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Nicotinell TTS patches are meant to help adults, 18 and older, who want to stop smoking. It isindicated for smoking cessation in people wishing to stop their cigarette consumption. Nicotinell patches are thus used in the treatment of tobacco dependence and support the symptoms of nicotine withdrawal.
Nicotine 35mg for a transdermal patch of 0.14g with an effective surface of 20cm².
The other components 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 g/m2 paper. Adhesive layer: Durotak 387-2516, Miglyol 812. Detachable protective sheet: siliconed aluminized polyester film.
Here's how to use the patch:
- Open the packet and peel off the protective layer from the patch.
- Stick the patch onto a clean, dry, and hairless area of your skin like your trunk, arm, or chest.
- Press down firmly on the patch and smooth the edges to ensure it sticks well.
- Leave the patch on for 24 hours and use a different spot for each new patch. Don't put a new patch on the same spot several days in a row.
After using, fold the used patch onto itself and throw it away safely out of children's reach. Don't cut the patch. Remember to wash your hands after handling the patch. If you go swimming, you can either remove the patch and stick it back on later, or cover it with a waterproof bandage. Just avoid directing shower water straight onto the patch.
However, not everyone should use these patches. Don't use Nicotinell if you're a non-smoker or only smoke occasionally, allergic to any of the patch's materials, or have a skin condition that would interfere with the patch. If you have liver or kidney problems, stomach or duodenal ulcers, you should talk to your doctor before using Nicotinell.
Take note of any symptoms like a craving to smoke, irritability, sleep problems, restlessness, impatience, or difficulty concentrating, which might indicate you're not getting enough nicotine. If you're experiencing symptoms like nausea, abdominal pain, diarrhea, excessive saliva, sweating, headache, dizziness, hearing loss, or general weakness, you may be getting too much nicotine.
Don't forget to tell your doctor or pharmacist about any other medicines you're taking. And, if you're pregnant or breastfeeding, consult a healthcare professional before using Nicotinell or any other medication.
The patches are available in packs of 7 or 28. Remember, they're only for adults 18 and over, not for children or teenagers below this age.
Please read the following full disclosure before purchasing or using this product:
SUMMARY OF PRODUCT CHARACTERISTICS
ANSM - Updated on: 09/02/2022
- NAME OF THE MEDICINAL PRODUCT
NICOTINELL TTS 14 mg/24 H, transdermal device
- QUALITATIVE AND QUANTITATIVE COMPOSITION
S(-)-Nicotine .......................................................................................................................... 35 mg
For a 1.3 g transdermal device with an effective surface area of 20 cm2.
For the complete list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Transdermal device.
- CLINICAL DATA
4.1. Therapeutic indications
This medicine is indicated for the treatment of tobacco dependence to alleviate the symptoms of nicotine withdrawal in individuals wishing to stop their tobacco consumption.
4.2. Dosage and method of administration
Dosage
Pediatric Population
Reserved for adults 18 years older.
It is recommended for adolescents not to use the treatment in combination with other nicotine replacement therapies.
It is not recommended to use NICOTINELL TTS in children under 18 years old. The degree of nicotine dependence will be assessed by the number of cigarettes consumed per day or by the Fagerström test.
This medication can be used as monotherapy or in combination with oral forms of nicotine substitutes such as NICOTINELL 2mg chewing gums or NICOTINELL 1mg lozenges.
In case of combination, it is advisable to seek medical advice.
The dosage of the transdermal system should be adjusted to the individual response: increasing the dose if abstinence from smoking is not complete or if withdrawal symptoms are observed, decreasing in case of suspected overdose.
The duration of treatment is about 3 months but can vary according to the 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 gums or NICOTINELL 1 mg lozenges):
People who, despite well-conducted monotherapy, continue to feel irresistible cravings to smoke, or people who have failed in monotherapy, can combine transdermal devices with an oral form acting more rapidly on withdrawal symptoms, such as NICOTINELL 2 mg chewing gums or NICOTINELL 1 mg lozenges.
The combination of transdermal devices with oral forms has yielded superior results to those obtained for each treatment taken separately.
