Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
ACETYLCYSTEINE
Rowex Ltd
Capsule
1996-11-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ACC 200 mg Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Acetylcysteine 200 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Hard Capsule. White, opaque, hard gelatin capsule, filled with a white to off white powder. 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 ADMINSTRATION ROUTE OF ADMINISTRATION: Oral. RECOMMENDED DOSAGE SCHEDULE ACUTE THERAPY – ADULTS (OVER 14 YEARS): The usual dose is three capsules (3 x 200 mg) daily. CHILDREN 6-14 YEARS: The usual dose is two capsules (2 x 200 mg) daily. CHRONIC THERAPY – ADULTS (OVER 14 YEARS): The usual daily dose is two capsules (2 x 200 mg). MUCOVISCIDOSIS – CHILDREN OVER 6 YEARS: The usual dose is three capsules (3 x 200 mg) daily. 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 25/10/2005_ _CRN 2016088_ _page number: 1_ 4.3 CONTRAINDICATIONS ACC is contra-indicated in patients who are hypersensitive to acetylcysteine and in patients with active peptic ulceration. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Each sachet contains the equivalent of 2.8 g of sucrose. This should be taken into account when trea Perskaitykite visą dokumentą