NICOTINE PATCHES Nicopatch 14mg 28 20 24H CM3

3400938380576

Pierre Fabre Pierre Fabre

NICOTINE PATCHES Nicopatch 14mg 28 20 CM3 24H: Nicopatch box 28 transdermal patches in 14mg of nicotine for 24 hours is recommended for the treatment of tobacco dependence.

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Partners with: KIT FOR HOMEOPATHIC STOP SMOKING TOBACCO Boiron, BAUDOUX PREPARATION STOP TOBACCO ESSENTIAL OILS 10ml, Nicopass 1.5mg nicotine 96 TABLETS WITHOUT SUGAR EUCALYPTUS, Nicopass 1.5 MG mint freshness 144 Tablets

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NICOTINE PATCHES Nicopatch 14mg 28 20 24H CM3


NICOTINE PATCHES Nicopatch 14mg 28 20 24H CM3


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


Description NICOTINE PATCHES Nicopatch 14mg 28 20 24H CM3


Nicopatch 14 mg box of 28 patches, which is recommended for the treatment of tobacco dependence. This medication is indicated for the treatment of tobacco dependence in smokers under 20 cigarettes a day to 20 to 30 cigarettes per day, to relieve the symptoms of nicotine withdrawal in patients who want to quit their tobacco .
For adults over 15 years.


Composition NICOTINE PATCHES Nicopatch 14mg 28 20 24H CM3  

:

  • 35mg nicotine patch for 20 cm². A patch delivers 14mg 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 dosage 14mg NICOTINE PATCHES 28 20 24H CM3

  • 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


Indications against NICOTINE PATCHES Nicopatch 14mg 28 20 24H CM3  

  • 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 28 transdermal patches.

Warnings on drugs


Attention drug Nicopatch 14 mg 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 Â (summary)

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

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

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

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

NICOPATCH 21 mg / 24 h: transdermal patch 30 cm2; box of 7.
-

NICOPATCH 21 mg / 24 h: transdermal patch 30 cm2; box of 28.
-

Laboratory Pierre Fabre Medicine

COMPOSITION Â (summary)
AT p 10 cm2 p 20 cm2 p 30 cm2
Nicotine released / 24 h 7 mg 14 mg 21 mg

INDICATIONS Â (summary)
This medication helps smokers to detoxify from 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 the cessation of smoking.
It is used exclusively in nicotine-dependent smokers, that is, who swallow the smoke and can not do without smoking for a few hours.
CONTRAINDICATIONS Â (summary)
This medication should not be used in the following cases:
  • non-smoker or occasional smoker,
  • Extended skin disease does not allow the patch to stick.
CAUTION Â (Contents)
In the context of a definitive detoxification, the cessation of tobacco is a prerequisite for the success of the treatment.
Do not use other medicines containing nicotine, such as chewing gums, without medical advice.
PRA © deposits are born © cessaires in case of ulcère stomach or Duoda © num , of failure Result © nal or hà © hepatic . In these situations, a 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 at the reach of children: unintentional application can cause serious accidents. Fold the stamp before discarding.
DRUG INTERACTIONS Â (summary)
Products contained in tobacco smoke can accelerate the elimination rate of certain medications, including theophylline. When quitting smoking, these medications can see their effect strengthened and signs of overdose may appear. Contact your doctor in case of any doubt.
PREGNANCY AND BREASTFEEDING (summary)
Pregnancy :
Smoking in pregnant women may cause fetal growth retardation. Stopping smoking is always desirable. In women who are highly addicted to nicotine, the use of this medication may be helpful, but the effects of nicotine alone on the fetus are poorly understood. This medication has the advantage of not exposing the fetus to other toxic substances present in tobacco smoke. In summary: if the idea is not to smoke and not to expose the fetus to nicotine intakes, the use of this medication is a lesser evil compared to tobacco.