Initial Treatment
It is advisable to start treatment with a 21mg/24 h transdermal device in combination with NICOTINELL 2mg chewing gums or NICOTINELL 1mg lozenges each time the urge to smoke appears. At least 4 tablets (1 mg) or chewing gums (2 mg) should be used. In most cases, 5 to 6 1 mg tablets or 2 mg chewing gums are sufficient. Do not take more than 15 1 mg tablets or 2 mg chewing gums per day.
In normal circumstances, treatment should last 6 to 12 weeks. Then, the nicotine dose should be gradually reduced.
Reducing the Nicotine Dose:
This can be done in 2 ways.
Option 1: Use transdermal devices at a lower dose, that is: NICOTINELL TTS 14 mg / 24 hours, transdermal device for 3 to 6 weeks followed by NICOTINELL TTS 7 mg / 24 hours, transdermal device again for 3 to 6 weeks in combination with the initial dose of NICOTINELL 1 mg, lozenge or NICOTINELL 2mg, medicinal chewing gum. Then, the number of tablets or gums should be gradually reduced. It is generally not recommended to use NICOTINELL 1 mg, lozenge or NICOTINELL 2 mg, medicinal chewing gum for more than 6 months (for the initial treatment and reducing the nicotine dose). However, some ex-smokers may need longer treatment to avoid relapse into smoking, but this should not exceed 9 months.
Option 2: Discontinuation of transdermal devices and gradual reduction in the number of 1 mg tablets or 2 mg chewing gums. It is generally not recommended to use NICOTINELL 1 mg, lozenge or NICOTINELL 2 mg, medicinal chewing gum for more than 6 months.
Mode of Administration
It is recommended to apply the device after opening on a dry skin surface without skin lesions, without redness or irritation, and where hair is sparse (trunk, upper part of the arm,...). Areas of skin folds should be avoided. The device should be pressed firmly onto the skin with the palms of the hands for 10 to 20 seconds.
A new transdermal device will 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 in order to avoid the risk of local irritation.
During handling, avoid contact with the eyes, nose and wash hands thoroughly after application to avoid eye irritation with the nicotine present on the fingers.
After use, used transdermal patches must be disposed of carefully and kept out of sight and reach of children.
Special Populations:
Renal insufficiency: Use with caution in patients with severe renal insufficiency as the clearance of nicotine and its metabolites may decrease, potentially leading to increased adverse effects.
Hepatic insufficiency: Use with caution in patients with severe hepatic insufficiency as the clearance of nicotine and its metabolites may decrease, potentially leading to increased adverse effects.
4.3. Contraindications
· Non-smoker or occasional smoker.
· Hypersensitivity to any of the constituents
· Skin condition that may hinder the use of a transdermal device
4.4. Special warnings and precautions for use
To ensure the best chances of success, the use of this medication must be accompanied by a complete cessation of smoking.
In case of recent myocardial infarction, unstable or worsening angina (including Prinzmetal angina), severe cardiac arrhythmias, uncontrolled high blood pressure or recent stroke, it is always recommended to first stop smoking without pharmacological aid but with psychological support.
If unsuccessful, the use of the NICOTINELL TTS transdermal device can be considered; however, clinical safety data in these patients are limited, so treatment should only be initiated under strict medical supervision. In case of a clinically significant increase in cardiovascular effects or other effects attributable to nicotine, the dosage of the nicotine transdermal device should be reduced or the treatment stopped.
Nicotine replacement therapies in combination should not be used in patients with known cardiovascular diseases unless the benefits outweigh the risks.
In case of diabetes, blood sugar may vary during the smoking cessation period, with or without nicotine replacement therapy. Therefore, it is important for diabetics to closely monitor their blood sugar levels when using this product.
In case of seizure, the potential risks and benefits associated with nicotine use should be carefully evaluated before use in patients taking anticonvulsant medications or with a history of epilepsy, as cases of seizures have been reported with the use of nicotine-containing medications.
Nicotine replacement therapies may exacerbate symptoms in patients suffering from esophagitis, oral and pharyngeal inflammation, gastritis, gastric ulcer or duodenal ulcer.
