Acetylcysteine 600mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acetylcysteine

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

R05CB01

INN (International Name):

Acetylcysteine

Dosage:

600mg

Pharmaceutical form:

Capsule

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03070000

Patient Information leaflet

Mucolight 600mg Capsules
(Acetylcysteine)
PACKAGE LEAFLET: INFORMATION FOR THE USER
!
If you are allergic to histamine. If you are not
able to tolerate food and drinks that contain
large amounts of histamine such as wine,
tomatoes or processed food, then Mucolight
Capsules are not suitable for you because
acetylcysteine affects how histamine is broken
down in the body. The most common
symptoms of histamine intolerance are
migraine headaches, flushing, hives and rhinitis
(stuffy, runny nose) and itching.
!
If you have asthma
WARNINGS AND PRECAUTIONS
Serious skin rashes (Steven-Johnson syndrome
and Lyell's syndrome) have rarely been reported
with the use of acetylcysteine. The rash can often
involve ulcers of the mouth, throat, nose, genitals
Talk to your doctor, pharmacist or nurse before
taking Mucolight Capsules:
!
If you have a history of stomach ulcers
!
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.
!
Are under 14 years of age
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MUCOLIGHT CAPSULES
4.
POSSIBLE SIDE EFFECTS
!
ARE ALLERGIC TO ACETYLCYSTEINE or any of the
other ingredients of this medicine (listed in
section 6)
Mucolight Capsules 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
MUCOLIGHT CAPSULES
1. WHAT MUCOLIGHT CAPSULES ARE AND
WHAT THEY ARE USED FOR
1.
WHAT MUCOLIGHT CAPSULES ARE AND WHAT THEY
ARE USED FOR
!
If you have any further questions, ask your
doctor, pharmacist or nurse.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
!
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
sa

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mucolight 600mg Capsules
Acetylcysteine 600mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 600 mg acetylcysteine. For the full list of
excipients, see
section 6.1.
3
PHARMACEUTICAL FORM
Almost white, crystalline powder, filled in white hard gelatin 00
Capsule size.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolight 600mg Capsules are a mucolytic agent for the adjunctive
therapy of
respiratory
tract
disorders
characterized
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
capsule) 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.
For oral use.
Swallow the capsule with a drink of water. The capsule should be taken
after food.
Hepatic and Renal Impairment
In patients with impaired kidney or liver function 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.
This medicine 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
capsule in the adolescent population. However, mild, moderate or
severe adverse
react