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Nicotinell 4 mg fresh mint, chewing gum, is a medicine containing nicotine , a substance present in tobacco. Nicotinell belongs to the range of nicotine substitutes for quitting smoking.
Nicotine is released slowly through the oral mucosa upon chewing the gum.
This medication is used as part of the treatment of tobacco addiction to relieve the symptoms of nicotine withdrawal in people wishing to quit smoking.
One chewing gum contains 4.00 mg of nicotine as nicotine-polacrilin (1:4) (20.00 mg).
The other ingredients are gum base (containing butylhydroxytoluene [E 321]), calcium carbonate, sorbitol (E 420), anhydrous sodium carbonate, sodium bicarbonate, polacriline, glycerol (E 422), levomenthol, acesulfame potassium, wax of Carnauba, talc, xylitol (E 967), mannitol (E 421), gelatin, titanium dioxide (E 171), purified water; saccharin, sodium saccharin (Nicotinell Fruit), sucralose, natural mint flavor.
The excipients with known effect are sodium, sorbitol.
Nicotinell 4mg fresh mint is available in boxes of 24 or 96 chewing gums.
Dosage of Nicotinell gummies 4 mg fresh mint
The chances of successful treatment are increased by completely stopping smoking . Nicotinell gum
Reserved for adults, are available in 2 dosages: 2 mg with Nicotinell 2 mg fresh mint and 4 mg. The right dosage for you depends on your level of nicotine addiction. In children under 18, this medication cannot be delivered without medical advice. Nicotinell 4 mg fresh mint is indicated for smokers who are highly to very highly dependent on nicotine, following a failure with the Nicotinell 2 mg dosage, or for smokers with withdrawal symptoms that are still significant with a risk of relapse. 2 mg gummies are indicated in other cases.
In case of appearance of undesirable effects observed with the use of chewing gum 4 mg, use gum dosed at 2 mg.
Method of administration : Nicotinell 4 mg fresh mint gums are used orally. One has to chew the gum and once the taste of it becomes strong, one places the gum between the gum and the cheek. We start chewing the gum again when the taste has faded. We alternate chewing and breaks over 30 minutes.
The gummies must be taken as soon as you feel like smoking, at the rate of 1 gummi every 1 to 2 hours, with 8 to 12 gummies per day. Failing that, chew a gum whenever you feel the urge to smoke. The maximum dose of Nicotinell fresh mint 4 mg is 15 gummies per day.
Duration of treatment : Duration of treatment depends on individual response, but should be continued for at least 3 months. After these 3 months, it is necessary to gradually reduce the number of chewing gums per day to stop the treatment when consuming 1 to 2 gums per day. Treatment beyond 6 months is not justified, except to avoid possible relapses. Taking Nicotinell 4 mg gum, beyond 9 months, requires advice from a health professional.
In the event of an overdose, signs similar to an excess of cigarettes are observed: general weakness, sweating, hypersalivation, throat irritation, nausea, vomiting, diarrhea, abdominal pain, hearing and visual disturbances, headaches , palpitations, shortness of breath and circulatory problems. Similarly, if your child has accidentally ingested Nicotinell 4 mg fresh mint gum, contact your doctor or an emergency service, as nicotine is dangerous in children. Keep Nicotinell 4 mg gums out of reach of children.
Contraindications of Nicotinell fresh mint 4mg chewing gum
If you are not usually a smoker or if you have an allergy to nicotine or to any of the excipients contained in Nicotinell, this medicine is contraindicated for you.
In addition, in the event of the following disorders, it is important to contact your doctor or pharmacist before taking Nicotinell 4 mg gum because the latter requires medical advice: cardiovascular disease (myocardial infarction, heart failure, angina pectoris, Prinzmetal's angina , heart rhythm disorder), history of stroke, high blood pressure, circulatory problems, liver and/or kidney failure, diabetes, thyroid disease (hyperthyroidism), peochromocytoma (disease of the adrenal glands causing severe high blood pressure), inflammation of the mouth or throat, esophagitis, gastritis, stomach or duodenal ulcer.
Chewing gums sometimes cause chewing difficulties for denture wearers. In this case, it is recommended to stop the treatment and use another pharmaceutical form. Ask your doctor or pharmacist.
Tell your doctor or pharmacist if you are taking medication or simply if in doubt. Quitting smoking can affect the action of certain drugs, such as theopylline (a drug used in the treatment of asthma), tacrine (a drug used in the treatment of schizophrenia), olanzapine and clozapine (a medicine used to treat diabetes) or insulin (a medicine used to treat diabetes). A dose adjustment may be necessary.
Avoid food and drink while taking Nicotinell 4mg gummies.
