Xtex 250 mg /5 ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbocisteine

Available from:

Rowa Pharmaceuticals Limited

ATC code:

R05CB; R05CB03

INN (International Name):

Carbocisteine

Dosage:

250 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Mucolytics; carbocisteine

Authorization status:

Marketed

Authorization date:

2017-07-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
XTEX 250 MG/5 ML 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 or nurse 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 or
nurse. 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.
IN THIS LEAFLET:
1. WHAT XTEX IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XTEX
3. HOW TO TAKE XTEX
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE XTEX
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT XTEX IS AND WHAT IT IS USED FOR
Xtex 250 mg/5 ml Oral Solution (called Xtex in this leaflet) contains
a medicine called carbocisteine. This
belongs to a group of medicines called ‘mucolytics’. It works by
making mucus (phlegm) less sticky. This
makes the mucus easier to cough up.
Xtex is used for problems 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 XTEX
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic to carbocisteine or any of the other ingredients of
this medicine (listed
in Section 6)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of the lips,
face, throat or tongue
•
You have an ulcer in your stomach or gut (small intestine).
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking Xtex.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before taking Xtex
if:
•
You have a history of stomach ulcers (peptic ulceration)
•
Your docto

Summary of Product characteristics

Health Products Regulatory Authority
02 September 2022
CRN00CN83
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xtex 250 mg /5 ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral solution contains 250 mg of carbocisteine.
Excipients with known effect:
Maltitol (E 965): 750 mg per 5 ml
Propylene glycol (E 1520): 30 mg per 5 ml
Sunset yellow FCF (E 110): 0.03 mg per 5 ml
Sodium methyl parahydroxybenzoate (E 219): 7 mg per 5 ml
Sodium propyl parahydroxybenzoate (E 217): 1 mg per 5 ml
Total sodium content: 44.5 mg per 5 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Xtex is an orange-coloured transparent solution with an orange
flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbocisteine is a mucolytic agent for the adjunctive therapy of
respiratory tract disorders characterised by excessive, viscous
mucus.
Xtex is indicated in adults and children aged 2 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dosage:
_Adults and children over 12 years_:
The usual dose is 15ml three times daily initially, reducing to 10ml
three times daily when a satisfactory response has been
obtained.
CHILDREN 2 YEARS AND OLDER:
The usual daily dose is 20mg/kg in divided doses.
_Children 6-12 years:_ Usual dose is one 5ml teaspoon (250mg) two to
three times daily
_Children 2-6 years:_ Usual dose is half a 5ml teaspoon (125mg) two to
three times daily.
CHILDREN UNDER 2 YEARS:
Not recommended.
Route of administration:
Oral use
Health Products Regulatory Authority
02 September 2022
CRN00CN83
Page 2 of 6
Method of administration:
It is recommended to drink a glass of water after each dose and plenty
of fluids during the day.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance carbocisteine, ​
​
other cisteine ​​related compounds, or any of the excipients
listed in section 6.1

Should not be administered in patients with active gastroduodenal
ulcer
4.4 SPECIAL WARNINGS AND PRE