Carbocisteine Labomed S.A. «sugar free» 750mg/5ml oral solution

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Saadav alates:

Labomed Pharmaceutical Company S.A. 84 Ioannou Metaxa str. 19441, Koropi Attica, Greece

ATC kood:

R05CB03

INN (Rahvusvaheline Nimetus):

CARBOCISTEINE 750 mg

Ravimvorm:

ORAL SOLUTION

Koostis:

CARBOCISTEINE 750 mg

Retsepti tüüp:

POM

Terapeutiline ala:

COUGH AND COLD PREPARATIONS

Toote kokkuvõte:

Licence number in the source country: NOT APPLICAPABLE

Volitamisolek:

Authorised

Loa andmise kuupäev:

2022-09-14

Infovoldik

PAGE 1 OF 6
PACKAGE LEAFLET
PAGE 2 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
Carbocisteine Labomed S.A. «sugar free» 750mg/5ml oral solution
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.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Carbocisteine «sugar-free» 750mg/5ml oral solution is and
what it is used for
2. What you need to know before you take Carbocisteine «sugar-free»
750mg/5ml oral
solution
3. How to take Carbocisteine «sugar-free» 750mg/5ml oral solution
4. Possible side effects
5.
How to store Carbocisteine «sugar-free» 750mg/5ml oral solution
6. Contents of the pack and other information
1.
WHAT CARBOCISTEINE «SUGAR-FREE» 750MG/5ML ORAL SOLUTION IS AND WHAT
IT IS USED FOR
This medicine thins bronchial secretions (mucus) and makes them easier
to cough up. This
medicine is for adults and adolescents aged over 15 years only.
It is used for patients with the breathing passages (respiratory
tract). These problems happen
when too much mucus is made or the mucus is too sticky.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE «SUGAR-FREE»
750MG/5ML ORAL
SOLUTION
DO NOT TAKE CARBOCISTEINE «SUGAR-FREE» 750MG/5ML ORAL SOLUTION:
•
If you are allergic (hypersensitive) to carbocisteine or any of the
other ingredients of this
medicine (especially methyl parahydroxybenzoate) listed in section 6.
•
If you suffer from peptic ulcers (stomach or gut ulcers).
WARNINGS AND PRECAU

Toote omadused

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SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 6
1.
NAME OF THE MEDICINAL PRODUCT
Carbocisteine Labomed S.A. «sugar free» 750mg/5ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 750mg of carbocisteine.
Excipients with known effect
Each 5ml of oral solution contain 96.1mg (4.2mmol) of sodium.
Each 5ml of oral solution contain 7.5mg of sodium methyl
parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution
Clear, amber-coloured liquid, with raspberry odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbocisteine «sugar free» 750mg/5ml oral solution is a mucolytic
agent for the adjunctive therapy of
respiratory tract disorders characterised by excessive and viscous
mucus in adults and adolescents aged
over 15 years.
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.
Use in patients with known active peptic ulceration.
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.
Combining drugs that affect bronchial secretions with cough
suppressants and/or substances that dry
up secretions (atropine-like agents) is not recommended.
PAGE 3 OF 6
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 gastroin