NOTICE
ANSM - Updated on: 02/05/2017
Description of the Medicine
NICORETTESKIN 10 mg / 16 hours, transdermal patch
Nicotine
© framed
Please read this leaflet carefully before you start using this medication as it contains important information for you.
You should always use this medication carefully following the information provided in this leaflet or by your doctor, or your pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· You should talk to your doctor if you feel uncomfortable or feel uncomfortable.
What is in this leaflet?
1. What is NICORETTESKIN 10 mg / 16 hours, transdermal patch and in which cases is it used?
2. What information should be known before using NICORETTESKIN 10 mg / 16 hours, transdermal patch?
3. How to use NICORETTESKIN 10 mg / 16 hours, transdermal patch?
4. What are the possible undesirable effects?
5. How to store NICORETTESKIN 10 mg / 16 hours, transdermal patch?
6. Contents of the package and other information.
1. WHAT NICORETTESKIN 10 mg / 16 hours, transdermal patch AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: MEDICINAL PRODUCTS USED IN NICOTINE DEPENDENCE - ATC code: N07BA01
NICORETTESKIN 10 mg / 16 hours, transdermal patch belongs to the range of medications designed to help you quit smoking.
This medication is indicated in the treatment of tobacco dependence to relieve the symptoms of nicotine withdrawal in subjects wishing to stop smoking.
2. BEFORE YOU BEGIN TO USE NICORETTESKIN 10 mg / 16 hours, transdermal patch?
Never use NICORETTESKIN 10 mg / 16 hours, transdermal patch:
AT· if you are allergic to nicotine or any of the other ingredients of this medication mentioned in section 6.
AT· if you do not smoke or if you are an occasional smoker,
AT· if you suffer from a skin condition that can hinder the use of a transdermal system.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Warnings and Precautions
Talk to your doctor or pharmacist before using NICORETTESKIN 10 mg / 16 hours, transdermal patch.
In order to succeed in quitting smoking, the complete cessation of smoking is essential.
Read health care advice carefully.
Some diseases require examination and medical follow-up before using this medication.
Thus, it is essential to consult your doctor before using this medication if you present:
AT· of recent past (< 3 month) of heart attack or stroke,
AT· chest pain (unstable angina pectoris), or stable angina pectoris,
AT· a heart condition affecting your heart rate or heart rate,
AT· an arterial hypertension that is not controlled by the medications,
AT· a history of allergic reactions manifested by swelling of the lips, face and throat (Angioedema) or associated cutaneous eruptions (urticaria). Sometimes the use of a NRT triggers this type of response,
AT· severe or moderate hepatic impairment,
AT· severe renal insufficiency,
AT· a diabetes,
AT· hyperthyroidism,
AT· a tumor of the surgical gland (phaeochromocytoma),
AT· an ulcer of the stomach or duodenum in evolution,
AT· a chronic condition of the throat,
AT· of asthma.
It is essential to consult your doctor before using this medication.
It is imperative to keep the transdermal patch out of the reach of children before and after use.
Indeed, the therapeutic dose intended for the adult could cause serious poisoning or even death in the child.
Some signs indicate an under-dosage. If you feel, despite treatment, a feeling of "lack" such as :
AT· need to smoke,
AT· irritability, sleep disturbances,
AT· agitation or impatience,
AT· difficulty of concentration.
Consult your doctor or pharmacist. It may be necessary to change the dosage of the medication.
Some signs may indicate overdose . In the event of signs of overdose, such as :
AT· nausea, abdominal pain, diarrhea,
AT· hypersalivation,
AT· sweating, headache, dizziness, hearing loss,
AT· general weakness.
It is imperative to adapt the treatment with the advice of your doctor or pharmacist.
If the NICORETTESKIN transdermal patch is combined with the oral forms of nicotine replacement drugs such as NICORETTE 2 mg, inhaler NICORETTE 10 mg, tablets to suck NICORETTE 2 mg, sublingual tablets NICORETTE MICROTAB 2 mg or NICORETTESPRAY 1 mg / dose, oral spraying solution, refer to the package leaflet for each of these medications for warnings and precautions for use.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Children and Youth
Not applicable.
