Dipentum 250mg hard Capsules

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:

250 milligram(s)

Farmacevtska oblika:

Capsule

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 250mg hard Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250mg olsalazine sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Beige, opaque, hard gelatin size 1 capsule radially printed "DIPENTUM
250 mg" in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of mild to moderate acute ulcerative colitis with or without
corticosteroids. The drug may also be used in the
long term maintenance or
remission of
ulcerative colitis.
It
is
particularly useful
where patients
cannot
tolerate
sulphazalazine because of sulpha intolerance.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be taken in divided doses with meals
GENERAL
Olsalazine taken on an empty stomach may sometimes lead to loose
stools or diarrhoea.
By taking the drug at the end of a
meal, this may be avoided.
Acute Mild Disease
_Adults including the elderly:_
Commence on 1 g daily in divided doses taken at
the end of meals.
Depending on the
patient’s response, the dose may be titrated upwards over a period
of one week to a maximum of 3g daily. Concommitant
oral or rectal steroids may be used. In the event of drug related
diarrhoea occurring, it may be transient. If it is not, 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 OF REMISSION
_Adults including the elderly:_ Two capsules may be taken twice daily
with food.
_Children and infants_: No specific recommendations are made.
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