Nicotinell 1mg lozenges

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Nicotine bitartrate

可用日期:

Haleon UK Ltd

ATC代码:

N07BA01

INN（国际名称）:

Nicotine bitartrate

剂量:

1mg

药物剂型:

Lozenge

给药途径:

Oromucosal

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04100200; GTIN: 5051562033208 5012131571903 5012131572009 5051562004604 5051562004703 5054563904393

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
_NICOTINE _
Compressed Lozenge
1 mg
MINT
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 stop smok-
ing. The nicotine in Nicotinell Mint relieves nicotine with-
drawal 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.
Warnings and pre

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicotinell
Mint 1 mg compressed lozenges
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece of_ _lozenge contains:
Active substance: 1 mg nicotine (corresponding to 3.072 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.
Patient counselling_ _and support normally improve the success rate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nicotinell Mint Lozenge 1 mg may be used alone _(a)_ or in combination
with
Nicotinell Transdermal Patch _(b)_.
POSOLOGY:
ADULTS AND ELDERLY
_(A)_ TREATMENT WITH NICOTINELL LOZENGES ONLY
Nicotinell Mint 1 mg Lozenge is recommended in smokers with a low to
moderate
nicotine dependency. It is not recommended in the case of smokers with
a strong or
very strong nicotine dependency.
The optimal strength is selected according to the following table:
Low to moderate
dependency
Moderate to strong
dependency
Strong to very strong
dependency
Less than 20 cigarettes /
day
From 20 to 30 cigarettes
/ day
Over 30 cigarettes /
day
Treatment
with
Nicotinell
Mint Lozenge
only
Low dose forms are
preferable
(1 mg lozenge)
Low (1 mg lozenge) or
high (2 mg lozenge) dose
forms are acceptable
depending on patient
characteristics and
preference.
High dose forms are
preferable
(2 mg lozenge)
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