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

Logo TOLECTIN® 400 capsules

SCHEDULING STATUS:
Schedule 3.

PROPRIETARY NAME
(and dosage form):

TOLECTIN® 400 capsules

COMPOSITION
Each capsule contains
tolmetin sodium 490,2 mg equivalent to 400 mg of tolmetin free acid.

PHARMACOLOGICAL CLASSIFICATION
A.3.1 Connective Tissue Medicines. Anti-rheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION
TOLECTIN is an orally administered, non-steroidal anti-inflammatory agent with analgesic and antipyretic activity. TOLECTIN relieves pain and reduces swelling, tenderness and stiffness. In those patients responding to TOLECTIN therapy, subjective clinical improvement usually begins within one to two days after starting treatment. Objective improvement can normally be seen within two weeks.

The exact mode of action of TOLECTIN is not known but no effect on pituitary or adrenal function has been demonstrated either in animal or in human studies. The results of various animal tests suggest that TOLECTIN acts directly at the site of inflammation and not by reflex action or by release of a mediator substance.

TOLECTIN is well absorbed and rapidly excreted; more than 80% of orally administered medicine is excreted in the urine within 24 hours, while peak plasma levels are found 30–60 minutes after ingestion of the medicine.

TOLECTIN reduces the symptoms of specific inflammatory conditions, but does not alter the progressive course of the underlying disease.

INDICATIONS
Osteoarthrosis
Rheumatoid arthritis
Juvenile rheumatoid arthritis
Ankylosing spondylitis
Scapulo-humeral periarthritis
Epicondylitis (tennis elbow)
Traumatic synovitis

CONTRA-INDICATIONS
TOLECTIN should not be used in patients in whom salicylates or other non-steroidal anti-inflammatory medicines produce hypersensitivity reactions. Patients who exhibit hypersensitivity to TOLECTIN should be withdrawn from therapy.
The safe use of TOLECTIN during pregnancy or lactation has not been established and is not recommended.
No teratogenic effects have been found in animals.
Because the safety and effectiveness have not been established in infants under 2 years of age, use of TOLECTIN is not recommended.

DOSAGE AND DIRECTIONS FOR USE
Usual adult dosage
The recommended starting dose of TOLECTIN is 1200 mg daily in divided doses. Control is usually achieved at doses of 600–1800 mg/day in divided doses.
Doses larger than 2000 mg/day have not been studied and are not recommended.

Usual children's dosage (2 years and older)
The recommended starting dose is 20 mg/kg/day in divided doses (three or four times daily). When control has been achieved, the usual dose ranges from 15–30 mg/kg/day. Doses higher than 30 mg/kg/day have not been studied and therefore are not recommended.
Daily salicylate requirements can usually be reduced and often stopped once clinical response to TOLECTIN has been obtained.
TOLECTIN may be administered together with gold salts or corticosteroids in rheumatoid arthritis.
Gastro-intestinal side-effects may be reduced by giving TOLECTIN with food or immediately after meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Headache, skin rash, dizziness, elevated blood pressure and oedema of the ankles have been reported. If headache persists despite dosage reduction, cessation of TOLECTIN therapy may be required. No sedation or euphoria has been observed during treatment with TOLECTIN.
Anaphylactoid reactions may occur and should be treated with adrenalin, corticosteroids, aminophyllin and antihistamines.
Heartburn, epigastric discomfort, diarrhoea, nausea and vomiting as well as a positive stool guaiac test have been encountered.
Comparative studies in animals have shown that TOLECTIN should be given with extreme caution to patients with active gastric or duodenal ulcers, weighing the possible beneficial anti-inflammatory effects against possible aggravation of the peptic ulcer. TOLECTIN should be used with caution in patients with a history of upper gastro-intestinal tract disease.
Peptic ulceration and gastro-intestinal bleeding have been reported in patients receiving TOLECTIN therapy.
While no renal or hepatic toxicity has been observed during treatment with TOLECTIN, patients with marked impairment of liver or kidney function should, on general principles, be closely monitored if TOLECTIN is administered and lower doses used.
TOLECTIN inhibits platelet function and prolongs bleeding time; therefore, patients who have pre-existing coagulation disorders should be carefully observed when TOLECTIN is administered.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms will probably be an aggravation of the adverse effects listed above. Treatment should be along conventional lines and such supportive therapy as indicated should be administered.

IDENTIFICATION
Orange, opaque capsule, with "TOLECTIN 400 MG" printed on it.

PRESENTATION
Carton containing one or more blister packs of 5 capsules each.
Securitainers containing 250 capsules.

STORAGE INSTRUCTIONS
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER
N/3.1/50

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG

Janssen Pharmaceutica (Pty) Ltd.,
(Reg No. 80/11122/07)
15th Road
Halfway House
1685

© Janssen Pharmaceutica (Pty) Ltd.

DATE OF PUBLICATION OF THIS PACKAGE INSERT
2 September, 1983.

                Code No. : 022902
                96K
® = TRADEMARK       

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