Description
Nicotinell Fresh Mint 2mg is indicated for the treatment of tobacco dependence in order to relieve nicotine withdrawal symptoms in subjects wishing to stop smoking. Although permanent cessation of smoking is preferred, Nicotinell Fresh Mint 2mg can be used in: - when a smoker is temporarily abstaining from smoking, - a smoking reduction strategy as a step towards permanent cessation.
Directions for use
How to use
By mouth. To be active, the nicotine contained in the gum and released by chewing must be absorbed by the oral mucosa. If the nicotine is swallowed with saliva, it has no effect. It is therefore important not to chew the gum too vigorously.
Steps :
- Chew the gum until the taste becomes strong.
- Place the gum between the gum and the cheek for about 10 minutes.
- When the taste fades, chew the gum again.
- Alternate chewing and pausing for 30 minutes, after which time the gum will no longer deliver nicotine.
The 2 mg nicotine gum is not suitable for smokers who are strongly or very strongly dependent on nicotine (Fagerström test score of 7 to 10 or smoking more than 20 cigarettes a day).
Duration of treatment
The duration of use is limited to 12 months.
Precautions for use
In cases of recent myocardial infarction, unstable or worsening angina (including Prinzmetal's angina), severe heart rhythm disorder, unstable hypertension or recent stroke, complete cessation of smoking without nicotine replacement therapy should always be recommended first. In case of failure in these nicotine-dependent smokers, the use of NICOTINELL MENTHE FRAICHEUR 2 mg Gum may be considered; however, clinical safety data in these patients are limited and initiation of treatment should only be under medical supervision. NICOTINELL Chewing Gum should be used with caution in patients with high blood pressure, stable angina, cerebrovascular disease, peripheral arterial occlusive disease, heart failure, diabetes, hyperthyroidism or pheochromocytoma, or severe hepatic or renal insufficiency. In these patients, complete cessation of smoking without nicotine replacement therapy should first be recommended. Swallowed nicotine may exacerbate symptoms in patients with esophagitis, oral or pharyngeal inflammation, gastritis or gastric ulcer. Doses of nicotine tolerated by adult smokers may cause severe or fatal intoxication in young children (see section 4.9). Denture wearers may have difficulty chewing gum: in this case, the use of another pharmaceutical form of nicotine replacement is recommended. Special warnings related to excipients: This medicine contains sorbitol. Therefore, patients with rare hereditary problems of fructose intolerance should not take this medicine. NICOTINELL MENTHE FRAICHEUR 2 mg gum contains 0.2 g/g of sorbitol (E420), a source of fructose at 0.04 g/g. The caloric intake of each gum is 1.0 Kcal/gum. This medicine contains 11.50 mg of sodium per chewing gum. This medicine contains hydroxytoluene (E321), which may cause local irritation of the oral mucosa.
Contraindications
Do not take Nicotinell Fresh Mint 2 mg sugar-free chewing gum in the following cases: - if you do not smoke or if you are an occasional smoker - in case of hypersensitivity to any of the ingredients.
Pregnancy and breastfeeding
Pregnancy
It is very important for you and your baby to stop smoking during pregnancy. Treatment with nicotine replacement products during pregnancy requires medical advice and monitoring. You should therefore consult the health professional who is following your pregnancy or your usual doctor or a doctor in a centre specialising in smoking cessation.
Breastfeeding
If you smoke heavily and do not plan to stop smoking, you should not breastfeed your child but use artificial milk. The use of this medicine should be avoided while breast-feeding, as nicotine passes into breast milk. However, if you wish to stop smoking and breastfeed your child, consult your doctor or a doctor at a centre specialising in smoking cessation.
Composition
The active substance is (for a medicated chewing gum):
Nicotine: 2 mg In the form of polacrilex nicotine
The other components are: Gum base (containing butylated hydroxytoluene (E321)), calcium carbonate, sorbitol (E420), sodium carbonate anhydrous, sodium bicarbonate, polacriline, glycerol (E422), purified water, levomenthol, natural mint flavour, mint fragrance, sucralose, acesulfame potassium, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax, talc.
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