Nacsys 600 mg Effervescent Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Acetylcysteine

Saatavilla:

Alpex Pharma (Irl) Limited

ATC-koodi:

R05CB; R05CB01

INN (Kansainvälinen yleisnimi):

Acetylcysteine

Annos:

600 milligram(s)

Lääkemuoto:

Effervescent tablet

Prescription tyyppi:

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

Terapeuttinen alue:

Mucolytics; acetylcysteine

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2017-06-02

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
NACSYS 600 MG EFFERVESCENT TABLETS.
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 NACSYS 600 mg effervescent tablets are_ _and what they are_ _used
for
2.
What you need to know before you take_ _NACSYS 600 mg effervescent
tablets
3.
How to take_ _NACSYS 600 mg effervescent tablets
4.
Possible side effects
5.
How to store NACSYS 600 mg effervescent tablets
6.
Other information
1. WHAT NACSYS 600 MG EFFERVESCENT TABLETS ARE_ _AND WHAT THEY ARE_ _
USED FOR
Acetylcysteine breaks down and loosens thick phlegm, making it runny
and easy to cough up.
Acetylcysteine is used in the treatment of airway diseases such as
bronchitis (inflammation of the
mucous membranes in the airways), emphysema, mucoviscidosis (cystic
fibrosis) and bronchiectasis
(chronic widening of an airway passage).
NACSYS 600 mg Effervescent tablets are only_ _indicated for adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ _NACSYS 600 MG EFFERVESCENT
TABLETS
DO NOT TAKE_ _NACSYS 600 MG EFFERVESCENT TABLETS

If you are allergic to acetylcysteine or any of the other ingredients
of this medicine (listed in
section 6).

Children under 2 years of age must_ _not take_ _this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking NACSYS 600 mg
effervescent tablets:

Acetylcysteine can cause shortness of breath due to muscle cramping of
the airways
(bronchospasms) especially in patients with asthma. If this occurs,
immediately stop the treatment
and c

Valmisteyhteenveto

Health Products Regulatory Authority
06 September 2023
CRN00DT7Q
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nacsys 600 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 600 mg of acetylcysteine.
Excipient(s) with known effect: contains sodium hydrogen bicarbonate
(E500) (equivalent to 115 mg of sodium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet.
Round, flat, white to yellowish effervescent tablet (1500 mg/tablet; ~
17 x 4.25mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acetylcysteine is indicated for use as a mucolytic in respiratory
disorders such as in bronchitis, emphysema, mucoviscidoses
and bronchiectasis. NACSYS 600 mg effervescent tablets is indicated in
adults _ONLY_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
1 effervescent tablet of 600 mg once daily.
_Paediatric population_
Children older than 2 years of age and adolescents:
The safety and efficacy is not established in children aged 2 years
and older and adolescents.
Children under 2 years of age:
The use of NACSYS 600 mg effervescent tablets is contraindicated in
children under 2 years of age (see section 4.3).
Method of administration
_ _
_Precautions to be taken before handling or administering the
medicinal product._
For patients with a reduced cough reflex (elderly and weakened
patients) are advised to take the effervescent tablet in the
mornings.
Dissolve NACSYS 600 mg effervescent tablets in half a glass of water.
This produces a solution that may be consumed
immediately.
NACSYS 600 mg effervescent tablets are contraindicated in children
under 2 years of age (see section 4.3). Other forms and
strengths of acetylcysteine are more suitable for are more suitable
for children >2 and adolescents.
4.3 CONTRAINDICATIONS
- Hypersensitivity to acetylcysteine or to any of the excipients
listed in section 6.1.
- The tablets should not be used by children under 2 years of age.
Health Products Re