Nicotinell nicotine patch 7mg/24h Tobacco Dependence Treatment

Nicotinell 7 mg/24 h transdermal patches are used in nicotine addiction .
This medication is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects wishing to stop their tobacco consumption.

The active ingredient is nicotine which will be released continuously. 
This medicine is reserved for adults and children over 15 years old .

The Nicotinell box is made up of 7 or 28 transdermal devices.
There are three sizes of transdermal patches 10, 20 and 30 cm², which correspond to 3 different dosages: 7, 14 and 21 mg/24 hours as withNicotinell 21mg/24 hours .

The active ingredient of this medication is S(-)-Nicotine 17.5 mg for a transdermal patch weighing 0.7 g and having a surface area of ​​10 cm². 

The other ingredients are: alkaline methacrylate copolymer (Eudragit E 100). Outer envelope: polyester film. Matrix layer: Durotak 387-2516, Miglyol 812, Eudragit E 100. Non-woven backing: 26 gsm paper. Adhesive layer: Durotak 387-2516, Miglyol 812. Detachable protective sheet: siliconed aluminized polyester film.

Dosage of Nicotinell 7 mg / 24 h in nicotine patches

Your degree of dependence on nicotine will allow you to know the dose to be administered. It will be evaluated by the Fagerström test or by the number of cigarettes consumed per day.

This dose should be increased if you experience "withdrawal" symptoms  : urge to smoke, irritability, trouble sleeping, restlessness or restlessness, and difficulty concentrating.
And on the contrary it should be reduced if you experience signs of overdose  : nausea, abdominal pain, diarrhea, hypersalivation, sweating, headache, dizziness, loss of hearing, and general weakness. 

Thus the treatment is divided into three phases which each last 3 to 4 weeks: the initial phase , then the treatment follow-up phase and finally the therapeutic weaning.

The duration of treatment is limited to 6 months . In case of treatment failure you should consult your doctor.  

Attention, in case of accidental overdose or if a child has sucked or applied a transdermal device, you must contact a doctor or an emergency medical service. Severe intoxication is manifested by hypotension, weak and irregular pulse, difficulty breathing, prostration, cardiovascular collapse and convulsions.
Any device used or not must be kept out of the reach of children. Indeed, the therapeutic dose intended for adults could cause serious or even fatal poisoning in children.

Here are some tips for using these nicotine patches. For perfect adhesion, you must strongly press the patch over 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 daily. The surface must be dry, healthy without injury or irritation and must be as free as possible.
You should fold the device on itself after use before disposing of it in a safe place.
The patch should not be cut.
In the event of prolonged sea bathing or swimming, you can remove the transdermal patch before bathing and immediately replace it on its holder. It can be reattached to well-dried skin.
The patch may be covered with a waterproof adhesive dressing for the duration of the bath.

Precautions for use of nicotine patches Nicotinell 7 mg / 24 h

Nicotinell transdermal patches 7 mg / 24 h are contraindicated for you if you do not smoke or if you are an occasional smoker, in the event of an allergy to one of the constituents, in the event of a skin condition that may interfere with use of a transdermal system.

You should first consult your doctor if you have severe or moderate hepatic and/or renal insufficiency, or an evolving gastric or duodenal ulcer.

If you are taking or have recently taken any other treatment, even if it can be purchased without a prescription, you should speak to your doctor or pharmacist to avoid any overdose or interaction.

Pregnant or breastfeeding women who smoke must first consult their doctor to decide whether or not to set up nicotine replacement therapy. If it is set up, a treatment follow-up will have to be carried out.

Do not hesitate to ask your doctor or pharmacist for advice or to consult the instructions for this medicine.

Please read the following full disclosure before purchasing or using this product:

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 09/02/2022

1. NAME OF THE MEDICINAL PRODUCT

NICOTINELL TTS 7 mg/24 H, transdermal patch

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

S(-)-Nicotine ....................................................................................................................... 17.5 mg

Per transdermal patch of 0.7 g with an effective surface area of 10 cm2.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Transdermal patch.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

This medicine is indicated in the treatment of tobacco dependence to relieve symptoms of nicotine withdrawal in individuals who want to quit smoking.

4.2. Posology and method of administration

Posology

Pediatric population

Reserved for adults and adolescents over 15 years of age. Patients under 18 years of age should seek medical advice before using the product.

