Nicopatch 21mg 24H 7 PATCHES

Nicopatch 21mg 24H 7 PATCHES View larger

3400938380637

Pierre Fabre Pierre Fabre

Nicopatch 21mg 24H 7 PATCHES: Nicopatch box of 7 patches in 21mg of nicotine per 24 hours is recommended for the treatment of tobacco dependence.

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Partners with: KIT FOR HOMEOPATHIC STOP SMOKING TOBACCO Boiron, Nicopass 2.5 MG TABLETS WITHOUT SUGAR MINT 36, Nicopass 2.5mg nicotine MINT TABLETS 96 for smoking cessation, BAUDOUX PREPARATION STOP TOBACCO ESSENTIAL OILS 10ml, Homeogum Zen Attitude Sublingual Lozenge Box 40g

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Nicopatch 21mg 24H 7 PATCHES


Nicopatch 21mg 24H 7 PATCHES


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

Description Nicopatch 21mg 24H 7 PATCHES

Nicopatch box of 7 patches in 21mg of nicotine per 24 hours is recommended for the treatment of tobacco dependence. This medication is indicated for the treatment of tobacco dependence in smokers over 20 cigarettes per day, to relieve the symptoms of nicotine withdrawal in patients who want to quit their tobacco use.

For adults over 15 years

Composition Nicopatch 21mg 24H 7 PATCHES


  • 52,5mg nicotine patch for 30 cm². A transdermal device delivers 21 mg of nicotine per 24 hours.
  • Excipients: alkaline methacrylates copolymer (Eudragit E 100). Outer shell: aluminized polyester film. Matrix layer: Duro-Tak 387-2516, miglyol 812, Eudragit E 100. nonwoven Support: paper 26 g / m2. Adhesive layer: Duro-Tak 387-2516, miglyol 812. removable protective sheet: aluminized polyester film silicone.


Nicopatch 21mg dosage 24H 7 PATCHES

  • Patch 1 by 24 hours

It is recommended to use the device after opening on a surface of dry skin without skin lesion, and where the hair is rare (scapula, hip, outer arm ...). The application site should be different from the previous site

Cons-indications Nicopatch 21mg 24H 7 PATCHES


  • Non-smoker or occasional smoker.
  • Hypersensitivity to any component.
  • Skin condition that may interfere with the use of a patch.


Transdermally

Read carefully the instructions

Packaging:  
box of 7 patches

Warnings on drugs

Please note, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your products in.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a field of customized message provided for that purpose.

Click here to find record of this drug on the website of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related side effect (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

Nicopatch

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)

NICOPATCH 7 mg / 24 h: transdermal device of 10 cm2; box of 7.
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NICOPATCH 7 mg / 24 h: transdermal device of 10 cm2; box of 28.
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NICOPATCH 14 mg / 24 h: transdermal patch 20 cm2; box of 7.
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NICOPATCH 14 mg / 24 h: transdermal patch 20 cm2; box of 28.
-

NICOPATCH 21 mg / 24 h: transdermal device 30 cm2; box of 7.
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NICOPATCH 21 mg / 24 h: transdermal device 30 cm2; box of 28.
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Laboratory Pierre Fabre Medicine

COMPOSITION (summary)
p 10 cm 2 p 20 cm2 p 30 cm2
Nicotine released / 24 h 7 mg 14 mg 21 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.
It is used exclusively in nicotine-dependent smokers, that is, who swallow the smoke and can not do without smoking for more than a few hours.
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, prior medical consultation is essential before using this medication and a cessation of smoking without alternative treatment may be necessary.
Nicotine is a toxic substance. 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 :
Smoking 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 weaning is achieved, a shorter patch should be changed after a period of 3 to 4 weeks and then stopped after use of the lowest dosage.
Apply the patch to a dry, low-haired area with no skin lesions. Release the adhesive surface and carefully apply the patch by pressing the entire surface. Change location every day.

Usual dosage:

  • Adult: the stamp is placed in the morning after the toilet. It should normally be kept until the next day.
It is recommended not to exceed 6 months of continuous treatment.
TIPS (summary)
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.
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. the weight gain should be controlled 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.
Keeping the patch at night helps to fight the symptoms of lack at the rising. Nevertheless, the night port can cause sleep disturbances. In this case, it may be preferable to remove the patch at bedtime.
Remember to wash hands after application and avoid contact with eyes or nose.
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 sense 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.


