NiQuitin Patch 14mg/24h - Smoking Cessation - 28 patches

1. NAME OF THE MEDICINAL PRODUCT

NIQUITIN 14 mg/24 hours, transdermal device

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Nicotine ........................................................................ 78.00 mg For one 15 cm2 transdermal device. For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

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 nicotine withdrawal symptoms 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. 4.2. Dosage and administration Reserved for adults and children over 15 years of age. 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. See table in the Product Monograph (printable or available at www.ansm.fr) - In combination with oral forms The combination of transdermal device treatment with oral forms NIQUITIN 2 mg Chewing Gum or Sucking Tablets can be done after smoking cessation according to the dosage described above. The reduction in smoking should lead the patient gradually to complete cessation of smoking. This cessation should be attempted as soon as possible within 6 months of starting treatment. If after 9 months of treatment, the attempt to stop smoking completely has failed, it is recommended that advice be sought from a health professional to consider an alternative strategy. It is recommended to apply the device after opening to a dry skin surface without skin lesions and where hairiness is scarce (trunk, upper arm). Do not apply to red, damaged or irritated skin. A new system should be applied every 24 hours to a different application site, preferably in the morning upon awakening. The device should be kept in its protective pouch until use. During handling, avoid contact with the eyes, nose and wash hands after application. 4.3. Contraindications - Non-smoker or occasional smoker. - Hypersensitivity to any of the ingredients. - Skin condition that may interfere with the use of a transdermal device. 4.4. Special warnings and precautions for use Special warnings - To ensure the best chance of success, the use of this medicine should be accompanied by a complete cessation of smoking. - Due to the pharmacological effects of nicotine, certain medical conditions require medical advice and supervision: o severe liver and/or kidney failure, o developing gastric or duodenal ulcers, - Nicotine is a toxic substance. In children, the application of this medicine can be fatal, so do not leave this device within the reach of children even after use. It is recommended that the device be folded on itself before disposal. Special precautions for use - In case of burning, stinging, itching, skin rash, during sun exposure, it is recommended to stop the treatment temporarily until the symptoms disappear. - In case of severe or persistent skin reaction, it is recommended to stop the treatment and to use another pharmaceutical form (see section 4.8).4.5. Interactions with other medicinal products and other forms of interaction Tobacco may, through a process of enzymatic induction due to aromatic hydrocarbons, reduce the blood concentrations of certain medicinal products such as caffeine, theophylline, imipraminic antidepressants, flecainide and pentazocine. Smoking cessation, especially when taking this drug, may lead to an increase in the concentrations of these active ingredients due to the reversibility of the enzymatic induction effect. For drugs with a narrow therapeutic margin, such as theophylline, smoking cessation should be accompanied, in addition to dosage adjustment, by close clinical and even biological monitoring, with the patient being informed of the risks of overdose. Because of its specific pharmacological, cardiovascular, neurological and endocrine properties, nicotine may, like tobacco: - lead to an increase in cortisol and cathecolamine concentrations, - require dosage adjustment of nifedipine, beta-blockers and insulin, - reduce the effects of diuretics, - slow the rate of healing of gastric ulcers by H2 antihistamines, - increase the incidence of adverse effects of estrogestogens 4.6. Pregnancy and lactation Pregnancy 1/ Experimental studies in several species have not shown any teratogenic or foetotoxic effect of nicotine administered at continuous flow and at maternotoxic doses. Under the same conditions of administration, fetal hypotrophy is observed at even higher doses in one species, the mouse, but not in the rat or rabbit. In the clinic, a limited number of observations have not yet been made showing any deleterious effects, either maternal or foetal, of nicotine used for smoking cessation. 2/ Smoking in pregnant women can cause intrauterine growth retardation, fetal death in utero, prematurity and neonatal hypotrophy, which seem to be correlated with the level of smoking and the period of pregnancy, as these effects are observed when smoking continues during the third trimester. The nicotine provided by substitution treatments is not without deleterious effects on the foetus, as shown by the haemodynamic repercussions observed. However, there are no epidemiological studies specifying the real impact of nicotine provided by substitution treatments on the foetus or the newborn. Consequently, - In pregnant women, it is always advisable to recommend complete cessation of tobacco consumption, without nicotine replacement therapy; - In the event of failure in the case of a highly addicted patient, smoking cessation with this drug is possible. In fact, the risk to the foetus in the event of continued smoking during pregnancy is probably greater than that expected from nicotine replacement therapy, since exposure to polycyclic hydrocarbons and carbon monoxide is added with smoking, and since the exposure to nicotine provided by the replacement therapy is less than or not greater than that associated with smoking. The aim is to achieve complete cessation of smoking, or even of replacement therapy, before the third trimester of pregnancy. Smoking cessation, with or without substitution treatments, should not be considered in isolation, but as part of a comprehensive treatment plan, taking into account the psycho-social context and any other dependencies that may be associated. It may be advisable to call on a consultation specialising in smoking cessation. In the event of partial or complete failure of the withdrawal, the continuation of treatment with a nicotine substitute after the 6th month of pregnancy can only be considered on a case by case basis. It is important to bear in mind the specific effects of nicotine, which could affect the foetus, particularly when it is near term. Breast-feeding Given the constant levels of nicotine in this form of replacement therapy, breast-feeding is not recommended when taking this medicine. 4.7. Effects on ability to drive and use machines Not applicable.4.8. Adverse reactions Nicotine transdermal devices may cause adverse reactions similar to nicotine administered by other means. Systemic adverse reactions: - palpitations - dizziness, headache, - nausea, vomiting, - insomnia, dreaming disorder Local adverse effects: - erythema and pruritus at the application site, more rarely oedema, burning sensation. These effects are mostly moderate and regress spontaneously after removal of the system. In case of severe or persistent skin reactions, it is recommended to stop the treatment and to use another form of nicotine substitute. Some symptoms such as dizziness, headache and insomnia may be related to smoking cessation. An increase in the occurrence of mouth ulcers may occur after smoking cessation. The causal relationship is not clearly established. 4.9. Overdose Nicotine overdose may occur if the treated patient had previously very low nicotine intakes or is concomitantly using other nicotine-based smoking cessation treatments. Symptoms of overdose are those of acute nicotine intoxication including nausea, hyper salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, hearing impairment and general weakness. At high doses, hypotension, weak and irregular pulse, respiratory distress, prostration, cardiovascular collapse and convulsions may occur. The doses of nicotine tolerated by smokers during treatment may lead to acute intoxication which may be fatal in young children. Action in case of overdose: Nicotine should be discontinued immediately and symptomatic treatment instituted. Assisted ventilation and oxygen therapy should be undertaken if necessary.

6. PHARMACEUTICAL DATA

6.1. List of excipients Ethylene/vinyl acetate copolymer (40% VA). Occlusive carrier: Ethylene, vinyl acetate, polyethylene terephthalate. Flow control membrane: Polyethylene film. Contact adhesive: Polyisobutylene. Release liner: Silicone polyester film 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2 years. 6.4. Special storage conditions Store at a temperature not exceeding +25 °C. 6.5. Nature and contents of packaging Transdermal device in a bag (PET/PE/Aluminium/Acrylonitrile polymer); box of 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)

- 379 563-2 or 34009 379 563 2 1: transdermal device in sachet (PET/PE/Aluminium/Acrylonitrile Copolymer); box of 28.

9. DATE OF FIRST AUTHORISATION/RENEWAL 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.