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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
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