NiQuitin 21 MG 28 PATCHES ANTI TOBACCO 24H STEP 1

NiQuitin 21 MG 28 PATCHES ANTI TOBACCO 24H STEP 1 View larger

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Niquitin Niquitin

NiQuitin 21 MG 28 PATCHES ANTI TOBACCO 24H Step 1 NiQuitin Patches nicotine replacement therapy are known to be effective. Transparent, they allow you a discreet withdrawal. They can make you invaluable in your attempt to quit smoking.

More details

The advice of your pharmacist

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Used for : stop tobacco smoking cessation

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NiQuitin 21 MG 28 PATCHES ANTI TOBACCO 24H STEP 1

 

For warnings, precautions for use

and cons-indications, please refer to the user manual.

 

DO NOT LET THIS MEDICINE OUT OF REACH OF CHILDREN

 

 

The patches are a good solution for smokers who want to take treatment once a day and forget about it. They are a great help to quit using them because you multiply your chances of success by both.

 

NiQuitin 21 MG 28 PATCHES ANTI TOBACCO 24H STEP 1

24 hours Efficiency: NiQuitin Clear Patches have exclusive control membrane. With the latter, a controlled amount of nicotine is delivered to the body for 24 hours.The body receives therefore always a constant dose of nicotine, which also helps to fight against the urge to light a cigarette on waking . NiQuitin Clear patches are transparent and therefore offer a discrete solution.

 

NiQuitin patches provide continuous and regular release of nicotine over 24 hours. They allow you therefore to fight against cravings throughout the day. NiQuitin Patches are patches of 24 who have a unique technology:

- Thanks to the flow control membrane, they regularly provide nicotine 24h

- With a pre-loaded adhesive nicotine, they release a larger amount of nicotine in the first two hours to fight against the urge to light a cigarette after waking up: they allow better and reduce cravings morning.

 

Step by Step:


Step 1 - 6 weeks

The first six weeks, use NiQuitin Clear - Step 1. Each patch releases for
throughout the day (24 h) 21 mg of nicotine to the body. Paste your first patch after
have crashed your last cigarette.

 

Step 2 - 2 weeks

The next two weeks, continue with NiQuitin Clear - Stage 2. Throughout the
day (24 h), each patch delivers 14 mg of nicotine to the body.

 

Step 3 - 2 weeks

You arrived here (e) the last step, NiQuitin Clear - Step 3. For 24 hours each
7 mg patch delivers nicotine to the body. You have followed the course of treatment?
In this case, you have more chances of successfully quitting

 

HOW TO USE NiQuitin 21 MG 28 PATCHES ANTI TOBACCO 24H STEP 1

COMPLETE STOP TOBACCO - Monotherapy:

NiQuitin Patches can be used in 2 or 3 steps, depending on your degree of tobacco dependence (Fagerström test), with decreasing dosages of 21 mg, 14 mg, 7 mg / 24 hours. As to the dosage of the patches will be reduced until you can do without nicotine.

 

Initial phase
3 to 4 weeks

Treatment monitoring
3 to 4 weeks

Washout
3 to 4 weeks

Score of 5 or more Fagerstrom test or smoking 20 cigarettes or more per day

Patch 21 mg / 24 h

Patch 14 mg / 24 h or

Patch 21 mg / 24h *

Patch 7 mg / 24 h

Patch or 14 mg / 24 h

Patch and 7 mg / 24 hours *

Less than 5 Fagerstrom test or smoking less than 20 cigarettes per day score

Patch 14 mg / 24 h or

to increase

Patch 21 mg / 24h *

Patch 14 mg / 24 h or

Patch 7 mg / 24 h **

Patch 7 mg / 24 h or discontinuation of treatment **

* According to the results on the withdrawal symptoms.
** In case of satisfactory results

The total duration of treatment should not exceed 6 months.

 

Mode of administration

Every day, preferably in the morning on waking, one gesture to do: put your patch on an area of dry skin without injury and where the hair is rare (trunk, upper arm). The location must be different every day.
Application time: 24 hours.
Duration of treatment: 10 to 12 weeks.
Warning: NiQuitin Patches do not cut themselves, otherwise the effectiveness of the dissemination of nicotine is no longer guaranteed.

 

USE CAUTION NiQuitin 21 MG 28 PATCHES ANTI TOBACCO 24H STEP 1

The total duration of treatment should not exceed 6 months.

In association with oral forms SUB medical CONTROL:

If during your treatment, you continue to experience uncontrollable cravings or if your treatment has failed, consult your doctor.

