ERDOMED HARD CAPSULES 300MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Erdosteine

Available from:

HYPHENS PHARMA PTE. LTD.

ATC code:

R05CB15

Pharmaceutical form:

CAPSULE

Composition:

Erdosteine 300mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

EDMOND PHARMA S.R.L

Authorization status:

ACTIVE

Authorization date:

2019-10-02

Summary of Product characteristics

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1
PACKAGE INSERT _ _
_ _
1.
TRADE NAME OF THE MEDICINAL PRODUCT
ERDOMED 300 MG HARD CAPSULES
Erdosteine 300 mg capsules are presented as size 1 hard gelatine
capsules, with green
cap and
yellow
body, containing an ivory powder.
ERDOMED 300 MG DISPERSIBLE TABLETS
Erdosteine 300 mg dispersible tablets are round, flat, light orange
tablets with score on
one side.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ERDOMED 300 mg hard capsules:
Each hard capsule contains: Erdosteine 300 mg
ERDOMED 300 mg dispersible tablets
Each dispersible tablet contains: Erdosteine 300 mg
Excipients with known effects:
Dispersible tablets:
Lactose and sun-set yellow lake
For complete list of excipients, see section. 6.1
3.
PHARMACEUTICAL FORM
Hard
capsules
Dispersible tablets
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Mucolytic agent for use in adults with acute and chronic respiratory
disorders (including
chronic
obstructive
pulmonary
disease,
acute
exacerbations
of
chronic
obstructive
pulmonary
disease,
rhinosinusitis,
pharingolaryngotracheitis,
acute
and
chronic
bronchitis) associated with excessive mucus production.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Elderly and adults above 18 years:
Oral formulations
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Posology
_ _
_300 mg hard capsules:_
1 capsule 2-3 times a day, for oral use.
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_300 mg dispersible tablets:_
1 tablet 2-3 times a day, for oral use.
Method of administration for
_dispersible tablets_
The tablets should be dissolved in a glass of water. The dispersion
should be stirred
with a spoon and drunk immediately. The score-line on the tablet does
not divide the
tablet into equal half-doses.
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2
4.3.
CONTRA-INDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Patients with active peptic ulcer.
Because
of
a
possible
interference
of
the
product
metabolites
with
methionine
metabolism, ERDOMED is contraindicated in patients suffering from
hepatic cirrhosis
and deficiency of the cystathionine-synthetase enzyme.
SINCE THERE ARE NO DATA IN PATIENTS WITH RE