RELISAN (film coated tablet)
(and dosage form):
RELISAN (film coated tablet)
Each tablet contains 500 mg of 4-(6-methoxy-2-naphthyl) butan-2-one (nabumetone).
A.3.1 Anti-rheumatics (anti-inflammatory agents)
Relisan is a member of a naphthalene series of synthetic compounds. Relisan has anti-inflammatory, analgesic and anti-pyretic properties but inhibits prostaglandin synthetase poorly and has no uricosuric activity. After oral administration unaltered Relisan is only rarely detected in the serum as it is extensively metabolised to mainly 6-methoxy-2-naphthyl acetic acid, a more potent inhibitor of prostaglandin synthetase responsible for Relisan's pharmacological activity. Steady state serum levels of 6-methoxy-2-naphthyl acetic acid are reached in 3 to 4 days with a serum half life of 20 to 23 hours. The absorption of Relisan, is not impaired by food, but may be increased by taking it with milk. The main metabolite is distributed to all tissues, excreted in milk, but shows no evidence of accumulation. The main method of excretion is via the urinary tract as a glucuronide conjugate of the metabolites.
Relisan is indicated for the symptomatic treatment of:
Pregnancy and lactation. Active or recent history of peptic ulceration. History of analgesic induced asthma.
Use in children under the age of 12 years.
Hypersensitivity reactions to Relisan or other nonsteroidal anti-inflammatory drugs.
There has been no experience of use in patients with impaired renal function. Relisan should not be used in renal failure.
Keep out of the reach of children.
DOSAGE AND DIRECTIONS FOR USE:
ADULTS: The recommended daily dosage is 2 tablets (1 g) taken as a single night time dose.
Blood levels are higher in elderly patients. In many cases 500 mg may give satisfactory relief.
The total daily dosage should not exceed 1 g.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most commonly reported side-effects are gastrointestinal symptoms including indigestion, nausea, dyspepsia, abdominal pain, flatulence and diarrhoea. Central nervous symptoms such as headache, dizziness and drowsiness have been reported. Skin rashes, pruritus, fluid retention and jaundice have also been reported.
Hypersensitivity reactions such as bronchospasm and anaphylactoid reactions may occur.
Should be used with caution in patients with severe hepatic impairment.
Relisan is highly bound to plasma proteins and patients receiving simultaneous anti-diabetic sulphonylureas, other highly bound sulphonamides and hydantoins, should be carefully observed for signs of overdosage to these drugs. Although Relisan will displace warfarin from its serum protein binding sites in vitro this has little or no effect in vivo, but patients should be monitored for idiosyncratic reactions.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There are no specific known symptoms of overdosage. There is no specific antidote. Treatment is by gastric lavage and appropriate supportive therapy.
Relisan: Dark red, film coated pillow shaped tablets with a caramel flavour.
High density polyethylene bottles containing 60 tablets or blister packaging in strips of 10 tablets.
Store in a cool, dry place (below 25°) and protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
P.O. Box 2080, Gallo Manor, 2052
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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