Breastfeeding:
Nicotine passes into breast milk, breastfeeding is discomfort 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 intended for large smokers or smokers of cigarettes rich in nicotine; a high dependence on nicotine can 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 leads to the condition of the smoker who has smoked too much and mainly results in a state of nausea and headaches. Difficulty in sight or hearing, tremors, dizziness are also possible;
  • an under-dosage causes symptoms of lack: irritability, nervousness, stomach cramps (kind of painful hunger), difficulty in concentration.
Once weaning has been achieved, a shorter patch should be taken after a period of 3 to 4 weeks and then stopped after use of the lowest dosage.
Apply the patch on a dry area, low in hairs, and free of skin lesions. Release the adhesive surface and carefully apply the stamp 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 overnight.
It is recommended not to exceed 6 months of continuous treatment.
TIPS (summary)
This medication can be used by smokers without medical consultation. 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 the failure.
Nicotine taken by way Cutana © e replacing cigarette PRA © feel the same nocività © Cardiovascular 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 which is fading with time. A cessation of lasting tobacco in the smoker assumes that the smoker considers tobacco to be a poison, an unacceptable dependence. It must be done to the idea that it will never smoke again, from the beginning of weaning. Every day without tobacco should be lived as a release, not as a martyrdom. 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 slight depressive condition is possible. the 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 valuable in fighting 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 put the stamp at bedtime.
Remember to wash your hands after application and avoid contact with eyes or nose.
POSSIBLE ADVERSE EFFECTS (summary)
Local reactions: redness and application-level disruption, which may require treatment to stop in case of major reactions.
Also: palpitations , headache, insomnia, dizziness , troubled dreams, nausea, vomiting.


GLOSSARY Â (summary)


Arta © rite
Disease of the arteries favored by the smoking and most often localized to the legs. It is characterized by a thickening of the arterial walls which hinders 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: obliterative artery disease of the lower limbs.


Details © pendence
Psychic or physical need caused by taking certain natural or medicinal substances. This condition may be accompanied by discontinuous symptoms, grouped under the term 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 effect of first passing hepatically.


© Duoda num
Part of the intestine into which food from the stomach penetrates.


Depressive state
A state of moral suffering combining demotion, fatigue, a sense of uselessness, self-appraisal. In the absence of treatment, the depressive condition may evolve into a serious depression with a sense of incurabil- ity, guilt, and a suicidal risk.


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


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


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


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


palpitations
Abnormal perception of irregular heartbeat.


overdose
Taking an excessive amount of a drug exposes you to an increase in the intensity of the undesirable effects or even to the appearance of particular undesirable effects.
This overdose may result from accidental or voluntary poisoning for suicide: please consult the poison control center in your area (see appendix). But most often, overdose is the consequence of an error in the understanding of the prescription, or the search for an increase in efficacy by a surgical surgery of the prescribed dosage © e. Finally, untimely tampering may lead to excessive absorption of the same substance contained in different medicines. Some medicines are particularly prone to this risk because they are considered (mistakenly) as harmless: vitamins A and D, aspirin, and so on. Stopping or decreasing medication intake will help eliminate problems associated with overdosage.


symptoms
Trouble felt by a person with an illness. A similar symptom may result in different illnesses and the same disease does not necessarily give the same symptoms in all patients.


ulcère
Injury of the skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor blood circulation.
  • 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 bacteria (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and taking certain medications (aspirin, NSAIDs, etc.).


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


way
  • Path (route of administration) used to administer the medications: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing passage of air (respiratory tract), 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: 20/03/2017

Description of the Medicine

NICOPATCH 14 mg / 24 h, transdermal patch

Nicotine

© framed

Please read this leaflet carefully and especially the health advice you will find at the end before 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 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 contact your doctor if you feel uncomfortable or feel less well.

Do not allow this medication to reach children.

What is in this leaflet?

1. What is NICOPATCH 14 mg / 24 h, transdermal patch and in which cases is it used?

2. What information should be known before using NICOPATCH 14 mg / 24 h, transdermal patch?

3. How to use NICOPATCH 14 mg / 24 h, transdermal patch?

4. What are the possible undesirable effects?

5. How to store NICOPATCH 14 mg / 24 h, transdermal patch?

6. Contents of the package and other information.

1. WHAT NICOPATCH 14 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 teenagers over 15 years of age.

This medication is used in nicotine addiction.