Adolescents (aged 15 to 17 years):

Adolescents (15 to 17 years of age) should follow the therapeutic regimen for complete smoking cessation mentioned below, but as data is limited, the duration of nicotine replacement therapy in this age group is limited to 10 weeks, after medical advice.

It is recommended that adolescents do not use this treatment in combination with other nicotine replacement therapies.

Children under 15 years of age:

NICOTINELL TTS is not recommended for use in children under 15 years of age.

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

This medicine can be used as monotherapy or in combination with oral forms of nicotine replacement therapy, such as NICOTINELL 2 mg chewing gum or NICOTINELL 1 mg lozenges.

In case of combination therapy, medical advice is recommended.

The dosage of the transdermal system should be adjusted according to individual response: increase the dose if smoking abstinence is not achieved or if withdrawal symptoms are experienced, decrease the dose in case of suspected overdose.

The treatment duration is approximately 3 months but may vary depending on individual response (do not use this medication for more than 6 months unless the potential benefit outweighs the risk for the smoker).

It is recommended not to use this medication beyond 6 months.

· In combination with oral forms (NICOTINELL 2 mg chewing gum or NICOTINELL 1 mg lozenges):

Individuals who, despite well-conducted monotherapy, continue to experience irresistible cravings to smoke or individuals who have failed monotherapy can combine transdermal patches with an oral form that acts more rapidly on withdrawal symptoms, such as NICOTINELL 2 mg chewing gum or NICOTINELL 1 mg lozenges.

The combination of transdermal patches with oral forms has shown superior results compared to each treatment used separately.

Initial treatment

It is recommended to start treatment with a 21 mg/24 h transdermal patch in combination with NICOTINELL 2 mg chewing gum or NICOTINELL 1 mg lozenges whenever the urge to smoke arises. At least 4 lozenges (1 mg) or chewing gums (2 mg) should be used. In most cases, 5 to 6 lozenges (1 mg) or chewing gums (2 mg) are sufficient. Do not take more than 15 lozenges (1 mg) or chewing gums (2 mg) per day.

Under normal circumstances, the treatment should last 6 to 12 weeks. Then, the nicotine dose should be gradually reduced.

Reduction of nicotine dose:

This can be done in 2 ways.

Option 1: Use lower-dose transdermal patches, i.e., NICOTINELL TTS 14 mg/24 hours transdermal patch for 3 to 6 weeks followed by NICOTINELL TTS 7 mg/24 hours transdermal patch for another 3 to 6 weeks in combination with the initial dose of NICOTINELL 1 mg lozenge or NICOTINELL 2 mg chewing gum. Then, the number of lozenges or chewing gums should be gradually reduced. It is generally not recommended to use NICOTINELL 1 mg lozenge or NICOTINELL 2 mg chewing gum for more than 6 months (for initial treatment and nicotine dose reduction). However, some ex-smokers may require longer treatment to prevent relapse, but it should not exceed 9 months.

Option 2: Discontinue the transdermal patches and gradually decrease the number of 1 mg lozenges or 2 mg chewing gums. It is generally not recommended to use NICOTINELL 1 mg lozenge or NICOTINELL 2 mg chewing gum for more than 6 months.

The maximum treatment duration is 9 months (for initial treatment and nicotine dose reduction phase). The combined use of oral forms with transdermal patches should be accompanied by complete smoking cessation and should not exceed a total of 12 weeks.

Mode of administration:

It is recommended to apply the patch after opening it on a dry skin area without cuts, redness, or irritation, and where there is sparse hair (such as the torso, upper arm, etc.). Folded skin areas should be avoided. The patch should be firmly pressed onto the skin with the palm of the hand for 10 to 20 seconds.

A new transdermal patch should be applied every 24 hours on a different application site from the previous one. The same application site should not be used for at least 7 days to avoid the risk of local irritation.

During handling, avoid contact with the eyes and nose, and wash hands thoroughly after application to prevent eye irritation from nicotine on the fingers.

After use, used transdermal patches should be carefully discarded and kept out of sight and reach of children.

Special populations:

Renal impairment: Use with caution in patients with severe renal impairment as the clearance of nicotine and its metabolites may decrease, potentially leading to increased adverse effects.

Hepatic impairment: Use with caution in patients with severe hepatic impairment as the clearance of nicotine and its metabolites may decrease, potentially leading to increased adverse effects.

