Rhinathiol 2% Children, syrup

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

CARBOCISTEINE

Inapatikana kutoka:

Sanofi Malta Limited

ATC kanuni:

R05CB03

INN (Jina la Kimataifa):

CARBOCISTEINE

Dawa fomu:

SYRUP

Tungo:

CARBOCISTEINE 20 mg/ml

Dawa ya aina:

OTC

Eneo la matibabu:

COUGH AND COLD PREPARATIONS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2006-12-12

Taarifa za kipeperushi

RHINATHIOL
Expectorant _CARBOCISTEINE 2% FOR CHILDREN _
syrup for children
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.
Keep out of the reach of children.
What is in this leaflet
1. What Rhinathiol Expectorant Carbocisteine is and what it is used
for
2. What you need to know before you take Rhinathiol Expectorant
Carbocisteine
3. How to use Rhinathiol Expectorant Carbocisteine
4. Possible side effects
5. How to store Rhinathiol Expectorant Carbocisteine
6. Contents of the pack and other information
1. WHAT RHINATHIOL EXPECTORANT CARBOCISTEINE 2 % SYRUP FOR CHILDREN IS
AND WHAT IT IS
USED FOR
Pharmacotherapeutic group: MUCOLYTICS - ATC code: R05CB03 (R:
respiratory system)
This medicine thins bronchial secretions (mucus) and makes them easier
to cough up (expectorate).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RHINATHIOL EXPECTORANT
CARBOCISTEINE 2 % SYRUP FOR CHILDREN
DO NOT TAKE RHINATHIOL EXPECTORANT CARBOCISTEINE 2 % SYRUP FOR
CHILDREN:
• if you are allergic (hypersensitive) to the active substance or
any of the other ingredients of this
medicine listed in section 6.
• if your child is under 2 years of age, as bronchial congestion may
become worse.
WARNINGS AND PRECAUTIONS
You (or your child) must not use medicines which suppress cough (cough
suppressants) or which dry
out bronchial secretions when taking Rhinathiol Expectorant
Carbocisteine. This is because
Rhinathiol Expectorant Carbocisteine thins secretions, making them
easier to cough up. Coughing is a
useful mechanism for expe

Tabia za bidhaa

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RHINATHIOL 2 PER CENT CHILDREN, SYRUP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CARBOCISTEINE
………………………...………………….…... 2.000 G
For 100 ml of syrup
One 5 ml measuring spoon contains 100 mg of carbocisteine.
Excipient(s) with known effect: 3.5 g of sucrose and 13 mg of sodium
per 5 ml measuring
spoon. Methyl parahydroxybenzoate (E218). Ponceau 4R (E124).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of bronchial secretion disorders, notably during the course
of acute bronchial
disease: acute bronchitis and acute episodes of chronic pulmonary
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One 5-ml measuring spoon contains 100 mg of carbocisteine.
Children aged 2 to 5 years: 200 mg per day, in 2 divided doses, i.e.
one 5-ml measuring
spoon 2 times per day.
Children aged over 5 years: 300 mg per day, in 3 divided doses, i.e.
one 5-ml measuring
spoon 3 times per day.
Treatment duration should be short and not exceed 8 to 10 days.
4.3
CONTRAINDICATIONS
• History of hypersensitivity to any of the ingredients
(particularly methyl parahydroxybenzoate
and other parahydroxybenzoate salts).
• Infants (under two years of age) (see section 4.4).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SPECIAL WARNINGS
In patients with thick and purulent sputum, fever or chronic bronchial
and pulmonary disease, the
clinical situation should be reassessed.
Productive cough, which is a fundamental bronchopulmonary defense
mechanism, should not be
Page 2 of 4
suppressed.
Combining drugs that affect bronchial secretions with cough
suppressants and/or substances that dry
up secretions (atropine-like agents) is irrational.
Mucolytic agents may induce severe bronchial congestion in infants.
Infant bronchial mucus
drainage capacities are limited due to the physiological
characteristics of their bronchial tree.
Mucolytics should ther