NiQuitin Fresh Mint 2mg Medicated Chewing Gum

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nicotine

Available from:

Chefaro Ireland DAC

ATC code:

N07BA; N07BA01

INN (International Name):

Nicotine

Dosage:

2 milligram(s)

Pharmaceutical form:

Medicated chewing-gum

Administration route:

oral use

Units in package:

4, 10, 30, 100 and 200

Prescription type:

Product not subject to medical prescription

Therapeutic group:

Drugs used in nicotine dependence

Therapeutic area:

Drugs used in nicotine dependence; nicotine

Therapeutic indications:

NiQuitin Fresh Mint Medicated Chewing Gum is used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms including cravings during a quit attempt. Permanent cessation of tobacco use is the eventual objective.

Authorization status:

Not marketed

Authorization date:

2015-07-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NIQUITIN FRESH MINT 2 MG OR 4MG MEDICATED CHEWING GUM
NICOTINE
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 healthcare professional has
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask a healthcare professional e.g. doctor, nurse, smoking cessation
advisor or pharmacist if
you need more information or advice.
-
If you get any side effects, talk to your healthcare professional.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you have not been able to stop smoking
after 9 months of
treatment with NiQuitin Fresh Mint 2 mg or 4mg Medicated Chewing Gums.
-
Throughout this leaflet NiQuitin Fresh Mint 2 mg and 4 mg Medicated
Chewing Gums are
referred to as NiQuitin Fresh Mint Gums.
WHAT IS IN THIS LEAFLET
1.
What NiQuitin Fresh Mint Gums are and what they are used for
2.
What you need to know before you use NiQuitin Fresh Mint Gums
3.
How to use NiQuitin Fresh Mint Gums
4.
Possible side effects
5.
How to store NiQuitin Fresh Mint Gums
6.
Contents of the pack and other information
1.
WHAT NIQUITIN FRESH MINT GUMS ARE AND WHAT THEY ARE USED FOR
NiQuitin Fresh Mint Gums are used to help people stop smoking. This
type of treatment is called
Nicotine Replacement Therapy or NRT.
It is the nicotine in cigarettes that can make you physically addicted
to them.
•
NiQuitin Fresh Mint Gums help you to give up smoking by replacing some
of the nicotine you
get from cigarettes.
•
This nicotine relieves some of the unpleasant symptoms that smokers
may have when they try
to give up. These include feeling ill or irritable.
•
The nicotine can also relieve your cravings for a cigarette and help
you to resist the urge to
smoke.
NiQuitin Fresh Mint Gums do not have the health dangers of tobacco.
This is because they do not
contain the tar, carbon monoxide or othe

Summary of Product characteristics

Health Products Regulatory Authority
24 January 2023
CRN00CX6Y
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NiQuitin Fresh Mint 2mg Medicated Chewing Gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewing gum contains 2 mg nicotine (equivalent to 14.20 mg
nicotine resinate)
Excipients with known effect:
Butylated hydroxytoluene (E321) 0.4266 mg/piece gum
Sorbitol (E420) 148.65 mg/piece gum
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated Chewing Gum
Off-white rectangular pillow shaped gum and is approximately 20 x 12
mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NiQuitin Fresh Mint Medicated Chewing Gum is used for the treatment of
tobacco dependence by relief of nicotine withdrawal
symptoms including cravings during a quit attempt (see section 5.1).
Permanent cessation of tobacco use is the eventual
objective.
NiQuitin Fresh Mint Medicated Chewing Gum should preferably be used in
conjunction with a behavioural support programme.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Users should make every effort to stop smoking completely during
treatment with NiQuitin Fresh Mint Medicated Chewing
Gums.
_Adults (18 years and over)_
NiQuitin Fresh Mint Medicated Chewing Gum 2mg is suitable for smokers
who smoke fewer than 20 cigarettes a day.
Behavioural therapy, advice and support will normally improve the
success rate.
The initial dosage should be individualised on the basis of the
patients nicotine dependence.
One piece of NiQuitin Fresh Mint Medicated Chewing Gums should be
chewed as directed whenever there is an urge to smoke,
to maintain complete abstinence from smoking.
Sufficient gums should be used each day usually 8-12, up to a maximum
of 15.
The treatment duration depends onthe needs of each smoker. In general
the use of the medicated chewing gum is 2- 3
months then the use of gums may be reduced gradually. When daily use
is 1-2 gums, use should be stopped. Any spare gums
should be retained, as cravings may suddenly return.
_