Other medicines and NICORETTESKIN 10 mg / 16 hours, transdermal patch
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines. This is especially important if you are taking medicines that contain clozapine (an antipsychotic), methadone (an opiate substitution treatment), ropinirole (a treatment for Parkinson's disease) or theophylline (used in the treatment of asthma).
NICORETTESKIN 10 mg / 16 hours, transdermal patch with food and beverages
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
Pregnancy
It is important to stop smoking during your pregnancy as this can slow down the growth of your baby. This may also result in premature delivery or late fetal deaths. It is advisable to stop smoking without using medicines containing nicotine.
If you are unable to stop smoking without nicotine replacement therapy, NICORETTESKIN may be used after consulting the health care professional who follows your pregnancy, your family doctor, or a doctor, a center specializing in helping people who want to quit smoking.
feeding
If you smoke a lot and do not plan to stop smoking, you should not breastfeed your child, but use artificial breastfeeding. The use of this medication is disliked during breastfeeding as nicotine passes into breast milk and can affect your child.
However, if you want to stop smoking and breastfeed your child, take the advice of your doctor or a doctor at a specialty smoking cessation center.
Driving and using machines
NICORETTESKIN 10 mg / 16 hours, transdermal patch has no effect or negligible effect on the ability to drive vehicles and use machines.
3. HOW TO USE NICORETTESKIN 10 mg / 16 hours, transdermal patch?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Reserved for adults and children over 15 years.
Dosage
Three sizes of transdermal devices are available: 9; 13.5; 22.5 cm 2 , corresponding to 3 different dosages: 10 mg / 16 hours, 15 mg / 16 hours, 25 mg / 16 hours .
The patch should be applied to a healthy part of the skin in the morning at sunrise, and removed at bedtime, about 16 h later. The treatment mimics the fluctuations of nicotine during the day in the smoker, without nicotine administration at night. The administration of nicotine on the day by the transdermal device does not cause the sleep disorders observed during a nicotine administration overnight.
AT· It is recommended for highly dependent smokers (Fagerström test score) 7) to start with the transdermal device 25 mg / 16 hours. A transdermal patch will be applied daily in the morning and withdrawn in the evening for 8 weeks.
AT· A dose reduction is then initiated. A transdermal device of 15 mg / 16 hours is used daily for 2 weeks, followed by a transdermal device mg / 16 hours also 2 weeks.
AT· It is recommended for moderately dependent smokers (Fagerström test score 5 and 6), starting with step 2 with the transdermal patch 15 mg / 16 hours.
o If stopping of tobacco is obtained the first week with dosage 15 mg / 16 hours, a transdermal patch will be applied daily in the morning and withdrawn in the evening for 8 weeks and then a transdermal device of 10 mg / 16 hours will be applied for 4 weeks.
o If after 1-7 days of use of the patch 15 mg / 16 hours, signs of lack persist, it is recommended to use a transdermal device mg / 16 hours and continue treatment according to the pattern of heavily dependent patients (see "Highly Dependent Smokers").
AT· It is recommended for low-level smokers (Fagerström test score 3 and 4) to start with Step 2 with the patch 15 mg / 16 hours applied daily for 8 weeks and to continue with a transdermal device 10 mg / 16 hours applied for 4 weeks.
Heavily to Dependent Smokers
Heavily Dependent Smokers | Medium-sized smokers | Low-Dependent Smokers |
(Fagerström test â ‰ ¥ 7) | (Fagerström test 5 - 6) | (Fagerström test 3-4) |
Transdermal device | Duration © e | Transdermal device | Duration © e | Transdermal device | Duration © e |
Step 1 | NICORETTESKIN 25 mg / 16 hours | 8 first weeks | | | | | | |
2nd step | NICORETTESKIN 15 mg / 16 hours | 2 weeks later | 2nd step | NICORETTESKIN 15 mg / 16 hours | 8 first weeks (NB: if smoking persists or if there is a high consumption of oral forms of substitutes, refer to the first week at step 1 of the " highly dependent smokers ") | 2nd step | NICORETTESKIN 15 mg / 16 hours | 8 first weeks |
Step 3 | NICORETTESKIN 10 mg / 16 hours | Last 2 weeks | Step 3 | NICORETTESKIN 10 mg / 16 hours | Next 4 weeks | Step 3 | NICORETTESKIN 10 mg / 16 hours | Next 4 weeks |
The whole treatment must last at least 3 month.
