Aceo Tablets Effervescent 600mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ACETYLCYSTEINE

Available from:

Stirling Anglian Pharmaceuticals Ltd Hillington Park Innovation Centre, 1 Ainslie Road, Hillington Park, Glasgow G52 4RU, United

ATC code:

R05CB01

INN (International Name):

ACETYLCYSTEINE

Pharmaceutical form:

EFFERVESCENT TABLET

Composition:

ACETYLCYSTEINE 600 milligram(s)

Prescription type:

POM

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2019-01-24

Patient Information leaflet

Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACEO 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 Aceo is and what it is used for
2. What you need to know before you take Aceo
3. How to take Aceo
4. Possible side effects
5. How to store Aceo
6. Contents of the pack and other information
1.
WHAT ACEO IS AND WHAT IT IS USED FOR
Aceo 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.
Aceo 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 TAKEACEO
DO NOT TAKE ACEO
•
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, Aceo must
not be used in children under 2 years of age.
•
Due to the high active substance content, Aceo must not be used in
children and
adolescents . Medicines in a suitable strength are available for this.
Page
2
of
6
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Aceo.
•
If you suffer from bronchial asthma, do not take this medicine.
•
Very rare skin reactions called Stevens-Johnson syndrome and Lyell
syndrome have
been seen in people taking acetylcysteine. If you not

Summary of Product characteristics

Page
1
of
8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aceo 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
Aceo 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 Aceo in children aged 2 years and older,
and adolescents, have not been
established.
Page
2
of
8
_Children under 2 years of age _
Aceo 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.
Aceo should be taken after food.
_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 active substance or to any of the excipients
listed in section 6.1.
Children less than 2 years of age (see section 4.4).
Due to the high active substance content Aceo must not be used in
children and adolescents. Other
strengths are avail