Nicorette Coolmint 2 mg, 40 lozenges

Nicorette Coolmint 2 mg lozenges are a discreet way to combat nicotine cravings and quitting symptoms in the form of a small lozenge.

• The tablets dissolve quickly in the mouth, helping to control nicotine cravings and easing nicotine withdrawal symptoms.

Nicorette Coolmint 2 mg lozenges are intended for use in the treatment of tobacco dependence by relieving nicotine withdrawal symptoms and cravings in smokers aged 18 years and over. The ultimate goal of their use is to permanently stop using tobacco products.

Whenever possible, Nicorette Coolmint 2 mg lozenges should be used in conjunction with a behavioural support programme.

Each lozenge contains 2 mg of nicotine (in the form of nicotine with cation exchanger).

Tablet core: Mannitol (E 421) Winterfresh RDE4-149 spray-dried xanthan gum (gum arabic (E 414), peppermint, menthol and eucalyptus flavours) Sodium carbonate anhydrous (E 500)(i) Sucralose (E 955) Acesulfame potassium (E 950) Magnesium stearate (E 470b).
Coating: Hypromellose (E 464) Winterfresh RDE4-149 (peppermint, menthol and eucalyptus flavours) Titanium dioxide (E 171) Sucralose (E 955) Sepifilm Gloss (hypromellose (E 464), microcrystalline cellulose (E 460), potassium aluminium silicate (E 555), titanium dioxide (E 171)) Acesulfame potassium (E 950) Polysorbate 80 (E 433).

The choice of lozenge strength to use depends on the patient’s smoking habits.

Adults

Nicorette Coolmint 2 mg lozenges are suitable for smokers with a low level of nicotine dependence, i.e. those who smoke their first cigarette during the day more than 30 minutes after waking up or who smoke 20 or fewer cigarettes per day. The lozenges should not be used for longer than 9 months. If the patient still feels the need for treatment, they should consult a healthcare professional. Behavioural therapy, including advice and support, usually increases the rate of successful treatment outcomes.

Immediate smoking cessation:
The patient should make every effort to stop smoking completely during treatment with Nicorette Coolmint.

Lozenges should be used whenever the urge to smoke occurs. A sufficient number of lozenges should be taken per day, most smokers usually need 8 to 12 lozenges, not exceeding 15 lozenges.

The duration of treatment is determined individually, but a period of up to six weeks is generally recommended to break the habit of smoking. Then the dose of nicotine should be gradually reduced by reducing the total number of lozenges used per day. Treatment should be discontinued when the dose is reduced to 1-2 lozenges per day.

Use a lozenge whenever you feel the urge to smoke to maintain complete abstinence from smoking. Keep any remaining lozenges in case you experience a sudden craving or urge to smoke.

Gradual smoking cessation by progressively reducing the number of cigarettes smoked:
For use by smokers who are unwilling or unable to quit smoking immediately.

Use the lozenge between smoking episodes to control the urge to smoke and extend the breaks between inhalations of cigarette smoke, aiming to reduce smoking as much as possible.

The number of lozenges used per day varies and depends on the patient’s needs. However, it should not exceed 15 lozenges per day.

If the number of cigarettes smoked per day has not been reduced after 6 weeks, the patient should seek professional advice.

Reducing tobacco use should lead to complete cessation of smoking. A quit attempt should be made as soon as the patient feels ready, but no later than 6 months after starting treatment. Once the number of cigarettes has been reduced to a level where the patient feels ready to quit completely, the recommended “immediate cessation” regimen outlined above should be followed. If a complete quit attempt has not been made within 6 months of starting treatment, consultation with an appropriate healthcare professional is recommended.

Method of administration

For use on the oral mucosa. Place one tablet in the mouth and wait for it to dissolve. Periodically move the tablet from one side of the mouth to the other and repeat this action until the tablet is completely dissolved (approximately 16-19 minutes). The tablet should not be chewed or swallowed whole.

Do not eat or drink while the lozenge is in your mouth.

Nicorette Coolmint 2 mg lozenges should only be used in adolescents (aged 12-17 years) if prescribed by a doctor. Nicorette Coolmint is contraindicated for use in children under 12 years of age. The safety and efficacy of Nicorette Coolmint 2 mg lozenges in children and adolescents have not been established.

Hypersensitivity to nicotine or any of the excipients.
Use in children under 12 years of age.
Use in people who have never smoked.