NOTICE
ANSM - Updated: 02/05/2017
Name of the drug
NICORETTESKIN 15 mg / 16 hours, transdermal patch
Nicotine
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is NICORETTESKIN 15 mg / 16 hours, transdermal patch and when is it used?
2. What you need to know before using NICORETTESKIN 15 mg / 16 hours, transdermal patch?
3. How to use NICORETTESKIN 15 mg / 16 hours, transdermal patch?
4. What are the possible side effects?
5. How to store NICORETTESKIN 15 mg / 16 hours, transdermal patch?
6. Contents of the package and other information.
1. WHAT NICORETTESKIN 15 mg / 16 hours transdermal patch AND WHAT IT IS USED FOR
Pharmacotherapeutic group: DRUGS USED IN NICOTINE DEPENDENCE - ATC code: N07BA01
NICORETTESKIN 15 mg / 16 hours, transdermal patch belongs to the range of drugs intended to help you quit smoking.
This medication is indicated for the treatment of smoking addiction to relieve the symptoms of nicotine withdrawal in subjects who wish to quit smoking.
2. BEFORE YOU USE NICORETTESKIN 15 mg / 16 hours, transdermal patch?
Never use NICORETTESKIN 15 mg / 16 hours, transdermal patch:
· if you are allergic to nicotine or any of the other ingredients of this medicine, listed in section 6.
· if you do not smoke or if you are an occasional smoker,
· if you have a skin condition that may interfere with the use of a transdermal system.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST
Warnings and precautions
Talk to your doctor or pharmacist before using NICORETTESKIN 15 mg / 16 hours, transdermal patch.
In order to successfully quit smoking, complete cessation of smoking is essential.
Read the health education tips carefully.
Some diseases require medical examination and follow-up before using this medicine.
Thus, it is essential to consult your doctor before using this medicine if you present:
· recent history (< 3 months) of heart attack or stroke,
· chest pain (unstable angina pectoris), or stable angina,
· a heart problem affecting your heart rate or rhythm,
· high blood pressure that is not controlled by medication,
· a history of allergic reactions such as swelling of the lips, face and throat (Quincke's edema) or rash associated with itching (hives). Sometimes the use of a TRN triggers this type of reaction,
· severe or moderate hepatic impairment,
· severe kidney failure,
· diabetes,
· hyperthyroidism,
· a tumor of the adrenal gland (pheochromocytoma),
· an evolving stomach or duodenum ulcer,
· a chronic condition of the throat,
· asthma.
It is essential to consult your doctor before using this medicine.
It is imperative to keep the transdermal patch out of the reach of children before and after use.
In fact, the therapeutic dose intended for adults could cause serious intoxication or even death in children.
Some signs reflect an underdose. If you feel, despite the treatment, a feeling of "lack" such as :
· craving to smoke,
· irritability, sleep disorders,
· agitation or impatience,
· difficulty concentrating.
Consult your doctor or your pharmacist. Indeed, it may be necessary to change the dosage of the drug.
Some signs may reflect an overdose . In case of signs of overdose, such as :
· nausea, abdominal pain, diarrhea,
· hypersalivation,
· sweating, headache, dizziness, hearing loss,
· general weakness.
It is imperative to adjust the treatment with the help of your doctor or pharmacist.
In case of combination of NICORETTESKIN transdermal patch with oral forms of nicotine substitutes such as NICORETTE 2 Medicated Chewing Gum mg, the inhaler NICORETTE 10 mg, sucking tablets NICORETTE 2 mg, sublingual tablets NICORETTE MICROTAB 2 mg or NICORETTESPRAY 1 mg / dose, oral spray solution, refer to the package leaflet for each of these medicines for warnings and precautions for use.
IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Children and adolescents
Not applicable.
Other medicines and NICORETTESKIN 15 mg / 16 hours, 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 that contain clozapine (an antipsychotic), methadone (an opioid substitution treatment), ropinirole (a treatment for Parkinson's disease) or theophylline (used in treatment of asthma).
NICORETTESKIN 15 mg / 16 hours, transdermal patch with food and drinks
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
It is important to stop smoking during your pregnancy as this can slow down the growth of your baby. It can also lead to premature birth or late fetal death. It is advisable to stop smoking without using drugs containing nicotine.
If you are unable to stop smoking without Nicotine Replacement Therapy, NICORETTESKIN can be used after consulting the health care professional following your pregnancy, your family doctor, or a doctor from a specialist care center. wishing to stop smoking.
feeding
If you smoke a lot and do not plan to stop smoking, you should not breastfeed but use artificial feeding. The use of this medication is not recommended during breastfeeding as nicotine passes into breast milk and may affect your child.
