Acetylcysteine 600mg effervescent tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acetylcysteine

Available from:

IPS Specials

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

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
200315/2
Ennogen
EP_A-CYS 600mg Leaflet
UK
English
160 x 270 mm
9 pt
1 of 1
9
06-05-16
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
Mucolight 600mg Effervescent Tablets
(Acetylcysteine)
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it
again.
!
If you have any further questions, ask your
doctor or pharmacist or nurse.
!
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
!
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET:
1.
WHAT MUCOLIGHT EFFERVESCENT TABLETS ARE
AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MUCOLIGHT EFFERVESCENT TABLETS
3.
HOW TO TAKE MUCOLIGHT EFFERVESCENT TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MUCOLIGHT EFFERVESCENT TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
Mucolight Effervescent Tablets contain a medicine
called Acetylcysteine. This belongs to a group of
medicines called mucolytics. It works by making
the mucus (phlegm) less sticky which makes the
mucus easier to cough up.
Acetylcysteine is used for problems with the
breathing passages (respiratory tract).
DO NOT TAKE MUCOLIGHT EFFERVESCENT TABLETS IF
YOU:
ARE ALLERGIC (HYPERSENSITIVE) TO
ACETYLCYSTEINE or any of the other ingredients
of this medicine (listed in section 6)
Are under 14 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before
taking Mucolight Effervescent Tablets:
!
If you have asthma
!
If you have a history of stomach ulcers
!
If you are allergic to

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