Nicotinell Support Icemint 2mg medicated chewing gum

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Nicotine

Commercializzato da:

Haleon UK Ltd

Codice ATC:

N07BA01

INN (Nome Internazionale):

Nicotine

Dosaggio:

2mg

Forma farmaceutica:

Medicated chewing-gum

Via di somministrazione:

Oromucosal

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04100200; GTIN: 5051562034304

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOTINELL ICEMINT 2 MG
NICOTINELL ICEMINT 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 or pharmacist 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 or pharmacist. 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 aborbed 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.
The gum contains a number of ingredients which help remove dental
staining, chewing Nicotinell
Gums will help improve the whiteness of your teeth.
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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicotinell Icemint 2mg Medicated Chewing Gum
Nicotinell Support Icemint 2mg medicated Chewing Gum
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One piece of medicated chewing gum contains 2 mg nicotine (as 10 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 is indicated in pregnant and lactating women making a
quit
attempt.
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 2 mg chewing gum is recommended in smokers with a low to
moderate nicotine dependency.
The 2 mg chewing gum may not be well suited to smokers with
a strong or very strong nicotine dependency.
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. Norma