AMBROBENE EXTRA STRENGTH

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

AMBROXOL HYDROCHLORIDE

Tilgængelig fra:

Teva Pharma B.V.

ATC-kode:

R05CB06

INN (International Name):

AMBROXOL HYDROCHLORIDE

Dosering:

6 Mg/Ml

Lægemiddelform:

Oral Solution

Recept type:

Product not subject to medical prescription

Terapeutisk område:

ambroxol

Autorisation status:

Not Marketed

Autorisation dato:

2013-05-03

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBROBENE EXTRA STRENGTH 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 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. 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).
WHAT IS IN THIS LEAFLET:
1.
What
Ambrobene Extra Strength 6 mg/ml Oral Solution is and what it is used
for
2.
What you need to know before you take Ambrobene Extra Strength 6 mg/ml
Oral Solution
3.
How to take Ambrobene Extra Strength 6 mg/ml Oral Solution
4.
Possible side effects
5.
How to store Ambrobene Extra Strength 6 mg/ml Oral Solution
6.
Contents of the pack and other information
1.
WHAT AMBROBENE EXTRA STRENGTH 6 MG/ML ORAL SOLUTION IS AND WHAT IT IS
USED FOR
Ambrobene Extra Strength 6 mg/ml Oral Solution contains the active
ingredient ambroxol hydrochloride.
This belongs to a group of medicines called mucolytics that help clear
airways from mucus.
Ambrobene Extra Strength 6 mg/ml Oral Solution is used to treat airway
conditions that require the
elimination of mucus (phlegm) in adults and children older than 2
years of age. It works by making mucus
thinner so that it can be cleared more easily.
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).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMBROBENE EXTRA STRENGTH 6 MG/ML
ORAL SOLUTION
DO NOT TAKE AMBROBENE EXTRA STRENGTH 6 MG/ML ORAL SOLUTION:
-
If you are allergic to ambroxol hydrochloride or any other ingredients
of this medicine (lis

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ambrobene Extra Strength 6 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains:
6 mg of ambroxol hydrochloride.
Excipient(s) with known effect:
Sorbitol liquid (E420): 245 mg of sorbitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless oral solution with raspberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A mucolytic therapy for the treatment
of airway diseases associated with abnormal
mucous secretion and transport
disturbances affecting mucous secretion and clearance in adults and
children older than 2 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The following dosages are recommended for Ambrobene Extra Strength 6
mg/ml Oral Solution (5 ml dose = one
syringe):
_PAEDIATRIC POPULATION:_
Children under 2 years: Ambrobene is contraindicated.
Children from 2 to 5 years: Take 1.25 ml (a quarter of a syringe) of
Ambrobene 6 mg/ml 3-times a day (every 8 hours)
(equivalent to 22.5 mg of ambroxol hydrochloride per day).
Children from 6 to 12 years: Take 2.5 ml (half a syringe) of Ambrobene
6 mg/ml 2 to 3 times a day (every 12 or 8
hours) (equivalent to 30-45 mg of ambroxol hydrochloride per day).
_ADULTS AND CHILDREN OVER 12 YEARS:_
Typically, during the first 2 to 3 days 5 ml (one syringe) of
Ambrobene 6 mg/ml should be taken 3 times daily (every 8
hours) (corresponding to 90 mg of ambroxol hydrochloride per day).
After that, take 5 ml (one syringe) of
Ambrobene
6 mg/ ml twice a day (every 12 hours) (equivalent to 60 mg ambroxol
hydrochloride per day).
At the dosage for adults and children over 12 years, an increased
effectiveness is possible with the dosage of 10 ml
6 mg/ml Ambrobene two times a day (every 12 hours) (corresponding to
120 mg of ambroxol hydrochloride per day).
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