Acetylcysteine 600mg capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Acetylcysteine

Dostopno od:

IPS Specials

Koda artikla:

R05CB01

INN (mednarodno ime):

Acetylcysteine

Odmerek:

600mg

Farmacevtska oblika:

Oral capsule

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 03070000

Navodilo za uporabo

!
If you have a history of stomach ulcers
!
Are under 14 years of age
!
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
Acetylcysteine 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.
Serious skin rashes (Steven-Johnson
syndrome and Lyell's syndrome) have rarely
Talk to your doctor, pharmacist or nurse before
taking Acetylcysteine Capsules:
DO NOT TAKE ACETYLCYSTEINE CAPSULES IF
YOU:
!
ARE ALLERGIC TO ACETYLCYSTEINE or any of
the other ingredients of this medicine (listed
in section 6)
WARNINGS AND PRECAUTIONS
!
If you have liver or kidney problems.
!
If you have asthma
!
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.
1.
WHAT ACETYLCYSTEINE CAPSULES ARE AND
WHAT THEY ARE USED FOR
5.
HOW TO STORE ACETYLCYSTEINE CAPSULES
!
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.
!
Keep this leaflet. You may need to read it
again.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
WHAT IS IN THIS LEAFLET:
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ACETYLCYSTEINE CAPSULES
3.
HOW TO TAKE ACETYLCYSTEINE CAPSULES
4.
POSSIBLE SIDE EFFECTS
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
1. WHAT ACETYLCYSTEINE CAPSULES
ARE AND WHAT THEY ARE USED FOR
Acetylcysteine 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

Lastnosti izdelka

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