Dipentum 250mg capsules

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Olsalazine sodium

Boleh didapati daripada:

UCB Pharma Ltd

Kod ATC:

A07EC03

INN (Nama Antarabangsa):

Olsalazine sodium

Dos:

250mg

Borang farmaseutikal:

Oral capsule

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 01050100; GTIN: 5015313012447

Risalah maklumat

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIPENTUM
®
250MG CAPSULES
(olsalazine sodium)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you only. Do not
pass it on to others. It may
harm them, even if their
symptoms are the same as yours.

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.

In this leaflet, Dipentum 250mg Capsules will be called
Dipentum.
WHAT IS IN THIS LEAFLET:
1.
What Dipentum is and what it is used for
2.
What you need to know before you take Dipentum
3.
How to take Dipentum
4.
Possible side effects
5.
How to store Dipentum
6.
Contents of the pack and other information
1.
WHAT DIPENTUM IS AND WHAT IT IS USED FOR
Dipentum belongs to a group of medicines called
aminosalicylates.
Dipentum works by reducing pain and swelling (inflammation)
in the intestine. It reduces the actions of substances in the
body that cause inflammation.
Dipentum is used to treat an inflammation of your large
intestine (colon) called ulcerative colitis. It is used for short-
term (acute) attacks (called "flare-ups"), and at a lower dose
to maintain the improvement (maintenance treatment) and
keep away further "flare-ups".
If untreated, a severe attack of ulcerative colitis may cause
death due to dehydration and bursting of the colon
(peritonitis).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DIPENTUM
DO NOT TAKE DIPENTUM IF:

You are allergic to olsalazine sodium or any of the other
ingredients of this medicine (listed in section 6)

You have ever had an allergic reaction to any salicylates
(e.g. aspirin and aspirin-containing products, including
those bought over the counter)

You have severe kidney disease
If any of the above apply to you talk to your doctor or

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Dipentum Capsules 250 mg
Olsalazine Sodium 250 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250mg olsalazine sodium.
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral treatment of mild active ulcerative colitis and maintenance of
remission.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
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.
A single dose should not exceed 1 g.
REMISSION
_Adults including the elderly:_ A dose of 0.5g should be taken twice
daily, at the
end of meals.
Olsalazine has been used concomitantly with gluco-corticosteroids.
4.3
CONTRAINDICATIONS
Hypersensitivity to olsalazine or other salicylates or any other of
the
excipients.
There is no experience of the use of olsalazine in patients with
significant
renal impairment. Olsalazine is contra-indicated in patients with
significant
renal impairment.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It is recommended to monitor patients with impaired kidney or liver
function.
Patients suffering from severe allergy or asthma should be observed
for signs
of worsening of these conditions.
It is recommended to monitor renal function in patients receiving
olsalazine,
by estimating serum creatinine before treatment, every 3 months for
the first
year, every 6 months for the next 4 years, and annually after 5 years
of
treatment.
Serious blood dyscrasias have been reported very rarely with
olsalazine.
Haematological investigations should be performed if the patient
develops
unexplained bleeding, bruising, purpura, anaemia, fever, sore throat
or mouth
ulcers. Treatment should be stopped if th