INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ASACOL enema

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ASACOL enema

COMPOSITION
Per 50 mL enema:
Mesalazine (5-aminosalicylic acid) 2 g
Antioxidant: 
Sodium metabisulphite 0,05 g
Preservative: 
Sodium benzoate 0,1% m/v

PHARMACOLOGICAL CLASSIFICATION
A 11.10 Medicines acting on gastro-intestinal tract, special combinations

PHARMACOLOGICAL ACTION
ASACOL (Mesalazine) enema acts locally, probably involving the inhibition of prostaglandin and leukotriene synthesis.
ASACOL (Mesalazine) is mostly excreted in the faeces either as 5-aminosalicylic acid (5-ASA) or N-acetyl-5-ASA.
About 20 percent of the 5-ASA released in the colon is absorbed and rapidly acetylated to N-acetyl-5-ASA, which is excreted in the urine.
The acetylated metabolite (active ingredient) has a half-life of approximately 10 hours and that of the parent compound approximately one hour.

INDICATIONS
ASACOL (Mesalazine) is used for the treatment and maintenance of remission in ulcerative colitis.

CONTRA-INDICATIONS
Allergy to salicylates

WARNING
Safety and efficacy have not been established in children.

DOSAGE AND DIRECTIONS FOR USE
Adult dose: Two gram administered at night per rectum

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Mild nausea, colic, headache, diarrhoea and anal irritation may occur.
Caution should be exercised in patients who have renal damage with a raised blood urea or proteinuria. Mesalazine (5-Aminosalicylic acid) should not be given with preparations which lower stool pH, e.g. lactulose, and thereby prevent release of the active ingredient. Allergic manifestations may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In case of accidental oral ingestion symptoms of overdosage include that of salicylism, e.g. dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, mental confusion, hyperventilation, fever, restlessness, ketosis, respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma; cardiovascular collapse and respiratory failure.
There is no specific treatment for overdosage of Asacol but early lavage is recommended, if accidentally taken by mouth.
Treatment is symptomatic and supportive.

IDENTIFICATION
A pale brown-pink, slightly aerated suspension with a slightly acrid odour

PRESENTATION
50 mL single enema

STORAGE INSTRUCTIONS
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
Z/11.10/205

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
27 June 1996

ETHIMED
Division of
NORISTAN LIMITED, WALTLOO, PRETORIA
Under licence to Tillots Pharma AG, Ziefen, Switzerland

        D 375/0

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