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

Appropriate management improves the chances of success in stopping smoking.

Carefully read the health advice at the end of this leaflet.

You should contact your doctor if your desire to smoke is not defeated after 6 months of treatment with this medication, if you feel no improvement or feel less well.

2. BEFORE YOU USE NICOPATCH 14 mg / 24 h, transdermal patch?

NEVER use NICOPATCH 14 mg / 24 h, transdermal patch:

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

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

AT· 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, the complete cessation of smoking is essential.

Carefully read the health care advice.

AT· You must consult a physician before using NICOPATCH, transdermal patch in case of recent myocardial infarction (heart attack), unstable angina or worsening including Prinzmetal angina, severe disorder heart rhythm, uncontrolled arterial hypertension, recent cerebral vascular accident.

AT· 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 surgical glands resulting in severe arterial hypertension),

o of severe liver and kidney disease,

o the ulcer of the stomach or the duodenum in evolution,

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

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

o 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 change the dosage of the medication.

AT· Some signs may indicate an overdose: in the event of signs of overdose, that is to say:

o nausea, abdominal pain, diarrhea,

o hypersalivation,

o sweating, headache, dizziness, hearing loss,

o general weakness,

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

In case of association with another nicotine replacement, it is recommended to ask for a medical opinion.

If in 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 intoxication or even mortal.

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

Other medicines and NICOPATCH 14 mg / 24 h, transdermal patch

Tobacco cessation, 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 required 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 therapy for opiate dependence (methadone).

- treatment of breast angina (nifedipine)

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

NICOPATCH 14 mg / 24 h, transdermal patch with food and beverages

Not applicable.

Pregnancy and breast feeding

If you are pregnant or nursing, planning to become pregnant or planning a pregnancy, ask your doctor for advice or pharmacist before taking this medication.

Pregnancy

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

The idea would be to stop smoking without using a medication. If you do not get it, this medication can be recommended to help you because the risk to your baby is much less than that related to the pursuit of smoking. Nicotine, whatever its form, can harm your child to be born.

Therefore, this medication should only be used after consulting the health care professional who is following your pregnancy, or your general practitioner or a physician. within a center specializing in smoking cessation.

feeding

This medication as well as smoking during breast-feeding 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 you are advised by your doctor.

Sport

Not applicable.

Driving and using machines

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

NICOPATCH 14 mg / 24 h, transdermal patch contains aluminum:

As a result, the patch must be removed before an MRI (Magnetic Resonance Imaging) is performed.

3. HOW TO USE NICOPATCH 14 mg / 24 h, transdermal patch?

Dosage

Reserved for adults and teenagers over 15 years of age.

NICOPATCH should not be used in smokers under 18 years of age without the recommendation of a health professional. Three sizes of stamps 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 appreciated 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 any signs of overdose: read the precautions section and do not hesitate to ask your pharmacist for advice.

The treatment takes place in 3 periods :

AT· Initial period : it lasts from 3 to 4 weeks and will allow you to get the tobacco stop.

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

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

The overall 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 the Fagerström test

or

Smokers under 20 cigarettes a day

NICOPATCH 14 mg / 24 h

or

increase to NICOPATCH 21 mg / 24 h *

NICOPATCH7 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, gum, ...) containing a maximum of 2 mg 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 varies 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.

Method of Administration

Transdermal pathway

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

AT· Remove the pre-cut protective sheet.

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

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

AT· The site of application should be changed every day by avoiding if possible to put the device back in the same place for a few days.

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

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

AT· Any device used or not used 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 in extended swimming pool, you have 2 possibilities:

o before the bath, remove the transdermal 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 during the bathing period.

AT· In case of short shower, the patch can be held in place by avoiding directing the shower spray 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

In case of persistent feeling of lack or in case of difficulty to stop this medication, consult your doctor.

If you used more than NICOPATCH 14 mg / 24 h, transdermal patch you should not have:

In the event of accidental overdose or if a child has sucked or applied a transdermal patch remove it immediately, wash the skin with water without soap, contact a physician or an emergency department the nearest hospital.

