Nicotinell Icemint 4mg medicated chewing gum

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Nicotine

Commercializzato da:

Novartis Consumer Health UK Ltd

Codice ATC:

N07BA01

INN (Nome Internazionale):

Nicotine

Dosaggio:

4mg

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: 5051562020109

Foglio illustrativo

Recto
Pharma code XXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use Nicotinell chewing-
gum carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your doctor, nurse or pharmacist if you need
more information or advice.
• If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
1. What Nicotinell chewing-gum is and what it is
used for
2. 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. Further 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 available in two strengths
(2 mg and 4 mg). This leaflet is for Nicotinell
Support Icemint 2mg and 4mg medicated
chewing-gum.
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 the
tobacco smoke such as tar and carbon monoxide.
Follow the chewing technique instructions in
section 3 to get the best effect.
The gum contains a number of ingredients which
help remove dental staining, chewing Nicotinell
Gums will help improve the whiteness of your teeth.
Nicotinell 2mg and 4mg gums can be used to help
you:
• Stop smoking completely
• Cut down the amount you smoke – perhaps
before you go on to stop completely
In addition, they may be used when you:
• Do not wish to smoke. For example in confined
spaces (in the car; in the house) or where others
(such as children) could be harmed by tobacco
smoke
• Are unable to smoke
• Develop cravings onc

Scheda tecnica

OBJECT 1
NICOTINELL ICEMINT 4MG MEDICATED CHEWING GUM
Summary of Product Characteristics Updated 04-Apr-2016 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Nicotinell Icemint 4 mg, medicated chewing-gums
2. Qualitative and quantitative composition
One piece of medicated chewing gum contains 4 mg 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 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
ADULTS AND ELDERLY
One piece of Nicotinell gum to be chewed when the user feels the urge
to smoke. Normally, 8-12 pieces
per day can be used, up to a maximum of 15 pieces per day.
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:
If an adverse event is noted when high dose forms are initiated, this
should be replaced by the lower
dosage form.
The characteristics of chewing-gum as a pharmaceutical form are such
that individually different nicotine
levels can result in the blood. Therefore, dosage frequency should be
adjusted according to individual
requirements within the stated maximum limit.
Directions for use:
1. One piece of gum should be chewed until the taste becomes strong.
2. The chew