Trebon 600 mg powder for oral solution

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Acetylcysteine

Tersedia dari:

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Kode ATC:

R05CB; R05CB01

INN (Nama Internasional):

Acetylcysteine

Dosis:

600 milligram(s)

Bentuk farmasi:

Powder for oral solution

Area terapi:

Mucolytics; acetylcysteine

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2020-06-19

Selebaran informasi

P A C K A G E L E A F L E T : I N F O R M A T I O N F O R T H E U S E
R
U133.... 04.2020
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 Trebon is and what it is used for
2. What you need to know before you take Trebon
3. How to take Trebon
4. Possible side effects
5. How to store Trebon
6. Contents of the pack and other information 1. WHAT TREBON IS AND WHAT IT IS USED FOR
Trebon contains the active substance acetylcysteine and dissolves
thick mucus in the airways.
Trebon is used to loosen mucus and to ease coughing up in cases
of lung diseases such as chronic bronchitis in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TREBON
DO NOT TAKE TREBON
• If you are allergic to acetylcysteine or any of the ingredients of
this medicine (listed in section 6).
• Children under 2 years of age must not take Trebon.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Trebon if you have
• asthma
If you have asthma then you should not take this medicine.
• skin and lining of the mouth and groin changes
The occurrence of severe skin reactions, has very rarely been
reported in connection with the use of acetylcysteine. If you
experience any skin and lining of the mouth and groin changes,
you should immediately stop taking this product and inform your
doctor.
• a history of stomach or bowel ulcers or currently have them.
• if you are allergic to histamine
Long-term therapy should be avoided in these patients, since
taking
Trebon
may
lead
to
symptoms
of
intolerance
(e.g.

Karakteristik produk

Health Products Regulatory Authority
19 June 2020
CRN008K7F
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trebon 600 mg powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet with powder used for the preparation of oral solution
contains 600 mg of acetylcysteine.
Excipients with known effect
Each sachet contains 2,167.9 mg sorbitol and 9.5 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
White powder with lemon flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Trebon is indicated in adults as a mucolytic therapy in chronic
bronchitis and other respiratory conditions associated
with thick mucus hypersecretion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In general the usual recommended dosage is:
600mg once daily
The dosage may be increased according to the instructions of the
treating doctor based on the assessment of treatment
outcomes.
Duration of treatment
The duration of therapy is dependent on the nature and severity of the
illness, and should be decided by the doctor.
_Paediatric population_
Children older than 2 years of age and adolescents
The safety and efficacy of Trebon is not established in children aged
2 years and older and adolescents (see section 4.4). Other
products with lower strengths of acetylcysteine are more suitable for
this age group.
Children under 2 years of age
Trebon is contraindicated in children aged under 2 years (see section
4.3).
_Elderly_
Limited data in patients over 65 years of age is available.
_Renal and hepatic impairment_
In patients with renal or hepatic impairment there is insufficient
data on whether dosage adjustments are required. Renal and
hepatic impairment can reduce clearance and increase acetylcysteine
plasma levels which may result in an increase in adverse
drug reactions due to drug accumulation (see section 5.2).
Method of administration
Dissolve the content of one sachet in half a glass of water. This
produces a solution that
s