Tobacco use during pregnancy harms you and your baby and can lead to stunted growth, even premature birth or fetal death. Consult your doctor if you want to quit smoking before taking Nicotinell 4 mg gum.
Similarly, when breastfeeding nicotine passes into breast milk, smoking and taking Nicotinell 4 mg gum are therefore not recommended. Consult your doctor about quitting smoking. If your doctor allows you to take Nicotinell 4 mg gum, it should be used immediately after breastfeeding and not during the two hours before the next breastfeeding.
Please read the following full disclosure before purchasing or using this product.
SUMMARY OF PRODUCT CHARACTERISTICS
ANSM - Updated on: 22/11/2021
- NAME OF THE MEDICINAL PRODUCT
NICOTINELL MINT FRESHNESS 4 mg SUGAR FREE, medicinal chewing gum
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotine ............................................................................................................ 4.00 mg
In the form of nicotine-polacrilin (1: 4) ............................................................................ 20.00 mg
For a medicinal chewing gum.
Excipients: Sorbitol (0.1 g), and butylhydroxytoluene (E 321).
For the full list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Medicinal chewing gum.
White, rectangular-shaped gum.
- CLINICAL DATA
4.1. Therapeutic indications
This medicine is indicated in the treatment of tobacco addiction in order to alleviate the symptoms of nicotine withdrawal in individuals wishing to stop their tobacco use.
NICOTINELL MINT FRESHNESS 4 mg gums are recommended when you experience significant withdrawal symptoms.
Proper support increases the chances of success in quitting smoking.
4.2. Dosage and method of administration
Dosage
Adults over 18 years and elderly
Patients must stop smoking completely during treatment with this medicine.
The 4 mg chewable gums are recommended for smokers who are heavily or very heavily dependent on nicotine and for those who have failed in a previous attempt to quit smoking with nicotine replacement therapy.
In case of adverse effects when using 4 mg chewing gums, use the 2 mg chewing gums.
The initial dosage choice should be determined according to individual needs based on nicotine dependence.
Chew a gum each time the urge to smoke appears.
The consumption of 4 mg chewing gums is usually 8 to 12 gums per day and must not exceed 15 gums per day. Do not use more than one gum per hour.
The characteristics of this pharmaceutical form are such that the nicotine levels obtained can vary from one individual to another. The frequency of administration will be adjusted accordingly, depending on individual needs within the maximum dosage limit.
The duration of treatment is individual. Normally, this treatment should be continued for at least three months.
After three months, the patient should gradually reduce the number of gums per day until the treatment is completely stopped.
The treatment will be stopped when consumption is reduced to 1 to 2 gums per day.
It is generally recommended not to use the chewing gums beyond 6 months. However, some "ex-smokers" may need a longer treatment to prevent relapses. Patients who have used a nicotine substitute beyond 9 months are advised to seek advice from a health professional.
Advice from a health professional can help a smoker quit smoking.
This medicine does not contain sugar.
Children and adolescents
NICOTINELL MINT FRESHNESS 4 mg sugar-free, chewing gum should not be administered in subjects under 18 years without medical advice. There is no experience of administering this medicine in subjects under 18 years.
Renal and hepatic impairment
This medicine should be used with caution in patients with moderate to severe renal impairment and/or moderate to severe hepatic impairment, as clearance of nicotine or its metabolites may be decreased with an increased potential for adverse effects.
Administration mode
· Chew the gum until the taste becomes strong.
· Place the gum between the gum and cheek.
· When the taste fades, chew the gum again.
· Alternate chewing and breaks for 30 minutes.
Drinking acidic drinks such as coffee or soda can decrease the absorption of nicotine through the oral mucosa. These drinks should be avoided in the 15 minutes preceding the intake of a chewing gum.
4.3. Contraindications
Interactions with other medicinal products and other forms of interaction:
Concomitant use of NICOTINELL MINT FRESHNESS chewing gum with certain medications or substances may affect their effectiveness or increase the risk of adverse effects. It is important to inform healthcare professionals about all medications, including over-the-counter products and herbal supplements, being taken.
Interactions may occur with the following:
- Medications that may decrease the effectiveness of NICOTINELL MINT FRESHNESS chewing gum:
-
Carbamazepine, phenobarbital, phenytoin (antiepileptic drugs): These medications may increase the breakdown of nicotine in the body, reducing its effectiveness.
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St. John's Wort (herbal supplement): St. John's Wort may increase the breakdown of nicotine, reducing its effectiveness.
- Medications that may increase the risk of adverse effects of NICOTINELL MINT FRESHNESS chewing gum:
-
Cimetidine (used to treat stomach ulcers and acid reflux): Cimetidine may increase nicotine blood levels and the risk of adverse effects.
-
Fluvoxamine (antidepressant): Fluvoxamine may increase nicotine blood levels and the risk of adverse effects.
