NICORETTESKIN 25MG/16H patch

3400939651002

Nicorette : patch Nicorette, gum Nicorette - Anti-tabac Nicorette : patch Nicorette, gum Nicorette - Anti-tabac

NICORETTESKIN PATCHES 25MG 16H TRANSDERMALLY DEVICE: This medicine is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in patients who want to quit their tobacco use.

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Partners with: KIT FOR HOMEOPATHIC STOP SMOKING TOBACCO Boiron, Nicorette GUM 4MG MENTE FRESH SUGAR 105, Nicorette 210 2MG GUM SUGAR FREE, BAUDOUX PREPARATION STOP TOBACCO ESSENTIAL OILS 10ml, Nicorette 4MG 105 FRUIT GUM SUGAR FREE

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NICORETTESKIN PATCHES 25MG 16H TRANSDERMAL DEVICE

For warnings, precautions for use and against-indications, please refer to the user manual.

Description NICORETTESKIN PATCHES 25MG 16H TRANSDERMAL DEVICE

This drug is indicated for the treatment of tobacco dependence in order to alleviate the symptoms of nicotine withdrawal in patients who wish to stop their tobacco use.
Nicoretteskin transdermal patches 25mg / 16h nicotine (step 1) is recommended for smokers strongly to strongly dependent.

For adults only (over 15 years)
Composition NICORETTESKIN PATCHES 25MG 16H TRANSDERMAL DEVICE:

  • To September 1 cm2 device: 15,75mg nicotine
  • Excipients: medium chain triglycerides, basic copolymer of butyl methacrylate, polyethylene terephthalate film (PET). matrix acrylate: acrylic copolymer adhesive solution, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate. release liner: polyethylene terephthalate film (PET) aluminized on one side and silicone on 2 sides.

For highly dependent smokers:

  • Step 1: 25mg / 16h:   One patch per day for 8 weeks
  • Step 2: 15mg / 16h:   One patch per day for 2 weeks
  • Step 3: 10mg / 16h   : 1 patch per day for 2 weeks

For weakly dependent smokers:

  • Start with step 2
  • Step 2: 15mg / 16h:   One patch per day for 8 weeks
  • Step 3: 10mg / 16h:   One patch per day for 4 weeks

The patch should be applied on a healthy part of the skin in the morning at sunrise, and removed at bedtime, about 16 hours later.
The application site should be changed every day, avoiding, if possible, to put the patch in the same place for several days.
transdermal

Deficiencies in vitamin C and vitamin E among tobacco smokers

Smoking causes a deficiency of vitamin C (ascorbic acid) and vitamin E (tocopherol).
Vitamin E and vitamin C are antioxidants, capable of neutralizing in our body the free radicals produced during inflammatory processes (smoking, cancer, Alzheimer disease). In fact, free radicals generated by tobacco smoke gradually destroys cellular membranes.
The vitamin E (tocopherol) acts synergistically with vitamin C, which is why the intake of vitamin C significantly reduced vitamin E deficiency observed in tobacco smokers.
Tobacco smokers always are deficient in vitamin E and vitamin C, it is for these reasons we recommend the food supplements rich in vitamin C (Acerola) and bioavailable vitamin E natural

Conditinnement:   box 7 transdermal patches, or box 28 transdermal patches

Warnings about medications

Attention, the drug is not a product like any other. Read the package leaflet before ordering. Do not let drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug

VIDAL OF THE FAMILY

NICORETTESKIN

Medication for smoking cessation

nicotine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

NICORETTESKIN 10 mg / 16 h: transdermal device ; box of 28 of 9 cm2.
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NICORETTESKIN 15 mg / 16 h: transdermal device ; box of 7 of 13.5 cm2.
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NICORETTESKIN 15 mg / 16 h: transdermal device ; box of 13.5 cm2.
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NICORETTESKIN 25 mg / 16 h: transdermal device ; box of 7 of 22.5 cm2.
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NICORETTESKIN 25 mg / 16 h: transdermal device ; box of 22.5 cm2.
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Laboratory

COMPOSITION (summary)
p 9 cm2 p 13.5 cm2 p 22.5 cm2
Nicotine released / 4 pm 10 mg 15 mg 25 mg

