Acetylcysteine 600mg effervescent tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acetylcysteine

Available from:

Special Order

ATC code:

R05CB01

INN (International Name):

Acetylcysteine

Dosage:

600mg

Pharmaceutical form:

Effervescent tablet

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03070000

Patient Information leaflet

EFFERVESCENT TABLETS
(ACETYLCYSTEINE)
10
TABLETS
600MG MUCOLIGHT
Batch No:
Best Before End:
Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
140115/3
Ennogen
Mucolight 600mg tabs_Carton 10's
UK
English
125 x 68 x 65 mm
8 pt
1 of 1
3
22-04-15
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Pantone 2582 C
Pantone 388 C
Pantone 137 C
Black
Keyline
BN No
EXP.
600MG
EFFERVESCENT TABLETS (ACETYLCYSTEINE) MUCOLIGHT
600MG
EFFERVESCENT TABLETS (ACETYLCYSTEINE) MUCOLIGHT
Each effervescent tablet contains 600mg acetylcysteine.
Also contains sorbitol (E420) and sodium.
For oral administration only. Use
as directed by your doctor.
Dissolve tablet in glass of water
and drink. Allow tablet to
completely dissolve before
drinking.
Please read enclosed Patient
Information Leaflet before use.
PL 40739/0031
MA Holder:
Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
POM
10
TABLETS
600MG
EFFERVESCENT TABLETS (ACETYLCYSTEINE) MUCOLIGHT
Put dispensing label here
600MG
EFFERVESCENT TABLETS
(ACETYLCYSTEINE) MUCOLIGHT
10 Tablets
Mucolight
Effervescent
Tablets
Mucolight
Effervescent
Tablets
Mucolight
Effervescent
Tablets
Keep out of the sight and reach of children.
Store product in its original packaging below 25°C.
Protect from moisture and light.
BN No
EXP.
EFFERVESCENT TABLETS
(ACETYLCYSTEINE)
20
TABLETS
600MG MUCOLIGHT
Batch No:
Best Before End:
Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
240614/1
Ennogen
Mucolight 600mg tabs_Carton 30's
UK
English
125 x 68 x 65 mm
8 pt
1 of 1
6
22-04-15
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Pantone 2582 C
Pantone 388 C
Pantone 137 C
Black
Keyline
BN No
EXP.
600MG
EFFERVESCENT TABLETS (ACETYLCYSTEINE) MUCOLIGHT
600MG
EF

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mucolight 600mg Effervescent Tablets
Acetylcysteine 600mg Effervescent Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 600 mg acetylcysteine.
Excipient(s) with known effect:
Sorbitol (E420) 695 mg/tablet
Sodium content 356.8 mg/tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent tablet.
White, round tablets with bevelled edges, 25mm in diameter
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolight 600 mg effervescent tablet is a mucolytic agent for the
adjunctive therapy
of respiratory tract disorders characterised by excessive, viscous
mucus, including
chronic obstructive airways disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In general the usual recommended dosage is:
Adults including elderly and adolescents 14 years: 600 mg (1
effervescent tablet)
once daily.
Duration of therapy: The duration of therapy is dependent on the
nature and severity
of the illness, and should be decided by the doctor.
The effervescent tablets should be dissolved completely in a glass of
water before use
and taken after food.
Hepatic and Renal Impairment
In patients with impaired kidney or liver impairment there is
insufficient data on
whether dosage adjustments are required. Hepatic and renal impairment
can reduce
clearance which may result in an increase in adverse drug reactions
due to drug
accumulation.
4.3
CONTRAINDICATIONS
Hypersensitivity to acetylcysteine or to any of the excipients listed
in section 6.1.
These tablets should not be used in children under 14 years of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Serious skin reactions such as Stevens-Johnson syndrome and Lyell’s
syndrome have been reported whilst taking acetylcysteine, but these
occur
rarely. For this reason, medical advice should be sought immediately
and
the patient should stop taking acetylcysteine in the event of
new-onset
changes to the skin and mucous membranes. See also section 4.8.
The