Mucotex 250 mg/5 ml syrup

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Carbocisteine

Tersedia dari:

Amdeepcha (Malta) Ltd

Kode ATC:

R05CB03

INN (Nama Internasional):

Carbocisteine

Dosis:

250 mg/5ml

Bentuk farmasi:

Syrup

Area terapi:

carbocisteine

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2019-01-18

Selebaran informasi

1
MUCOTEX 250 MG/5 ML SYRUP
CARBOCISTEINE
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
WHAT IS IN THIS LEAFLET
1.
What Mucotex Syrup is and what it is used for
2.
What you need to know before you take Mucotex Syrup
3.
How to take Mucotex Syrup
4.
Possible side effects
5.
How to store Mucotex Syrup
6.
Contents of the pack and other information
1.
WHAT MUCOTEX SYRUP IS AND WHAT IT IS USED FOR
Mucotex 250 mg/5 ml syrup (called Mucotex Syrup in this leaflet)
contains a medicine called
carbocisteine. This belongs to a group of medicines called
“mucolytics” used in the antibacterial
treatment of respiratory infections, in the presence of bronchial
hypersecretion. It works by making
the mucus (catarrh) less sticky. This makes the mucus easier to exit
when coughing.
Mucotex
Syrup is used for problems in the airways when there is too much mucus
or when it is too
sticky.
You must talk to your doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCOTEX
SYRUP
DO NOT TAKE MUCOTEX
SYRUP:
-
if you have a gastroduodenal ulcer;
-
if you are allergic to carbocisteine or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Mucotex Syrup:
-
Asthmatic patients and with a history of bronchospasm,
-
Severe respiratory insufficiency,
-
Debilitated patients. Due to the decrease of the cough reflex, there
is risk of obstruction of the
airway as a

Karakteristik produk

Health Products Regulatory Authority
27 September 2022
CRN00D3RC
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mucotex 250 mg/5 ml syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of syrup contains 250 mg carbocisteine.
Excipient(s) with known effect: each 5 ml of syrup contains 7.5 mg
methyl parahydroxybenzoate (E218) and 2887.5 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
Yellow- amber liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbocisteine is a mucolytic agent for the adjunctive therapy of
respiratory tract disorders characterised by excessive and
viscous mucus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Dosage is based upon an initial daily dosage of 2250 mg carbocisteine
in divided doses, reducing to 1500 mg daily in divided
doses when a satisfactory response is obtained e.g. for normal syrup
15 ml 3 times a day reducing to 10 ml 3 times a day.
_Paediatric population_
2 - 5 years: 1.25 - 2.5ml, four times a day.
6 - 12 years: 5 ml, three times a day.
Carbocisteine is contraindicated in children aged less than 2 years.
Method of administration
Use the measuring device to measure the appropriate amount, whether
its use is for an adult or a child. The syringe for oral
administration is graduated per 0.25ml. One graduation, 0.25ml
corresponds to 12.5mg of carbocisteine.
_How to use the syringe:_
Step 1: Check the measurements on the side of the syringe to see how
much to fill it.
Step 2: Push the syringe's plunger all the way down. Then put the tip
of the syringe into the medicine bottle.
Step 3: Slowly pull back on the plunger until the syringe fills to the
appropriate mark. Make sure there are not any large air
bubbles in the syringe. If there are, empty the syringe and try again.
Step 4: Place the end of the syringe into the mouth against the cheek
and carefully press the plunger down slowly to gently
release the medicine. After use rep ace the bottle cap. Wash the
syringe in warm water an