However, if you want to stop smoking and breastfeeding, consult your doctor or a doctor at a smoking cessation center.
Driving and using machines
NICORETTESKIN 15 mg / 16 transdermal patch has no effect or negligible effect on the ability to drive and use machines.
3. HOW TO USE NICORETTESKIN 15 mg / 16 hours, transdermal patch?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
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 transdermal patch should be applied to a healthy part of the skin in the morning at dawn, and removed at bedtime by h later. The treatment mimics the fluctuations of nicotine during the day in the smoker, without administration of nicotine at night. Daytime nicotine administration by the transdermal patch does not cause sleep disturbances seen during overnight nicotine administration.
· It is recommended for heavily dependent smokers (Fagerström test score ≥ 7) to start with the transdermal patch 25 mg / 16 hours. A transdermal patch will be applied daily in the morning and removed at night for 8 weeks.
· Dose reduction is then initiated. A transdermal patch of 15 mg / 16 hours is used daily for 2 weeks and then a transdermal patch 10 mg / 16 hours during also 2 weeks.
· It is recommended for moderately addicted smokers (Fagerström test score 5 and 6), to start with step 2 with the transdermal patch 15 mg / 16 hours.
o If smoking cessation is obtained the first week with dosing 15 mg / 16 hours, a transdermal patch will be applied daily in the morning and removed in the evening, for 8 weeks then a transdermal patch of 10 mg / 16 hours will be applied during 4 weeks.
o If after 1-7 days of use of the patch 15 mg / 16 hours, the signs of lack persist, it is recommended to use a transdermal patch 25 mg / 16 hours and continue treatment according to the pattern of highly dependent patients (see "highly dependent smokers").
· It is recommended that low-dose smokers (Fagerström test score 3 and 4) start with step 2 with the transdermal patch. mg / 16 hours applied daily for 8 weeks and continue with a transdermal patch 10 mg / 16 hours applied during 4 weeks.
Smokers strongly to weakly dependent
Highly dependent smokers | Moderately addicted smokers | Slightly dependent smokers |
(Fagerström test ≥ 7) | (Fagerström test 5 - 6) | (Fagerström test 3-4) |
Transdermal patch | duration | Transdermal patch | duration | Transdermal patch | duration |
Step 1 | NICORETTESKIN 25 mg / 16 hours | First 8 weeks | | | | | | |
2nd step | NICORETTESKIN 15 mg / 16 hours | 2 next weeks | 2nd step | NICORETTESKIN 15 mg / 16 hours | First 8 weeks (NB: if smoking persists or if there is a high consumption of oral forms of substitutes, refer to stage 1 of the "highly dependent smoking" scheme from the first week) | 2nd step | NICORETTESKIN 15 mg / 16 hours | First 8 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 entire treatment should last at least 3 month.
The duration of the treatment may however vary depending on the individual response.
It is recommended not to use transdermal patches beyond 6 month. Some "ex-smokers" may, however, require a longer duration of treatment to avoid relapse.
If during your treatment, you continue to feel irrepressible cravings for smoking or if your treatment has failed, ASK YOUR DOCTOR OR PHARMACIST.
He may advise you to associate the NICORETTESKIN transdermal devices with oral forms of substitution (medicinal chewing gums NICORETTE 2 mg, inhaler NICORETTE 10 mg, sucking tablets NICORETTE 2 mg sublingual tablets NICORETTE MICROTAB 2 mg or NICORETTESPRAY 1 mg / dose, oral spray solution).
In case of combination of NICORETTESKIN with an oral substitution form, the dosage to follow is the same as when these drugs are used alone in monotherapy. For the dosage of the oral form, consult the package leaflet of the chosen drug.
In case of association, use only one oral form at a time over a period of 24 hours.
Administration mode
· Wash your hands before applying the transdermal patch.
· Open the bag with a pair of scissors and take out the patch.
· Apply the patch immediately after opening on a dry skin surface, without skin lesions and where hair is scarce (hip, upper arm or chest).
· 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.
· Apply the sticky part with your fingers and remove the remaining part of aluminum foil.
· Press the transdermal patch firmly on the skin with your fingers.
· Rub firmly with your fingers on the edges so that the patch sticks properly.
· The patch should be applied in the morning and removed at bedtime, approximately 16 hours later.
· The application site should be changed daily avoiding, if possible, replacing the patch at the same place for a few days.
· It is essential to fold the transdermal patch on itself after use before disposing of it in a safe place.
· Any transdermal patch used or not should be kept out of the reach of children.
· During handling, avoid contact with eyes, nose and wash hands after application.
· Do not cut the transdermal patch.