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


hepatic
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


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 - Last updated: 23/03/2017

Name of the medicinal product

NICOPATCH 21 mg / 24 h, transdermal patch

Nicotine

framed

Please read this leaflet carefully and especially the health education tips you find at the end before using this medication as it contains important information for you.

You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

Do not use this medication for children.

What is in this leaflet?

1. What is NICOPATCH 21 mg / 24 h, transdermal patch and in which cases it is used?

2. What should I know before using NICOPATCH 21 mg / 24 h, transdermal patch?

3. How to use NICOPATCH 21 mg / 24 h, transdermal patch?

4. What are the possible side effects?

5. How to store NICOPATCH 21 mg / 24 h, transdermal patch?

6. Package contents and other information.

1. WHAT IS NICOPATCH 21 mg / 24 h, transdermal patch AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: MEDICINAL PRODUCTS USED IN NICOTINE DEPENDENCE

ATC code: N07BA01

Reserved for adults and adolescents over 15 years of age.

This drug is used in nicotine addiction.

This drug is indicated for the treatment of tobacco dependence in order to alleviate symptoms of nicotine withdrawal in subjects wishing to stop smoking

Tailored management improves the chances of success in stopping smoking.

Read the health education tips carefully at the end of this leaflet.

You should contact your doctor if you do not feel the urge to smoke after 6 months of treatment with this medication if you do not feel better or feel less well.

2. BEFORE YOU USE NICOPATCH 21 mg / 24 h, transdermal patch?

NEVER use NICOPATCH 21 mg / 24 h, transdermal patch:

· if you do not smoke or if you are an occasional smoker,

· if you are allergic to nicotine or any of the constituents,

· if you have a skin condition that can interfere with the use of a transdermal system.

If in doubt, it is essential to seek the advice of your doctor or pharmacist

Warnings and Precautions

In order to succeed in quitting smoking, complete cessation of smoking is essential.

Read health education tips carefully.

· You should consult a physician prior to use of NICOPATCH, a transdermal patch in case of recent myocardial infarction (heart attack), unstable angina or worsening including Prinzmetal angina, severe heart rhythm disorder, uncontrolled hypertension controlled, recent stroke.

· Some diseases require examination and medical follow-up before using this medication. Thus, in the case of:

o stable cardiovascular disease, severe arterial hypertension or heart failure,

o cerebral vascular disorder or arteritis of the lower limbs,

o of diabetes,

o hyperthyroidism or pheochromocytoma (disease of the adrenal glands causing severe hypertension),

o severe liver and kidney disease,

o stomach ulcer or evolving duodenum,

it is essential to consult your doctor before using this medication.

· Some signs indicate an under-dosage. If you feel, despite the treatment, a feeling of "lack" like in particular:

o compelling need to smoke,

o irritability, sleep disturbances,

o agitation or impatience,

o difficulty of concentration,

Consult your doctor or pharmacist. Indeed, it may be necessary to modify the dosage of the drug.

· Some signs may reflect an overdose: if there are signs of overdose, ie:

o nausea, abdominal pain, diarrhea,

o hypersalivation,

o sweating, headache, dizziness, hearing loss,

o general weakness,

it is imperative to adapt the treatment with the advice of your doctor or pharmacist.

If combined with another nicotine replacement, it is recommended to seek medical advice.

In case of doubt do not hesitate to seek the advice of your doctor or pharmacist

children

It is imperative to keep the transdermal device out of the reach of children before and after use.

Indeed, the therapeutic dose intended for the adult could cause in the child a very serious poisoning or even lethal.

After use, it is recommended to fold the patch on itself before discarding.

Other medicines and NICOPATCH 21 mg / 24 h, transdermal patch

Stopping smoking, with or without this medication, may affect the action of certain other medicines taken at the same time.

Dose adjustments by your doctor may be necessary if you are taking the following medications:

- treatment of asthma (theophylline),

- treatment of schizophrenia (clozapine),

- treatment of Parkinson's disease (ropinirole),

- treatment of diabetes (insulin),

- substitution treatment for opioid dependence (methadone).

