Rhinathiol Sugar-Free 5% Expectorant, syrup sweetened with saccharin sodium

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

CARBOCISTEINE

Tilgængelig fra:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC-kode:

R05CB03

INN (International Name):

CARBOCISTEINE 50 mg/ml

Lægemiddelform:

SYRUP

Sammensætning:

CARBOCISTEINE 50 mg/ml

Recept type:

OTC

Terapeutisk område:

COUGH AND COLD PREPARATIONS

Autorisation status:

Withdrawn

Autorisation dato:

2006-11-15

Indlægsseddel

RHINATHIOL SUGAR-FREE 5 PER CENT EXPECTORANT SYRUP
FOR ADULTS
CARBOCISTEINE
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.
Keep out of the reach of children
.
WHAT IS IN THIS LEAFLET
1.
What RHINATHIOL SUGAR-FREE 5 PER CENT EXPECTORANT is and what it is
used for
2.
What you need to know before you take RHINATHIOL SUGAR-FREE 5 PER CENT
EXPECTORANT
3.
How to take RHINATHIOL SUGAR-FREE 5 PER CENT EXPECTORANT
4.
Possible side effects
5.
How to store RHINATHIOL SUGAR-FREE 5 PER CENT EXPECTORANT
6.
Contents of the pack and other information
1.
WHAT RHINATHIOL SUGAR-FREE 5 PER CENT EXPECTORANT 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).
This medicine is for adults and adolescents aged over 15 years only.
It is used for patients with recent productive cough who have
difficulty expectorating.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RHINATHIOL SUGAR-FREE 5
PER CENT EXPECTORANT
DO NOT TAKE RHINATHIOL SUGAR-FREE 5 PER CENT EXPECTORANT:
•
if you are allergic to carbocisteine or any of the other ingredients
of this medicine (especially methyl
parahydroxybenzoate) listed in section 6.
WARNINGS AND PRECAUTIONS
You must not use medicines which suppress the cough (cough
suppressants) or which dry out
bronchial secretions when taking RHINATHIOL SUGAR-FREE 5 PER CENT
EXPECTORANT.
This is because RHINATHIOL SUGAR-FREE 5 PER CENT EXPECT

Produktets egenskaber

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RHINATHIOL SUGAR-FREE 5 PER CENT EXPECTORANT, SYRUP SWEETENED WITH
SACCHARIN SODIUM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CARBOCISTEINE
………………………...………………….…….. 5.000 G
One 15-ml measuring cap contains 750 mg carbocisteine and 90 mg
sodium. One 15-ml
measuring cap = 0.020 Kcal.
Excipients with known effect: sodium methyl parahydroxybenzoate
(E219), sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medication is indicated in adults and adolescents aged over 15
years for the treatment
of recent respiratory disease involving difficulty in expectorating
(i.e. difficulty in expelling
bronchial secretions in sputum).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route
FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OF AGE ONLY. This product is
suitable for patients following low-carbohydrate or low-calory diets.
-
One
15-ml
measuring
cap
contains
750
mg carbocisteine.
-
Take one 15-ml measuring capful 3 times daily, preferably outside
mealtimes.
-
Treatment should be short and should not exceed 5 days
4.3
CONTRAINDICATIONS
Hypersensitivity to carbocisteine or to any of the excipients listed
in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE SPECIAL WARNINGS
Productive coughs is a fundamental defense mechanism of the
bronchopulmonary system,
and as such should not be suppressed.
Page 2 of 4
Combining drugs that affect bronchial secretions with cough
suppressants and/or substances that dry up
secretions (atropine-like agents) is irrational.
PRECAUTION FOR USE
Caution is recommended in the elderly, in patients with a history of
gastroduodenal ulcers, and
in
those
taking
concomitant
medications
which
may
cause
gastrointestinal
bleeding.
If
gastrointestinal bleeding occurs, patients should discontinue
medication.
This medicinal product contains sodium. This medicinal product
contains 90 mg of sodium per
15 m