INDICATIONS (summary)
This medication helps smokers detoxify tobacco. The transdermal device (patch) contains nicotine, the main active substance in tobacco; it passes through the skin, gains blood and acts on the nervous system, thus allowing the smoker not to feel the symptoms due to smoking cessation.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • non-smoker or occasional smoker,
  • extensive skin disease that does not allow the patch to stick.
WARNING (Contents)
With a view to definitive detoxification, cessation of smoking is a necessary condition for successful treatment.
Do not use other medicines containing nicotine, such as chewing gums, without medical advice.
Precautions are necessary in case of stomach or duodenal ulcer , renal or hepatic insufficiency : in these situations, a prior medical consultation is essential before using this medication and a cessation of tobacco without substitute treatment may be necessary. be necessary.
Do not leave the new or used stamp within the reach of children: unintentional application can cause serious accidents. Fold the stamp before discarding.
DRUG INTERACTIONS (summary)
The products contained in tobacco smoke can accelerate the rate of elimination of certain drugs, especially theophylline. When smoking cessation, these drugs can see their effect strengthened and signs of overdose may appear. Contact your doctor in case of any doubt.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
Tobacco use in pregnant women may cause fetal growth retardation. Stopping tobacco is always desirable. In women who are highly dependent on nicotine, the use of this medication may be an aid, but the effects of nicotine alone on the fetus are poorly understood. This drug has the advantage of not exposing the fetus to other toxic substances present in tobacco smoke. In summary: if the ideal is not to smoke and not to expose the fetus to nicotine intake, the use of this drug is a lesser evil compared to tobacco.

Breastfeeding:
Nicotine passes into breast milk, and breast-feeding is not recommended during treatment.
DIRECTIONS FOR USE AND DOSAGE (summary)
There are 3 dosages corresponding to 3 different patch surfaces: the amount of nicotine passing through the blood is proportional to the surface area of the patch .
The strongest dosage is for large smokers or nicotine-rich cigarette smokers; a high dependence on nicotine may also lead moderate smokers to prefer strong dosage.
In practice, it is useful to know the signs of under or overdose to adapt the choice of dosage after 1 or 2 days of treatment:
  • the overdose results in the condition of the smoker who has smoked too much and is mainly reflected in a nauseous condition and headaches. Difficulty in sight or hearing, trembling, dizziness are also possible;
  • an under-dosage causes symptoms of lack: irritability, nervousness, stomach cramps (kind of painful hunger), difficulty concentrating.
Once the weaning has been achieved, it is advisable to switch to a less dosed patch after a period of 8 weeks and then to stop after using the lowest dosage.
Put the patch on a dry area, low in hairs, and free from skin lesions. Release the adhesive surface and carefully apply the patch by pressing the entire surface. Change location every day.
Remember to wash hands after application and avoid contact with eyes or nose.

Usual dosage:

  • Adult: the patch is placed in the morning after the toilet and taken off at bedtime; do not use more than one stamp per day.
Keeping the patch at night helps to fight the symptoms of lack at the rising. Nevertheless, the night port can cause sleep disturbances. Therefore, it is preferable to remove the patch at bedtime.
It is recommended not to exceed 12 months of continuous treatment.
This medication may be used alone or in combination with 2 mg gums or NICORET inhaler . In this case, follow the recommendations of your doctor.
TIPS (summary)
Nicotine taken by way skin to replace the cigarette has the same cardiovascular harmful than that in tobacco. Only the risk of lung cancer disappears. When smoking cessation is motivated by urgent medical reasons: recent infarction , arteritis , gastritis or ulcer , it is preferable to stop the absorption of nicotine in all its forms.
Like all smoke-free methods used to help smokers, this drug can only be effective when the will to quit is personal and accompanied by strong motivation. It is this motivation that will make it possible to fight against the desire to smoke, without being forced to make constant appeal to the will that dulls over time. A cessation of lasting tobacco in the smoker assumes that the smoker considers tobacco to be a poison, an unacceptable addiction. It must be done to the idea that it will never smoke, from the beginning of weaning. Every day without tobacco must be experienced as a release, not as a calvary. The smoker who is in this state of mind is a good candidate for definitive weaning.
Stopping smoking, which is a real drug, causes many problems: weight gain is frequent, concentration disorders can last several weeks. A mild depressive condition is possible. Weight gain should be countered by a diet, and if possible by a sports program that has the advantage of reconciling the smoker with his body. Do not hesitate to consult your doctor in case of difficulty; his advice and experience will be invaluable in the fight against relapses.
This medication can be used by smokers without medical advice. It is available without a prescription and can be accessed directly in certain pharmacies. Nevertheless, do not hesitate to have your choice chosen by your pharmacist. His advice is precious. He can help you determine the best time to quit and explain the causes of failure.
If prescribed by a doctor on a prescription devoted exclusively to nicotinic substitutes, this medicinal product can be taken over by the Health Insurance up to 150 euros per year.
POSSIBLE ADVERSE EFFECTS (summary)
Local reactions: redness and itching at the level of the application, which may necessitate stopping the treatment in the event of a significant reaction.
Also: palpitations , headaches, insomnia, dizziness , dreams, nausea, vomiting.