4.3. Contraindications

· Non-smokers or occasional smokers.

· Hypersensitivity to any of the components.

· Skin conditions that may interfere with the use of a transdermal patch.

4.4. Special warnings and precautions for use

To ensure the best chances of success, the use of this medication should be accompanied by complete smoking cessation.

In case of recent myocardial infarction, unstable or worsening angina (including Prinzmetal's angina), severe cardiac arrhythmias, uncontrolled hypertension, or recent stroke, it is always recommended to first recommend smoking cessation without pharmacological assistance but with psychological support.

In case of failure, the use of NICOTINELL TTS transdermal patch can be considered; however, since clinical safety data in these patients is limited, initiation of treatment should only be done under strict medical supervision. If there is a clinically significant increase in cardiovascular effects or other effects attributable to nicotine, the nicotine transdermal patch dose should be reduced or treatment discontinued.

Nicotine replacement therapies should not be used in combination in patients with known cardiovascular diseases unless the benefits outweigh the risks.

In case of diabetes, blood glucose levels may vary during the period of smoking cessation, with or without nicotine replacement therapy. Therefore, it is important for diabetics to closely monitor their blood glucose when using this product.

In case of an epileptic seizure, the potential risks and benefits associated with nicotine intake should be carefully evaluated before its use in patients taking anticonvulsant medications or with a history of epilepsy, as cases of seizures have been reported with medications containing nicotine.

Nicotine replacement therapies can exacerbate symptoms in patients with esophagitis, oral and pharyngeal inflammation, gastritis, gastric ulcer, or gastro-duodenal ulcer.

NICOTINELL TTS should be used with caution in patients with:

o Severe hypertension, stable angina, cerebrovascular disease, peripheral occlusive arterial disease, or heart failure,

o Diabetes, hyperthyroidism, or pheochromocytoma,

o Severe hepatic and/or renal impairment,

o Gastric ulcer.

Nicotine is a toxic substance. Nicotine doses tolerated by adult smokers can cause severe or even fatal poisoning in young children (see section 4.9).

Even a previously used transdermal system may contain a residual amount of toxic nicotine in children. NICOTINELL TTS should be kept out of the reach and sight of children.

NICOTINELL TTS transdermal patch should be used with caution in patients with skin conditions (see section 4.2). Patients with a history of dermatitis are at higher risk of developing generalized skin disorders or localized erythema, edema, or rash lasting more than 4 days.

In case of severe or persistent skin reactions, it is recommended to discontinue the treatment and use an alternative pharmaceutical form.

The NICOTINELL TTS transdermal patch contains aluminum. Therefore, it should be removed before undergoing magnetic resonance imaging (MRI) to avoid interference.

4.5. Interactions with other medicinal products and other forms of interaction

Tobacco, through a process of enzyme induction due to aromatic hydrocarbons, can decrease blood concentrations of certain drugs such as caffeine, theophylline, imipramine antidepressants, flecainide, and pentazocine.

Smoking cessation, especially when using this medication, can lead to an increase in the concentrations of these active substances due to the reversibility of the enzyme induction effect.

For drugs with a narrow therapeutic margin, such as theophylline, smoking cessation should be accompanied by dose adjustment and close clinical or even biological monitoring, with informing the patient of the risks of overdose.

Due to its specific pharmacological properties (cardiovascular, neurological, and endocrine), nicotine can, like tobacco:

· Lead to an increase in cortisol and catecholamine concentrations,

· Require dose adjustment of nifedipine, beta-blockers, and insulin,

· Reduce the effects of diuretics,

· Slow the healing rate of gastric ulcers when using H2 antihistamines,

· Increase the incidence of adverse effects of estrogen-progestogen combinations.

4.6. Fertility, pregnancy, and lactation

Pregnancy:

1/ Experimental studies conducted in several species have not shown teratogenic or fetotoxic effects of continuous administration of nicotine, even at maternotoxic doses. In the same administration conditions, fetal growth restriction is observed at even higher doses in one species, mice, but not in rats or rabbits.

In clinical practice, limited observations have not shown any deleterious effects, maternal or fetal, of nicotine used for smoking cessation.

2/ Smoking during pregnancy can lead to intrauterine growth restriction, stillbirth, prematurity, and neonatal hypotrophy, which seem to be correlated with the extent of tobacco exposure and the timing of exposure during pregnancy, as these effects occur when tobacco exposure continues during the third trimester.

