Nicotinell Support Icemint 4mg medicated chewing gum

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Nicotine

Доступна з:

Haleon UK Ltd

Код атс:

N07BA01

ІПН (Міжнародна Ім'я):

Nicotine

Дозування:

4mg

Фармацевтична форма:

Medicated chewing-gum

Адміністрація маршрут:

Oromucosal

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04100200; GTIN: 5051562034502

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOTINELL ICEMINT 2 MG
NICOTINELL ICEMINT 4 MG
NICOTINE
MEDICATED CHEWING-GUMS
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) and
five flavours (Fruit, Mint,
Icemint, Liquorice and Classic). This leaflet is for Nicotinell
Icemint 2mg and 4mg medicated
chewing-gums.
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.
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 whe

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicotinell Icemint 4 mg, medicated_ _chewing-gums
Nicotinell Support Icemint 4mg medicated Chewing Gum
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:
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 t