Nicotinell TTS 10, 7mg/24 hours Transdermal Patch

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Nicotine

Prieinama:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC kodas:

N07BA; N07BA01

INN (Tarptautinis Pavadinimas):

Nicotine

Dozė:

7 milligram(s)/24 hours

Vaisto forma:

Transdermal patch

Recepto tipas:

Product not subject to medical prescription

Gydymo sritis:

Drugs used in nicotine dependence; nicotine

Autorizacija statusas:

Marketed

Leidimo data:

1995-11-02

Pakuotės lapelis

NICOTINELL TTS 30, 21 MG/24 HOURS
TRANSDERMAL PATCH
NICOTINELL TTS 20, 14 MG/24 HOURS
TRANSDERMAL PATCH
NICOTINELL TTS 10, 7 MG/24 HOURS
TRANSDERMAL PATCH
NICOTINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if
you feel worse.
WHAT IS IN THIS LEAFLET:
1.
What Nicotinell Patches are and what they are used for
2.
What you need to know before you use Nicotinell
Patches
3.
How to use Nicotinell Patches
4.
Possible side effects
5.
How to store Nicotinell Patches
6.
Contents of the pack and other 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:
STEP 1: Nicotinell TTS
30 patches
Each patch contains
52.5mg of nicotine and
releases 21mg of nicotine
over 24 hours.
STEP 2: Nicotinell TTS
20 patches
Each patch contains 35mg
of nicotine and delivers
14mg of nicotine over
24 hours.
STEP 3: Nicotinell TTS
10 patches
Each patch contains
17.5mg of nicotine and
releases 7mg of nicotine
over 24 hours.
2. WHAT YOU NEED TO KNOW 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

Prekės savybės

Health Products Regulatory Authority
20 April 2023
CRN00DHPL
Page 1 of 9
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 .
For a full list of excipients, see section 6.1
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
Method of administration
Nicotinell TTS should be used as soon as it has been removed from the
child-resistant pouch. Following removal of the
metallic backing, the Nicotinell TTS patch should be applied to an
area of dry skin with no skin lesions and little hair on the
trunk or upper arm and held in position for 10-20 seconds with the
palm of the hand. It should not be applied to skin that is
red, broken or irritated. Each patch should be removed after 24 hours
and disposed of safely (see "Warnings"). A different site
of application should be chosen each day and 7 days should be allowed
to elapse before a new patch is applied to the same
area of skin to avoid risk of local irritation. During handling, avoid
contact with the eyes and nose and wash your hands after
application. After removal, used patches should be disposed of
carefully and kept out of the sight and reach of children.
The dosage must not be adjusted by cutting a patch.
Adults over 18 years and the elderly
ABRUPT CESSATION OF SMOKING
Users should stop smoking completely during treatment with Nicotinell
TTS.
Sizes of 30cm
2
, 20cm
2
and 10cm
2
are available to permit gradual withdrawal of nicot