Nicotinell Kauwgom cool mint 4mg

What this product is used for

Used as an aid to help stop smoking.

Do not use if

• You are allergic to nicotine or any of the other ingredients in this medicine. These ingredients are listed in section 6.
• You are a non-smoker.

Take extra care

Risk warning:

Pregnancy and breastfeeding

• Pregnancy: Do NOT use unless specifically advised by a doctor.
• Breastfeeding: Do NOT use unless specifically advised by a doctor.

Active ingredient

Each Nicotinell chewing gum contains 4 mg nicotine (as 20 mg nicotine polacrilex).

Excipients

Gum base (contains butylated hydroxytoluene (E321)), calcium carbonate, sorbitol (E420), anhydrous sodium carbonate, sodium bicarbonate, polacrilex, glycerol (E422), purified water, levomenthol, natural mint flavour, mint millicaps, sucralose, acesulfame potassium, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax and talc.

Dosage

To improve your chances of quitting smoking successfully, you should stop smoking completely when you start using the gum and throughout the entire treatment period.

Nicotinell chewing gum is available in two strengths: 2 mg and 4 mg. The appropriate strength depends on your previous smoking habits.

You should use Nicotinell 4 mg chewing gum if:

• You are a smoker with a strong or very strong nicotine dependence (more than 30 cigarettes per day).
• You were previously unsuccessful in quitting smoking using the 2 mg gum.
• Your withdrawal symptoms remain so severe that there is a risk of relapsing.

If none of the above applies, the 2 mg gum should be used.

If the higher strength (4 mg) causes side effects, switching to the lower strength (2 mg) should be considered.

Method of administration

Start using the product on your quit day. To quit smoking successfully with this treatment, you must stop smoking completely.

Chew one piece of gum whenever you feel the urge to smoke.

• Do not use more than one piece at a time.
• Do not use more than one piece per hour.

1. Chew the gum slowly until the taste becomes strong.
2. Stop chewing and place the gum between your gum and cheek.
3. Start chewing again when the taste fades.
4. Repeat this process for about 30 minutes to allow gradual nicotine release.

Do not swallow the gum.

Adults aged 18 years and over

Chew one piece of gum whenever you feel the urge to smoke. Generally, one piece should be used every one to two hours. Usually, 8–12 pieces per day are sufficient.

If you still feel the urge to smoke, additional pieces may be used.

Do not use more than 15 pieces of the 4 mg gum per day.

Treatment duration varies from person to person but should normally continue for at least 3 months. After 3 months, gradually reduce the number of gums used each day. Treatment should stop when consumption has been reduced to 1–2 pieces per day.

In general, Nicotinell should not be used for longer than 6 months. Some former smokers may require a longer treatment period to prevent relapse.

If you are still using the gum after 9 months, consult your doctor or pharmacist.

Following professional support and advice increases your chances of success.

Use in children and adolescents

Nicotinell should not be used by persons under 18 years of age unless recommended by a doctor.

Directions for use

• Chew slowly until the taste becomes stronger.
• Do not eat or drink while chewing.
• Place the gum between the gum and cheek.
• Chew again when the taste fades.
• Repeat this process for approximately 30 minutes for gradual nicotine release.
• Use the 4 mg strength if you smoke more than 30 cigarettes per day.
• For 20–30 cigarettes per day, the strength depends on user preference and individual characteristics.
• At the start, use one gum every 1–2 hours; usually 8–12 pieces per day are sufficient.
• After 3 months, gradually reduce the dosage and stop when using only 1–2 pieces per day.
• It is recommended not to use the product for longer than 6 months.
• If you have not stopped using the gum after 9 months, consult your doctor.

Marketing Authorisation Holder

GlaxoSmithKline Consumer Healthcare B.V.
Van Asch van Wijckstraat 55G
3811 LP Amersfoort
The Netherlands

Always read the package leaflet.