Nicotinell Tropical Fruit 4 mg medicated chewing-gum

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Nicotine

Commercializzato da:

Haleon Ireland Limited

Codice ATC:

N07BA; N07BA01

INN (Nome Internazionale):

Nicotine

Dosaggio:

4 milligram(s)

Forma farmaceutica:

Medicated chewing-gum

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

Drugs used in nicotine dependence; nicotine

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2012-01-20

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOTINELL TROPICAL FRUIT 2 MG MEDICATED CHEWING-GUM
NICOTINELL TROPICAL FRUIT 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.
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 doctor or 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.
WHAT IS IN THIS LEAFLET:
1.
What Nicotinell Tropical Fruit is and what it is used for
2.
What you need to know before you take Nicotinell Tropical Fruit
3.
How to use Nicotinell Tropical Fruit
4.
Possible side effects
5.
How to store Nicotinell Tropical Fruit
6.
Contents of the pack and other information
1.
WHAT NICOTINELL TROPICAL FRUIT IS AND WHAT IT IS USED FOR
Nicotinell Tropical Fruit belongs to a group of medicines which are
used to help you stop smoking.
Nicotinell Tropical Fruit chewing-gum 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 nicotine craving and withdrawal symptoms in nicotine
dependency. It thereby
-
counteracts the relapse in smoking in smokers who are motivated to
stop or
-
facilitate smoking reduction in smokers who cannot or are reluctant to
stop.
Patient counselling and support normally improve the success rate.
Nicotinell Tropical Fruit is indicated for smokers aged 18 years and
above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICOTINELL TROPICAL FRUIT
DO NOT TAKE NICOTINELL TROPICAL FRUIT
•
if you are allergic 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 before using Nicotinell Tropical Fruit if you
have:
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Scheda tecnica

Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicotinell Tropical Fruit 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)).
Excipients with known effect: sorbitol (0.1 g), sodium (11 mg) and
butylhydroxytoluene (E321)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Medicated chewing-gum.
The coated chewing-gum is off-white in colour and rectangular in
shape.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of tobacco dependence by providing relief of nicotine
craving and nicotine withdrawal symptoms, and by facilitating
smoking cessation in smokers motivated to stop smoking or facilitating
smoking reduction in smokers who cannot or are
reluctant to stop.
Patient counselling and support normally improve the success rate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND ELDERLY
Users should stop smoking completely during treatment with Tropical
Fruit medicated chewing-gum.
The dosage should be chosen on the basis of the patient's nicotine
dependence. The 4 mg medicated chewing-gum is
intended to be used by smokers with a strong nicotine dependency and
by those who have previously failed to stop smoking
with the 2 mg gum. In other cases, the 2 mg gum shall be used.
The optimal strength is selected according to the following table:
Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 2 of 8
IF AN ADVERSE EVENT OCCURS WITH THE USE OF THE HIGH DOSE FORM, USE OF
THE LOW DOSE FORM SHOULD BE CONSIDERED.
THE INITIAL DOSAGE SHOULD BE INDIVIDUALIZED ON THE BASIS OF THE
PATIENT'S NICOTINE DEPENDENCE.
One piece of Nicotinell Tropical Fruit medicated chewing-gum to be
chewed when the user feels the urge to smoke.
Normal use is 8-12 pieces per day, up to a maximum of 15 pieces a day
for the 4 mg gum. Do not use more than one gum per
hour.
The char