Acetylcysteine 600mg capsules

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 capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 03070000; GTIN: 5060254924649

Informasjon til brukeren

280 MM
160 MM
260 MM
140 MM
10
10
10
280 MM
160 MM
260 MM
140 MM
10
10
10
10
10
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 MUCOLIGHT CAPSULES ARE AND WHAT
THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MUCOLIGHT CAPSULES
3.
HOW TO TAKE MUCOLIGHT CAPSULES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MUCOLIGHT CAPSULES
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
1. WHAT MUCOLIGHT CAPSULES ARE
AND WHAT THEY ARE USED FOR
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
DO NOT TAKE MUCOLIGHT CAPSULES IF YOU:
!
ARE ALLERGIC 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 Capsules:
!
If you have asthma
!
If you have a history of stomach ulcers
!
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

Preparatomtale

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