AMBROBENE

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

AMBROXOL HYDROCHLORIDE

Fáanlegur frá:

Teva Pharma B.V.

ATC númer:

R05CB06

INN (Alþjóðlegt nafn):

AMBROXOL HYDROCHLORIDE

Skammtar:

3 Mg/Ml

Lyfjaform:

Oral Solution

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

ambroxol

Leyfisstaða:

Not Marketed

Leyfisdagur:

2013-05-03

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBROBENE 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 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 3 mg/ml Oral Solution is and what it is used for
2.
What you need to know before you take Ambrobene 3 mg/ml Oral Solution
3.
How to take Ambrobene 3 mg/ml Oral Solution
4.
Possible side effects
5.
How to store Ambrobene 3 mg/ml Oral Solution
6.
Contents of the pack and other information
1.
WHAT AMBROBENE 3 MG/ML ORAL SOLUTION IS AND WHAT IT IS USED FOR
Ambrobene 3 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 3 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 3 MG/ML ORAL SOLUTION
DO NOT TAKE AMBROBENE 3 MG/ML ORAL SOLUTION:
-
If you are allergic to ambroxol hydrochloride or any other ingredients
of this medicine (listed in section
6).
-
Children up to 2 years.
-
If you have rare hereditary problems of fructose intolerance.
WARNINGS AND PRECAUTIONS
Talk to your doc

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ambrobene 3 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains:
3 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 3 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 2.5 ml
(half
a syringe)
of
Ambrobene 3 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 5 ml (one syringe) of Ambrobene 3
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 10 ml (two syringes) of
Ambrobene 3 mg/ml should be taken 3 times daily (every
8 hours) (corresponding to 90 mg of ambroxol hydrochloride per day).
After that, take 10 ml (two syringes) of
Ambrobene 3 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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