Broxivan 3 mg/ml Oral solution

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

AMBROXOL HYDROCHLORIDE

Tilgængelig fra:

Medochemie Iberia S.A Rua Jose Maria Nicolau, no 6, 7oB, São Domingos de Benfica, Lisbon, Portugal

ATC-kode:

R05CB06

INN (International Name):

AMBROXOL HYDROCHLORIDE

Lægemiddelform:

ORAL SOLUTION

Sammensætning:

AMBROXOL HYDROCHLORIDE 3 milligram(s)/millilitre

Recept type:

OTC

Terapeutisk område:

COUGH AND COLD PREPARATIONS

Produkt oversigt:

Licence number in the source country: NOT APPLICAPABLE

Autorisation status:

Authorised

Autorisation dato:

2021-08-16

Indlægsseddel

Page
1
of
5
PACKAGE LEAFLET: INFORMATION FOR THE USER
BROXIVAN 3 MG/ML ORAL SOLUTION
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 has 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. 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 5 days (within 3 days
in children aged less than 6 years).
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 Broxivan is and what it is used for
2.
What you need to know before you take Broxivan
3.
How to take Broxivan
4.
Possible side effects
5.
How to store Broxivan
6.
Contents of the pack and other information
1.
WHAT BROXIVAN IS AND WHAT IT IS USED FOR
Ambroxol, the active ingredient of this medicine, belongs to a group
of medicines called mucolytics,
which reduces the viscosity of mucus, fluidizing it and facilitating
its elimination.
This medicine is indicated for mucous-dissolving treatment in diseases
of the bronchi and the lungs
with thick mucus, in adults and children from 2 years old.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days (within 3 days in
children aged less than 6 ye

Produktets egenskaber

Page
1
of
7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Broxivan 3 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of oral solution contains 3 mg ambroxol hydrochloride.
Each 5 ml of oral solution contains 15 mg ambroxol hydrochloride.
Excipients with known effect: benzoic acid.
This medicine contains 0.51 mg benzoic acid in each ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Colourless to slightly yellowish, clear, vanilla and cherry flavoured
liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolytic therapy of productive cough in acute or chronic
bronchopulmonary diseases associated with
abnormal mucus secretion and impaired mucus transport, in adults and
children aged over 2 years old.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should not be exceeded for more than 5 days without the
advice of a doctor.
Posology
_Adults _
10 ml (30 mg of ambroxol hydrochloride), 3 times a day (every 8
hours), which means a daily
maximum of 90 mg of ambroxol hydrochloride.
_Paediatric population _
_Adolescents over 12 years old _
10 ml (30 mg of ambroxol hydrochloride), 3 times a day (every 8
hours), which means a daily
maximum of 90 mg of ambroxol hydrochloride.
_Children from 6 to 12 years old _
5 ml (15 mg of ambroxol hydrochloride), 2-3 times a day, which means a
daily maximum of 45 mg of
ambroxol hydrochloride. After 2-3 days, once the patient improves, the
dosage regimen can be
reduced to 2 times a day every 12 hours.
_Children from 2 to 5 years old _
2.5 ml (7.5 mg of ambroxol hydrochloride), 3 times a day (every 8
hours), which means a daily
maximum of 22.5 mg of ambroxol hydrochloride. After 2-3 days, once the
patient improves, the
dosage regimen can be reduced to 2 times a day every 12 hours. In this
population, a doctor should be
consulted.
Page
2
of
7
_Children under 2 years _
This medicine is contraindicated in children younger than 2 years.
_Patients with renal or hepatic impairment _
In case of moder