Nicorette freshmint 4 mg Lozenges

Product Details & Mandatory Information

Nicotine lozenges to aid smoking cessation in cases of severe tobacco dependence.

Mandatory Information

Nicorette® Freshmint 4 mg Lozenges

Active ingredient: Nicotine.

Areas of Application

Nicorette® Freshmint 4 mg lozenges are used to relieve nicotine withdrawal symptoms and reduce the craving for smoking. They help adult smokers aged 18 and over to quit smoking or gradually reduce cigarette consumption.

Suitable for smokers with severe tobacco dependence, for example:

• First cigarette within 30 minutes of waking up

• More than 20 cigarettes per day

The lozenges help with typical withdrawal symptoms such as:

• Craving for cigarettes

• Irritability

• Nervousness

• Restlessness

• Difficulty concentrating

• Sleep disturbances

• Increased appetite

Application

Slowly let the lozenge dissolve in your 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 about 20 minutes.

Dosage for Adults aged 18 and over

Immediate Smoking Cessation

• Start with 8–12 lozenges daily

• Use 1 lozenge each time you have a craving for cigarettes

• After about 6 weeks, gradually reduce the daily number

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

Gradual Smoking Reduction

• Replace individual cigarettes with lozenges

• Continuously reduce cigarette consumption

• Then completely quit smoking and gradually taper off the lozenges

Maximum Daily Dose

• No more than 15 lozenges within 24 hours

Children and Adolescents

• Adolescents aged 12 to 17 years only on medical prescription

• Not suitable for children under 12 years

Contraindications

Nicorette® Freshmint 4 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 be made after consulting a doctor.

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

Interactions

Please inform your doctor or pharmacist if you are taking other medications at the same time, 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

If you experience any of the following symptoms, stop use immediately and seek medical attention:

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

• Shortness of breath

• Difficulty swallowing

• Hives

Composition

Active ingredient

• 4 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 smoking reduction

• Suitable for smokers with strong nicotine dependence

For information on effects and possible undesirable effects, please refer to the package leaflet, consult your doctor, or pharmacist.