The complete cessation is preferable.

 

PRESENTATION NiQuitin 21 MG 28 PATCHES ANTI TOBACCO 24H STEP 1

Transmission 28 24 Niquitin 14mg Patches Step 1 and 2

 

IT IS IMPORTANT TO CONSULT A DOCTOR IN THE ABSENCE OF AMELIORATION.EN IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST.

 

THE COUNCIL OF PHARMACIST Un Conseil ? Une Question ?

 

- The degree of nicotine dependence will be assessed by the number of cigarettes smoked per day or the Fagerström test.

- This medicine may be used alone or in combination with chewing gum 2 mg or NiQuitin lozenges NiQuitin 2 mg.

When used in combination, it is advisable to seek medical advice.

 

 

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

NIQUITIN transdermal patch

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)

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

NIQUITIN 14 mg / 24 h: transdermal device 15 cm2; box of 7.
-

NIQUITIN 14 mg / 24 h: transdermal device 15 cm2; box of 28.
-

NIQUITIN 21 mg / 24 h: transdermal device of 22 cm2; box of 7.
-

NIQUITIN 21 mg / 24 h: transdermal device of 22 cm2; box of 28.
-

Omega Pharma Laboratory

COMPOSITION (summary)
p 7 cm2 p 15 cm2 p 22 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)
The setting of the patch must lead to a complete stop of the tobacco.
Do not use other medicines containing nicotine, such as chewing gums.
Do not leave the new or used stamp within the reach of children: unintentional application can cause serious accidents. Fold the stamp before discarding.
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.
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 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 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.


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 - Updated on: 16/06/2017

Name of the medicinal product

NIQUITIN 21 mg / 24 hours, transdermal patch

Nicotine

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take 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 LEAVE THIS MEDICINE FOR CHILDREN.

What is in this leaflet?

1. What is NIQUITIN 21 mg / 24 hours, transdermal patch and in what cases is it used?

2. What should I know before taking NIQUITIN 21 mg / 24 hours, transdermal patch?

3. How to take NIQUITIN 21 mg / 24 hours, transdermal patch?

4. What are the possible side effects?

5. How to store NIQUITIN 21 mg / 24 hours, transdermal patch?

6. Package contents and other information.

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

Drugs used in nicotine addiction - ATC code: N07BA01.

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

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

2. BEFORE YOU TAKE NIQUITIN 21 mg / 24 hours, transdermal patch?

Do not take NIQUITIN 21 mg / 24 hours, transdermal patch:

· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.

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

· in the case of skin disorders which may 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.

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

· severe hepatic and / or renal insufficiency,

· ulcer of the stomach or duodenum in evolution,

· history of seizures.

Talk to your doctor or pharmacist before using NIQUITIN.

If you have diabetes you should monitor your blood sugar level more often than usual when you start using transdermal nicotine devices. Your insulin or medication needs may change.

If you are in hospital because of a heart attack, severe heart rhythm disorder or heart attack , you should try to stop smoking without using nicotine replacement therapy unless your doctor has told you recommended use. When you leave the hospital, you can use a nicotine replacement therapy normally.

If you have heart problems , you should consult a health professional before using nicotine replacement therapy for progressive or combination therapy.

If you have skin rash , swelling or rash , you should stop using the patch and consult a health care professional.

If you have dermatitis , it is likely that you have a reaction to the transdermal patch.

Precautions for use

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

· compelling need to smoke,

· irritability, sleep disturbances,

· agitation,

· difficulty of concentration.

Consult your doctor or pharmacist. It may be necessary to change the dosage of the medication.

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

· nausea, abdominal pain, diarrhea,

· hypersalivation,

· sweating, headache, dizziness, hearing loss,

· general weakness.

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

In the event of burning, tingling, itching, rash, sun exposure, it is recommended to stop treatment until the symptoms disappear.

If you gradually stop smoking (such as using nicotine patches before you stop smoking) and you experience side effects, you should stop smoking. If the effects do not fade, remove the patch; you will be able to start using it again when you feel better.

(See section 4 "What are the possible side effects?").

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Children and Youth

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

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

Indeed, the therapeutic dose intended for adults could cause severe or even fatal poisoning in children.

Keep all medicines out of the reach and sight of children.

Other medicines and NIQUITIN 21 mg / 24 hours, transdermal patch

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

NIQUITIN 21 mg / 24 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 medicine.

Pregnancy

It is very important to quit smoking during your pregnancy for you and your child.

If you are pregnant, you must stop smoking without nicotine replacement therapy. However, if you have tried and your attempt has failed, a nicotine replacement therapy may be recommended by a health professional to help you quit smoking.