- Medications affected by nicotine:
-
Insulin: Nicotine may affect insulin sensitivity and blood glucose levels in people with diabetes. Close monitoring of blood glucose levels is recommended when using NICOTINELL MINT FRESHNESS chewing gum.
-
Theophylline (used to treat asthma and chronic obstructive pulmonary disease): Nicotine may increase the breakdown of theophylline, reducing its effectiveness.
-
Warfarin (anticoagulant): Nicotine may affect the breakdown of warfarin, potentially altering its anticoagulant effect. Close monitoring of prothrombin time (INR) is recommended.
These are not all the possible interactions. It is important to consult a healthcare professional or pharmacist for specific advice based on individual circumstances and medications being taken.
There are no relevant clinical data on possible interactions between nicotine gum and other medications.
Smoking cessation itself requires certain therapeutic adjustments. Smoking, but not nicotine, is associated with an increase in the activity of the enzyme CYP1A2. Smoking cessation may result in a decrease in the clearance of substrates of this enzyme and an increase in plasma levels of certain drugs metabolized by CYP1A2, particularly those with a narrow therapeutic margin such as theophylline, tacrine, olanzapine, and clozapine.
In addition, the increased subcutaneous absorption of insulin that occurs when quitting smoking may require a reduction in the insulin dose.
4.6. Fertility, pregnancy, and lactation
Pregnancy:
Smoking during pregnancy is associated with reproductive risks and intrauterine growth retardation. It is recommended, in the first instance, to advise pregnant women to quit smoking without the aid of nicotine replacement therapy. If unsuccessful, the use of nicotine replacement therapy can be considered. However, the use of oral nicotine replacement therapy should only be considered after assessing that the benefits to the mother outweigh the potential risks to the fetus.
Breastfeeding:
Nicotine passes into breast milk in quantities that may affect the child even at therapeutic doses. NICOTINELL gum, like smoking, should be avoided during breastfeeding. If smoking cessation is not achieved, the use of the gum during breastfeeding should only be decided upon medical advice. If this medicine is used during breastfeeding, the gum should be taken immediately after breastfeeding and should not be taken during the two hours preceding the next breastfeeding session. The use of oral nicotine replacement therapy can only be administered after assessing that the benefits to the mother outweigh the potential risks to the child.
Fertility:
Smoking increases the risk of infertility in both women and men. Both in men and in animals, it has been demonstrated that nicotine can impair sperm quality. In animals, a decrease in fertility has been demonstrated.
4.7. Effects on ability to drive and use machines
There is no evidence of any risk regarding the ability to drive or operate machinery when using the gum at the recommended doses. However, it should be taken into consideration that smoking cessation may cause behavior changes.
4.8. Undesirable effects
The nicotine from chewing gum can cause adverse effects similar to nicotine absorbed through smoking due to the pharmacological effects of nicotine, which are dose-dependent. Non-dose-dependent adverse effects include jaw pain, erythema, urticaria, hypersensitivity, angioedema, and anaphylactic shock.
Most reported adverse effects occur during the first 3 to 4 weeks of treatment.
The nicotine delivered by the gum can sometimes cause mild throat irritation and increased salivation at the beginning of treatment.
Swallowing too much nicotine can cause hiccups. Individuals with digestive disorders may experience mild signs of dyspepsia or heartburn at the beginning. Symptoms can be relieved by chewing the gum more slowly.
Excessive consumption of chewing gum by individuals who did not inhale tobacco smoke can cause nausea, dizziness, and headaches.
The occurrence of aphthous ulcers may be more frequent when quitting smoking.
In rare cases, the gum may cause alteration to dental prostheses or amalgam fillings if adhered to them.
Some symptoms such as dizziness, headaches, and insomnia may be related to smoking cessation and may be due to inadequate nicotine dosage.
Cold sores may occur when quitting smoking, but their relationship with nicotine treatment is not established.
The patient may remain nicotine-dependent after quitting smoking.
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 encouraged to report any suspected adverse reactions via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the Regional Pharmacovigilance Centers network - Website: www.signalement-sante.gouv.fr.
4.9. Overdose
In case of overdose, symptoms corresponding to heavy tobacco consumption may be observed.
The acute lethal dose orally is approximately 0.5 to 0.75 mg of nicotine per kg of body weight, which corresponds to 40 to 60 mg in adults.
Even low doses of nicotine are toxic in children and can cause symptoms of intoxication that can be fatal. In case of suspected intoxication in a child, immediate medical attention should be sought.
An overdose with nicotine gum can only occur if multiple gums are chewed at the same time. Generally, the toxicity of nicotine after ingestion is minimized by the occurrence of early nausea and vomiting.
