Nicotinell Cool Mint 4 mg, medicated chewing-gum

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Nicotine

Fáanlegur frá:

Haleon Ireland Limited

ATC númer:

N07BA; N07BA01

INN (Alþjóðlegt nafn):

Nicotine

Skammtar:

4 milligram(s)

Lyfjaform:

Medicated chewing-gum

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Drugs used in nicotine dependence; nicotine

Leyfisstaða:

Marketed

Leyfisdagur:

2001-04-06

Upplýsingar fylgiseðill

GSK Consumer Healthcare
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOTINELL COOL MINT 4 MG MEDICATED CHEWING-GUM
Nicotine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Nicotinell
Cool Mint 4 mg medicated chewing-gum carefully to get the best results
from it.
Always take this medicine exactly as described in this leaflet or as
your pharmacist has told
you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
SEE SECTION 4.
•
You must contact a doctor if you still need to use Nicotinell after 9
months
WHAT IS IN THIS LEAFLET:
1.
What Nicotinell medicated chewing-gum is and what it is used for
2.
What you need to know before you take Nicotinell medicated chewing-gum
3.
How to take Nicotinell medicated chewing-gum
4.
Possible side effects
5.
How to store Nicotinell medicated chewing-gum
6.
Contents of the pack and other information
1.
WHAT NICOTINELL IS AND WHAT IT IS USED FOR
Nicotinell belongs to a group of medicines which are used to help you
to stop smoking.
Nicotinell contains the active substance nicotine,
When chewed, nicotine is released slowly and absorbed through the
lining of the mouth.
This medicinal product is used to relieve the nicotine withdrawal
symptoms in nicotine
dependency, as an aid to smoking cessation.
Patient counselling and support normally improve the success rate.
GSK Consumer Healthcare
1.3.1- PIL
Confidential
Page 2
Nicotinell Mint 2 mg, 4 mg medicated chewing-gum
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICOTINELL
DO NOT TAKE NICOTINELL
•
If you are allergic (hypersensitive) to nicotine or any of the other
ingredients of this
medicine (listed in section 6)
•
If you are a non-smoker.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR

Vara einkenni

Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicotinell Cool Mint 4 mg, medicated chewing-gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece of medicated chewing-gum contains:
Active substance: 4 mg nicotine (as 20 mg nicotine – polacrilin
(1:4)).
Excipient(s) with known effect: sorbitol (0.1 g)and
butylhydroxytoluene (E321).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated chewing-gum.
Each piece of coated medicated chewing-gum is off-white in colour and
rectangular in shape.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of nicotine withdrawal symptoms, in nicotine dependency as an
aid to smoking cessation.
The 4 mg strength is used when severe withdrawal symptoms are
experienced.
Patient counselling and support normally improve the success rate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS OVER 18-YEARS OLD AND ELDERLY
Users should stop smoking completely during treatment with Nicotinell
medicated chewing-gum.
The 4 mg medicated chewing-gum is intended to be used by smokers with
a strong or very strong nicotine dependency and
those who have previously failed to stop smoking with the aid of
nicotine replacement therapy.
The optimal dosage form is selected according to the following table:
If an adverse event occurs with the use of the high dose form (4 mg
medicated chewing-gum), use of the low dose form (2 mg
medicated chewing-gum) should be considered.
The initial dosage should be individualised on the basis of the
patients nicotine dependence.
One piece of Nicotinell medicated chewing-gum to be chewed when the
user feels the urge to smoke.
If Nicotinell 4 mg medicated chewing-gum is selected, normally use
8-12 pieces per day, up to a maximum of 15 pieces per
day.
Do not use more than 1 gum per hour.
Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 2 of 7
The characteristics of medicated chewing-gum as a pharmaceutical form
are such that