Smoking cessation during pregnancy requires medical advice and follow-up. You should therefore consult the doctor who follows your pregnancy or your usual doctor or a doctor at a center specialized in smoking cessation.

Ask your doctor or pharmacist for advice before taking any medicine.

feeding

If you smoke a lot and do not plan to stop smoking, you should not breastfeed your child, but use artificial breastfeeding.

Use of this medication is not recommended during breast-feeding.

However, if you want to stop smoking and breast-feed your child, take advice from your doctor or a doctor at a smoking cessation center.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Not applicable.

NIQUITIN 21 mg / 24 hours, transdermal device does not contain excipient with known effect.

3. HOW TO TAKE NIQUITIN 21 mg / 24 hours, transdermal patch?

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

Reserved for adults and children over 15 years of age.

Transdermal nicotine devices should not be used in children under 15 years of age.

Adolescents (15-17 years) should not use nicotine transdermal devices beyond 10 weeks without the advice of a health professional. They should not stop smoking (eg by using nicotine transdermal devices before stopping tobacco) or use a combination (eg using multiple types of nicotine replacement therapy).

Three stamp sizes are available: 7, 15 and 22 cm 2 corresponding to 3 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:

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

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

o 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.

If during your treatment you continue to feel irrepressible cravings or if your treatment has failed, CONSULT YOUR DOCTOR. He or she may advise you to combine NIQUITIN transdermal patches with alternative oral forms (NIQUITIN 2 mg chewable tablets or NIQUITIN 2 mg tablets).

The total duration of treatment should not exceed 6 months.

· Complete cessation of smoking

Initial phase 3 to 4 weeks

Treatment follow-up 3 to 4 weeks

Smoking cessation 3 to 4 weeks

Score of 5 or more on the Fagerström test or Smoker of 20 or more cigarettes per day

NIQUITIN 21 mg / 24 h

NIQUITIN 14 mg / 24 h or NIQUITIN 21 mg / 24h *

NIQUITIN 7 mg / 24 h or NIQUITIN 14 mg / 24 h then NIQUITIN 7 mg / 24 h *

Score less than 5 on the Fagertröm test or Smoker less than 20 cigarettes per day

NIQUITIN 14 mg / 24 hr or increase to NIQUITIN 21 mg / 24 hr *

NIQUITIN 14 mg / 24 h or NIQUITIN 7 mg / 24 h **

NIQUITIN 7 mg / 24 h or discontinuation **

* Based on results on withdrawal symptoms.

** In case of satisfactory results.

· Progressive shutdown

If you have difficulty quitting completely, CONSULT YOUR DOCTOR.

He may consider allowing you to smoke during the first 2 weeks of starting treatment with NIQUITIN transdermal devices. You can then start using NIQUITIN 21 mg / 24 hours, transdermal patch while you still smoke. After 2 weeks, you stop smoking and continue the treatment as described below.

Stop Preparation

Initial stage

Treatment follow-up

Therapeutic withdrawal

Score of 5 or more on the Fagerström test or Smoker of 20 or more cigarettes per day

2 weeks

6 weeks

2 weeks

2 weeks

NIQUITIN 21 mg / 24 h / d

NIQUITIN 21 mg / 24 h / d

NIQUITIN 14 mg / 24 h / d

NIQUITIN 7 mg / 24 h / d

Stop Preparation

Initial stage

Treatment follow-up

Therapeutic withdrawal

Fagerström score below 5 or Smoker under 20 cigarettes per day

2 weeks

6 weeks

2 weeks

2 weeks

NIQUITIN 14 mg / 24h / day or increase to NIQUITIN 21 mg / 24 h *

NIQUITIN 14 mg / 24h / day or increase to NIQUITIN 21 mg / 24 h *

NIQUITIN 7 mg / 24 h / day or increase to NIQUITIN 14 mg / 24 h *

NIQUITIN 7 mg / 24 h / d or discontinuation of treatment

* Based on results on withdrawal symptoms.

Method and route of administration

Transdermal pathway.

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

Remove the pre-cut detachable protective sheet.

Apply NIQUITIN immediately after opening on a surface of dry skin, without skin lesion and where hairiness is rare: trunk, upper arm, preferably in the morning on waking.

Do not apply on a red, irritated or injured skin surface.

To ensure perfect grip, press firmly on the entire surface for about 10 seconds with the palm of your hand.

The device must remain in place for 24 hours.

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 be stored in its protective pouch until it is used.

