ASACOL TABLETS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Equity Pharmaceutical (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS MESALAZINE 400,0 mg

Authorization status:

Registered

Authorization date:

1990-09-11

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S3
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ASACOL TABLETS, MESALAZINE (5-AMINOSALICYLIC ACID), 400 mg (tablets)
ASACOL 800, MESALAZINE (5-AMINOSALICYLIC ACID), 800 mg (tablets)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ASACOL
TABLETS

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your
pharmacist.

ASACOL 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.
1.
WHAT ASACOL TABLETS CONTAINS
The active substance is mesalazine (also known as 5-aminosalicylic
acid).
ASACOL TABLETS: each tablet contains Mesalazine (5-aminosalicylic
acid) 400 mg.
ASACOL 800 Tablets: each tablet contains Mesalazine (5-aminosalicylic
acid) 800 mg.
The other ingredients are:

lactose monohydrate (the 400 mg and 800 mg tablets contain 76,4 mg and
152,8 mg of lactose
monohydrate respectively), magnesium stearate (vegetable origin),
povidone, sodium starch glycolate
(Type A) and talc.

Film-coating contains:

Macrogol 6000, methacrylic acid-methylmethacrylatecopolymer, talc,
triethyl citrate and iron oxides
(yellow pigment and red pigment)
Contains sugar (lactose monohydrate).
2.
WHAT ASACOL TABLETS IS USED FOR
ASACOL contains mesalazine. This is an anti-inflammatory medicine used
to treat ulcerative colitis.
3.
BEFORE YOU TAKE ASACOL TABLETS
DO NOT TAKE ASACOL TABLETS:

If you are allergic (hypersensitive) to mesalazine or any of the other
ingredients of ASACOL tablets

If you are allergic (hypersensitive) to salicylates (e.g. aspirin)

If you tend to bleed easily or for a longer time than normal

If you have an ulcer in your stomach or in the first part of the small
bowel (duodenum)

If you have severe kidney problems

If you have severe liver problems
TAKE SPECIAL CARE WITH ASACOL TABLETS:
Please tell your doctor if you have any medical conditions or
illnesses,

Summary of Product characteristics

PROFESSIONAL INFORMATION
SCHEDULING STATUS S3
PROPRIETARY NAME AND DOSAGE FORM
ASACOL TABLETS
ASACOL 800 Tablets
COMPOSITION
Per ASACOL TABLETS (400 mg tablet): Mesalazine (5-aminosalicylic acid)
400 mg
Per ASACOL 800 mg tablet: Mesalazine (5-aminosalicylic acid) 800 mg
_Excipients_:
The 400 mg and 800 mg tablets contain 76,4 mg and 152,8 mg of lactose
monohydrate respectively. Other
excipients are magnesium stearate, povidone, sodium starch glycolate
(Type A) and talc.
Film-coating contains:
Macrogol 6000, methacrylic acid-methylmethacrylatecopolymer, talc,
triethyl citrate, red pigment (ferric
oxide) and yellow pigment (ferric oxide).
Contains sugar (lactose monohydrate).
PHARMACOLOGICAL CLASSIFICATION
A 11.10 Medicines acting on gastrointestinal tract, other.
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
The acrylic based resin coating, which is pH-dependent (pH=7), delays
the release of mesalazine (5-
aminosalicylic acid) until the tablet reaches the distal ileum and
colon. There it acts locally, probably
involving the inhibition of prostaglandin and leukotriene synthesis.
PHARMACOKINETIC PROPERTIES
Mesalazine is mostly excreted in the faeces either as 5-aminosalicylic
acid (5-ASA) or N-acetyl-5-ASA.
About 20 per cent 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
_Ulcerative Colitis_:
ASACOL is used for the treatment and maintenance of remission in
ulcerative colitis.
CONTRAINDICATIONS
Hypersensitivity to mesalazine or to any of the other ingredients of
ASACOL tablets
Sensitivity to salicylates
Severe renal impairment (GFR less than 30 mℓ per minute)
Severe liver impairment
Gastric and duodenal ulcers
Bleeding tendency
WARNINGS AND SPECIAL PRECAUTIONS
Blood tests (differential blood count, liver function parameters such
as ALT or AST; serum creatinine) and
urinary status (dip