Viscolex Syrup 250 mg / 5 ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbocysteine

Available from:

Pinewood Laboratories Ltd

ATC code:

R05CB; R05CB03

INN (International Name):

Carbocysteine

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:

1986-10-15

Patient Information leaflet

148
148
210
210
Package Leaflet: Information for the user
Viscolex Syrup 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 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 Viscolex Syrup is and what it is used for.
2.
What you need to know before you take Viscolex Syrup.
3.
How to take Viscolex Syrup.
4.
Possible side effects.
5.
How to store Viscolex Syrup.
6.
Contents of the pack and other information.
1.
What Viscolex Syrup is and what it is used for
Viscolex Syrup is used to help treat lower respiratory tract disorders
(disorders of the breathing passages) where the lungs
produce too much mucus or the mucus is too thick. It contains
carbocisteine which is a mucolytic agent that is used to dissolve
and break down thick mucous in conditions such as chronic asthma or
bronchitis.
2.
What you need to know before you take Viscolex Syrup
Do not take Viscolex Syrup:
•
If you are allergic to carbocisteine or any of the other ingredients
of this medicine (listed in section 6).
•
If you have an active peptic ulcer.
•
Do not give to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Viscolex Syrup:
•
If you are an older patient
•
If you have a history of gastrointestinal ulcers
•
If you are taking medication known to cause gastrointestinal bleeding
•
If you have a history of peptic ulcer
•
If you are on a low sodium diet
•
If you have a rare hereditary fructose intolerance or an intolerance
to some sugars.
Other m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Viscolex Syrup 250 mg / 5 ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral solution contains carbocisteine 250 mg.
_Excipients_
Each 5 ml contains: 3 g sucrose, 0.625 mg sunset yellow (E110), 4.5 mg
sodium methyl parahydroxybenzoate (E219),
0.9 mg sodium ethyl
parahydroxybenzoate (E215),
0.6 mg sodium propyl
parahydroxybenzoate (E217) and <15 mg
ethanol.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, yellow, oral solution with odour and flavour of orange.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Viscolex Syrup is a mucolytic agent
indicated in children over the age of 2 and also in adults.
It
is an adjunctive
therapy in lower respiratory tract disorders characterised by
excessive viscous mucous.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
The usual dosage is 15ml (750mg) 3 times daily initially, reducing to
10ml (500mg) 3 times daily when a satisfactory
response has been obtained.
_Children_
6 – 12 years:
The usual dosage is 5ml (250mg) two to three times daily.
2 – 5 years:
The usual dose is 2.5ml (125mg) three times daily.
_Under 2 years_
Not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to carbocisteine or any of the excipients listed in
section 6.1.
Patients with active peptic ulceration.
Children under 2 years of age.
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