However, the duration of treatment may vary depending on the individual response.
It is recommended not to use transdermal devices beyond 6 month. Some "ex-smokers" may however require a longer treatment time to avoid relapse.
If you continue to experience irreversible cravings for treatment or if your treatment has failed, ask your physician or pharmacist for advice.
He may advise you to associate NICORETTESKIN transdermal patches with alternative oral forms (NICORETTE 2 Medicated Chewing Gums mg, inhaler NICORETTE 10 mg, sucking tablets NICORETTE 2 mg, sublingual tablets NICORETTE MICROTAB 2 mg or NICORETTESPRAY 1 mg / dose, buccal spraying solution).
If NICORETTESKIN is combined with an oral form of substitution, the dosage to be followed is the same as when these medicines are used alone in monotherapy. For the dosage of the oral form, consult the package leaflet.
In case of association, use only one oral form at a time in a period of 24 hours.
Administration mode
AT· Wash your hands before applying the patch.
AT· Open the sachet using a pair of scissors and remove the patch.
AT· Apply the patch immediately after opening on a surface of dry skin, without skin lesions and where the hair is rare (hip, upper arm or chest).
AT· Remove as much of the aluminum foil as possible. Avoid as much as possible touching the sticky surface of the transdermal patch with your fingers.
AT· Apply the sticky part with your fingers and remove the remaining part of aluminum foil.
AT· Press the transdermal patch firmly on the skin with your fingers.
AT· Rub firmly with your fingers on the edges for the transdermal patch to stick properly.
AT· The patch should be applied in the morning and removed at bedtime, approximately 16 hours later.
AT· The site of application should be changed every day by avoiding if possible to put the transdermal device at the same place for a few days.
AT· It is essential to fold the patch on itself after use before throwing it in a safe place.
AT· Any transdermal device used or not must be kept out of the reach of children.
AT· During handling, avoid contact with eyes, nose and hand washing after application.
AT· Do not cut the patch.
AT· In case of sea bath or extended swimming pool, you have 2 possibilities :
o Before bathing, remove the patch and place it back on its support. It can be glued to a dry skin.
o Cover the transdermal patch with a waterproof adhesive dressing for the duration of the bath.
AT· In case of short shower, the patch can be held in place by avoiding directing the shower spray on it.
Duration of treatment
The duration of use is limited to 6 months . |
In case of persistent feeling of lack or in case of difficulty to stop this medication, consult your doctor.
If you used more than NICORETTESKIN 10 mg / 16 hours, transdermal patch that you should not have
Immediately consult your doctor or pharmacist.
In case of accidental overdose or if a child has sucked or applied a transdermal device CONTACT A DOCTOR OR AN EMERGENCY SERVICE.
Severe intoxication may occur and may include hypotension, weak and irregular pulse, respiratory distress, prostration, cardiovascular collapse and convulsions.
If you forget to use NICORETTESKIN 10 mg / 16 hours, transdermal patch
Not applicable.
If you stop using NICORETTESKIN 10 mg / 16 hours, transdermal patch
Not applicable.
If you have any further questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
Very common: Affects more than 10 users out of 100
- (pruritus).
Frequency: affects 1 to 10 users out of 100
- Eruptions and urticaria,
- nausea and vomiting,
- digestive disorders,
- redness of the skin,
- headaches,
- Ã © dizziness.
Uncommon: affects 1 to 10 users in 1000
- palpitations (sensation unusual to your heartbeat), or fast heart rate (tachycardia),
- abnormal dreams,
- excessive sweating, hot flushes,
- fatigue, discomfort, pain / discomfort in the chest, difficult breathing (dyspnea),
- response to the application site,
- allergic reactions,
- hypertension,
- pain in the muscles,
- sensation of tingling that can spread around the site of application.
Very rare: affects less than 1 user in 10,000
- Heart rhythm disorders.
Undetermined Frequency: Can not be estimated on the basis of available data
- pain / stomach in the stomach,
- allergic reaction including swelling of the face and mouth (Angioedema).