- treatment of angina pectoris (nifedipine)

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

NICOPATCH 21 mg / 24 h, 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 for advice or pharmacist before taking this medication.

Pregnancy

It is very important to quit smoking during your pregnancy as this can harm your baby. Besides a low birth weight, smoking can also cause premature birth or the birth of a stillborn baby.

The ideal would be to quit smoking without using medication. If this does not work, this medication may be recommended to help you because the risk to your baby is much lower than the risk of smoking. Nicotine, whatever its form, can harm your unborn child.

Therefore, this medication should only be used after consulting the healthcare professional who is following your pregnancy, or your general practitioner, or a doctor at a smoking cessation center.

feeding

This medication as well as smoking during breastfeeding should be avoided because nicotine passes into breast milk which can harm your child.

If you have not been able to stop smoking and are breastfeeding, it is best to use nicotine pellets or other oral forms rather than patches. Nicopatch can only be used during breast-feeding if advised by your doctor.

Sport

Not applicable.

Driving and using machines

This medicinal product has no known effect on the ability to drive and use machines when used at the recommended dosage.

NICOPATCH 21 mg / 24 h, transdermal patch contains aluminum:

Therefore, the patch must be removed before performing an MRI (Magnetic Resonance Imaging).

3. HOW TO USE NICOPATCH 21 mg / 24 h, transdermal patch?

Dosage

Reserved for adults and adolescents over 15 years of age.

NICOPATCH should not be used in smokers under 18 years of age without recommendation from a health care professional. Three patch sizes are available: 10, 20 and 30 cm² corresponding to three 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 fits your need.

The dose should be increased if you experience symptoms of "lack". It should be decreased if you experience signs of overdose: read the chapter on precautions for use and do not hesitate to ask your pharmacist for advice.

The treatment takes place in 3 periods :

· Initial period : it lasts from 3 to 4 weeks and will allow you to get quit smoking.

· Follow-up of treatment : this period consolidates the cessation of smoking and begins nicotine withdrawal

· Therapeutic Withdrawal : This period should allow you to stop treatment.

The total treatment lasts on average 3 months

However, the duration of treatment may vary depending on the individual response.

The total duration of treatment should not exceed 6 months.

Initial stage

3 to 4 weeks

Treatment follow-up

3 to 4 weeks

Therapeutic withdrawal

3 to 4 weeks

Score of 5 or more on the Fagerström test

or

Smokers of 20 or more cigarettes per day

NICOPATCH 21 mg / 24 h

NICOPATCH 14 mg / 24 h

or

NICOPATCH 21 mg / 24 hr *

NICOPATCH 7 mg / 24 h

or

NICOPATCH 14 mg / 24 h

then

NICOPATCH 7 mg / 24 hr *

Score below 5 in Fagerström test

or

Smokers under 20 cigarettes a day

NICOPATCH 14 mg / 24 h

or

increase to NICOPATCH 21 mg / 24 h *

NICOPATCH 7 mg / 24 h **

or

NICOPATCH 14mg / 24 h

cessation of treatment **

or

NICOPATCH 7 mg / 24 h

* according to the results on withdrawal symptoms.

** in case of satisfactory results.

If you continue to feel irrepressible cravings or if your treatment has failed, talk to a health care professional. He may advise you to associate the patch with an oral form of nicotinic substitute (tablet, chewing gum, ...) containing a maximum of 2 mg of nicotine. Patches and another form of nicotine replacement can only be used at the same time under medical supervision. Use an oral form whenever the irrepressible urge to smoke appears despite treatment with a patch. The number to use per day is variable and depends on your needs. Generally, 5 to 6 per day are sufficient. During weaning, gradually reduce the number of oral forms used per day.

Administration mode

Transdermal pathway

· Open the sachet with a pair of scissors and remove the patch.

· Remove the pre-cut detachable protective sheet.

· Apply NICOPATCH immediately after opening on a surface of dry skin, without skin lesion and where the hair is rare: scapula, hip, external face of the arm ....

· To ensure perfect grip, press firmly over the entire surface for at least 10 seconds with the palm of your hand. Avoid moving areas such as joints, prone to rubbing clothing.

