NiQuitin Patch 7mg/24h - Smoking Cessation - 28 patches

1. NAME OF THE MEDICINAL PRODUCT

NIQUITIN 7 mg/24 hours, transdermal device

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Nicotine ....................................................................................................................................... 36.00 mg For one 7 cm2 transdermal device. For a full list of excipients, see 6.1.

3. PHARMACEUTICAL FORM

Transdermal device. Transparent transdermal device.

4. CLINICAL DATA

4.1 Therapeutic indications

This medicinal product is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects wishing to stop smoking. Although permanent cessation of smoking is preferred, this drug may be used in a smoking reduction strategy as a step towards permanent cessation.

4.2. Dosage and method of administration

For adults and children over 15 years of age only. DOSAGE The degree of nicotine dependence will be assessed by the number of cigarettes consumed per day or by the Fagerström test. This medicine may be used as monotherapy or in combination with NIQUITIN 2 g chewing gum or NIQUITIN 2 mg chewable tablets. If used in combination, medical advice should be sought. - QUITTING TOBACCO o Monotherapy: Initial phase 3 to 4 weeks Follow-up treatment 3 to 4 weeks Withdrawal from treatment 3 to 4 weeks Fagerström test score of 5 or more or Smoking 20 or more cigarettes per day NIQUITIN 21 mg/24 h NIQUITIN 14 mg/24 h or NIQUITIN 21 mg/24 h* NIQUITIN 7 mg/24 h or NIQUITIN 14 mg/24 h then NIQUITIN 7 mg/24 h* Fagerström score less than 5 or Smoker of less than 20 cigarettes per day NIQUITIN 14 mg/24 h or increase to NIQUITIN 21 mg/24 h* NIQUITIN 14 mg/24 h or NIQUITIN 7 mg/24 h** NIQUITIN 7 mg/24 h or discontinue** * Depending on results of withdrawal symptoms. ** In case of satisfactory results. The dosage of the transdermal system should be adapted to the individual response: increase the dose if smoking abstinence is not complete or if withdrawal symptoms are observed, decrease in case of suspected overdose. The duration of treatment is approximately 3 months but may vary according to individual response. It is recommended not to use this drug beyond 6 months. - In combination with oral forms In combination with NIQUITIN 2 mg Gum or NIQUITIN 2 mg Chewable Tablets: Individuals who, in spite of well-managed monotherapy, continue to experience cravings to smoke, or individuals who have failed monotherapy, may combine the transdermal devices with an oral form that has a faster onset of withdrawal symptoms, such as NIQUITIN 2 mg Gum or NIQUITIN 2 mg Suckable Tablets. The combination of transdermal devices with chewing gums has been shown to be superior to either treatment alone. Initial Treatment Treatment should begin with a 21 mg/24 hr transdermal device applied to the skin daily in the morning and removed and replaced the following morning, in combination with NIQUITIN Chewing Gum 2 mg or NIQUITIN Chewable Tablet 2 mg. Chew one gum or suck one tablet each time the urge to smoke arises with a minimum of 4 NIQUITIN Gum or 4 NIQUITIN 2 mg tablets per day. Usually 5 or 6 gums or tablets provide adequate effect. Do not use more than 24 gums or 24 tablets per day. This full dose should be used for 6 to 12 weeks, after which a gradual withdrawal from substitutes should be initiated. This should be done in the following way: Use the lower dose transdermal devices, 14 mg/24 h for 3-6 weeks and then 7 mg/24 h for 3-6 weeks while continuing to use the same number of 2 mg chewing gum or 2 mg sucking tablet as at the start of treatment, and then reduce the number of 2 g chewing gum or 2 mg sucking tablet used per day, up to a maximum of 12 months total treatment. Recommended dosage: Period Transdermal device 2 mg chewing gum or 2 mg sucking tablet Initial treatment 6-12 weeks One device 21 mg/24 h/d Ad libitum (5-6 chewing gums or sucking tablets/d) Gradual weaning 3-6 weeks later One device 14 mg/24 h/d Continue to use the number of chewing gums or sucking tablets needed 3- Next 6 weeks One device 7 mg/24 h/d Continue to use the required number of gums or sucking tablets Up to 12 months Gradually reduce the number of gums or sucking tablets until cessation -

