Rhinathiol Sugar Free 5% Expectorant

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CARBOCISTEINE

Available from:

Sanofi Malta Limited

ATC code:

R05CB03

INN (International Name):

CARBOCISTEINE

Pharmaceutical form:

SYRUP

Composition:

CARBOCISTEINE 50 mg/ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-11-15

Patient Information leaflet

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

Summary of Product characteristics

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-calorie diet.
-
One 15-ml measuring cap contains 750 mg carbocisteine.
-
Take one 15-ml measuring capful 3 times daily, preferably between
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 cough 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.
PRECAUTIONS 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