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HSA Approval

NICOTINELL TTS 10 TRANSDERMAL THERAPEUTIC SYSTEM 7 mg/24 hrs

SIN06528P

NICOTINELL TTS 10 TRANSDERMAL THERAPEUTIC SYSTEM 7 mg/24 hrs

NICOTINELL TTS 10 TRANSDERMAL THERAPEUTIC SYSTEM 7 mg/24 hrs

November 12, 1991

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

Regulatory Information

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

Therapeutic

Pharmacy Only

Formulation Information

PATCH

**Dosage/Directions for use** The patient should be told to stop smoking completely as soon as treatment with Nicotinell TTS is started. Nicotinell TTS is intended for use in adults over the age of 18 years. If you are under 18 years old, ask a healthcare professional before use. One Nicotinell TTS should be applied daily and left on the skin for 24 hours. Since the amount of nicotine released from Nicotinell TTS per cm2 is constant, the dose administered is determined solely by the contact area of the system. To avoid local irritation of the skin, a new site of application should be chosen each day. Nicotinell TTS is available in three dosage strengths: Nicotinell TTS 30, Nicotinell TTS 20 and Nicotinell TTS 10. The dosage cannot be adjusted by cutting the TTS transdermic system. Nicotinell TTS 30 is generally intended for smokers with a consumption of more than 20 cigarettes a day. Nicotinell TTS 20 is sufficient for smokers with a consumption of up to 20 cigarettes daily. Nicotinell TTS 10 is designed to reduce nicotine replacement towards the end of therapy. Treatment should be initiated with one of the larger systems (Nicotinell TTS 30 or 20) and reduced in stages. The dosage can be adapted to the patient's response after a few days. Heavy smokers should be given Nicotinell TTS 30 followed by Nicotinell TTS 20 and finally Nicotinell TTS 10 for about 4 weeks in each case. Moderate smokers should use Nicotinell TTS 20 for about 8 weeks and Nicotinell TTS 10 for about 4 weeks. Smoking cessation therapy should not expose the user to more nicotine than smoking. After removing the protective foil, the nicotine patch should be applied to a clean, dry, hair-free and unbroken area of skin (free from lotion, alcohol, or traces of ointment) on your chest, back, upper arm or hip. With your hand held over the entire surface of the patch, press it against the skin for 10–20 seconds. Make sure that the patch adheres properly at the edges. To minimize the risk of skin irritation, do not apply the Nicotinell transdermal patches at the same spot twice in a row. You should instead allow a week to pass before using the same spot again. This prevents the skin from becoming irritated (red) or damaged. Wash your hands after applying the transdermal patch to avoid irritating your eyes and nose from nicotine from your fingers. If the patient has not stopped smoking with the aid of Nicotinell TTS at the end of the treatment period, treatment should be discontinued. Another withdrawal attempt can be made with Nicotinell TTS at a later point. _Note_ Nicotinell TTS can be used to supplement smoking cessation programmes, self-motivation techniques, behavioural therapy, or psychotherapy.

TRANSDERMAL

Medical Information

**Indications/Methods of use** To aid smoking cessation; to reduce addictive behavior and the various withdrawal symptoms in nicotine-dependent smokers. Treatment should not exceed 3 months. Data currently available show that application of Nicotinell TTS compared with placebo is effective in the short term. The long-term success of treatment after smoking cessation does not depend on Nicotinell TTS, but is essentially determined by the patient's willpower and any further psychological support he or she may be receiving.

Contraindications Hypersensitivity of the skin to nicotine or one of the components of TTS, systemic skin disease, unstable or worsening angina pectoris, acute myocardial infarction, severe cardiac arrhythmias, recent cerebrovascular accident, pregnancy and lactation.

N07BA01

nicotine

Manufacturer Information

gsk consumer healthcare singapore pte. ltd.

LTS LOHMANN THERAPIE-SYSTEME AG

Active Ingredients

NICOTINE

17.5 mg/10 sq cm

Nicotine

Documents

Patient Information Leaflets

1.4.4 Nicotinell Transdermal Patch 10 (proposed).pdf

Approved: April 14, 2020

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