· In case of sea bath or extended pool, you have 2 possibilities :
o Before bathing, remove the patch and replace immediately on its support. It can be glued on a well dried skin.
o Cover the transdermal patch with a waterproof adhesive bandage for the duration of the bath.
· In the case of a short shower, the transdermal patch can be held in place by avoiding directing the shower jet over it.
Duration of treatment
The duration of use is limited to 6 months . |
If you continue to feel lightheaded or if you have difficulty stopping this medicine, consult your doctor.
If you have used more NICORETTESKIN 15 mg / 16 hours, transdermal patch that you should have
Immediately consult your doctor or pharmacist.
In case of accidental overdose or if a child has sucked or has applied a transdermal patch CONTACT A PHYSICIAN OR EMERGENCY SERVICE.
Severe intoxication may occur and may include hypotension, weak and irregular pulse, difficulty breathing, prostration, cardiovascular collapse and seizures.
If you forget to use NICORETTESKIN 15 mg / 16 hours, transdermal patch
Not applicable.
If you stop using NICORETTESKIN 15 mg / 16 hours, transdermal patch
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: affects more than 10 users in 100
- itching (pruritus).
Frequent: affects 1 to 10 users in 100
- rashes and hives,
- nausea and vomiting,
- digestive disorders,
- redness of the skin,
- headache,
- dizziness.
Uncommon: affects 1 to 10 users in 1000
- palpitations (unusual feeling to your heartbeat), or rapid heartbeat (tachycardia),
- abnormal dreams,
- excessive sweating, hot flashes,
- fatigue, malaise, pain / discomfort in the chest, difficult breathing (dyspnea),
- reaction to the application site,
- allergic reactions,
- hypertension,
- pain in the muscles,
- tingling sensation that can spread around the application site.
Very rare: affects less than 1 user in 10,000
- Heart rhythm disorders.
Not known: can not be estimated from the available data
- pain / discomfort in the belly,
- allergic reaction including swelling of the face and mouth (Quincke's edema).
Dizziness, headaches, sleep disturbances, mouth sores may be related to stopping smoking and not to your treatment.
In case of combination of the NICORETTESKIN transdermal patch with the oral forms of nicotine substitutes NICORETTE (Medicated chewing gums NICORETTE 2 mg, the inhaler NICORETTE 10 mg, sucking tablets NICORETTE 2 mg, sublingual tablets NICORETTE MICROTAB 2 mg or NICORETTESPRAY 1 mg / dose, oral spray solution), refer to the package leaflet for each of these medicines.
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr .
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE NICORETTESKIN 15 mg / 16 hours, transdermal patch?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of this month.
Store at a temperature not exceeding 25 ° C.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What NICORETTESKIN contains 15 mg / 16 hours, transdermal patch
· The active substance is :
Nicotine................................................. .................................................. .................... 23.62 mg
For a transdermal patch of 13.5 cm 2 .
A transdermal device delivers 15 nicotine mg during 16 hours.
· The other components are:
Medium chain triglycerides, basic butyl methacrylate copolymer, film of polyethylene terephthalate (PET).
Acrylate matrix
Adhesive solution of acrylic copolymer, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate.
Detachable protective sheet
Polyethylene terephthalate (PET) film aluminized on one side and silicone on both sides.
Each transdermal patch is packaged in a heat sealed laminated dose bag made of paper, PET film, nitrile acrylic copolymer and aluminum.
What NICORETTESKIN 15 mg / 16 hours, transdermal patch and contents of the pack
Transdermal patch (box of 7, 14 or 28).
Semi-transparent, beige transdermal device consisting of an outer layer, a nicotine source layer, an adhesive layer and an aluminized and silicone release liner.
Not all presentations may be marketed.
Marketing Authorization Holder
JOHNSON & JOHNSON HEALTH BEAUTY FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Operator of the marketing authorization
JOHNSON & JOHNSON HEALTH BEAUTY FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
LTS LOHMANN THERAPY-AG SYSTEM (LTS)
LOHMANNSTR. 2
56626 ANDERNACH
GERMANY
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Tips:
Stopping smoking as soon as possible leads to immediate health benefits. It's never too late to quit even if you have smoked a long time and a lot . |
As soon as you stop smoking:
· You will no longer absorb the irritating and toxic substances of cigarettes,
· You will see some improvements: progressive disappearance of headaches, cough, irritation of the throat, shortness of breath,
· You will often have the satisfaction of getting better sleep, flavor of food, smells and improving your physical performance,
· You will reduce your risk of developing lung cancer or cardiovascular disease.
Moreover, in heart or arterial diseases (angina pectoris, arteritis of the lower limbs ...), it is particularly imperative to successfully quit smoking.
What is smoking addiction?
