INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
SURGAM 200 TABLETS
SURGAM 300 TABLETS
SURGAM SA CAPSULES

SCHEDULING STATUS
S3

PROPRIETARY NAME
(and dosage form)

SURGAM 200 TABLETS
SURGAM 300 TABLETS
SURGAM SA CAPSULES

COMPOSITION
Surgam 200 tablets
        Each tablet contains 200 mg of tiaprofenic acid.

Surgam 300 tablets
        Each tablet contains 300 mg of tiaprofenic acid.

Surgam SA
        Each capsule contains 300 mg tiaprofenic acid in a controlled release form.

PHARMACOLOGICAL CLASSIFICATION
A.3.1 Anti-inflammatory agents.

PHARMACOLOGICAL ACTION
Surgam (tiaprofenic acid) is a molecule of non-steroidal structure with anti-inflammatory and analgesic properties. Surgam is an inhibitor of prostaglandin biosynthesis. Surgam has been shown not to cause suppression of proteoglycan synthesis.

Pharmacokinetics:
Tablets 200 mg and 300 mg
Following oral administration, maximum serum concentration is attained after ± 1 hour. Drug elimination half-life is within the range of 1,5 - 2,5 hours. Surgam penetrates the synovial membrane and is retained at relatively constant levels within the synovial fluid throughout an eight-hour period.

Surgam SA
Following oral administration of the controlled release form, the maximum serum concentration is comparable with that of the standard 300 mg tablet. The maximum serum concentration is prolonged for periods of 6 to 8 hours.

INDICATIONS
Surgam is indicated for disorders where inflammatory conditions are dominant as in:

¾        ¾Rheumatic disorders: including rheumatoid arthritis, osteoarthritis, epicondylitis.

¾        ¾Trauma: including fractures, lacerations, sprains.

¾        Post-operative trauma: including dental, orthopaedic, gynaecological procedures and meniscectomy.

CONTRA-INDICATIONS
Surgam is contra-indicated in patients with gastro-duodenal ulcers. Surgam should be avoided in patients having suffered asthmatic attacks, urticaria or other allergic reactions after the administration of aspirin or other medication of the same category.

DOSAGE AND DIRECTIONS FOR USE
Tablets 200 mg and 300 mg
The normal initial dosage of Surgam is 400 - 600 mg daily divided into two doses or three doses at meal times. The maintenance dose should be individually adjusted according to the therapeutic results obtained, usually 300 to 600 mg daily.

Surgam SA
Two capsules to be taken once daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Digestive problems such as heartburn or diarrhoea and gastro-intestinal bleeding may occur.

There may be allergic manifestations to Surgam such as skin eruptions and swelling of the eyelids.

Surgam should be avoided in patients having suffered from asthmatic attacks or urticaria after administration of aspirin or other non-steroidal anti-inflammatories.

The safety of Surgam in pregnancy has not been established. Surgam should not be administered to pregnant or lactating women.

In cases of prolonged administration of Surgam to patients being treated with anti-coagulants, the dosage should be adjusted according to the prothrombin time.

Surgam must be used with caution in patients with a peptic ulcer or renal disease.

Abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been reported.

Urinary symptoms (bladder pain, dysuria and frequency) haematuria or cystitis may occur. Non specific inflammatory changes, sometimes severe, of the bladder have been observed when treatment with tiaprofenic acid has been prolonged for months after the onset of these urinary symptoms. Should these urinary symptoms occur, treatment with tiaprofenic acid must be discontinued to obtain recovery.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms would include gastro-intestinal discomfort, nausea vomiting, diarrhoea. There is no known antidote. Gastric lavage should be performed if recent ingestion has occurred and symptomatic treatment given.

IDENTIFICATION
Surgam 200 tablet        White to creamy-white scored tablet with E and 009 appearing on either side of the breakline.
Surgam 300 tablet         White to creamy-white biconvex tablet, diameter 11 mm with breakline. The tablets are engraved with Surgam and 300 on either side of the breakline and Roussel logo on the reverse side.
Surgam SA        Hard gelatin capsule filled with off-white pellets with transparent pink body and opaque maroon cap printed with Surgam S.A. and Roussel logo.

PRESENTATION
Surgam 200 tablets        Available in blister packs of 15 and 90 tablets.
Surgam 300 tablets        Available in blister packs of 60 tablets.
Surgam SA        Available in blister packs of 60 capsules.

STORAGE INSTRUCTIONS
Surgam 200 tablets        Store in a cool, dry place, below 25°C. Protect from light.
Surgam 300 tablets        Store in a cool, dry place, below 25°C. Protect from light.
Surgam SA        Store at an ambient temperature below 30°C. Protect from light.

Keep out of reach of children.

REGISTRATION NUMBER
Surgam 200 tablets : P/3.1/56
Surgam 300 tablets : R/3.1/19
Surgam SA : W/3.1/90

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Roussel Laboratories (Pty) Limited
REG. NO. 66/01057/07
5th Street
Marlboro Ext. 1
Sandton
2199

DATE OF PUBLICATION OF THIS PACKAGE INSERT
09 September 1994
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