Headaches, headaches, sleep disorders, mouth ulcers may be related to stopping smoking and not to your treatment.
If the NICORETTESKIN transdermal patch is combined with the oral forms of nicotinic substitutes NICORETTE (NICORETTE 2 medicated chewing gum mg, the NICORETTE 10 inhaler mg, tablets to suck NICORETTE 2 mg, sublingual tablets NICORETTE MICROTAB 2 mg or NICORETTESPRAY 1 mg / dose, buccal spraying solution), refer to the package leaflet for each of these medicines.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr .
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE NICORETTESKIN 10 mg / 16 hours, transdermal patch?
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date stated on the carton and sachet. The redemption date refers to the last day of that month.
Keep at a temperature not exceeding 25 ° C.
Do not throw any medicines into the sewer or with the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What NICORETTESKIN contains 10 mg / 16 hours, transdermal patch
AT· The active substance is :
Nicotine................................................. .................................................. .................... 15.75 mg
For a transdermal device of 9 cm 2 .
A transdermal device 10 mg nicotine for 16 hours.
AT· The other components are:
Medium chain triglycerides, basic copolymer of butyl methacrylate, film of polyethylene terephthalate (PET).
Acrylate Matrix
Adhesive solution of acrylic copolymer, potassium hydroxide, croscarmellose sodium, acetylacetonate of aluminum.
Detachable protective sheet
Polyethylene terephthalate film (PET) aluminized on one side and silicone on both sides.
Each transdermal patch is packaged in a heat-sealed laminated pouch consisting of paper, PET film, acrylic nitrile copolymer and aluminum.
What is NICORETTESKIN 10 mg / 16 hours, transdermal device and contents of the outer packaging
Transdermal device (box of 7, 14 or 28).
A semi-transparent, beige transdermal device consisting of an outer layer, a nicotine source layer, an adhesive layer and a siliconized and aluminized removable protective sheet.
Not all presentations may be marketed.
Holder of the marketing authorization
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Operator of the marketing authorization
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
LTS LOHMANN THERAPY-SYSTEME AG (LTS)
LOHMANNSTR. 2
56626 ANDERNACH
GERMANY
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last date on which this notice was revised is as follows:
[To be subsequently completed by the Contractor]
Other
Detailed information on this medicinal product is available on the website of the ANSM (France).
Advice on health education:
Stopping smoking as soon as possible results in immediate health benefits. It's never too late to quit smoking even if you smoke a long time and a lot . |
As soon as you stop smoking:
AT· You will no longer absorb the irritating and toxic substances of the cigarette,
AT· You will notice some improvements: progressive disappearance of the headaches, the cough, the irritation of the throat, the shortness of breath,
AT· You will often have the satisfaction of getting better sleep, food flavor, odors and improve your physical performance,
AT· You will reduce your risk of developing lung cancer or cardiovascular disease.
Moreover, in cardiac or arterial diseases (angina pectoris, arteritis of the lower limbs ...), it is especially imperative to succeed in quitting smoking.
What is tobacco dependence?
Dependence on tobacco is twofold:
AT· Psychological dependence :
Smoking a cigarette involves a ritual of automatic and rehearsal gestures associated with particular circumstances (pleasure, response to stress, intellectual stimulation, support for morale, need for a gesture of conviviality). This is psychological and behavioral dependence.
AT· Physical Dependency :
The need for the nicotine body is due to the effects of this substance on the nervous system. It is physical dependence. Failure to satisfy this need results in a sense of lack (see description in the chapter " How to overcome your physical dependency ?").
Nicotinic substitutes are intended to treat this dependence.
How to overcome your psychological dependency?
AT· The complete cessation of tobacco is necessary to increase your chances of success, but more:
o Choose a day J in the period that seems most favorable to you.
o Throw away your last pack of cigarettes, your lighter and put away your ashtrays.
o In a couple of smokers, it is preferable that the attempt to stop is made at the same time by both spouses.
AT· Keep your family and colleagues working as you quit smoking. Ask them to respect your decision (do not smoke near you, stop offering you cigarettes).
AT· Prepare to cope with the desire to smoke. It can occur abruptly and in an intense manner especially during the first few weeks after the cessation of smoking, but does not last more than 3 or 4 minutes.