GLOSSARY (summary)


arteritis
Arterial disease favored by smoking and most often localized to the legs. It is characterized by a thickening of the arterial walls which interferes with blood circulation and causes pain during walking (intermittent claudication). Lower limb arteritis increases the risk of myocardial infarction and requires medication. At an advanced stage, it can be treated surgically.
Synonym: Occlusive arteriopathy of the lower limbs.


addiction
Psychic or physical need caused by taking certain natural or medicinal substances. This condition may be accompanied, at cessation of the catch, by various symptoms, grouped under the term of withdrawal syndrome.


transdermal device
System, sometimes called patch or patch, allowing the absorption of a drug through the skin: it ensures the diffusion of the active substance to the blood vessels of the dermis. The substance then circulates in the blood and can act as if it had been swallowed or injected. This device avoids the first-pass effect of the liver.


duodenum
A part of the intestine into which food from the stomach penetrates.


depressed state
State of moral suffering associating a demotivation, a fatigue, a feeling of uselessness, of self-depreciation. In the absence of treatment, the depressive state may develop into a serious depression with a feeling of incurability, guilt, and a suicidal risk.


gastritis
Inflammation of the stomach favored by stress, tobacco, alcohol and certain drugs such as aspirin or anti-inflammatory drugs.


hepatic
Inflammation of the liver. It may be due to a drug, a virus, alcohol or some other cause.
Viral hepatitis usually heals without treatment. Unlike hepatitis A and E almost always benign, hepatitis B and C can become chronic: the virus persists in the patient's body which remains contagious but does not necessarily suffer from liver problems. Chronic hepatitis is said to be active when the virus continues to destroy liver cells, resulting in increased transaminases in the blood.


infarct
Destruction of part of the cardiac muscle (myocardium), deprived of blood by obstruction of its arteries.


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


palpitations
Abnormal perception of irregular heartbeat.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).


dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Updated on: 02/05/2017

Description of the Medicine

NICORETTESKIN 25 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 25 mg / 16 hours, transdermal patch and in which cases is it used?

2. What information should be known before using NICORETTESKIN 25 mg / 16 hours, transdermal patch?

3. How to use NICORETTESKIN 25 mg / 16 hours, transdermal patch?

4. What are the possible undesirable effects?

5. How to store NICORETTESKIN 25 mg / 16 hours, transdermal patch?

6. Contents of the package and other information.

1. WHAT NICORETTESKIN 25 mg / 16 hours, transdermal patch AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: MEDICINAL PRODUCTS USED IN NICOTINE DEPENDENCE - ATC code: N07BA01

NICORETTESKIN 25 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 25 mg / 16 hours, transdermal patch?

Never use NICORETTESKIN 25 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 25 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 25 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 25 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 25 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 25 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.

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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 NICORETTESKIN 25 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 25 mg / 16 hours, transdermal patch

Not applicable.

If you stop using NICORETTESKIN 25 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 25 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 25 mg / 16 hours, transdermal patch

AT· The active substance is :

Nicotine................................................. .................................................. ..................... 39.37 mg

For a transdermal device of 22.5 cm 2 .

A transdermal device 25 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 25 mg / 16 hours, transdermal patch 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.

Get all Nicorette products to help you stop smoking: Nicorette patch, Nicorette gum, inhaler

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All smokers know, quitting smoking is not an easy task! The lack of nicotine leads to withdrawal syndrome which causes irritability, anxiety, sadness. For a stress-free withdrawal, you will find here the suitable products for stop smoking: patch, gum, lozenges, tablets, inhleur and homeopathy anti tobacco ... We are available via chat, do not hesitate to Contact to get personalized advice.

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