Broxivan 6 mg/ml Oral solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMBROXOL HYDROCHLORIDE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

R05CB06

INN (International Name):

AMBROXOL HYDROCHLORIDE 6 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

AMBROXOL HYDROCHLORIDE 6 mg/ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-08-16

Patient Information leaflet

Page
1
of
5
PACKAGE LEAFLET: INFORMATION FOR THE USER
BROXIVAN 6 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.
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.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BROXIVAN
DO NOT TAKE BROXIVAN
-
If you are allergic to ambroxol hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
-
For children under 2 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Broxivan.
-
if you have kidney or severe liver problems, this medicine should only
be used after asking a
doctor;
-
if you have a bronchial motor activity disorder (problems with your
lungs) along with a large
production of secretion (risk of a mucous plug), you should not take
this medicine;
-
if you develop a skin rash (including lesions of the mucous membranes
suc

Summary of Product characteristics

Page
1
of
6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Broxivan 6 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of oral solution contains 6 mg ambroxol hydrochloride.
Each 5 ml of oral solution contains 30 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.
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 (60 mg of ambroxol hydrochloride), 2 times a day (every 12
hours), which means a daily
maximum of 120 mg of ambroxol hydrochloride.
Once the patient improves, the dose can be cut in half.
_Paediatric population _
_Adolescents and children over 2 years old _
Broxivan 3 mg/ml oral solution is available for children and
adolescents.
_Children under 2 years _
This medicine is contraindicated in children younger than 2 years.
_Patients with renal or hepatic impairment _
In case of moderate to severe renal/hepatic impairment the dosage of
ambroxol hydrochloride should
be adjusted (see sections 4.4).
Method of administration
Broxivan is for oral use.
Broxivan can be taken with or without food.
Page
2
of
6
To facilitate administration of the oral solution the package contains
a volume-measuring device.
The duration of treatment should not exceed 5 days without medical
advice. In the case of acute
respiratory conditions, medical advice should be sought if symptoms do
not improve or get worse after
5 days of treatment.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in