NICOTINELL TTS should be used with caution in patients with:
· severe hypertension, stable angina, cerebrovascular disease, peripheral artery disease, heart failure,
· diabetes, hyperthyroidism or pheochromocytoma,
· severe liver and/or kidney insufficiency,
· gastric ulcer.
Nicotine is a toxic substance. The doses of nicotine tolerated by adult smokers can cause serious or even fatal poisoning in young children (see section 4.9).
Even a used transdermal patch may contain a residual amount of nicotine toxic to children. NICOTINELL TTS should be kept out of sight and reach of children.
NICOTINELL TTS, transdermal device should be used with caution in patients with skin conditions (see section 4.2). Patients with a history of dermatitis are more at risk of developing generalized skin disorders or localized erythema, swelling, or a rash lasting more than 4 days.
In case of severe or persistent skin reaction, it is recommended to stop treatment and use another pharmaceutical form.
The NICOTINELL TTS transdermal device contains aluminium. Therefore, it should be removed before an MRI (magnetic resonance imaging) examination to avoid interferences.
4.5. Interactions with other medicinal products and other forms of interaction
Tobacco can, through a process of enzymatic induction due to aromatic hydrocarbons, decrease blood concentrations of certain drugs such as caffeine, theophylline, imipraminic antidepressants, flecainide, and pentazocine.
The cessation, especially abrupt cessation, of tobacco use, particularly when this medication is taken, can lead to an increase in the concentrations of these active substances related to the reversibility of the enzyme induction effect.
For drugs with a narrow therapeutic range, such as theophylline, quitting smoking should be accompanied, in addition to dosage adjustment, by close clinical and possibly biological monitoring, with information given to the patient about the risks of overdosing.
Through its specific pharmacological properties, cardiovascular, neurological and endocrine, nicotine can, like tobacco:
· lead to an increase in cortisol and catecholamine concentrations,
· require a dosage adjustment of nifedipine, beta-blockers, insulin,
· reduce the effects of diuretics,
· slow the healing rate of gastric ulcers by H2 antihistamines,
· increase the incidence of side effects of estroprogestatives.
4.6. Fertility, pregnancy, and breastfeeding
Pregnancy
1/ Experimental studies carried out in several species have not shown a teratogenic or fetotoxic effect of nicotine administered at a continuous rate, even at maternotoxic doses. Under the same administration conditions, fetal growth retardation is observed at even higher doses in one species, the mouse, but not in the rat or rabbit.
In the clinic, a still limited number of observations do not show any harmful maternal or fetal impact of nicotine used in the indication for smoking cessation.
2/ Smoking in pregnant women can cause intrauterine growth retardation, fetal death in utero, prematurity, neonatal growth retardation, which seem to be correlated with the extent of tobacco exposure as well as the period of pregnancy as these effects are observed when tobacco exposure continues into the third trimester.
The nicotine provided by substitution treatments is not without harmful effects on the fetus, as evidenced by the observed hemodynamic impact. However, there is no epidemiological study specifying the actual impact of the nicotine provided by substitution treatments on the fetus or newborn.
Therefore,
· in pregnant women, it is always recommended to completely stop tobacco consumption, without nicotine replacement therapy;
· in the event of failure with a heavily dependent patient, smoking cessation with this medication is possible. Indeed, the risk incurred for the fetus, in case of continued smoking during pregnancy, is likely higher than that expected during nicotine replacement therapy, as tobacco adds exposure to polycyclic hydrocarbons and carbon monoxide, and the exposure to nicotine provided by the substitution treatment is lower or is not higher than that related to tobacco consumption.
The goal is to achieve complete cessation of tobacco use, or even substitution treatments, before the third trimester of pregnancy. Quitting smoking, with or without substitution treatments, should not be considered in isolation but should be part of comprehensive care, taking into account the psychosocial context and any other associated dependencies. It may be desirable to consult a specialist in smoking cessation.
In the event of partial or complete failure of withdrawal, continuing treatment with a nicotine substitute after the 6th month of pregnancy can only be considered on a case-by-case basis. The effects of nicotine itself, which could impact the fetus, especially when it is near term, should be kept in mind.
