AceCil 600mg effervescent tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Acetylcysteine

Prieinama:

Essential-Healthcare Ltd

ATC kodas:

R05CB01

INN (Tarptautinis Pavadinimas):

Acetylcysteine

Dozė:

600mg

Vaisto forma:

Effervescent tablet

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 03070000; GTIN: 0721107354062

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
AceCil 600 mg Effervescent Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 600 mg acetylcysteine.
Excipient(s) with known effect: contains sodium (146 mg per tablet)
and
aspartame (20 mg per tablet, equal to 11 mg phenylalanine).
For the full list of excipients, see section 6.1.
Thickness: 4.95 mm; diameter: 18.0 mm.
3
PHARMACEUTICAL FORM
Effervescent tablet.
White, round and smooth effervescent tablets.
Thickness: 4.95 mm; diameter: 18.0 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acetylcysteine is indicated for pulmonary conditions, requiring
viscosity
reduction of the bronchial secretion to facilitate productive
coughing, such as
in bronchitis, emphysema, mucoviscidose, and bronchiectasis.
AceCil 600 mg Effervescent Tablets is indicated in adults _only_.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
600 mg (1 effervescent tablet) once daily.
_Paediatric population _
Children under 2 years of age
AceCil 600 mg Effervescent Tablets is contraindicated for use in
children
under 2 years of age (see section 4.3).
Children 2 years of age and older, and adolescents
The safety and efficacy is not established in children aged 2 years
and older
and adolescents. Other forms and strengths of acetylcysteine are more
suitable
for these patient groups.
Method of administration
Administer the required dose by dissolving an effervescent tablet in
half a
glass of water, to obtain a solution which can be ingested directly.
Patients with a muffled cough reflex (elderly and debilitated
patients) are
advised to take the tablet in the morning.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
The tablets should not be used in children under 2 years of age.
The tablets should not be used in children and pregnant women with
phenylketonuria.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bronchospasms may occur with the use of acetylcysteine. If
br