Aceteff 600mg effervescent tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Acetylcysteine

Prieinama:

Dunelm Pharmaceuticals Ltd

ATC kodas:

R05CB01

INN (Tarptautinis Pavadinimas):

Acetylcysteine

Dozė:

600mg

Vaisto forma:

Effervescent tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 03070000; GTIN: 05060234710002

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
2 McMillan Close, Saltwell Business Park
Low Fell
GATESHEAD
NE9 5BF
ACETEFF TM 600MG EFFERVESCENT TABLETS
ACETYLCYSTEINE
WHAT IS IN THIS LEAFLET
1. What Aceteff Tablets are and what they are used for
2. What you need to know before you take Aceteff Tablets
3. How to take Aceteff Tablets
4. Possible side effects
5. How to store Aceteff Tablets
6. Contents of the pack and other information
1. WHAT ACETEFF TABLETS ARE AND WHAT THEY ARE USED FOR
Aceteff
TM
600mg Effervescent Tablets (called Aceteff tablets in this leaflet)
contain
the active ingredient acetylcysteine which belongs to a group of
medicines called
‘mucolytics’. Aceteff tablets are used for problems with the
breathing passages (also
known as your respiratory tract). Sometimes too much mucus (phlegm) is
made or
the phlegm is too sticky. The tablets work by making mucus thinner and
less sticky so
it is easier to cough up.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACETEFF TABLETS
DO NOT TAKE ACETEFF TABLETS:
•
if you are allergic (hypersensitive) to acetylcysteine or any of the
ingredients of this
medicine (listed in section 6).
•
if you are under 14 years of age.
If you are not sure, talk to your doctor, pharmacist or nurse before
taking this
medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Aceteff tablets and
tell them if you
have:
•
liver or kidney problems
•
asthma
•
a history of stomach ulcers
•
intolerance to histamine. If you are not able to tolerate food and
drinks that contain
large amount of histamine such as wine, tomatoes or processed food,
then Aceteff
tablets are not suitable for you because Aceteff 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 (Stevens-Johnson syndrome and Lyell syndrome) have
rarely
been reported with the use of acetylcysteine. The rash can often
involve ulcers of
the mouth, th

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aceteff 600mg Effervescent Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 600mg acetylcysteine.
Excipients with known effect:
Each effervescent tablet contains 20mg aspartame (E591) and 145mg
sodium (as
sodium hydrogen carbonate).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent tablet.
Circular white tablet approximately 18mm in diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolytic
therapy
for
adjunctive
therapy
of
respiratory
tract
disorders
associated with excessive, viscous mucous secretions in adults and
adolescents
14 years of age and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Unless prescribed otherwise, the following dosage is recommended for
Aceteff 600mg Effervescent Tablets.
Adults and adolescents 14 years of age and over
One effervescent tablet daily (equivalent to 600mg acetylcysteine per
day).
Aceteff 600 mg Effervescent Tablets are not recommended in children
under
14
years
of
age
for
whom
a
lower
strength
formulation
of
acetylcysteine should be prescribed.
Hepatic and renal impairment
Hepatic
and
renal
impairment
can
reduce
clearance
and
increase
acetylcysteine plasma levels which may results in an increase in
adverse
drug reactions due to drug accumulation.
METHOD OF ADMINISTRATION
Aceteff 600mg Effervescent Tablets are to be taken after meals.
Dissolve
one whole tablet completely in a glass of water. Aceteff effervescent
tablets should not be subdivided.
The duration of therapy is dependent on the nature and severity of the
illness, and should be decided by the doctor treating the patient.
Upon storage over time a slight odour of hydrogen sulfide occurs as a
result of the normal aging process of the tablets. This is harmless
and does
not affect the tolerability or effectiveness of the product.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Aceteff
600mg
Effervesc