Pulmoclase sugar free 750mg/5ml syrup

Country: Malta

Language: English

Source: Medicines Authority

Available from:

OLVOS SCIENCE S.A. 4 Eleftherias str., 14564, Kifisia Athens , Greece

ATC code:

R05CB03

INN (International Name):

750 mg/5ml

Pharmaceutical form:

SYRUP

Composition:

750 mg/5ml

Prescription type:

POM

Therapeutic area:

COUGH AND COLD PREPARATIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-06-23

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pulmoclase «sugar free» 750mg/5ml syrup
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 your 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 Pulmoclase sugar-free750mg/5ml syrup is and what it is used
for
2. What you need to know before you take Pulmoclase
sugar-free750mg/5ml syrup
3. How to take Pulmoclase sugar-free750mg/5ml syrup
4. Possible side effects
5.
How to store Pulmoclase sugar-free750mg/5ml syrup
6. Contents of the pack and other information
1.
WHAT PULMOCLASE SUGAR-FREE750MG/5ML SYRUP IS AND WHAT IT IS USED FOR
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 PULMOCLASE SUGAR-FREE750MG/5ML
SYRUP
DO NOT TAKE PULMOCLASE SUGAR-FREE750MG/5ML SYRUP:
•
If you are allergic (hypersensitive) 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 Pulmoclase sugar-free750mg/5ml syrup.
This is because
Pulmoclase sugar-free750mg/5ml syrup thins secretions, making them
easier to cough up.
Coughing is a useful mechanism for expectorati

Summary of Product characteristics

PAGE 1 OF 6
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 6
1.
NAME OF THE MEDICINAL PRODUCT
Pulmoclase sugar free 750mg/5ml syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of syrup contains 750mg of carbocisteine.
Excipients with known effect
Each 5ml of syrup contains 96.1mg (4.2mmol) of sodium.
Each 5ml of syrup contains 7.5mg of sodium methyl parahydroxybenzoate.
Each 5ml of syrup contains 250.0 mg of glycerol.
Each 5ml of syrup contains 4.05mg of propylene glycol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup
Clear, amber-coloured liquid, with raspberry odour.
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 diets.
One dose of 5ml three times daily initially; if symptoms improve, the
dose may be lowered to 2 times
a day, i.e. total 10ml/day. The maximum daily dose is 15ml.
Do not exceed the stated dose.
A smaller volume of this product is needed, compared to other
carbocisteine products, to achieve the
same recommended dose.
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 3 OF 6
Combining drugs that affect bronchial secretions with cough
suppressants and/or substances that dry
up secretions (atropine-like agents) is not recommended.
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 gastrointestina