Nicorette 15mg Patch

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

NICOTINE

Disponível em:

McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

Código ATC:

N07BA01

DCI (Denominação Comum Internacional):

NICOTINE 15 mg

Forma farmacêutica:

TRANSDERMAL PATCH

Composição:

NICOTINE 15 mg

Tipo de prescrição:

OTC

Área terapêutica:

OTHER NERVOUS SYSTEM DRUGS

Status de autorização:

Withdrawn

Data de autorização:

2006-08-30

Folheto informativo - Bula

355
black
xxx 
Nicorette Patch  
2007-11-20/LKL-c
618693
Häfte/Booklet 
618687
England/GB
80 x 70 mm  --  36 pages
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618693c_info.pdf   07-11-20   06.56.40
PATCH
NICOTINE
TRANSDERMAL PATCH
06-0810
PERSONALISED SUPPORT PROGRAMME
ENROL ON THE INTERNET OR CALL 
NOW ON 0800 244 838.
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618693
618693c.qxd  07-11-20  06.59  Sida 1
A GUIDE FOR USERS
WHAT YOU SHOULD KNOW ABOUT
NICORETTE
®
NICORETTE
®
NICORETTE
®
15 MG PATCH 
10 MG PATCH 
5 MG PATCH
Step 1 
Step 2 
Step 3
PLEASE READ THIS LEAFLET CAREFULLY before you start using
this medicine. It provides useful information on how 
to use it safely. Keep the leaflet, you might need it again.
If you think you are having side-effects, have any
questions or are not sure about anything please 
ASK YOUR DOCTOR, NURSE OR PHARMACIST.
IN THIS LEAFLET
1
WHAT THIS MEDICINE IS FOR
_PAGE 4_
2
BEFORE USING THIS MEDICINE
_PAGE 6_
3
■
DO NOT USE NICORETTE PATCH
_PAGE 6_
■
TALK TO YOUR DOCTOR, NURSE OR PHARMACIST
_PAGE 6_
■
IF YOU ARE PREGNANT OR BREAST-FEEDING
_PAGE 7_
3
HOW AND WHEN TO USE THIS MEDICINE
_PAGE 9_
■
HOW TO USE NICORETTE PATCH
_PAGE 9 _
■
WHEN TO USE NICORETTE PATCH 
_PAGE 11_
■
HOW TO S

Características técnicas

Version No:5, 
 Approved copy 
SNAS BV 1456 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Nicorette 15mg Patch  
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Nicotine, 15mg released over 16 hours use.  Each patch is 30
sq.cm, containing 
nicotine 0.83mg/sq.cm. 
For excipients see section 6.1 
3 
PHARMACEUTICAL FORM 
Transdermal Patch 
4 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 
Nicorette
Patch is indicated for the relief of nicotine withdrawal symptoms
as an aid 
to smoking cessation in adults and children over 12 years
of age. It is also indicated in 
pregnant and lactating women (see section 4.6). 
If possible, Nicorette Patch should be used in conjunction with a
behavioural support 
programme. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
The  patient  should  make  every  effort  to  stop  smoking  completely  during  treatment 
with Nicorette Patch.  

Behavioural therapy, advice and support will normally improve the
success rate.  

Nicorette Patch should be applied to
clean, dry intact areas of hairless skin, for 
example on the hip, upper arm, or chest.  These areas should be
varied each day and 
the same site should not be used on consecutive days. 

There is no clinically significant difference in
bioavailability of nicotine when the 
patch is applied to either the hip, upper arm or chest. 

_ADULTS (OVER 18 YEARS OF AGE)_ 
The daily dose is one patch delivering 15mg,
10mg or 5mg nicotine as appropriate, 
with application limited to 16 hours in a 24 hour period in
each case. 

Daily treatment commences with one 15mg (30cm
2
) patch, applied on waking 
(usually in the morning) and removed 16
hours later (usually at bedtime).   
After removal, used patches should be disposed of carefully (see
warnings). 

Treatment should continue at this dose
for an initial