NiQuitin Extra Fresh Mint 2mg medicated chewing gum

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Nicotine

Fáanlegur frá:

Omega Pharma Ltd

ATC númer:

N07BA01

INN (Alþjóðlegt nafn):

Nicotine

Skammtar:

2mg

Lyfjaform:

Medicated chewing-gum

Stjórnsýsluleið:

Oromucosal

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04100200; GTIN: 5012616264603 5012616264627 5012616264641

Upplýsingar fylgiseðill

2
MG OR
4
MG
MEDICATED CHEWING GUM
EXTRA FRESH MINT
NICOTINE
IN THIS LEAFLET:
1. What NiQuitin Extra Fresh Mint Gum does
2. Check before you use NIQUITIN EXTRA FRESH MINT GUM
3.
How to use NIQUITIN EXTRA FRESH MINT GUM
4.
Possible side-effects
5.
How to store NIQUITIN EXTRA FRESH MINT GUM
6.
Further information
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use
NIQUITIN EXTRA FRESH MINT GUM carefully to get the best results from
it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask a healthcare professional
(doctor,
nurse, smoking cessation advisor or pharmacist).
• Throughout this leaflet NIQUITIN EXTRA FRESH MINT 2 MG & 4 MG
MEDICATED CHEWING GUMS are referred to as NIQUITIN EXTRA FRESH MINT GUM.
1. WHAT NIQUITIN EXTRA FRESH MINT GUM DOES
2. CHECK BEFORE YOU TAKE NIQUITIN EXTRA FRESH MINT GUM
3. HOW TO USE NIQUITIN EXTRA FRESH MINT GUM
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE NIQUITIN EXTRA FRESH MINT GUM
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use this medicine after the ‘EXP’ date shown on the
blister
pack and outer packaging. The expiry date refers to the last day of
the month.
• Store in the original package.
• Do not store above 25˚C.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
WHAT NIQUITIN EXTRA FRESH MINT GUM CONTAINS
THE ACTIVE SUBSTANCE IS NICOTINE. Each piece of gum contains 2 mg or 4
mg (in the form of a resin complex called nicotine resinate). THE
OTHER INGREDIENTS ARE chewing gum base, contains butylated
hydroxytoluene (E321), Sorbitol (E420), Xylitol (E967), Calcium
Carbonate
(E170), Sodium Carbonate anhydrous (E500), Glycerol (E422), Acesulfame
Potassium (E950), Sucralose (E995), Talc and Flavours. Coating
contains Xylitol (E967), Mannitol (E421),

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
NiQuitin Extra Fresh Mint 2 mg Medicated Chewing Gum
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated chewing gum contains 2 mg nicotine (equivalent to 14.20
mg
nicotine resinate).
Excipients with known effect:
Sorbitol (E 420)
148.65 mg/piece gum
Sodium 10.42 mg /piece gum.
Xylitol (E967) 365.11mg/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 Extra 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.
This product is indicated in pregnant and lactating women making a
quit attempt.
NiQuitin Extra 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 Extra Fresh Mint Gum should be chewed slowly according to the
instructions.
NiQuitin Extra Fresh Mint 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 stop smoking completely during
treatment
with NiQuitin Extra Fresh Mint Gum.
NiQuitin Extra Fresh Mint Gum should be chewed a