Nicotinell Spearmint 4 mg medicated chewing-gum

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Nicotine

Tillgänglig från:

Haleon Ireland Limited

ATC-kod:

N07BA; N07BA01

INN (International namn):

Nicotine

Dos:

4 milligram(s)

Läkemedelsform:

Medicated chewing-gum

Receptbelagda typ:

Product not subject to medical prescription

Terapiområde:

Drugs used in nicotine dependence; nicotine

Bemyndigande status:

Not marketed

Tillstånd datum:

2012-02-10

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOTINELL SPEARMINT 2 MG MEDICATED CHEWING-GUM
NICOTINELL SPEARMINT 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 Spearmint is and what it is used for
2.
What you need to know before you take Nicotinell Spearmint
3.
How to use Nicotinell Spearmint
4.
Possible side effects
5.
How to store Nicotinell Spearmint
6.
Contents of the pack and other information
1. WHAT NICOTINELL SPEARMINT IS AND WHAT IS USED FOR
Nicotinell Spearmint belongs to a group of medicines which are used to
help you to stop smoking.
Nicotinell Spearmint 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 Spearmint is indicated for smokers aged 18 years and above.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICOTINELL SPEARMINT
DO NOT TAKE NICOTINELL SPEARMINT

If you are allergic to nicotine or any of the ingredients of this
medicine (listed in section 6).

If you are a non-smoker.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Nicotinell Spearmint if you have:

any heart problems you should consult a healthcare professional befo

Produktens egenskaper

Health Products Regulatory Authority
18 April 2023
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicotinell Spearmint 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 Nicotinell
Spearmint 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:
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18 April 2023
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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 Spearmint 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 characte