Acetylcysteine Stirling Anglian 600 mg effervescent tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Acetylcysteine

Available from:

Stirling Anglian Pharmaceuticals Ltd

ATC code:

R05CB; R05CB01

INN (International Name):

Acetylcysteine

Dosage:

600 milligram(s)

Pharmaceutical form:

Effervescent tablet

Therapeutic area:

Mucolytics; acetylcysteine

Authorization date:

2019-07-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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.
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
DO NOT TAKE

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 that dissolve phlegm can block the airways of young
children,
must not be used in children under 2 years of age.

Due to the high active substance content, must not be
used in children and
adolescents . Medicines in a suitable strength are available for this.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking .

If you suffer from bronchial asthma, do not take this medicine.

Very rare skin

Summary of Product characteristics

Health Products Regulatory Authority
22 July 2019
CRN008LM2
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
22 July 2019
CRN008LM2
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
Hypersensitivity to the a