Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
NICOTINE
Novartis Consumer Health UK Limited
NICOTINE
4 Milligram
Unknown
Product not subject to medical prescription
Withdrawn
2010-06-13
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Nicotine Medicated Chewing Gum 4 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One piece of medicated chewing-gum contains 4mg Nicotine (as 20mg Nicotine-polacrilin (1:4)). For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated chewing gum Each piece of uncoated chewing-gum is off-white in colour and rectangular in shape. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Boots Nicotine Chewing Gum treatment is indicated for the relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. Boots Nicotine Chewing Gum 4mg is for use when severe withdrawal symptoms are experienced. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and Elderly: Users should stop smoking completely during treatment with Boots Nicotine Chewing Gum. One piece of Boots Nicotine Chewing Gum to be chewed when the user feels the urge to smoke. Normally, 8-12 pieces per day, up to a maximum of 15 pieces per day. The characteristics of chewing gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit. Directions for use: 1. One piece of gum should be chewed until the taste becomes strong. 2. The chewing gum should be rested between the gum and cheek. 3. When the taste fades, chewing should commence again. 4. The chewing routine should be repeated for 30 minutes. After three months, the user should gradually cut down the number of pieces chewed each day until they have stopped using the product. Boots Nicotine Medicated Chewing Gum is sugar-free. Children and young adults: Boots Nicotine Chewing Gum should not be use Leggi il documento completo