Nicotinell TTS 30 patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nicotine

Available from:

Haleon UK Ltd

ATC code:

N07BA01

INN (International Name):

Nicotine

Dosage:

21mg/24hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04100200; GTIN: 5012131570203 5012131570302

Patient Information leaflet

Recto
Pharma code XXX
Pharma code XXX
Patch programme
Step 1: Nicotinell TTS 30,
21 mg/24 hour Transdermal Patch
Step 2: Nicotinell TTS 20,
14 mg/24 hour Transdermal Patch
Step 3: Nicotinell TTS 10,
7 mg/24 hours Transdermal Patch
Nicotine
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.
• 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 Patch is a nicotine replacement therapy
(NRT) which reduces:
• some of the unpleasant withdrawal effects that
frequently occur when giving up smoking such as
feeling ill or irritable.
• your desire to smoke by providing some of the
nicotine previously inhaled from cigarettes and
therefore helps your willpower to resist cigarettes.
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.
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 can be used to help you:
• stop smoking completely
• cut down the amount you smoke – perhaps before
you go on to stop completely.
In addition, they may be used when you:
• do not wish to smoke. For example in confined
spaces (in the car: in the house) or where others
(such as children) could be harmed by tobacco
s

Summary of Product characteristics

OBJECT 1
NICOTINELL TTS 30
Summary of Product Characteristics Updated 01-May-2018 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Nicotinell TTS 30
NicAssist 21mg/24 Hour Transdermal Patch
2. Qualitative and quantitative composition
Each Nicotinell TTS 30 patch contains 52.5 mg S(-)-nicotine which
provides an average absorption rate
of 21 mg nicotine in 24 hours.
3. Pharmaceutical form
Transdermal patch.
The Nicotinell TTS patch is a transdermal therapeutic system,
consisting of a round, flat, matrix-type self-
adhesive, yellowish-ochre coloured patch. It is protected by a
rectangular metallic release liner backing to
be discarded before application.
Nicotinell TTS 30 patch 21mg/24 Hour has a drug releasing area of 30
cm
2
and is printed CG EME on
the patch surface.
4. Clinical particulars
4.1 Therapeutic indications
Nicotinell patches relieve and/or prevent cravings and nicotine
withdrawal symptoms associated with
tobacco dependence. They are indicated to aid smokers wishing to quit
or reduce prior to quitting, to
assist smokers who are unwilling or unable to smoke, and as a safer
alternative to smoking for smokers
and those around them.
Nicotinell patches are indicated in pregnant and lactating women
making a quit attempt.
Nicotinell patches should preferably be used in conjunction with a
behavioural support programme.
4.2 Posology and method of administration
Adults:
For individuals smoking 20 cigarettes or more a day, it is recommended
that treatment be started with
Nicotinell TTS 30 (Step 1) once 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.