. Then, the number of tablets or chewing gum should be reduced gradually. It is generally not recommended to use NICOTINELL 1 mg, lozenge or NICOTINELL 2 mg, chewing gum for more than 6 months. However, some ex-smokers may need treatment for a longer period of time to prevent them from resuming smoking, but this should not exceed more than 9 months.

Option 2: Stop using transdermal patches and gradually reduce the number of tablets or chewing gums. It is generally not recommended to use NICOTINELL 1 mg, lozenge or NICOTINELL 2 mg chewing gum for more than 6 months. However, some ex-smokers may need longer treatment to prevent them from returning to smoking. This treatment should not exceed 9 months. Recommended dosage: Period Transdermal patches 1 mg lozenge or 2 mg chewing gum Initial treatment (followed by option 1 or 2 below) First 6 to 12 weeks 1 patch 21 mg / 24 hours If necessary, 5 to 6 tablets or gummies daily are recommended. Reduction of nicotine dose – option 1 First 3 to 6 weeks 1 device 14 mg / 24 hours Continue using tablets or chewing gum if necessary. Next 3 to 6 weeks 1 device 7 mg / 24 hours Continue to use tablets or chewing gum if necessary. Up to 9 months in total --- Gradually reduce the number of tablets or gums. Reduction of nicotine dose – option 2 Up to 9 months in total --- Gradually reduce the number of tablets or gums. If you continue to use lozenges or chewing gums and transdermal patches after 9 months, it is advisable to consult a doctor or pharmacist.

Method of administration

TRANSDERMAL USE · Open the sachet using a pair of scissors and remove the transdermal device. · Remove the pre-cut removable protective sheet. · Apply NICOTINELL TTS immediately after opening to a surface of dry skin, without skin lesions and where hair growth is rare: trunk, upper part of the arm, etc. · To ensure perfect adhesion, press firmly over the entire surface for approximately 10 seconds with the Palm of the hand. · The device must remain in place for 24 hours. · The application site should be changed every day, avoiding if possible replacing the device in the same place for a few days. · It is essential to fold the device on itself after use before throwing it away in a safe place. · Any device used or not must be kept out of the reach of children. · During handling, avoid contact with eyes and nose and wash hands after application. · Do not cut the transdermal patch. · In the event of prolonged sea or swimming pool bathing, you have 2 options: o before bathing, remove the transdermal patch and immediately place it back on its support. It can be glued back onto well-dried skin. o cover the transdermal patch with a waterproof adhesive dressing for the duration of the bath. · In the event of a short shower, the transdermal patch can be kept in place by avoiding directing the shower jet onto it.

Treatment duration

For complete cessation of smoking: The duration of use is limited to 6 months. If the feeling of withdrawal persists or if you have difficulty stopping this medication, consult your doctor. Symptoms and instructions in case of overdose If you use more NICOTINELL TTS 14 mg/24 H, transdermal patch than you should: In case of accidental overdose or if a child has sucked or A transdermal patch is applied. CONTACT A DOCTOR OR EMERGENCY SERVICE. Severe poisoning can occur and is manifested by hypotension, weak and irregular pulse, difficulty breathing, prostration, cardiovascular collapse and convulsions. Instructions for missing one or more doses Not applicable. Risk of withdrawal syndrome Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects Like all medicines, this medicine can cause side effects, but they do not occur systematically in everyone. Some side effects can be serious5. HOW TO STORE NICOTINELL TTS 14 mg/24 H, transdermal patch?

Keep out of the reach and sight of children. Expiry date Do not use NICOTINELL TTS 14 mg/24 H, transdermal patch after the expiry date mentioned on the box. Storage conditions Store at a temperature below 25°C, only in closed bags. If necessary, warnings against certain visible signs of deterioration Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active substances and excipients What does NICOTINELL TTS 14 mg/24 H, transdermal patch contain? The active substance is: S(-)

-Nicotine ............................................. .................................................. ................................... 35 mg The other ingredients are: Alkaline methacrylate copolymer (EUDRAGIT E100 ), polyester film, Durotak 387-2516, miglyol 812, 26 g/m2 paper, silicone aluminized polyester film Dosage form and contents What is NICOTINELL TTS 7 mg/24 H, transdermal patch and contents of the pack ? This medication comes in the form of a transdermal patch. Holder GLAXOSMITHKLINE SANTE GRAND PUBLIC 100 ROUTE DE VERSAILLES CS 80001 78164 MARLY-LE-ROI CEDEX Operator GLAXOSMITHKLINE SANTE GRAND PUBLIC 100 ROUTE DE VERSAILLES CS 80001 78164 MARLY-LE-ROI CEDEX Manufacturer FAMAR FRANCE 1, AVENUE DU CHAMP S DE MARS 45072 ORLEANS CEDEX or NOVARTIS PHARMA S.A.S. 26, RUE DE LA CHAPELLE 68330 HUNINGUE or FAMAR S.A. AVLON PLANT 48TH KM NATIONAL ROAD ATHENS-LAMIA 19011 AVLONA ATTIKI GREECE Names of the medicine in the member states of the European Economic Area Not applicable. Notice Approval Date The last date this notice was approved is {date}. Marketing authorization under exceptional circumstances Not applicable. Internet information Detailed information on this medicine is available on the Afssaps (France) website. Information reserved for healthcare professionals Not applicable.

Other ADVICE / HEALTH EDUCATION Quitting smoking as soon as possible has immediate health benefits. It is never too late to quit smoking even if you have smoked for a long time and a lot. As soon as you stop smoking: · You will no longer absorb the irritating and toxic substances from cigarettes, · You will be able to notice certain improvements: gradual disappearance of headaches, cough, throat irritation, shortness of breath , · You will often have the satisfaction of finding better sleep, the taste of food, the smells and of improving your physical performance, · You will reduce your risks of developing lung cancer or cardiovascular disease. Furthermore, in heart or arterial diseases (angina, arteritis of the lower limbs, etc.), it is particularly imperative to successfully quit smoking. What is tobacco dependence? Tobacco dependence is twofold: · Psychological dependence: Smoking a cigarette leads to a ritual of automatic and repetitive gestures associated with particular circumstances (pleasure, response to stress, intellectual stimulation, moral support, need for a gesture of conviviality). This is psychological and behavioral dependence. · Physical dependence: The body's need for nicotine is due to the effects of this substance on the nervous system. This is physical dependence. Failure to satisfy this need leads to a feeling of lack