· The application site should be changed every day, avoiding, if possible, relocating the device to the same location for a few days.

· The device must remain in place for 24 hours. If you have difficulty falling asleep, seek the advice of your pharmacist or doctor.

· It is essential to fold the device on itself after use before disposing of it in a safe place.

· Any device used or not used must be kept out of the reach of children.

· During handling, avoid contact with eyes, nose and hands after application.

· Do not cut the patch.

· In case of sea bath or in extended pool, you have 2 possibilities:

o before the bath, remove the transdermal patch and immediately place it on its support. It can be glued to a well-dried skin.

o cover the transdermal patch with a tight adhesive dressing for the duration of the bath.

· In case of short shower, the transdermal device can be held in place while avoiding directing the jet of the shower on it.

Frequency of Administration

Change the device after 24 hours.

Duration of treatment

For the complete cessation of tobacco:

The total duration of treatment should not exceed 6 months

If you have persistent drowsiness or if you have difficulty with this medication, talk to your doctor.

If you used more than NICOPATCH 21 mg / 24 h, transdermal patch you should:

In the event of accidental overdose or if a child has sucked or applied a transdermal patch remove it immediately, wash the skin with soap-free water, contact a doctor or emergency department at the nearest hospital.

Severe intoxication can occur and is manifested by hypotension, weak and irregular pulse, respiratory discomfort, prostration, cardiovascular collapse and convulsions.

Immediately consult your doctor or pharmacist.

If you forget to use NICOPATCH 21 mg / 24 h, transdermal patch:

Apply a patch as soon as possible and continue your treatment as normal. Do not use two patches at the same time.

If you stop using NICOPATCH 21 mg / 24 h, transdermal patch:

Not applicable

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Some effects may be severe: Remove the patch and tell your doctor immediately if you experience the following:

Allergic reactions that may cause swelling of the face, skin and mouth, lowered blood pressure and difficulty breathing.

If any of the following side effects occur, talk to your doctor or pharmacist

Very common (more than 1 in 10 people) : redness and itching at the point of application (where NICOPATCH is in contact with your skin), edema (swelling) and burning sensation at the point of application.

In the event of a severe or persistent skin reaction, it is recommended that you stop taking this medication and consult your doctor or pharmacist to use another form of nicotine replacement to help you quit smoking.

These effects are usually the result of applying the device every day to the same place on the skin. The daily change of site of application makes it possible to disappear naturally any irritation and to reduce the discomfort to the minimum.

Common (1 to 10 people in 100 ) : nausea, headache, dizziness, abnormal dreams, muscle pain or sleep disorders (insomnia), restlessness, anxiety, nervousness.

These effects are often moderate and disappear spontaneously and rapidly after removal of the device.

Uncommon (1 to 10 people in 1,000) : attention problems, drowsiness, mood swings, irritability, depressed mood, confusion, palpitations (irregular heartbeat and rapid heartbeat), vomiting.

Other effects include paraesthesia (numbness or tingling) at the application site that may spread beyond the application site of the transdermal patch.

Buccal mouth ulcers may be linked to smoking cessation and not to your treatment.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE NICOPATCH 21 mg / 24 h, transdermal patch?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the packet and the box. The expiry date refers to the last day of that month.

Store in the original package.

Store at a temperature not exceeding 25 ° C.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What NICOPATCH contains 21 mg / 24 h, transdermal patch

The active substance is:

Nicotine................................................. .................................................. 52.5 mg

For a transdermal device of 30 cm².

A transdermal device delivers 21 mg of nicotine per 24 hours.

The other components are:

Copolymer of alkaline methacrylates (Eudragit E100)

External envelope : Aluminum polyester film

Layers of the matrix : Duro-Tak 387-2516, Miglyol 812, Eudragit E100

Nonwoven support : 26 g / m² paper

Adhesive layer : Duro-Tak 387-2516, Miglyol 812

Detachable protective sheet : Silicone-coated polyester film

What is NICOPATCH 21 mg / 24 h, transdermal patch and contents of the pack

This medication is in the form of a transdermal device.

Box of 7, 14, 21 or 28 transdermal devices.

Not all pack sizes may be marketed.

