Dipentum 500mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Olsalazine sodium

Inapatikana kutoka:

UCB Pharma Ltd

ATC kanuni:

A07EC03

INN (Jina la Kimataifa):

Olsalazine sodium

Kipimo:

500mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 01050100; GTIN: 5015313012454

Taarifa za kipeperushi

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIPENTUM
®
500MG TABLETS
(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 500mg Tablets 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)

If you have ever had an allergic reaction to any
salicylates (e.g. aspirin and aspirin-containing products,
including those bought over the counter)

If you have severe kidney disease
If
any of the above apply to you talk to your docto

Tabia za bidhaa

1
NAME OF THE MEDICINAL PRODUCT
Dipentum Tablets 500 mg
Olsalazine Sodium 500 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olsalazine sodium 500.0mg
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablet
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
ACUTE MILD DISEASE:
Adults including elderly: Commence on 1 g daily in divided doses and
depending upon the patient response, titrate the dose upwards to a
maximum
of 3 g daily over one week.
A single dose should not exceed 1 g.
Olsalazine should be taken with food.
REMISSION:
Adults including the elderly: one tablet (0.5 g) twice daily, taken
with food.
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 there is a suspicion or
evidence of a
blood dyscrasia.
Patients or their carers should be instructed how to recognise the
signs of
haematotoxicity and should be advised to contact their physicians
immediately
if the sympto