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Logo ARCANAFENAC® 25 mg Tablets
ARCANAFENAC® 50 mg Tablets
ARCANAFENAC® Injection

SCHEDULING STATUS:
Schedule 3

PROPRIETARY NAME
(and dosage form):

ARCANAFENAC® 25 mg Tablets
ARCANAFENAC® 50 mg Tablets
ARCANAFENAC® Injection

COMPOSITION:
Enteric coated tablets containing 25 mg (50 mg)
diclofenac sodium.
Each 3 mL ampoule contains 75 mg diclofenac sodium with 4% benzyl alcohol as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 - Anti-rheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
Diclofenac sodium is a non-steroidal compound with analgesic anti-flammatory, antirheumatic and antipyretic properties.
Diclofenac sodium is eliminated principally by metabolism and subsequent urinary and biliary excretion of glucuronide and sulphate conjugates of the metabolites.
The principal metabolite in man is the 4-hydroxy derivative of diclofenac sodium. The amount excreted in urine accounts for 20 - 30% of the dose and that in bile for 10 - 20%. The mean terminal elimination half-life is 1,2 to 1,8 hours.
Tablets:
A single 50 mg dose of enteric coated tablets results in maximum plasma concentrations of about 1500 ng/mL at 1,5 to 2 hours after ingestion.

INDICATIONS:
Tablets:
Rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis. Treatment of post traumatic pain and inflammation. Symptomatic treatment of primary dysmenorrhoea.
Injection:
For use as initial therapy for inflammatory and degenerative rheumatic diseases. Painful conditions due to inflammation of non-rheumatic origin and acute attacks of gout.

CONTRA-INDICATIONS:
Patients with a history of active gastro-intestinal bleeding or peptic ulceration. Severe hepatic or renal impairment. Contra-indicated in aspirin-sensitive patients, and in patients hypersensitive to any of the ingredients in these products.

WARNINGS:
Serious interactions have been reported after the use of high dose methotrexate with diclofenac. Safety during pregnancy has not yet been established.

DOSAGE AND DIRECTIONS FOR USE:
Arcanafenac 25 mg and Arcanafenac 50 mg Tablets:
In adults the dosage is 25 to 50 mg three times daily depending on the severity of the condition. The maintenance dose should be adjusted to the minimum that will provide continuous therapeutic control. The tablets should be swallowed whole, with or after a meal. The dosage in children is 2 mg per kilogram body mass daily.
Arcanafenac Injection:
75 mg by deep intragluteal injection once daily, or two times daily, in severe or hospitalised cases. Each injection must be given at a different site. Not to be given by intravenous injection. Eachinjection should be separated by an interval of a few hours. Parenteral administration should not be given for more than a few days, if necessary the treatment can be continued by oral therapy.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disorders, including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and gastro-intestinal bleeding have been reported. Other side-effects include vertigo, headache, skin rashes, pruritis, tinnitus, depression, drowsiness, nervousness, insomnia, irritability, agitation, minor hearing disorders, oedema, palpitations, blurred vision and other ocular reactions. Hypersensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been observed. Dizziness, eczema, haemolytic anaemia may also occur.
It is advisable to perform blood counts in patients undergoing prolonged treatment.
Arcanafenac should be given with care to patients with cardiovascular disease, bleeding disorders, in those who are receiving coumarin anti-coagulants, and in patients with impaired hepatic or renal function.
Acute allergic reactions have been reported. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
Allergic reactions which include angio-oedema, bronchospasm, urticaria, and anaphylactic reactions, have occurred.
In view of the product's inherent potential to cause fluid retention, heart failure may be pricipitated in some compromised patients.
Plasma concentrations are significantly decreased by the concomitant administration of therapeutic doses of aspirin.
When given together with preparations containing lithium or digoxin, diclofenac sodium may raise their plasma concentrations.
Concomitant administration of glucocorticoids or other non-steroidal anti-inflammatory agents may aggravate gastro-intestinal side-effects.
Concurrent administration with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects.
Should be used with caution in patients with asthma or bronchoconstriction.
Use carefully in elderly patients.
Decreased platelet aggregation with increased bleeding time may occur.
May increase the half-life of probenecid.
Use with care together with other protein-bound medicines e.g. Tolbutamide, Coumarin and Hydantoin.

SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
Tablets:
25 mg tablets: Yellowish-mustard enteric coated tablet.
50 mg tablets: Light brown enteric coated tablet.
Injection:
A clear, colourless to slightly amber solution in amber ampoules.

PRESENTATION:
Tablets:
25 mg tablets: Blister packs of 100 tablets and securitainers of 500 tablets.
50 mg tablets: Blister strips of 21 tablets and securitainers of 500 tablets.
Injection:
Amber glass ampoules in packs of 5 and 50.

STORAGE INSTRUCTIONS:
Store below 25° C.
Protect tablets from moisture.
Protect ampoules from heat and light.
Do not refrigerate ampoules.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
25 mg tablets: Y/3.1/148
50 mg tablets: Y/3.1/149
Injection: Z/3.1/265
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Merck (Pty) Ltd
Fedlife Park
Tonetti Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKER INSERT:
Tablets: 31 August 1990.
Injection: 29 November 1991.
PAR 0041M/5-95
® = Registered Trademark

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