Niquitin 4mg medictated chewing gum
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-04-2024
Summary of Product characteristics
(SPC)
24-04-2024
Active ingredient:
nicotine
Available from:
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
ATC code:
N07BA01
INN (International Name):
nicotine
Dosage:
4mg
Pharmaceutical form:
Medicated Chewing Gum
Administration route:
Oral use
Units in package:
packs of 4, 10, 30, 100 and 200
Prescription type:
Product not subject to medical prescription
Manufactured by:
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
Therapeutic group:
Drugs used in nicotine dependence
Therapeutic indications:
e treatment of tobacco dependence by relief of nicotine withdrawal symptoms including cravings during a quit attempt
Authorization status:
Authorised
Authorization date:
2015-07-24
Patient Information leaflet
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIQUITIN 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 Menthol Mint 2 mg or
4mg Medicated Chewing Gums.
-
Throughout this leaflet NiQuitin2 mg or
4 mg Medicated Chewing Gums are referred to as NiQuitin
Medicated Gums.
WHAT IS IN THIS LEAFLET
1.
What NiQuitin Medicated Gums are and what they are used for
2.
What you need to know before you use NiQuitin Mint Gums
3.
How to use NiQuitin Medicated Gums
4.
Possible side effects
5.
How to store NiQuitin Medicated Gums
6.
Contents of the pack and other information
1.
WHAT NIQUITIN MEDICATED GUMS ARE AND WHAT THEY ARE USED FOR
NiQuitin Medicated 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 Medicated 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
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Niquitin 4 mg medictated chewing gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewing gum contains 4 mg nicotine (equivalent to 28.40 mg nicotine resinate)
Excipients with known effect:
Butylated Hydroxytoluene (E321) 0.4266 mg/piece gum
Sorbitol (E420) 137.55 mg/piece gum
Sodium 14.0mg/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 Medicated 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 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 Medicated Chewing Gums.
_Adults (18 years and over)_
NiQuitin 4mg Medicated Chewing Gum is suitable for smokers who smoke more 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 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 gradua
Read the complete document