Marketing Authorization Holder

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Marketing Authorization Operator

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Maker

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Names of the medicinal product in the Member States of the European Economic Area

Not applicable

The last date on which this notice has been revised is

<{MM / YYYY}> <{YYYY month}.>

Other

Detailed information on this medicine is available on the ANSM website (France).

ADVICE / HEALTH EDUCATION

Stopping smoking as soon as possible results in immediate health benefits.

It's never too late to quit even if you've smoked a long time and a lot.

As soon as you stop smoking:

· you will no longer absorb the irritating and toxic substances of the cigarette;

· you will see some improvements: progressive disappearance of the headaches, the cough, the irritation of the throat, the shortness of breath;

· you will often have the satisfaction of regaining better sleep, food flavor, odor and improve your physical performance;

· 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 particularly imperative to succeed in quitting smoking.

It's never too late to quit even if you've smoked a long time and a lot.

What is tobacco dependence ?

Tobacco addiction is twofold:

· Psychological dependence:

Smoking a cigarette involves a ritual of automatic and repetitive 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.

· Physical dependence:

The need for the nicotine body is due to the effects of this substance on the nervous system. This is physical dependence. Failure to satisfy this need results in a sense of lack (see description in the chapter " How to overcome your physical dependence ?"). Nicotinic substitutes aim to treat this dependence.

How to overcome your psychological addiction?

· Stopping smoking 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.

· Tell your family and co-workers that you quit smoking. Ask them to respect your decision (no smoking near you, no longer offering you cigarettes).

· Prepare yourself to cope with the desire to smoke. It may occur suddenly and severely, especially during the first few weeks after the cessation of smoking, but does not last more than 3 or 4 minutes.

You have to anticipate 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 to chew gum ;

o count to 100;

o do some deep breaths;

o out of the room;

o change activity ...

· Avoid situations associated with taking cigarettes (coffee, aperitif ....), avoid temptations (settle with non-smokers).

Find cigarette compensation (leisure, sport, cultural activity ...).

How to overcome your physical addiction?

If you are addicted to nicotine, the success of your approach may require the use of nicotine substitutes.

In order to assess your level of dependence, the Fagerström test is offered.

FAGERSTRÖM TEST

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 to not smoke in places where it is forbidden?

- yes: 1

- no: 0

What cigarette of the day would you be the hardest to give up?

- the first: 1

- another: 0

How many cigarettes do you smoke per day?

- 10 or less: 0

- 11 to 20: 1

- 21 to 30: 2

- 31 or more: 3

Do you smoke at a more sustained 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 0 to 2: you are not addicted to nicotine.

You can stop smoking without the need for nicotine replacement.

If you are concerned about this decision, consult your pharmacist or doctor.

· score 3 to 4: you are weakly dependent on nicotine.

· score 5 to 6: you are moderately addicted to 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 to your situation.

· score 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 doctor, possibly as part of a specialized smoking cessation counseling.

Weaning-related disorders may 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:

o compelling need to smoke,

o irritability, sleep disturbances,

o agitation or impatience,

o difficulty of concentration,

take the advice of your doctor or pharmacist as doses may need to be adjusted.

How do you get help?

· Support from health professionals

The support, advice and follow-up that your doctor or pharmacist can give you will be valuable during the first six months of your smoking cessation. You can also use a specialized smoking cessation counseling, especially if you have already failed.

· 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.

Dietetics

In the months following tobacco cessation, you may find 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 allows to learn: the relapse is not a failure.

Analyze the reasons why you took back the tobacco.

· Because of the physical dependence

This may have been poorly taken into account or reappeared after several months, occasionally, for example, by prolonged stays in smoky atmospheres.

· Because of excessive weight gain

It may be necessary to change your diet somewhat before your next attempt to quit smoking.

· Because of a decline in motivation, because of a painful event or a difficult period, because of psychological difficulties that appeared during the cessation of smoking (depression, anxiety ...), because of a situation very tempting. Understand the reason for this relapse to prevent it if possible during the next attempt.

In all cases, do not hesitate to ask for advice from a health professional or to use a specialized consultation to help with smoking cessation.

If you have started smoking again, do not get discouraged, experience shows that your chances of success increase after one or more attempts to quit.

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