Exputex 250mg / 5ml Oral Solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Carbocisteine

Dostupné z:

Phoenix Labs

ATC kód:

R05CB; R05CB03

INN (Medzinárodný Name):

Carbocisteine

Dávkovanie:

250 mg/5ml

Forma lieku:

Oral solution

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Mucolytics; carbocisteine

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1985-12-20

Príbalový leták

PATIENT INFORMATION LEAFLET
(Carbocisteine)
Read all of this leaflet carefully before you start taking this
medicine.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1.
What Exputex Oral Solution is and what it is used for
2.
Before you take Exputex Oral Solution
3.
How to take Exputex Oral Solution
4.
Possible side effects
5.
How to store Exputex Oral Solution
6.
Further information
1.
WHAT EXPUTEX ORAL SOLUTION IS AND WHAT IT IS USED FOR
Exputex Oral Solution contains the active ingredient carbocisteine,
which liquefies viscous mucus and assists in the clearance of phlegm.
2.
BEFORE YOU TAKE EXPUTEX ORAL SOLUTION
Do NOT take the solution if you:
•
are allergic (hypersensitive) to carbocisteine or any of the other
ingredients in the solution _(see Section 6 and end of Section 2)_
•
suffer from peptic ulcers (stomach ulcers)
Take special care
Talk to your doctor before taking the solution if you have:
•
a history of peptic ulcers (stomach ulcers)
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have
recently taken any other medicines, including medicines obtained
without a
prescription.
Taking Exputex Oral Solution with food and drink.
You can take the solution with or without food.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant,
think you may be pregnant or are planning to become pregnant, or if
you are breast-feeding.
Exputex Oral Solution should not be taken by pregnant or
breast-feeding women unless advised to by a doctor.
Ask your doctor or pharmacist for advice before taking any medicine
during pregnancy, or if you are breast-feeding.
Driving and using machinery
Exputex Oral Solution should not have any e

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Exputex 250mg / 5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of liquid contains 250 mg of Carbocisteine.
Excipients: Contains sunset yellow (E110), parahydroxybenzoates (E215,
E217, E219), ethanol, and salts containing
sodium.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution.
A viscous, orange coloured liquid with an odour of condensed milk and
orange.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a mucolytic adjunct for respiratory tract disorders characterised
by excessive or viscous mucous.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
Adults
The usual dose is three 5 ml spoonfuls three times daily initially,
reducing to two 5 ml spoonfuls three times daily when
a satisfactory response has been obtained.
Children
6-12 years:
The usual dose is one 5ml spoonful (250 mg) two to three times daily.
2-5 years:
The usual dose is half a 5ml spoonful (125 mg) two to three times
daily.
Under 2 years:
Not recommended.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to carbocisteine or to
any of the excipients in Exputex.
Use in patients with known active peptic ulceration.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Because of the possible effects on the mucous glands of the stomach,
this product
should be used with caution in
patients with a history of peptic ulceration and avoided in patients
with active ulceration.
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