NiQuitin Fresh Mint 2mg medicated chewing gum

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Nicotine

Διαθέσιμο από:

Omega Pharma Ltd

Φαρμακολογική κατηγορία (ATC):

N07BA01

INN (Διεθνής Όνομα):

Nicotine

Δοσολογία:

2mg

Φαρμακοτεχνική μορφή:

Medicated chewing-gum

Οδός χορήγησης:

Oromucosal

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04100200; GTIN: 5000347078415 5000347078422 5000347078439

Φύλλο οδηγιών χρήσης

The Marketing Authorisation holder is Omega Pharma Ltd,
32 Vauxhall Bridge Road, London, SW1V 2SA, UK. and all
enquiries should be sent to this address.
NiQuitin is a registered trade mark of ELAN PHARMA
INTERNATIONAL LTD.
The leaflet was last revised in October 2015.

Αρχείο Π.Χ.Π.

OBJECT 1
NIQUITIN FRESH MINT 2 MG MEDICATED CHEWING
GUMS
Summary of Product Characteristics Updated 30-Dec-2015 | Omega Pharma
Ltd
1. Name of the medicinal product
NiQuitin Fresh Mint 2 mg Medicated Chewing Gums.
2. Qualitative and quantitative composition
Each medicated chewing gum contains 2 mg nicotine (equivalent to 10.9
mg nicotine resinate).
Excipients with known effect:
Sorbitol (E 420) 156.31 mg/piece gum
Maltitol liquid 25 mg/piece gum
Butyhydroxytoluene (E 321) 0.49 mg/piece gum
Sodium 11.4 mg /piece gum.
For full list of excipients see 6.1.
3. Pharmaceutical form
Medicated chewing gum.
Off-white rectangular pillow-shaped gum.
4. Clinical particulars
4.1 Therapeutic indications
NiQuitin Fresh Mint 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.
NiQuitin Fresh Mint Gum is indicated in pregnant and lactating women
making a quit attempt.
NiQuitin Fresh Mint Gum should preferably be used in conjunction with
a behavioural support
programme.
4.2 Posology and method of administration
_DIRECTIONS FOR USE:_
NiQuitin Fresh Mint Gum should be chewed slowly according to the
instructions.
NiQuitin Fresh Mint 2 mg Gum is suitable for smokers who have their
first cigarette of the day more than
30 minutes after waking up.
Behavioural therapy, advice and support will normally improve the
success rate.
The chewing gums should be used whenever there is an urge to smoke
according to the “chew and rest“
technique described on the pack. After about 30 minutes of such use,
the gum will be exhausted. Not
more than 15 pieces of the chewing gum may be used each day.
Absorption of nicotine is through the buccal mucosa, any nicotine
which is swallowed being destroyed by
the liver.
ADULTS (18 YEARS AND OVER)
_ABRUPT CESSATION OF SMOKING:_
Users should make every effort to