The nicotine provided by nicotine replacement therapies is not devoid of deleterious effects on the fetus, as evidenced by the observed hemodynamic impact. However, there is no epidemiological study specifying the real impact of nicotine provided by nicotine replacement therapies on the fetus or newborn.

Therefore,

· In pregnant women, complete smoking cessation without nicotine replacement therapy should always be recommended.

· In case of failure in heavily dependent pregnant patients, smoking cessation using this medication is possible. The risk to the fetus associated with continued smoking during pregnancy is likely to be higher than the expected risk of nicotine replacement therapy since tobacco exposure adds exposure to polycyclic hydrocarbons and carbon monoxide, and the exposure to nicotine provided by the replacement therapy is lower or not greater than that associated with tobacco consumption.

The objective is to achieve complete smoking cessation, including discontinuation of nicotine replacement therapies, before the third trimester of pregnancy. Smoking cessation, with or without nicotine replacement therapy, should not be considered in isolation but should be part of comprehensive care, taking into account the psychosocial context and other possible dependencies. It may be advisable to seek specialized consultation for smoking cessation.

In case of partial or complete failure of smoking cessation, the continuation of nicotine replacement therapy after the 6th month of pregnancy can only be considered on a case-by-case basis. The potential effects of nicotine on the fetus should be kept in mind, especially when close to term.

Breastfeeding:

Nicotine is excreted in breast milk. Considering the consistent nicotine concentrations with this form of replacement therapy, breastfeeding is not recommended during treatment with this medication. If smoking cessation is not achieved, oral forms of nicotine replacement therapy should be preferred over NICOTINELL TTS transdermal patches. However, the use of any form of nicotine replacement therapy in breastfeeding women should only be initiated if the expected benefits for the mother outweigh the potential risks for the infant.

Fertility:

In animals, nicotine has been shown to impair fertility (see section 5.3).

In humans, smoking decreases fertility in both men and women, but the specific contribution of nicotine to these effects is not known.

4.7. Effects on ability to drive and use machines.

4.8. Adverse effects

In principle, NICOTINELL TTS can cause adverse effects similar to those of nicotine absorbed through smoking. Description of adverse effects:

A clinical trial showed that skin reactions at the application sites are the most frequent adverse effects. This led to premature discontinuation of NICOTINELL TTS transdermal patches in approximately 4% of trial participants. These reactions include burning at the application site, edema, erythema, irritation, itching, rash, urticaria, and blisters. Most skin reactions resolved within 48 hours, but in more severe cases, erythema and infiltration lasted from 1 to 3 weeks. Significant skin reactions usually occur between 3 and 8 weeks after the start of treatment.

Adverse effects such as upper respiratory tract infection and cough may be related to chronic bronchitis in long-term smokers.

Oral aphthous ulcers may develop in relation to smoking cessation, but any relationship with nicotine treatment has not been established.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr

4.9. Overdose

Nicotine overdose can occur if the treated patient had very low nicotine intake prior to treatment or if other nicotine-based smoking cessation treatments are used concomitantly.

Symptoms of overdose are those of acute nicotine poisoning, including pallor, excessive sweating, vomiting, blurred vision, nausea, hypersalivation, abdominal pain, diarrhea, cold sweats, headache, dizziness, decreased hearing and visual acuity, tremors, mental confusion, and general weakness. At high doses, hypotension, weak and irregular pulse, respiratory distress, prostration, cardiovascular collapse, and seizures may occur.

Nicotine doses tolerated by smoking individuals during treatment can cause acute intoxication that can be fatal in young children.

Management in case of overdose:

Nicotine transdermal patches should be immediately removed in case of overdose or if the patient shows signs of overdose. The patient should immediately consult a doctor. The skin should be washed with water and dried. Soap should not be used as it can increase nicotine absorption.

Nicotine will continue to be released into the bloodstream for several hours after removal of the transdermal patch due to nicotine deposition in the skin.

Overdose by ingestion:

Nicotine intake should be immediately stopped. The patient should immediately consult a doctor and receive symptomatic treatment.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: Drugs used in nicotine dependence, ATC code: N07BA.

