Dipentum 500mg Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

OLSALAZINE SODIUM

Dostopno od:

Atnahs Pharma UK Limited

Koda artikla:

A07EC; A07EC03

INN (mednarodno ime):

OLSALAZINE SODIUM

Odmerek:

500 milligram(s)

Farmacevtska oblika:

Tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Aminosalicylic acid and similar agents; olsalazine

Status dovoljenje:

Marketed

Datum dovoljenje:

2014-09-26

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dipentum 500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg olsalazine sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A yellow capsule-shaped tablet debossed with ‘D500’ on one side
and a score line on the other.
The score line is only to faciiltate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of mild to moderate ulceration colitis with or without
corticosteroids.
The drug may also be used in the
long-term maintenance of remission of ulcerative colitis.
It is particularly useful where patients cannot tolerate
sulphasalazine because of sulpha intolerance.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral
Recommended dosage schedules
To be taken in divided dose, with meals.
Acute mild disease
Adults including the elderly:
Commence on 1 gram daily in divided doses depending on patient
responses titrate
dosage upwards to the maximum of 3 g daily over 1 week.
Concomitant oral or rectal steroids may be used.
In the
event of drug related diarrhoea occurring,
it may be transient.
If it is not,
the dose may be reduced; where diarrhoea
continues despite this reduction the drug should be stopped.
A single dose should not exceed 1 g
Long-term maintenance
_Adults including the elderly_:
One tablet may be taken twice daily with food.
_Children and infants_:
No specific recommendations are made.
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