Nicorette freshmint 2 mg Lozenges

Product Details & Mandatory Information

Nicotine lozenges to aid smoking cessation in smokers with low to moderate tobacco dependence.

Mandatory Information

Nicorette® Freshmint 2 mg Lozenges

Active Ingredient: Nicotine.

Indications

Nicorette® Freshmint 2 mg Lozenges are used to relieve nicotine withdrawal symptoms and reduce cravings for smoking. They support adult smokers aged 18 and over in quitting smoking or gradually reducing their cigarette consumption.

Suitable for smokers with low to moderate tobacco dependence, for example:

• First cigarette more than 30 minutes after waking up

• Up to 20 cigarettes per day

The lozenges help with typical withdrawal symptoms such as:

• Cravings

• Irritability

• Nervousness

• Restlessness

• Difficulty concentrating

• Sleep disturbances

• Increased appetite

Application

Allow the lozenge to dissolve slowly in the mouth. Occasionally move it from one side of the mouth to the other.

• Do not chew

• Do not swallow whole

• Do not eat or drink during use

A lozenge usually dissolves completely within approximately 20 minutes.

Dosage for adults aged 18 and over

Immediate cessation

• Initially 8–12 lozenges daily

• Use 1 lozenge each time a craving occurs

• After about 6 weeks, gradually reduce the daily number

• Stop use as soon as only 1–2 lozenges are needed daily

Gradual reduction

• Replace individual cigarettes with lozenges

• Continuously reduce cigarette consumption

• Then complete cessation and gradual tapering off of the lozenges

Maximum daily dose

• No more than 15 lozenges within 24 hours

Children and adolescents

• Adolescents aged 12 to 17 years only after medical consultation

• Not suitable for children under 12 years

Contraindications

Nicorette® Freshmint 2 mg Lozenges must not be used:

• In case of hypersensitivity to nicotine or any of the other ingredients

• In children under 12 years

• By non-smokers

Pregnancy and lactation

During pregnancy, smoking cessation should ideally be achieved without nicotine replacement therapy. If this is not possible, use should only occur after medical consultation.

During lactation, use should ideally be avoided. If necessary, the lozenge should be used immediately after breastfeeding.

Interactions

Please inform your doctor or pharmacist if you are taking other medications simultaneously, especially with:

• Theophylline

• Tacrine

• Clozapine

• Ropinirole

Possible side effects

Very common

• Headaches

• Cough

• Hiccups

• Nausea

• Irritation of the mouth, tongue, or throat

Common

• Dry mouth

• Indigestion

• Abdominal pain

• Flatulence

• Diarrhea

• Vomiting

• Heartburn

• Fatigue

• Hypersensitivity reactions

Occasional

• Palpitations

• Increased blood pressure

• Skin rash

• Itching

• Increased sweating

• Difficulty breathing

• Mouth ulcers

• Belching

• Sleep disturbances

Rare

• Difficulty swallowing

• Decreased sensation in the mouth

Severe allergic reactions

Discontinue use immediately and seek medical attention if any of the following symptoms occur:

• Swelling of the face, lips, tongue, or throat

• Shortness of breath

• Difficulty swallowing

• Hives

Composition

Active ingredient

• 2 mg nicotine per lozenge (as nicotine resinate)

Other ingredients

Tablet core:

• Mannitol (E421)

• Xanthan gum

• Peppermint flavor

• Sodium carbonate (E500)

• Sucralose (E955)

• Acesulfame potassium (E950)

• Magnesium stearate

Film coating:

• Hypromellose (E464)

• Peppermint flavor

• Titanium dioxide (E171)

• Sucralose (E955)

• Acesulfame potassium (E950)

• Polysorbate 80 (E433)

• Microcrystalline cellulose (E460)

• Muscovite (E555)

Special features

• Sugar-free

• Fresh mint flavor

• Discreet application

• Supports smoking cessation and reduction

• Suitable for adult smokers with low to moderate nicotine dependence