Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
ACETYLCYSTEINE
Rowex Ltd
ACETYLCYSTEINE
600 Milligram
Tablets Effervescent
Withdrawn
2007-05-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ACC 600 mg Effervescent Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg Acetylcysteine Ph.Eur. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Effervescent Tablet. White, round, smooth tablets, having a smell of blackberries. 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:_ The tablets should be dissolved in about a half a glass of water. _Adults:_ 1 effervescent tablet daily preferably in the evening. 4.3 CONTRAINDICATIONS ACC is contra-indicated in patients who are hypersensitive to acetylcysteine and in patients with active ulceration. ACC 600 mg Effervescent Tablets should not be given to children under 14 years of age. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE ACC should be given to newborn infants only if absolutely vital. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION ACC should not be administered with oral antibiotics with the exception of amoxycillin, cefuroxime, doxycycline, erythromycin and thiamphenicol. The concomitant administration of ACC with oral antibiotics results in reduction of the effectiveness of the antibiotics. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 25/10/2005_ _CRN 2016087_ _page number: 1_ Antibiotics should be taken at least 2 hours before or 2 hours after taking ACC. 4.6 PREGNANCY AND LACTATION ACC Effervescent Tablets should not be administered in pregnancy or during lactation. 4.7 EFFECTS ON ABILITY TO DR Lugege kogu dokumenti