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

Immediately consult your doctor or pharmacist.

If you forget to use NICOPATCH 14 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 14 mg / 24 h, 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.

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

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, consult your doctor or pharmacist

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

In case of severe or persistent skin reactions, it is advisable to stop treatment by this route and to consult your doctor or pharmacist to use another form of nicotine replacement to help you To stop smoking.

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

Frequent (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 quickly after the device is removed.

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

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

Buccal mouth ulcers can be related to smoking cessation and not your treatment.

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 Pharmacovigilance Centers - Website: www.ansm.sante.fr

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

5. HOW TO STORE NICOPATCH 14 mg / 24 h, transdermal patch?

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

Do not use this medicine after the expiration date stated on the packet and case . The redemption date refers to the last day of that month.

Store in the original package.

Keep at a temperature not exceeding 25ºC.

Do not throw any medication into the sewer or with the household garbage Ask your pharmacist to discard any medications you are no longer using. These measures will help to protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What NICOPATCH contains 14 mg / 24 h, transdermal patch

AT· The active substance is:

Nicotine................................................. .................................................. 35.0 mg

For a transdermal device of 20 cm².

A transdermal device delivers 14 mg of nicotine per 24 hours.

AT· The other components are:

Copolymer of alkaline methacrylates (Eudragit E100)

External envelope : Aluminized polyester film

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

Non woven support : Paper 26 g / m²

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

Detachable protective film: Aluminum silicone polyester film

What is NICOPATCH 14 mg / 24 h, transdermal patch and contents of the outer package

This medication is in the form of a transdermal device.Box of 7, 14, 21 or 28 transdermal devices.

Not all presentations may be marketed.

Holder of the marketing authorization

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Operator of the marketing authorization

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Maker

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Names of medicines 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 medicinal product can be found on the website of the ANSM (France).

ADVICE / 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 irritant and toxic substances of the cigarette;

AT· you may notice some improvements: progressive disappearance of headaches, cough, irritation of the throat, shortness of breath;

AT· you will often have the satisfaction of regaining better sleep, food flavor, odor and improving 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.

It is never too late to quit smoking even if you smoke a long time and a lot.

What is tobacco dependence ?

Dependence on tobacco is twofold:

AT· Psychological dependence:

Smoking a cigarette involves a ritual of automatic and reactive gestures associated with particular circumstances (pleasure, response to stress, intellectual stimulation, support for morale, need for 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. 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 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 in addition:

o choose a day J in the period that seems to you the most favorable;

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· Warn your loved ones and your colleagues working that 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 way especially during the first few weeks after stopping smoking, but does not last more than 3 or 4 minutes.

You have to predict what you will do in this case there and act very fast 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 activity ...

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

Find cigarette compensation (recreation, 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.

FAGERSTRÃ-M TEST

How long after your waking 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

What cigarette of the day would you be the most difficult 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're so sick that you have to stay in bed almost all day?

- yes: 1

- no: 0

TOTAL POINTS

AT· score 0 to 2: you are not dependent on nicotine.

You can quit smoking without the need for nicotine replacement.

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

AT· Score 3 to 4: You are weakly dependent on nicotine.

AT· score 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 most appropriate treatment for you.

AT· 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 counseling.

Weaning-related problems 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 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?

AT· Support from health professionals

The support, advice and follow-up that your doctor or pharmacist can provide 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 failed.

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.

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 a pathway accident, as a normal event that lets you learn: relapse is not a failure.

Analyze the reasons why you took back the tobacco.

AT· Because of physical dependence

This may have been misunderstood or reappearing after several months, occasionally, for example, from prolonged periods of time in smoky atmospheres.

AT· Due to excessive weight gain

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

AT· Because of a decreased motivation, due to a painful event or a difficult period, because of psychological difficulties appearing at the cessation of the tobacco (depression, anxiety tà © ...), because of a very tempting situation. 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 be discouraged, experience shows that your chances of success increase after one or more attempts to quit.

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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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