Acetylcysteine 600mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Acetylcysteine

Tilgjengelig fra:

Ennogen Healthcare Ltd

ATC-kode:

R05CB01

INN (International Name):

Acetylcysteine

Dosering :

600mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 03070000; GTIN: 5060254924731

Informasjon til brukeren

Acetylcysteine 600mg 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, 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET:
1.
WHAT ACETYLCYSTEINE TABLETS ARE AND WHAT
THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ACETYLCYSTEINE TABLETS
3.
HOW TO TAKE ACETYLCYSTEINE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ACETYLCYSTEINE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ACETYLCYSTEINE TABLETS ARE
AND WHAT THEY ARE USED FOR
Acetylcysteine 600mg 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).
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ACETYLCYSTEINE TABLETS
DO NOT TAKE ACETYLCYSTEINE 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 Acetylcysteine Tablets:
!
If you have asthma
!
If you have a history of stomach ulcers
!
If you are allergic to histamines
!
If you have liver or kidney problems.
If you notice any changes to your skin or mucus
membranes such as the inside of your nose, mouth
and lips, you should STOP TAKING THESE TABLETS
IMMEDIATELY AND SEEK MEDICAL ADVICE (see
section 4 Possible side effects).
OTHER MEDICINES AN

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mucolight 600mg Tablets
Acetylcysteine 600mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg acetylcysteine.
Excipient with known effect
Sodium (less than 23mg per tablet)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White, round convex tablets 13mm in diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolight 600 mg 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
In general the usual recommended dosage is:
Adults including elderly and adolescents 14 years and older: 600 mg (1
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.
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.
For oral use.
Swallow the tablet with a drink of water. The tablet should be taken
after food.
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.
There are no studies on the efficacy and safety of once daily
acetylcysteine 600 mg
effervescent tablet in the adolescent population. However, m