NiQuitin Tropical Fruit 2 mg medicated chewing gum

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Nicotine

Tilgjengelig fra:

Chefaro Ireland DAC

ATC-kode:

N07BA; N07BA01

INN (International Name):

Nicotine

Dosering :

2 milligram(s)

Legemiddelform:

Medicated chewing-gum

Administreringsrute:

oral use

Enheter i pakken:

4, 10, 30, 100 and 200

Resept typen:

Product not subject to medical prescription

Terapeutisk gruppe:

Drugs used in nicotine dependence

Terapeutisk område:

Drugs used in nicotine dependence; nicotine

Indikasjoner:

NiQuitin 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.

Autorisasjon status:

Not marketed

Autorisasjon dato:

2015-07-24

Informasjon til brukeren

Package leaflet: Information for the user
NiQuitin Tropical Fruit 2 mg and 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 Tropical Fruit 2 mg or 4mg Medicated Chewing
Gums.
-
Throughout this leaflet NiQuitin Tropical Fruit 2 mg or 4 mg Medicated
Chewing Gums are
referred to as NiQuitin Tropical Fruit Gums.
What is in this leaflet
1.
What NiQuitin Tropical Fruit Gums are and what they are used for
2.
What you need to know before you use NiQuitin Tropical Fruit Gums
3.
How to use NiQuitin Tropical Fruit Gums
4.
Possible side effects
5.
How to store NiQuitin Tropical Fruit Gums
6.
Contents of the pack and other information
1.
What NiQuitin Tropical Fruit Gums are and what they are used for
NiQuitin Tropical Fruit 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 Tropical Fruit 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 Tropical Fruit Gums do not have the health dangers of
tobacco. This is because they

Preparatomtale

Health Products Regulatory Authority
16 April 2021
CRN0096M8
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NiQuitin Tropical Fruit 2 mg 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) 112.60 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 Tropical Fruit 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 Tropical Fruit 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 Tropical Fruit Medicated Chewing
Gums.
ADULTS (18 YEARS AND OVER)
NiQuitin Tropical Fruit 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 Tropical Fruit 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 on the 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