Acetylcysteine Stirling Anglian 600 mg effervescent tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Acetylcysteine

Dostupno od:

Stirling Anglian Pharmaceuticals Ireland Limited

ATC koda:

R05CB; R05CB01

INN (International ime):

Acetylcysteine

Doziranje:

600 milligram(s)

Farmaceutski oblik:

Effervescent tablet

Područje terapije:

Mucolytics; acetylcysteine

Status autorizacije:

Not marketed

Datum autorizacije:

2019-07-19

Uputa o lijeku

NAC 600 mg ET SAP
1.3.1 IE Package Leaflet English
1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACETYLCYSTEINE STIRLING ANGLIAN 600 MG
EFFERVESCENT TABLETS
For adults
acetylcysteine
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Acetylcysteine Stirling Anglian 600 mg effervescent tablets is
and what it is used for
2.
What you need to know before you take Acetylcysteine Stirling Anglian
600 mg effervescent tablets
3.
How to take Acetylcysteine Stirling Anglian 600 mg effervescent
tablets
4.
Possible side effects
5.
How to store Acetylcysteine Stirling Anglian 600 mg effervescent
tablets
6.
Contents of the pack and other information
1.
WHAT ACETYLCYSTEINE STIRLING ANGLIAN 600 MG EFFERVESCENT TABLETS IS
AND WHAT IT IS USED
FOR
Acetylcysteine Stirling Anglian 600 mg effervescent tablets contains
the active substance
acetylcysteine. Acetylcysteine belongs to a group of medicines called
mucolytics which work by
thinning the mucus (phlegm) so that it can be coughed up more easily.
Acetylcysteine Stirling Anglian 600 mg effervescent tablets is used to
loosen mucus and to ease
coughing up in cases of respiratory diseases with viscous mucus.
It should be used in adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACETYLCYSTEINE
STIRLING ANGLIAN 600 MG EFFERVESCENT TABLETS DO NOT TAKE
ACETYLCYSTEINE STIRLING ANGLIAN 600 MG EFFERVESCENT TABLETS
•
if you are allergic to acetylcysteine or any of the other ingredients
of this medicine (listed in
section 6).
•
in children under 2 years
Medicines t

Svojstava lijeka

Health Products Regulatory Authority
27 September 2022
CRN00CYTX
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acetylcysteine Stirling Anglian 600 mg effervescent tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 600 mg acetylcysteine.
Excipients with known effect
Each effervescent tablet contains:
-6.04 mmol (138.79 mg) sodium
-70 mg of lactose
-0.52 mg of sorbitol (E420)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet
White, round tablets with a score line on one side. The effervescent
tablets have a diameter of 20 mm.
The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acetylcysteine Stirling Anglian is indicated in adults as a mucolytic
agent for the treatment of respiratory tract diseases in which
a reduction in bronchial secretion viscosity is required to facilitate
expectoration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
600 mg acetylcysteine once daily.
_Paediatric population:_
_ _
_Children aged 2 years and older, and adolescents_
The safety and efficacy of Acetylcysteine Stirling Anglian in children
aged 2 years and older, and adolescents, have not been
established.
_Children under 2 years of age_
Acetylcysteine Stirling Anglian is contraindicated in children 0 to 2
years (see sections 4.3 and 4.4).
_Duration of therapy_
Duration of therapy should be determined by the clinician, depending
on the nature and severity of the condition
Method of administration
For oral use
Before oral use the tablet should be dissolved in half a glass of
water.
Acetylcysteine Stirling Anglian should be taken after food.
Health Products Regulatory Authority
27 September 2022
CRN00CYTX
Page 2 of 7
_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.
4.3 CONTRAINDICATIONS
Hypersensitivit