Bronchotussine

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

BROMHEXINE HYDROCHLORIDE

Disponibil de la:

Adelco-Chromatourgia Anthinon E. Colocotronis Bros S.A. 37 Pireos Str, 183 46, Moschato, Athens, Greece

Codul ATC:

R05CB02

INN (nume internaţional):

BROMHEXINE HYDROCHLORIDE 4 mg/5ml

Forma farmaceutică:

SYRUP

Compoziție:

BROMHEXINE HYDROCHLORIDE 4 mg/5ml

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

COUGH AND COLD PREPARATIONS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2005-12-26

Prospect

PATIENT INFORMATION LEAFLET
1.
DEFINITION OF THE PHARMACEUTICAL PRODUCT
1.1
PRODUCT NAME:
ΒRΟNCHOTUSSINE
1.2
COMPOSITION:
Active ingredient: Bromhexine hydrochloride
Excipients: Sorbitol, Glycerin, Methylparaben, Propylparaben, Alcohol,
Cherry Essence, Citric
Acid Monohydrate, Demineralised Water.
1.3
PHARMACEUTICAL FORM:
Syrup
1.4
ACTIVE INGREDIENT CONTENT:
Ν-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl) amine hydrochloride
(=bromhexine
hydrochloride) 4mg/5ml
1.5
DESCRIPTION-PACKAGING:
Clear, colourless syrup contained in a plastic bottle (100 ml).
1.6
PHARMACOTHERAPEUTICAL CATEGORY:
Mucolytic- expectorant
1.7
MARKETING AUTHORIZATION HOLDER-MANUFACTURER:
ADELCO – CHROMATOURGIA ATHINON E. COLOCOTRONIS BROS S.A.,
37 PIREOS STR., 183 46 MOSCHATO, ATHENS-GREECE
TEL.[phone], FAX: [phone]
2.
WHAT YOU SHOULD KNOW ABOUT THE DRUG PRESCRIBED BY YOUR PHYSICIAN
The information of this leaflet refers only to this particular
medicine.
Please read it carefully. It will provide you with important
information, but it cannot explain
everything to you. If you still have some questions or if you are not
sure about something, ask
your physician or pharmacist.
2.1
GENERAL INFORMATION:
Bromhexine is a synthetic derivative of the herbal active ingredient
vasicine.
Preclinically, it has been proved that bromhexine increases the
proportion of serous bronchial
secretions. Bromhexine also enhances mucus transport by reducing mucus
viscosity and by
activating the ciliated epithelium (mucociliary clearance).
In clinical studies, bromhexine showed mucolytic and mucokinetic
action in the bronchial tracts
area which facilitates expectoration and eases cough.
As
a result
of
bromhexine administration, the concentrations of antibiotics
(amoxicilline,
erythromycin, oxytetracycline) in saliva and bronchopulmonary
secretions, are increased.
2.2
INDICATIONS:
As an assistant agent for the liquefaction of the mucous secretions of
the respiratory tract in
cases
of
acute
and
chronic
bronchopulmonary
diseases
(bronchitis,
e

Caracteristicilor produsului

1. NAME OF THE PHARMACEUTICAL PRODUCT
BRONCHOTUSSINE
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN ACTIVE INGREDIENT
Ν-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl)amine hydrochloride
(=bromhexine
hydrochloride) 4mg/5ml
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL DATA
4.1
THERAPEUTIC INDICATIONS
As an assistant agent for the liquefaction of the mucous secretions of
the respiratory tract in
cases
of
acute
and
chronic
bronchopulmonary
diseases
(bronchitis,
emphysema,
tracheobronchitis, chronic asthmatic bronchitis).
During acute exacerbation of bronchitis it should be administered in
combination with the
appropriate antibiotic.
4.2
DOSAGE AND ADMINISTRATION
Adults and children over 12 years:
8-16 mg
3 times daily
Children 5-12 years:
4 mg
3 times daily
Children under 5 years:
2 mg
3 times daily
General dosage scheme for children: 0.5 mg/kg of weight daily.
DURATION OF TREATMENT SHOULD NOT EXCEED 8-10 DAYS WITHOUT MEDICAL
ADVICE.
NOTIFICATION:
Patients
treated
with
Bronchotussine
should
be
informed
about
a
possible
increase in the secretions flow.
During the initiation of the treatment for adults, the maximum daily
dose (48 mg) may be
required, divided in three doses.
During administration in acute respiratory conditions, you should ask
your physician’s advice if
the symptoms do not withdraw rapidly.
4.3
CONTRAINDICATIONS
Bronchotussine should not be used in patients with known
hypersensitivity to bromhexine or
any other ingredient of the product.
In cases of rare hereditary conditions, which may be incompatible with
any of the excipients of
the drug (please consult section 4.4 “Special precautions and
warnings during use”), the use of
the drug is contraindicated.
4.4
SPECIAL PRECAUTIONS AND WARNINGS DURING USE
It must be administered with caution in patients with active duodenal
ulcer, active tuberculosis
or severe hepatic damage.
During the use of the drug, an increase in the volume of the liquefied
bronchial secretions may
be induced and if they are not removed by the cough, special support
may be requi