Abrupt cessation of tobacco consumption after daily and prolonged use results in a withdrawal syndrome comprising at least four of the following symptoms: dysphoria or depressed mood, insomnia, irritability, feelings of frustration or anger, anxiety, difficulty concentrating, restlessness or impatience, slowed heart rate, increased appetite, weight gain. The sensation of an overpowering need for nicotine is considered a distinct clinical symptom of withdrawal syndrome.

Clinical studies have shown that nicotine replacement products can help smokers abstain from smoking or reduce their tobacco consumption by alleviating withdrawal symptoms.

The harmful effects of continued tobacco intoxication in patients with coronary heart disease and/or patients with a history of stroke have been clearly demonstrated. Studies conducted in these patients have shown no deleterious effects of nicotine replacement therapy.

5.2. Pharmacokinetic properties

Absorption

Nicotine is directly absorbed through the skin into the systemic circulation.

A single application of NICOTINELL TTS in healthy smokers who have quit smoking shows that absorption occurs gradually, and the first detectable levels of nicotine are found 1 to 2 hours after application. Then, a progressive increase in plasma concentrations leads to a plateau reached between 8 to 10 hours after application.

After removal of the transdermal patch, plasma concentrations of nicotine decline more slowly than would be expected based on the plasma elimination half-life of nicotine (after intravenous administration: 2 hours).

The probable existence of cutaneous deposition explains that approximately 10% of nicotine reaching the bloodstream comes from the skin after patch removal. The absolute bioavailability of the transdermal patch, compared to intravenous nicotine infusion, is approximately 77%.

The area under the curve (0-24 h) of nicotine plasma levels increases proportionally to the nicotine dose delivered by NICOTINELL TTS 7 mg, 14 mg, and 21 mg patches per 24 hours. After repeated application of the 14 mg/24 h and 21 mg/24 h patches, average plasma concentrations at steady-state range from 7.1 to 12.0 ng/ml and from 10.3 to 17.7 ng/ml, respectively.

Distribution

The volume of distribution of nicotine is significant, ranging from 1 to 3 l/kg.

Nicotine crosses the blood-brain barrier and the placenta.

Nicotine binding to plasma proteins is negligible (<5%).

Elimination

Elimination occurs mainly via hepatic metabolism, and the main metabolites are cotinine and nicotine 1-N-oxide. Renal elimination of unchanged nicotine is pH-dependent and minimal under alkaline urinary pH conditions.

Nicotine passes into breast milk.

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

7. 6.1. List of excipients

   Alkaline methacrylates copolymer (EUDRAGIT E 100)

   External envelope: Polyester film

   Matrix layer: Durotak 387-2516, miglyol 812, eudragit E 100

   Non-woven backing 26 g/m2 paper

   Adhesive layer: Durotak 387-2516, miglyol 812

   Detachable protective film (43 mm x 41 mm): Silicone-coated aluminum polyester film

   6.2. Incompatibilities Not applicable.

   6.3. Shelf life 3 years.

   6.4. Special precautions for storage Store below 25°C, only in closed sachets.

   6.5. Nature and contents of the outer packaging Transdermal patch, 10 cm2, in sachet (paper/aluminum). Box of 7, 14, 21, or 28.

   Not all pack sizes may be marketed.

   6.6. Special precautions for disposal and handling No special requirements.

   7. MARKETING AUTHORISATION HOLDER GLAXOSMITHKLINE SANTE GRAND PUBLIC 23 RUE FRANCOIS JACOB 92500 RUEIL-MALMAISON

   8. MARKETING AUTHORISATION NUMBER(S) · 34009 334 675 6 2: 17.5mg transdermal patch, 10 cm2, in sachet (paper/aluminum). Box of 7. · 34009 334 676 2 3: 17.5mg transdermal patch, 10 cm2, in sachet (paper/aluminum). Box of 14. · 34009 334 677 9 1: 17.5mg transdermal patch, 10 cm2, in sachet (paper/aluminum). Box of 21. · 34009 334 678 5 2: 17.5mg transdermal patch, 10 cm2, in sachet (paper/aluminum). Box of 28.

   9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [to be completed later by the marketing authorization holder]

   10. DATE OF REVISION OF THE TEXT [to be completed later by the marketing authorization holder]

   11. DOSIMETRY Not applicable.

   12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable.

   CONDITIONS OF PRESCRIPTION AND DELIVERY Medicine not subject to medical prescription.