Tobacco addiction is twofold:
· Psychological dependence :
Smoking a cigarette entails a ritual of automatic and repetitive gestures associated with particular circumstances (pleasure, stress response, intellectual stimulation, support for morale, need for the gesture of conviviality). It is about psychological and behavioral dependence.
· Physical dependence :
The body's need for nicotine is due to the effects of this substance on the nervous system. It's about physical dependence. The non-satisfaction of this need leads to a feeling of lack (see description in the chapter " How to overcome your physical dependence ?").
Nicotine substitutes aim to treat this dependence.
How to overcome your psychological dependence?
· Complete smoking cessation 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 arrest attempt be made at the same time by both spouses.
· Notify your family and coworkers that you are quitting. Ask them to respect your decision (do not smoke near you, do not offer cigarettes).
· Prepare to deal with the desire to smoke. It can occur abruptly and intensely especially during the first few weeks after stopping smoking, but does not last more than 3 or 4 minutes.
You must anticipate what you will do in this case and act very quickly not to "crack" like for example:
o drink a big glass of water,
o to chew gum,
o count to 100,
o make some deep breaths,
o leave the room,
o change of activity ...
· Avoid situations associated with taking cigarettes (coffee, aperitif, ...), avoid temptations (settle with non-smokers).
· Find compensation for cigarettes (leisure, sport, cultural activity ...).
How to overcome your physical dependence?
If you are addicted to nicotine, the success of your approach may require the use of nicotine substitutes.
To assess your level of dependence, the Fagerström test is offered.
TEST OF FAGERSTROM
How long after you wake up do you smoke your first cigarette? | |
· within 5 minutes: 3 | |
· from 6 to 30 minutes: 2 | |
· from 31 to 60 minutes: 1 | |
· after 60 minutes: 0 | |
Do you find it difficult not to smoke in places where it is forbidden? | |
· yes: 1 | |
· No: 0 | |
Which cigarette of the day would it be the hardest to give up? | |
· the first: 1 | |
· another: 0 | |
How many cigarettes do you smoke a day? | |
· 10 or less: 0 | |
· 11 to 20: 1 | |
· 21 to 30: 2 | |
· 31 or more: 3 | |
Do you smoke at a faster pace in the morning than in the afternoon? | |
· yes: 1 | |
· No: 0 | |
Do you smoke when you are so sick that you have to stay in bed almost all day? | |
· yes: 1 | |
· No: 0 | |
TOTAL POINTS | |
score from 0 to 2 : you are not addicted to nicotine.
You can stop smoking without the need for a nicotine replacement.
However, if you are not sure, consult your pharmacist or doctor.
score of 3 to 4 : you are weakly dependent on nicotine.
score of 5 to 6 You are moderately addicted to nicotine.
The use of nicotine substitutes will increase your chances of success.
Take advice from your pharmacist or doctor to help you choose the most appropriate treatment for you.
score of 7 to 10 : you are highly or very strongly addicted to nicotine.
The use of nicotine replacement is recommended to help you overcome this addiction to nicotine. This treatment must be used in sufficient and appropriate doses.
Take advice from your pharmacist or doctor, possibly as part of a specialized consultation to help with smoking cessation.
Withdrawal disorders can persist for a long time and the duration of treatment should be sufficient, usually one to three months.
If you feel, despite the treatment, a feeling of persistent "lack" such as :
· craving to smoke,
· irritability, sleep disorders,
· agitation or impatience,
· difficulty concentrating,
Take advice from your doctor or pharmacist as dose adjustment may be necessary.
How to help you?
· The support of health professionals
The accompaniment, the advice, the follow-up that can bring you your doctor or your pharmacist will be precious during the first six months of your stop of the tobacco. You can also use a specialized smoking cessation counseling, especially if you have already failed.
· Psychological support
Quitting 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 you.
· Dietetics
In the months after stopping smoking, you may experience moderate weight gain.
If you have concerns in this area, you can contact a health professional who will advise you.
You started smoking again, why?
Consider this relapse as an accident of course, as a normal event that can learn: the relapse is not a failure.
Analyze why you started smoking again.
· Because of physical dependence
This may have been poorly taken into account or may reappear after several months, for example, prolonged stays in smoky atmospheres.
· Due to excessive weight gain
It may be necessary to change your eating habits a little before your next quit attempt.
· Because of a decrease in motivation , because of a painful event or a difficult period, because of psychological difficulties appeared at the stop of the tobacco (depression, anxiety ...), 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 seek advice from a health professional or to resort to a specialized consultation of help with smoking cessation.
If you have started smoking again, do not be discouraged, experience shows that your chances of success increase after one or more stopping attempts. |