ACC 600 Milligram Tablets Effervescent

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

ACETYLCYSTEINE

可用日期:

Rowex Ltd

INN（国际名称）:

ACETYLCYSTEINE

剂量:

600 Milligram

药物剂型:

Tablets Effervescent

授权状态:

Withdrawn

授权日期:

2007-05-31

产品特点

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