Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ACETYLCYSTEINE
Rowex Ltd
200mg Milligram
Granules
1998-12-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ACC 200 mg Granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of ACC 200 mg granules contains Acetylcysteine 200 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Granules White granules with an odour and taste of orange. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ACC is indicated as an adjunct in the treatment of chronic bronchitis or other respiratory conditions associated with the excessive production of viscous mucous. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: Oral. RECOMMENDED DOSAGE SCHEDULE: ACUTE THERAPY - ADULTS (OVER 14 YEARS): One Sachet (200 mg), 3 times daily. CHILDREN 2-6 YEARS: One Sachet (200 mg), 2 times daily. INFANTS UNDER 2 YEARS: One sachet (200 mg) daily. The granules should be dissolved in a glass of water. In acute exacerbations a treatment period of 5-10 days is usually adequate but may be extended if necessary. In chronic bronchitis relief of symptoms may be noticeable after treatment for 1-2 months but treatment may be extended for up to six months, e.g. during winter season. When oral antibiotics or drugs are required they should be administered 2 hours apart from Acetylcysteine. 4.3 CONTRAINDICATIONS ACC is contra-indicated in patients who are hypersensitive to acetylcysteine and in patients with active peptic IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/09/2006_ _CRN 2028454_ _page number: 1_ ulceration. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Each sachet contains the equivalent of 2.8 g of sucrose. This should be taken into account when treating diabetic patients. ACC should be given to new-born infants only if absolutely necessa Les hele dokumentet