Octasa 1g suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mesalazine

Available from:

Tillotts Pharma UK Ltd

ATC code:

A07EC02

INN (International Name):

Mesalazine

Dosage:

1gram

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01050100; GTIN: 07640129621989 07640129621996

Patient Information leaflet

Reading way (42)
Reading way (42)
Reading way (42)
Reading way (42)
Package leaflet: information for the user
Octasa 1g Suppositories
Mesalazine
Read all of this leaflet carefully before you start using 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 signs of illness 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.
What is in this leaflet:
1. What Octasa 1g Suppositories are and
what they are used for
2. What you need to know before you use
Octasa 1g Suppositories
3. How to use Octasa 1g Suppositories
4. Possible side effects
5. How to store Octasa 1g Suppositories
6. Contents of the pack and other information
1. What Octasa 1g Suppositories are
and what they are used for
Octasa 1g Suppositories contain the active
substance mesalazine (also known as
5-aminosalicylic acid) which is an anti-
inflammatory drug used in the treatment of
Ulcerative proctitis – a disease of the
back passage (rectum) in which the lining of
the bowel becomes inflamed (red and
swollen).
Symptoms can include rectal bleeding,
frequent diarrhoea and abdominal pain.
The suppositories act locally in the rectum
to
reduce
inflammation
and
can
also
prevent further episodes (flares) of ulcerative
proctitis.
2. What you need to know before you
use Octasa 1g Suppositories
Do not use Octasa 1g Suppositories
–
If you are allergic to salicylic acid, to
salicylates such as acetylsalicylic acid
(aspirin) or to the other ingredient of this
medicine (listed in section 6).
–
If you have a serious liver or kidney disease.
Warnings and precautions
Talk to your doctor before using Octasa
1g Suppositories
–
If you have a history of problems with
your lungs, particularly if you suffe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Octasa 1 g Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1 g mesalazine.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Suppository
Appearance: light beige coloured, torpedo-shaped suppositories
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute mild to moderate ulcerative proctitis.
Maintenance of remission of ulcerative proctitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and older people:
_Acute treatment _
One Octasa 1 g Suppository once daily (equivalent to 1 g mesalazine
daily) inserted
into the rectum.
_Maintenance treatment _
One Octasa1 g Suppository once daily (equivalent to 1 g mesalazine
daily) inserted
into the rectum.
Paediatric population
There is little experience and only limited documentation for an
effect in children.
Method of administration
For rectal administration only.
Octasa 1 g Suppositories should be administered preferably at bedtime.
Treatment with Octasa 1 g Suppositories must be administered regularly
and
consistently, because only in this way can healing be successfully
achieved.
Duration of treatment
The duration of use is determined by the physician.
4.3
CONTRAINDICATIONS
Octasa 1 g Suppositories are contraindicated in patients with:
- known hypersensitivity to salicylates or to the excipient listed in
section 6.1
- severe impairment of hepatic or renal function
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood tests (differential blood count; liver function parameters such
as ALT or AST;
serum creatinine) and urinary status (dip-sticks) should be determined
prior to and
during treatment, at the discretion of the treating physician. As a
guideline, follow-up
tests are recommended 14 days after commencement of treatment, then a
further two
to three tests at intervals of 4 weeks.
If the findings are normal, follow-up tests should be carried out
every 3 months. If
additional symptoms occur, these tests should be performed