Breastfeeding
Nicotine is excreted in breast milk. Given the consistency of nicotine concentrations with this form of substitution, breastfeeding is not recommended during treatment with this medication. If smoking cessation is not achieved, oral forms of nicotine replacement therapy should be favored over NICOTINELL TTS, transdermal device. 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, it has been shown that nicotine can impair fertility (see section 5.3).
In humans, smoking decreases the fertility of both men and women, the specific contribution of nicotine to these effects is not known.
4.7. Effects on the ability to drive vehicles and use machines
Not applicable.
Not applicable.
4.8. Adverse effects
In principle, NICOTINELL TTS can cause side 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 side effects. This led to the premature discontinuation of NICOTINELL TTS, a transdermal device in about 4% of the participants in the clinical trial. These reactions include burning at the application site, edema, erythema, irritation, itching, rash, hives, and vesicles. 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 induced in long-time smokers.
Mouth ulcers may develop in connection with smoking cessation, but any relation to nicotine treatment is not established.
Declaration of suspected adverse effects
The declaration of suspected adverse effects after authorization of the drug is important. It allows for continuous monitoring of the drug's benefit/risk ratio. Healthcare professionals report any suspected adverse effects through the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.
4.9. Overdose
An overdose of nicotine may occur if the patient being treated previously had very low nicotine intake or if they concurrently use other nicotine-based treatments for smoking cessation.
Symptoms of overdose are those of acute nicotine poisoning including paleness, hyperhidrosis, vomiting, blurred vision, nausea, hypersalivation, abdominal pain, diarrhea, cold sweats, headaches, dizziness, reduced auditory and visual acuity, tremors, mental confusion, and general weakness. At high doses, hypotension, weak and irregular pulse, respiratory distress, prostration, cardiovascular collapse, and convulsions may appear.
The doses of nicotine tolerated by smoking subjects during treatment can lead to acute poisoning that can be fatal in young children.
Procedure 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 surface should be washed with water then dried. Soap should not be used as it can increase the absorption of nicotine.
Nicotine will continue to be released into the bloodstream for several hours after the removal of the transdermal device due to a deposit of nicotine in the skin.
Overdose by ingestion:
All nicotine intake must be immediately stopped. The patient should immediately consult a doctor and should be treated symptomatically.
- PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: DRUGS USED IN NICOTINE DEPENDENCE, ATC code: N07BA.
Abrupt cessation of tobacco use after daily and prolonged use results in a withdrawal syndrome that includes 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 urgent need for nicotine is considered a separate 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 decreasing withdrawal symptoms.
The harmful effects of continued tobacco poisoning in patients with coronary disease and/or patients with a history of stroke have been clearly demonstrated. Studies in these patients have shown no deleterious effect of nicotine substitutes.
5.2. Pharmacokinetic properties
Absorption
Nicotine is directly absorbed through the skin into the systemic circulation.
Single application of NICOTINELL TTS in a healthy smoker, who has stopped smoking, shows that absorption occurs gradually and that the first detectable levels of nicotine are found 1 to 2 hours after application. Then, a gradual rise in plasma concentrations leads to a plateau reached between 8 to 10 hours after application.
After removal of the transdermal device, plasma concentrations of nicotine decrease more slowly than the half-life of nicotine elimination (after intravenous administration: 2 hours) would suggest.
The probable existence of a skin deposit explains that about 10% of the nicotine reaching the bloodstream comes from the skin after removal of the device. The absolute bioavailability of the transdermal device, compared to intravenous infusion of nicotine, is about 77%.
The areas under the curve (0-24 h) of nicotine levels increase proportionally to the nicotine dose delivered by the NICOTINELL TTS 7 mg, 14 mg, and 21 mg per 24 h transdermal devices. After repeated application of the 14 mg / 24 h and 21 mg / 24 h devices, mean plasma concentrations at steady state vary respectively from 7.1 to 12.0 ng/ml and from 10.3 to 17.7 ng/ml.
Distribution
The volume of distribution of nicotine is significant, ranging between 1 and 3 l/kg.
Nicotine passes the blood-brain barrier and into the placenta.
The binding of nicotine to plasma proteins is negligible (<5%).
