Acetylcysteine Essential-Healthcare 600 mg effervescent tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Acetylcysteine

थमां उपलब्ध:

Ascot Laboratories (Ireland) Limited

ए.टी.सी कोड:

R05CB; R05CB01

INN (इंटरनेशनल नाम):

Acetylcysteine

फार्मास्यूटिकल फॉर्म:

Effervescent tablet

चिकित्सीय क्षेत्र:

Mucolytics; acetylcysteine

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2018-03-29

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
ACETYLCYSTEINE ESSENTIAL-HEALTHCARE 600MG EFFERVESCENT TABLETS
Acetylcysteine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
WHAT IS IN THIS LEAFLET
1.
What Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets is
and what it is used for
2.
What you need to know before you take Acetylcysteine
Essential-Healthcare 600mg
Effervescent Tablets
3.
How to take Acetylcysteine Essential-Healthcare 600mg Effervescent
Tablets
4.
Possible side effects
5.
How to store Acetylcysteine Essential-Healthcare 600mg Effervescent
Tablets
6.
Contents of the pack and other information
1.
WHAT ACETYLCYSTEINE ESSENTIAL-HEALTHCARE 600MG EFFERVESCENT TABLETS IS
AND WHAT IT IS
USED FOR
Acetylcysteine breaks down tough, sticky mucus, so that the liquid is
thin and can be easily coughed
up. This medicine can be used in respiratory diseases such as
bronchitis, emphysema, mucoviscidose
and bronchiectasis.
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets is
indicated for adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACETYLCYSTEINE
ESSENTIAL-HEALTHCARE 600MG
EFFERVESCENT TABLETS
DO NOT TAKE ACETYLCYSTEINE ESSENTIAL-HEALTHCARE 600MG EFFERVESCENT
TABLETS
-
if you are allergic to acetylcysteine or any of the other ingredients
of this medicine (listed in
section 6).
-
if your child is under 2 years of age.
-
if you are a child or pregnant woman suffering from phe

उत्पाद विशेषताएं

Health Products Regulatory Authority
21 October 2022
CRN00CZ53
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acetylcysteine Essential-Healthcare 600 mg effervescent tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 600 mg acetylcysteine.
Excipient(s) with known effect: contains sodium (146 mg per tablet)
and aspartame (20 mg per tablet, equal to 11 mg
phenylalanine).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet.
White, round and smooth effervescent tablets.
Thickness: 4.95 mm; diameter: 18.0 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acetylcysteine is indicated for pulmonary conditions, requiring
viscosity reduction of the bronchial secretion to facilitate
productive coughing, such as in bronchitis, emphysema, mucoviscidose,
and bronchiectasis.
Acetylcysteine Essential-Healthcare 600 mg Effervescent Tablets is
indicated in adults _only_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
600 mg (1 effervescent tablet) once daily.
_Paediatric population_
Children under 2 years of age
Acetylcysteine Essential-Healthcare 600mg Effervescent Tablets is
contraindicated for use in children under 2 years of age (see
section 4.3).
Children 2 years of age and older, and adolescents
The safety and efficacy is not established in children aged 2 years
and older and adolescents. Other forms and strengths of
acetylcysteine are more suitable for these patient groups.
Method of administration
Administer the required dose by dissolving an effervescent tablet in
half a glass of water, to obtain a solution which can be
ingested directly.
Patients with a muffled cough reflex (elderly and debilitated
patients) are advised to take the tablet in the morning.
Health Products Regulatory Authority
21 October 2022
CRN00CZ53
Page 2 of 5
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
The tablets should not be used in children under 2 years of a