Nicotinell Liquorice 4mg medicated chewing gum

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nicotine

Available from:

Haleon UK Ltd

ATC code:

N07BA01

INN (International Name):

Nicotine

Dosage:

4mg

Pharmaceutical form:

Medicated chewing-gum

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04100200; GTIN: 5012131574300

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOTINELL LIQUORICE 2 MG
NICOTINELL LIQUORICE 4 MG
NICOTINE
MEDICATED CHEWING-GUMS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor orpharmacist has
told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctoror pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor orpharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1.
What Nicotinell chewing-gum is and what it is used for
2.
What you need to know before you take Nicotinell chewing-gum
3.
How to take Nicotinell chewing-gum
4.
Possible side effects
5.
How to store Nicotinell chewing-gum
6.
Contents of the pack and other information
1.
WHAT NICOTINELL CHEWING-GUM IS AND WHAT IT IS USED FOR
Nicotinell medicated chewing-gum is a nicotine replacement therapy
(NRT) which is used to help you
to stop smoking. It is used to relieve and /or prevent withdrawal
symptoms and reduce the cravings
you get when you try and stop smoking or when cutting down on the
number of cigarettes you smoke.
It is available in two strengths (2 mg and 4 mg).
The chewing-gum contains nicotine, which is one of the substances in
tobacco. When chewed,
nicotine is released slowly and absorbed through the lining of the
mouth. Nicotinell chewing-gum
does not contain the other harmful substances found in tobacco smoke
such as tar and carbon
monoxide.
Ideally you should always aim to stop smoking completely, but
Nicotinell gums can be used in a
number of ways to help you:
•
cut down the amount you smoke – perhaps before you go on to stop
completely.
•
to reduce the number of cigarettes you smoke - which can increase the
chances that you will
move on to quit completely
In addition, they m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicotinell
®
liquorice 4mg medicated chewing gum
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One piece of medicated chewing gum contains 4mg nicotine (as 20 mg
nicotine – polacrilin (1:4)).
For excipients, see section 6.1
3
PHARMACEUTICAL FORM
Medicated chewing gum.
Each piece of coated chewing gum is off-white in colour and
rectangular in shape.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicotinell gum relieves and/or prevents craving and nicotine
withdrawal
symptoms associated with tobacco dependence. It is indicated to aid
smokers
wishing to quit or reduce prior to quitting, to assist smokers who are
unwilling
or unable to smoke, and as a safer alternative to smoking for smokers
and
those around them.
_ _
Nicotinell gum should preferably be used in conjunction with a
behavioural
support programme.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS OVER 18 YEARS OF AGE AND THE ELDERLY
The 4 mg chewing gum is intended to be used by smokers with a strong
or very strong nicotine dependency and those who have previously
failed to stop smoking with the aid of nicotine replacement therapy.
The
optimal dosage form is selected according to the following table:
Low to
moderate
dependency
Moderate to strong dependency
Strong to very
strong dependency
Less than 20 cigarettes /
day
From 20 to 30 cigarettes / day
Over 30 cigarettes / day
Low dose forms
are preferable
(2 mg gum)
Low (2 mg gum) or high (4 mg
gum) dose forms are acceptable
depending on patient characteristics
and preference.
High dose forms
are preferable
(4 mg gum)
Low dosage forms acceptable
High dosage forms acceptable
If an adverse event is noted when high dose forms are initiated, this
should be replaced by the lower dosage form.
One piece of Nicotinell gum to be chewed when the user feels the urge
to
smoke. Do not use more than 1 gum per hour. Normally, 8-12 pieces per
day can be used, up to a maximum of 15 pieces per day.
The characteristics of chewing-gum as a pharmaceu