The risk of intoxication from swallowing the gum is low. The release of nicotine from the gum is slow, and the amount of nicotine absorbed by the stomach and intestines is very low, and if any were absorbed, it would be inactivated in the liver.
Signs and symptoms of overdose should be the same as those of acute nicotine poisoning, including general weakness, sweating, pallor, excessive sweating, hypersalivation, sore throat, nausea, vomiting, diarrhea, abdominal pain, auditory and visual disturbances (sensory disorders), headaches, dizziness, tremors, confusion, and fatigue. Prostration, hypotension, cardiovascular collapse, coma, respiratory failure, and seizures may occur in cases of significant overdose.
Treatment of overdose:
In case of overdose (e.g., excessive chewing of gums), immediate medical assistance is required. Nicotine intake should be immediately stopped, and the patient should be treated symptomatically with vital signs monitoring.
- Pharmacological properties
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: MEDICINE USED IN NICOTINE DEPENDENCE, ATC code: N07BA01.
Mechanism of action
Nicotine, the primary alkaloid in tobacco-derived products, is a naturally occurring substance that acts on the autonomic nervous system. It is an agonist of nicotinic receptors in the central and peripheral nervous systems, exerting pronounced effects on the central nervous system and cardiovascular system. When consumed through tobacco, nicotine creates dependence, resulting in a sense of craving and other withdrawal symptoms upon cessation of administration. These withdrawal symptoms include an intense urge to smoke, dysphoria, insomnia, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness, and increased appetite or weight gain. Chewing gums replace a portion of the nicotine that would have been delivered through tobacco and reduce the intensity of withdrawal symptoms and strong cravings to smoke.
Pharmacokinetic properties
Absorption
When the gum is chewed, nicotine is continuously released in the mouth and rapidly absorbed through the buccal mucosa. Due to the swallowing of saliva containing nicotine, a certain amount of nicotine reaches the stomach and intestines where it is inactivated.
Distribution
The peak plasma concentration after a single administration of a 4 mg gum is approximately 9.3 ng/ml (after 60 minutes) (the average nicotine level after smoking a cigarette is 15 to 30 ng/ml).
Elimination
Nicotine is primarily eliminated through hepatic metabolism, with small amounts of unchanged nicotine excreted in the urine. The plasma half-life is approximately 3 hours.
Nicotine crosses the blood-brain barrier, placenta, and is detectable in breast milk.
Preclinical safety data
Nicotine has shown positive results in some in vitro genotoxicity tests; however, negative results have also been obtained with the same tests. Nicotine has shown negative results in in vivo tests.
Animal experiments have shown that nicotine causes post-implantation loss and decreases fetal growth.
The results of carcinogenicity tests have not provided clear evidence of a carcinogenic effect of nicotine.
- Pharmaceutical particulars
6.1. List of excipients
Chewing gum base (containing butylhydroxytoluene (E321)), calcium carbonate, sorbitol (E420), anhydrous sodium carbonate, sodium bicarbonate, polacrilin, glycerol (E422), purified water, levomenthol, natural mint flavor, mint fragrance, sucralose, potassium acesulfame, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax, talc.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
30 months.
6.4. Special precautions for storage
Store at a temperature not exceeding +25°C.
6.5. Nature and contents of the pack
2 or 12 chewing gums in blister packs (PVC/PVDC/Aluminium).
Boxes of 2, 12, 24, 36, 48, 60, 72, 96, 120, or 204.
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and handling
The disposal of used gums should be done with caution.
- MARKETING AUTHORISATION HOLDER
GLAXOSMITHKLINE SANTE GRAND PUBLIC
23 RUE FRANCOIS JACOB
92500 RUEIL MALMAISON
- MARKETING AUTHORISATION NUMBER(S)
· 363 154-0 or 34009 363 154 0 2: 2 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 363 155-7 or 34009 363 155 7 0: 12 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 363 156-3 or 34009 363 156 3 1: 24 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 363 158-6 or 34009 363 158 6 0: 36 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 363 159-2 or 34009 363 159 2 1: 48 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 363 160-0 or 34009 363 160 0 3: 60 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 363 161-7 or 34009 363 161 7 1: 72 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 363 162-3 or 34009 363 162 3 2: 96 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 373 304-5 or 34009 373 304 5 9: 120 chewing gums in blister packs (PVC/PVDC/Aluminium).
· 393 955-1 or 34009 393 955 1 7: 204 chewing gums in blister packs (PVC/PVDC/Aluminium).
- DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[to be completed by the marketing authorisation holder]
- DATE OF REVISION OF THE TEXT
[to be completed by the marketing authorisation holder]
- DOSIMETRY
Not applicable.
- INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND DELIVERY
Medicine not subject to medical prescription.