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

DRUGS USED IN NICOTINE DEPENDENCE, ATC Code: N07BA01. Abrupt cessation of smoking after prolonged daily use results in a withdrawal syndrome including at least four of the following symptoms: dysphoria or depressed mood, insomnia, irritability, feelings of frustration or anger, anxiety, difficulty concentrating, restlessness or impatience, slowed heart rate, increased appetite, increased weight. The sensation of craving for nicotine is considered to be a clinical symptom in its own right of the withdrawal syndrome. Clinical studies have shown that nicotine replacement products can help smokers to abstain from smoking or to reduce their tobacco consumption by reducing withdrawal symptoms. The adverse effects of continued smoking in patients with coronary artery disease and/or a history of stroke have been clearly demonstrated. Studies in these patients have shown that there is no deleterious effect of nicotine replacement therapy.

5.2. Pharmacokinetic properties

Nicotine is absorbed directly through the skin into the systemic circulation. Plasma concentrations of nicotine reach a plateau within 2-4 hours after application of the transdermal system. A relatively constant plasma concentration persists for 24 hours. After repeated daily application of NIQUITIN, equilibrium is achieved on the second application with dose-dependent concentrations maintained throughout the day. Plasma nicotine concentrations are dose-dependent for all three NIQUITIN dosages. After repeated application of NIQUITIN 22, 15 or 7 cm2, the mean maximum steady-state plasma nicotine concentrations are approximately 17 ng/ml, 12 ng/ml, 6 ng/ml respectively. For comparison, smoking a cigarette every half hour leads to mean plasma concentrations of about 44 ng/ml. The sharp and early peak in blood nicotine levels observed with cigarette smoking is not observed with NIQUITIN. After withdrawal from the system, plasma nicotine concentrations are slower to decrease than would be expected from the plasma elimination half-life of nicotine, determined after intravenous administration, which is 2 hours. The probable existence of skin deposition explains why about 10% of the nicotine reaching the bloodstream comes from the skin after withdrawal from the system. The volume of distribution of nicotine is large (about 2.5 l/kg). Nicotine crosses the blood-brain barrier, the placenta and is found in breast milk. Plasma protein binding is negligible Occlusive media: ethylene, vinyl acetate, polyethylene terephthalate. Flow control membrane: polyethylene film. Contact adhesive: polyisobutylene. Release liner: siliconised polyester film.

6. Incompatibilities

Not applicable.

6.1. Shelf life

2 years.

6.2. Special precautions for storage

Store at a temperature not exceeding +25°C.

6.3. 6.3. Nature and contents of packaging Transdermal device in a sachet

(PET/PE/Aluminium/acrylonitrile polymer); box of 7, 14 and 28. 6.6. Special precautions for disposal and handling No special requirements.

7. MARKETING AUTHORISATION HOLDER

Laboratoires GLAXOSMITHKLINE SANTE GRAND PUBLIC 100, route de Versailles BP 23 78164 Marly-Le-Roi Cedex

8. MARKETING AUTHORISATION NUMBER(S)

- 357 196-7: transdermal device in sachet (PET/PE/Aluminium/Acrylonitrile Copolymer); box of 28. 9. DATE OF FIRST AUTHORISATION/REPEAL OF AUTHORISATION [to be completed by the holder] 10. DATE OF UPDATE OF TEXT [to be completed by the holder] 11. DOSIMETRY Not applicable. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable. CONDITIONS OF PRESCRIPTION AND DELIVERY Medicinal product not subject to medical prescription.