Elimination
Its elimination is mainly hepatic, and the main metabolites are cotinine and nicotine 1-N-oxide. The renal elimination of unchanged nicotine is pH-dependent and minimal in case of alkaline urine pH.
Nicotine passes into breast milk.
5.3. Preclinical safety data
Not applicable.
- PHARMACEUTICAL DATA
6.1. List of excipients
Alkaline methacrylates copolymer (EUDRAGIT E 100)
Outer cover:
Polyester film
Matrix layer:
Durotak 387-2516, miglyol 812, eudragit E 100
Non-woven support
Paper 26 g/m2
Adhesive layer
Durotak 387-2516, miglyol 812.
Removable protective sheet (58 mm x 56 mm)
Siliconized aluminized polyester film.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store at a temperature below 25°C, only in sealed sachets.
6.5. Nature and contents of the outer packaging
Transdermal device of 20 cm2, in sachet (paper/aluminium). Box of 7, 14, 21 or 28.
6.6. Special precautions for disposal and handling
No special requirements.
- MARKETING AUTHORISATION HOLDER
GLAXOSMITHKLINE CONSUMER HEALTHCARE
23 RUE FRANCOIS JACOB
92500 RUEIL-MALMAISON
- MARKETING AUTHORISATION NUMBER(S)
· 34009 334 679 1 3: 35 mg in 20 cm2 transdermal device in sachet (paper/aluminium). Box of 7.
· 34009 334 681 6 3: 35 mg in 20 cm2 transdermal device in sachet (paper/aluminium). Box of 14.
· 34009 334 682 2 4: 35 mg in 20 cm2 transdermal device in sachet (paper/aluminium). Box of 21.
· 34009 334 683 9 2: 35 mg in 20 cm2 transdermal device in sachet (paper/aluminium). Box of 28.
- DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[to be completed later by the holder]
- DATE OF REVISION OF THE TEXT
[to be completed later by the holder]
- DOSIMETRY
Not applicable.
- INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
PRESCRIPTION AND DISPENSING CONDITIONS
Medication not subject to medical prescription.
NICOTINELL TTS has no or negligible influence on the ability to drive and use machines. However, it should be remembered that nicotine withdrawal syndrome can alter the ability to react and therefore caution should be exercised when driving a vehicle or operating machinery.
4.8. Undesirable effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The undesirable effects are similar to those obtained with other forms of nicotine replacement therapies and are dose-dependent. Many of the adverse effects are typical of nicotine withdrawal symptoms.
The most commonly reported adverse reactions are application site reactions (pruritus, erythema, burning sensation, edema, and urticaria).
Less commonly, systemic adverse events such as palpitations, headache, nausea and vomiting, dizziness, insomnia, and dyspepsia have been reported.
4.9. Overdose
Cases of overdose are rare and usually occur in those who have ingested nicotine. Nicotine intoxication should be suspected if the following symptoms occur: pallor, cold sweat, nausea, salivation, abdominal pain, diarrhea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion.
In severe cases, the following symptoms may occur: hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and generalized convulsions.
In case of overdose or suspected overdose, medical attention should be sought immediately. The patient should be kept under close surveillance.
- Pharmacological properties
5.1. Pharmacodynamic properties
NICOTINELL TTS is a nicotine replacement therapy (NRT) that releases nicotine, which is then absorbed transdermally. Nicotine binds to nicotine receptors in the central nervous system, enhancing the release of neurotransmitters, including dopamine. Dopamine plays a critical role in mediating the reinforcement and reward effect of smoking.
5.2. Pharmacokinetic properties
The transdermal system delivers nicotine at a constant rate, maintaining stable plasma nicotine levels over 24 hours, thus avoiding the peaks and troughs associated with intermittent dosage forms. The nicotine is metabolized in the liver and excreted mainly via the urine.
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
5.4. Storage and Shelf Life
Keep out of the reach and sight of children.
Store at room temperature below 25°C. Do not use NICOTINELL TTS after the expiry date which is stated on the box.
Remember to always follow the instructions provided in the patient information leaflet or given by your doctor or pharmacist. These measures are designed to help you quit smoking, and remember that willpower is always the most important factor. If you need further help or information, consult your doctor or pharmacist.
