Ambroxol Tussilene 6 mg/ml, syrup

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Διαθέσιμο από:

Laboratorios Azevedos - Industria Farmaceutica SA Estrada Nacional 117-2 Alfragide, 2614-503 Amadora, Portugal

Φαρμακολογική κατηγορία (ATC):

R05CB06

INN (Διεθνής Όνομα):

AMBROXOL HYDROCHLORIDE 30 mg/5ml

Φαρμακοτεχνική μορφή:

SYRUP

Σύνθεση:

AMBROXOL HYDROCHLORIDE 30 mg/5ml

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

COUGH AND COLD PREPARATIONS

Περίληψη προϊόντος:

Licence number in the source country: NOT APPLICAPABLE

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2023-02-02

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBROXOL TUSSILENE 6 MG/ML, SYRUP
AMBROXOL HYDROCHLORIDE
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 or nurse
have 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 or
nurse. 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 8 days.
What is in this leaflet
1.
What Ambroxol Tussilene is and what it is used for
2.
What you need to know before you take Ambroxol Tussilene
3.
How to take Ambroxol Tussilene
4.
Possible side effects
5.
How to store Ambroxol Tussilene
6.
Contents of the pack and other information
1.
What Ambroxol Tussilene is and what it is used for
Ambroxol Tussilene reduces the viscosity of the bronchial secretions.
The mucous becomes more fluid.
Ambroxol Tussilene has a stimulating effect over the bronchial mucosa
causing the production of more
fluid secretions. Moreover, it enhances pulmonary surfactant
production of the alveoli and the bronchi
and its drainage. Enhances pulmonary surfactant production and
stimulates ciliary activity
These mechanisms, together with the stimulation of the bronchial
epithelial cilia activity, maintain and
improve the auto-clearance capacity of the airways. Due to its
fluidizing and expectorant action it
promotes and accelerated the process of mucous clearance from the
alveoli.
Adjunctive mucolytic antibacterial treatment of respiratory infections
in the presence of bronchial
hypersecretion.
You must talk to a doctor if you do not feel better or if you feel
worse after 8 days.
2. What you need to know before you take Ambroxol Tussilene
Do not take Ambroxol Tussilene
- if you are allergic to ambroxol or any of the o

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ambroxol Tussilene 6 mg/ml, syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
Excipients with known effect:
Sorbitol (E420) – 716 mg/ml (70 % sorbitol solution)
Ethanol at 96% - 49.35 mg/ml
Propylene glycol (E1520) – 40 mg/ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup
Colourless clear solution with strawberry-mint flavour
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Adjuvant mucolytic antibacterial therapy for respiratory infections in
the presence of hypersecretion.
4.2 Posology and method of administration
Posology
5 ml of syrup = 1 full tea spoon
The treatment should not exceed more than 5-7 days without medical
advice.
Adults and children over 12 years: 10 ml (2 tea spoons), twice a day.
This scheme is suitable for the treatment of acute disorders of
respiratory tract and for initial treatment
of chronic conditions up to 14 days.
Pediatric population
Treatment for children under 12 years, depending on the severity of
the disease, is recommended
dosage regimen:
Children from 6 to 12 years: 5 ml (1 tea spoon), 2-3 times a day
(corresponding to 1,2 mg/Kg of body
mass)
Children from 2 to 5 years: 2,5 ml (½ tea spoon), 3 times a day
(corresponding to 1,25 mg/Kg of body
mass)
Children from 1 to 2 years: 2,5 ml (½ tea spoon), 2 times a day
(corresponding to 1,6 mg/Kg of body
mass)
These dosages corresponding to the initial treatment; the dosages
could be halved after 14 days.
Method of administration
Ambroxol Tussilene should be taken at meal times.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
In case of rare hereditarily conditions that may be incompatible with
one of the excipients (see section
4.4).
In case of alcoholism, you should be careful with this medicine (see
section 4.4).
4.4 Special warnings and precautions for use
The recommended maximum daily dose (20 ml) Amb