NICOTINELL TTS 10 7 mg/24 hours Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NICOTINE

Available from:

Novartis Consumer Health UK Limited

INN (International Name):

NICOTINE

Dosage:

7 mg/24 hours

Pharmaceutical form:

Transdermal Patch

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

NICOTINELL TTS 30,  
21MG/24 HOURS TRANSDERMAL PATCH
NICOTINELL TTS 20,  
14MG/24 HOURS TRANSDERMAL PATCH
NICOTINELL TTS 10,  
7 MG/24 HOURS TRANSDERMAL PATCH
NICOTINE
PATCH PROGRAMME 
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. 
However, you still need to use Nicotinell Patches  
carefully to get the best results from them.
•  Keep this leaflet. You may need to read it again.
•  Ask your pharmacist if you need more information
or advice.
•  You must talk to your doctor if you do not feel
better or if you feel worse.
•  If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Nicotinell Patches are and what they are 
used for
2. Before you use Nicotinell Patches
3. How to use Nicotinell Patches
4. Possible side effects
5. How to store Nicotinell Patches
6. Further information
1. WHAT NICOTINELL PATCHES ARE AND 
WHAT THEY ARE USED FOR
Nicotinell Patches are for application to the skin.
When applied to the skin, nicotine passes from the
patch, through the skin and into your body. Nicotinell
patches help you stop smoking as part of an overall
treatment programme.
If you need advice before starting to use nicotine
patches, talk to your doctor, nurse, pharmacist or
a trained counsellor. A support programme will
increase your chances of quitting smoking.
THERE ARE 3 STEPS:
1. Nicotinell TTS 30 (Step 1) patches contain 52.5mg 
of nicotine and deliver on average 21mg of 
nicotine over 24 hours.
2. Nicotinell TTS 20 (Step 2) patches contain 35mg of 
nicotine and deliver on average 14mg of nicotine 
over 24 hours.
3. Nicotinell TTS 10 (Step 3) patches contain 17.5mg 
of nicotine and deliver on average 7mg of nicotine 
over 24 hours.
2. BEFORE YOU USE NICOTINELL PATCHES
DO NOT USE THE PATCHES if you:
•  are allergic to nicotine or to any of the other  
ingredients in the patc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicotinell TTS 10, 7mg/24 hours Transdermal Patch.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patch contains 17.5mg S (-) nicotine, average absorption rate 7mg in 24 hours.
Drug releasing surface area – 10 cm
2 .
3 PHARMACEUTICAL FORM
Transdermal Patch.
Transdermal therapeutic system, consisting of a round, flat, matrix-type self-adhesive yellowish-ochre coloured patch,
printed ‘CG CWC’ on the patch surface.
It is protected by a rectangular metallic release liner backing to be discarded before application.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of nicotine dependence, as an aid to smoking cessation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
Users should stop smoking completely during treatment with Nicotinell TTS.
For individuals smoking 20 cigarettes or more a day, it is recommended that treatment be started with Nicotinell TTS
30 (STEP 1) daily, applied to a dry non-hairy area of the skin on the trunk or upper arm. Those smoking less than this
are recommended to start with Nicotinell TTS 20 (STEP 2). Sizes of 30cm
2
, 20cm
2
and 10cm
2
are available to permit
gradual withdrawal of nicotine replacement, using treatment periods of 3-4 weeks for each size.
The size of patch may be adjusted according to individual response, maintaining or increasing the dose if abstinence is
not achieved or if withdrawal symptoms are experienced. Total treatment periods of more than 3 months and daily
doses above 30cm
2
have not been evaluated. The treatment is designed to be used continuously for 3 months but not
beyond. However, if abstinence is not achieved at the end of the 3 month treatment period, further treatments may be
recommended following a re-evaluation of the pati