Mucodyne 375 mg Capsules, Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbocisteine

Available from:

Ipsen Pharmaceuticals Limited

ATC code:

R05CB; R05CB03

INN (International Name):

Carbocisteine

Dosage:

375 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Mucolytics; carbocisteine

Authorization status:

Not marketed

Authorization date:

1975-01-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mucodyne 375 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 375 mg of Carbocisteine.
Excipients: Each capsule contains sunset yellow (E110) and 22mg of
lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, Hard (capsule).
Size No. 1 opaque, yellow, capsule, hard having an identification mark
printed “mucodyne 375” in black ink and
containing a white to almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbocisteine is a mucolytic agent for the adjunctive therapy of
respiratory tract disorders characterised by excessive or
viscous mucus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage:
Adults:
2 capsules three times a day initially, reduced to 1 capsule 4 times a
day when a satisfactory response has
been attained.
Children:
It is not recommended that this formulation be used for children.
4.3 CONTRAINDICATIONS
1.
Use in patients with a known hypersensitivity to Carbocisteine.
2.
Use in patients with active peptic ulceration.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is recommended in the elderly, in those with a history of
gastroduodenal ulcers, or those taking concomitant
medications known to cause gastrointestinal bleeding. If
gastrointestinal bleeding occurs, patients should discontinue
medication.
Because of the possible effect on the mucous glands of the stomach,
this product should be used with caution in
patients with a history of peptic ulceration.
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