It is essential to fold the device on itself, place it in the bag from which you took your new transdermal device after use before throwing it in a safe place, out of reach of children or animals.

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

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

Do not cut the patch.

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

· before the bath, remove the transdermal patch and immediately place it on its support. It can be glued to a dry skin,

· 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.

Duration of treatment

Reducing tobacco consumption should gradually lead to a complete cessation of smoking.

This should be stopped as soon as possible within 6 months of starting treatment. If after more than 9 months after initiation of treatment, the attempt to stop smoking has failed, it is recommended to seek advice from a health professional to consider another strategy.

If you take more than NIQUITIN 21 mg / 24 hours, transdermal patch you should not have

In case of accidental overdose or if a child has sucked or applied a transdermal device, contact a physician or an emergency service.

Severe intoxication may occur and may include hypotension, weak and irregular heartbeat, respiratory discomfort, prostration, cardiovascular collapse and convulsions.

If you have used too many transdermal devices, you can start feeling bad, dizzy and sick. Remove the transdermal patches and wash your skin with water, and dry, then consult a doctor immediately.

If you forget to take NIQUITIN 21 mg / 24 hours, transdermal patch

Not applicable.

If you stop taking NIQUITIN 21 mg / 24 hours, 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.

Adverse reactions are listed below by frequency of onset.

Very common (affects more than 1 in 10 people)

· reactions at the site of application of the transdermal device,

· sleep disorders including insomnia and onirism disorders,

· nausea, vomiting,

· headache,

· feeling dizzy.

Common (affects between 1 in 10 people and 1 in 100 people)

· nervousness,

· tremors,

· short breathing,

· cough,

· painful or swollen throat,

· indigestion,

· stomach pain,

· diarrhea

· constipation,

· sweating,

· dry mouth,

· joint, muscle, chest or limb pain,

· fatigue and general weakness,

· throbbing (feeling his heart beat),

Very rare (affects less than 1 in 10,000 people),

· photosensitivity of the skin,

· symptoms of a severe allergic reaction that includes sudden wheezing, chest tightness, skin rash, general feeling of weakness.

You may have mild redness and itching, burning and tingling of the skin where the transdermal patch was placed. This disappears rapidly after removal of the transdermal patch. Rarely, a more severe reaction at the application site may occur. If this happens, stop using the patch and tell your doctor.

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 NIQUITIN 21 mg / 24 hours 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 package after EXP. The expiry date refers to the last day of that month.

Store at a temperature not exceeding 30 ° 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 NIQUITIN contains 21 mg / 24 hours, transdermal patch

· The active substance is:

Nicotine................................................. .................................................. ........................ 114.00 mg

For a transdermal device of 22 cm 2 .

· The other components are:

Ethylene / vinyl acetate copolymer (40% AV)

Occlusive support: ethylene, vinyl acetate, polyethylene terephthalate.

Flow control membrane: polyethylene film.

Contact adhesive: polyisobutylene.

Detachable protective layer: silicone polyester film.

What is NIQUITIN 21 mg / 24 hours, transdermal patch and contents of the pack

This medicinal product is in the form of transdermal devices in sachets; Box of 7, 14 or 28.

Not all pack sizes may be marketed.

Marketing Authorization Holder

LABORATOIRES OMEGA PHARMA FRANCE

20 STREET ANDRE GIDE

92320 CHATILLON

Marketing Authorization Operator

LABORATOIRES OMEGA PHARMA FRANCE

20 STREET ANDRE GIDE

92320 CHATILLON

Maker

CATALENT UK PACKAGING LIMITED

LANCASTER WAY

WINGATES INDUSTRIAL PARK

Westhoughton

GREATER MANCHESTER

BL5 3 XX

UK

OR

FAMAR AVE ANTHOUSSA PLANT

ANTHOUSSA AVENUE 7

ANTHOUSSA ATTIKI

15344

GREECE

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

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

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

Health Education Council:

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 can see some improvements: progressive disappearance of headaches, cough, irritation of the throat, 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.

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 D day in the period that you think is 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.

· 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 must 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 counting up 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.

FAGERSTROM 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:

· compelling need to smoke,

· irritability, sleep disturbances,

· agitation or impatience,

· 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 appearing at 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.

Get all Niquitin range to help you stop smoking. Patches, tablets, chewing on Care and nature, your bio pharmacy online!

Anti Smoking Nicotinell patches Nicoretteskin Nicopatch Niquitin: Find a selection of our nicotine substitute in your medicine bio care and kind. Fight effectively against the small inconveniences of daily life with effective remedies and quality.

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