Acetylcysteine Essential-Healthcare 600 mg effervescent tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

ACETYLCYSTEIN

Dostopno od:

Essential-Healthcare Ltd.

Koda artikla:

R05CB; R05CB01

INN (mednarodno ime):

ACETYLCYSTEIN

Odmerek:

600 milligram(s)

Farmacevtska oblika:

Effervescent tablet

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Mucolytics; acetylcysteine

Status dovoljenje:

Not marketed

Datum dovoljenje:

2018-03-29

Navodilo za uporabo

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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acetylcysteine
Essential-Healthcare 600mg Effervescent Tablets
Ÿ
If your child is between 2 and 18 years of age. Other forms and
strengths of acetylcysteine are more suitable for these patient
groups.
Ÿ
If you suffer from bronchial asthma, you can also suffer from
bronchospasms. If this occurs, immediately stop the treatment and
consult a doctor.
Ÿ
If you have a history of stomach ulcers, because Acetylcysteine
Essential-Healthca

Lastnosti izdelka

Health Products Regulatory Authority
14 January 2021
CRN00C3VF
Page 1 of 6
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
14 January 2021
CRN00C3VF
Page 2 of 6
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