ASACOL SUPPOSITORIES SUPPOSITORY

País: Sudáfrica

Idioma: inglés

Fuente: South African Health Products Regulatory Authority (SAHPRA)

Disponible desde:

Equity Pharmaceutical (Pty) Ltd

Dosis:

See ingredients

formulario farmacéutico:

SUPPOSITORY

Composición:

EACH SUPPOSITORY CONTAINS MESALAZINE 500 mg

Estado de Autorización:

Registered

Fecha de autorización:

1998-04-06

Información para el usuario

Page 1 of 10
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
ASACOL SUPPOSITORIES, 500 MG, SUPPOSITORIES
MESALAZINE (5-AMINOSALICYLIC ACID)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ASACOL
SUPPOSITORIES
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
-
ASACOL SUPPOSITORIES has been prescribed for you personally and you
should not share
your medicine with other people. It may harm them, even if their
symptoms are the same as yours.
WHAT IS IN THIS LEAFLET
1.
What ASACOL SUPPOSITORIES is and what it is used for
2.
What you need to know before you use ASACOL SUPPOSITORIES
3.
How to use ASACOL SUPPOSITORIES
4.
Possible side effects
5.
How to store ASACOL SUPPOSITORIES
6.
Contents of the pack and other information
1.
WHAT ASACOL SUPPOSITORIES IS AND WHAT IT IS USED FOR
ASACOL SUPPOSITORIES contains mesalazine, which is an
anti-inflammatory medicine used for:
•
The treatment and maintenance of remission in ulcerative colitis.
•
Treatment of mild to moderate proctitis and proctosigmoiditis.
Ulcerative colitis is a disease of the large bowel (colon) and back
passage (rectum), in which the
lining of the bowel becomes inflamed (red and swollen). ASACOL
SUPPOSITORIES act locally in
the rectum to reduce this inflammation. They can also be used to
prevent further episodes of ulcerative
Page 2 of 10
colitis. ASACOL SUPPOSITORIES are particularly useful when the
symptoms of ulcerative colitis
affect the rectum.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ASACOL SUPPOSITORIES
DO NOT USE ASACOL SUPPOSITORIES:
•
If you are hypersensitive (allergic) to mesalazine or to the other
ingredient of ASACOL
SUPPOSITORIES (listed in section 6).
•
If you are hypersensitive (allergic) to aspirin or other salicylates.
•
If you have had serious kidney or liver problems.
•
If you are pregnant or breastfeeding your infant.
•
This medicine should not be used by children.
•
If you have bleeding tendencies.
•
I

Ficha técnica

Page 1 of 13
SCHEDULING STATUS
1. NAME OF THE MEDICINE
ASACOL SUPPOSITORIES, (500 mg) Suppositories
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per suppository: Mesalazine (5-aminosalicylic acid) 500 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suppositories
An opaque, pale beige, torpedo-shaped suppository with a faint fatty
odour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASACOL SUPPOSITORIES is used for the treatment and maintenance of
remission in ulcerative
colitis.
The
suppositories
are
used
for
the
treatment
of
mild
to
moderate
proctitis
and
proctosigmoiditis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adult dose: _ In proctitis and proctosigmoiditis one suppository to
be inserted rectally up to three times
daily, after defaecation. The dosage is dependent upon the severity of
the disease and it may be
possible to reduce the dosage as the condition improves.
S3
Page 2 of 13
4.3 CONTRAINDICATIONS
Hypersensitivity to mesalazine or to any other excipients, see section
6.1.
History of allergy to salicylates.
Severe liver impairment.
Patients with impaired renal function (GFR less than 30 ml per
minute).
Safety in pregnancy and lactation has not been established.
Safety and efficacy have not been established in children.
Bleeding tendencies.
History of mesalazine-induced cardiac hypersensitivity.
Salicylate sensitive asthma.
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 medical practitioner. As a guideline,
follow-up tests are recommended 14
days after commencement of treatment and then every 4 weeks for the
following 12 weeks. If the
findings are normal, follow-up tests should be carried out every three
months. If additional signs
appear, these tests should be performed immediately.
_ _
_Renal impairment _
ASACOL SUPPOSITORIES should not be used in patie