Abrolin Oral Solution 15mg/5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMBROXOL HYDROCHLORIDE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

R05CB06

INN (International Name):

AMBROXOL HYDROCHLORIDE 15 mg/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

AMBROXOL HYDROCHLORIDE 15 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2015-05-14

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ABROLIN 15 MG/5 ML ORAL SOLUTION
ABROLIN 30 MG/5 ML ORAL SOLUTION
Ambroxol hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use 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 Abrolin is and what it is used for
2.
What you need to know before you take Abrolin
3.
How to use Abrolin
4.
Possible side effects
5.
How to store Abrolin
6.
Contents of the pack and other information
1.
WHAT ABROLIN IS AND WHAT IT IS USED FOR
Abrolin contains the active ingredient ambroxol hydrochloride. This
belongs to a group of medicines called
mucolytics (cough and cold preparations) that help clear airways from
mucus.
Abrolin 15 mg/5 ml is used to treat wet (productive) cough in children
from 6 to 12 years of age.
Abrolin 30 mg/5 ml is used to treat wet (productive) cough in adults
and adolescents over 12 years of age.
Wet (productive) cough is associated with disorders of the lungs and
bronchial tubes when excess mucus is
produced. Abrolin works by making mucus thinner and loosens it, so
that it can be coughed up more easily.
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 ABROLIN
DO NOT USE ABROLIN
-
if you are allergic to ambroxol or any of the other ingredients of
this medicine (listed in section 6).
-
in children under six years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Abrolin:
-
if you have or have had liver or kidney problems
There

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Abrolin 15 mg/5 ml oral solution
Abrolin 30 mg/5 ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abrolin 15 mg/5 ml oral solution: One ml contains 3 mg ambroxol
hydrochloride.
Abrolin 30 mg/5 ml oral solution: One ml contains 6 mg ambroxol
hydrochloride.
Excipient with known effect:
Each ml of Abrolin contains 0.35 g of sorbitol (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Colourless or pale yellow liquid, with odour of strawberry
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.
Abrolin 15 mg/5 ml oral solution is indicated in children from 6 to 12
years of age.
Abrolin 30 mg/5 ml oral solution is indicated in adults and
adolescents over 12 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The following dosages are recommended for Abrolin:
_[Abrolin 15 mg/5 ml:]_
_Children from 6 to 12 years of age _
5 ml oral solution (15 mg ambroxol hydrochloride) administered 2 to 3
times daily (equivalent to 30–45 mg
ambroxol hydrochloride per day).
_Children under 6 years of age _
Abrolin is contraindicated in children under 6 years of age (see
section 4.3).
_[Abrolin 30 mg/5 ml:]_
_Adults and adolescents over 12 _
_years of age_
5 ml oral solution (30 mg ambroxol hydrochloride) administered 3 times
daily (equivalent to 90 mg
ambroxol hydrochloride per day) during the first 2 to 3 days. After
that, 5 ml oral solution is administered
twice daily (equivalent to 60 mg ambroxol hydrochloride per day).
For adults, the dose may be increased up to 60 mg ambroxol
hydrochloride (10 ml of Abrolin 30 mg/5ml)
twice daily (equivalent to 120 mg ambroxol hydrochloride per day) if
needed.
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_Paediatric population _
_Children from 6 to 12 years of age _
Other