Nicotinell Mint 2 mg compressed lozenge

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Nicotine

Pieejams no:

Haleon Ireland Limited

ATĶ kods:

N07BA; N07BA01

SNN (starptautisko nepatentēto nosaukumu):

Nicotine

Deva:

2 milligram(s)

Zāļu forma:

Compressed lozenge

Receptes veids:

Product not subject to medical prescription

Ārstniecības joma:

Drugs used in nicotine dependence; nicotine

Autorizācija statuss:

Marketed

Autorizācija datums:

2003-11-04

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOTINELL MINT 2 MG COMPRESSED LOZENGE
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 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 lozenge
after 9 months.
WHAT IS IN THIS LEAFLET:
1.
What Nicotinell Mint Lozenge is and what it is used for
2.
What you need to know before you take Nicotinell Mint Lozenge
3.
How to take Nicotinell Mint Lozenge
4.
Possible side effects
5.
How to store Nicotinell Mint Lozenge
6.
Contents of the pack and other information
1.
WHAT NICOTINELL MINT LOZENGE IS AND WHAT IT IS USED FOR
Nicotinell Mint Lozenge belongs to a group of medicines which are used
to help you stop smoking.
Nicotinell Mint Lozenge contains the active substance nicotine.
When sucked, nicotine is released slowly and absorbed through the
lining of the mouth.
This medicinal product is used to help people to stop smoking. The
nicotine in Nicotinell Mint relieves
nicotine withdrawal symptoms and cravings when you stop smoking or
temporarily reduce smoking in order
to facilitate smoking cessation. By relieving the withdrawal symptoms
and cravings Nicotinell Mint
_ _
counteracts a smoking relapse in smokers who are motivated to stop
smoking.
Patient counselling and support normally improve the success rate.
Nicotinell Mint Lozenge is indicated for smokers aged 18 years and
above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICOTINELL MINT LOZENGE
DO NOT TAKE NICOTINELL MINT LOZENGE
•
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.
WA

Produkta apraksts

Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicotinell Mint 2 mg compressed lozenge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece oflozenge contains:
Active substance: 2 mg nicotine (corresponding to 6.144 mg nicotine
bitartrate dihydrate).
Excipient(s) with known effect: aspartame (0.01 g) and maltitol (0.9
g).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Compressed lozenge
White, mint flavoured, round biconvex lozenge
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of tobacco dependence by providing relief of nicotine
withdrawal symptoms including cravings (see section 5.1),
thereby facilitating smoking cessation or temporary smoking reduction
in smokers motivated to quit smoking. Permanent
cessation of tobacco use is the eventual objective.
The 2 mg strength is used when severe withdrawal symptoms are
experienced.
Patient counsellingand support normally improve the success rate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ADULTS AND ELDERLY
Nicotinell Mint 2 mg Lozenge 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 strength is selected according to the following table:
This section has been moved from further down. This has been accepted
by the RMS.
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 (2 mg
lozenge), use of the low dose form (1 mg lozenge) should
be considered.
The initial dosage should be individualised on the basis of the
patient's nicotine dependence. One piece of lozenge to suck
when the user feels the urge to smoke.
Initially, 1 lozenge should be taken every 1-2 hours. The usual dosage
is 8-12 lozenges per day. For smoking cessation and
smoking reduction with Nicotinell Lozenge, the maximum daily dose is
15 lozenge