You have to predict what you will do in this case and act very quickly so as not to "crack" as for example:
o drink a large glass of water,
o chewing gum,
o counting up to 100,
o do some deep breaths,
o out of the room,
o change of activity ...
AT· Avoid situations associated with taking cigarettes (coffee, aperitif, ...), avoid temptations (settle with non-smokers).
AT· Find cigarette compensation (leisure, sport, cultural activity ...).
How to overcome your physical dependency?
If you are addicted to nicotine, the success of your procedure may require the use of nicotine replacements.
In order to assess your level of dependency, the Fagerström test is offered.
FAGERSTROM TEST
How long after your waking do you smoke your first cigarette? | |
AT· within 5 minutes: 3 | |
AT· from 6 to 30 minutes: 2 | |
AT· from 31 to 60 minutes: 1 | |
AT· after 60 minutes: 0 | |
Do you find it difficult to not smoke in places where it is forbidden? | |
AT· yes: 1 | |
AT· no: 0 | |
What cigarette of the day would you be the hardest to give up? | |
AT· the first: 1 | |
AT· another: 0 | |
How many cigarettes do you smoke per day? | |
AT· 10 or less: 0 | |
AT· 11 to 20: 1 | |
AT· 21 to 30: 2 | |
AT· 31 or more: 3 | |
Do you smoke at a more sustained pace in the morning than in the afternoon? | |
AT· yes: 1 | |
AT· no: 0 | |
Do you smoke when you're so sick that you have to stay in bed almost all day? | |
AT· yes: 1 | |
AT· no: 0 | |
TOTAL POINTS | |
score from 0 to 2 : you do not have to nicotine.
You can quit smoking without the need for nicotine replacement.
However, if you are concerned about this decision, consult your pharmacist or doctor.
score of 3 to 4 : you are weakly dependent on nicotine.
score from 5 to 6 : you are moderately dependent on nicotine.
The use of nicotine substitutes will increase your chances of success.
Consult with your pharmacist or doctor to help you choose the treatment best suited for you.
score of 7 to 10 : you are strongly or very strongly dependent on nicotine.
The use of nicotine substitutes is recommended to help you overcome this addiction to nicotine. This treatment should be used in sufficient and appropriate dosage.
Consult with your pharmacist or physician, if necessary, as part of a specialized smoking cessation consultation.
Weaning-related disorders may persist for a long time and the duration of treatment should be sufficient, usually from one to three months.
If you feel, despite the treatment, a feeling of persistent "lack" :
AT· need to smoke,
AT· irritability, sleep disturbances,
AT· agitation or impatience,
AT· difficulty of concentration,
Take the advice of your doctor or pharmacist as a dose adjustment may be required.
How do you get help?
AT· Support from health professionals
The support, advice, follow-up that your doctor or pharmacist can give you will be valuable during the first six months of your cessation of smoking. You can also use a special smoking cessation counseling service, especially if you have already been unsuccessful.
AT· Psychological support
Stopping smoking requires a supportive family and social environment. If you are concerned that the difficulties are too great, psychological support or temporary treatment can help.
AT· The diet
In the months following tobacco smoking, you may experience moderate weight gain.
If you have any concerns in this area, you can contact a health professional who will be able to advise you.
You started smoking again, why?
Consider this relapse as an accident of course, as a normal event that lets you learn: the relapse is not a failure.
Analyze the reasons why you took back the tobacco.
AT· Because of physical dependence
This may have been poorly taken into account or reappeared after several months, occasionally, for example, from prolonged periods of time in smoky atmospheres.
AT· Because of excessive weight gain
It may be necessary to change your diet somewhat before your next attempt to stop smoking.
AT· Due to a decline in motivation , due to a painful event or a difficult period, due to psychological difficulties arising from the cessation of smoking (depression, anxiety t ...), because of a very tempting situation. Understand the reason for this relapse to prevent it if possible during your next attempt.
In all cases, do not hesitate to ask for advice from a health professional or to have a special consultation for smoking cessation help.
If you have started smoking again, do not be discouraged, experience shows that your chances of success increase after one or more attempts to quit. |