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

Logo NISAID 25 CAPSULES

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

NISAID 25 CAPSULES

COMPOSITION:
Each NISAID 25 capsule contains 25 mg
Indomethacin B.P.

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

PHARMACOLOGICAL ACTION:
NISAID is a non-steroidal anti-inflammatory medicine with analgesic and antipyretic properties. NISAID's mode of action may be due to a decreased biosynthesis of prostaglandins in peripheral tissues. NISAID affords relief of symptoms but does not alter the course of the underlying disease.

INDICATIONS:
NISAID is indicated in the symptomatic treatment of:
Rheumatoid arthritis
Osteoarthritis
Degenerative joint disease of the hip
Ankylosing/spondylitis
Gout
NISAID is also indicated for relief of:
Acute inflammatory musculoskeletal disorders, low back pain and fever.
Inflammation, pain, trismus and oedema following dental procedures.
Inflammation, pain, trismus and oedema following orthopaedic procedures associated with reduction and immobilisation of fractures or dislocations.
Pain associated with primary dysmenorrhoea.

CONTRA-INDICATIONS:
Hypersensitive to NISAID/indomethacin, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory medicines. Nasal polyps associated with angio-oedema.
Active, latent or history of peptic ulcer or gastrointestinal lesions. Pregnancy or breast feeding.

WARNINGS:
Serious interactions have been reported after the use of high doses of methotrexate with indomethacin. The combined use of indomethacin with diflunisal has been associated with fatal gastro-intestinal haemorrhage. Indomethacin and diflunisal should therefore not be used concomitantly.

DOSAGE AND DIRECTIONS FOR USE:
NISAID may be taken with food, milk or an antacid.
The recommended dosage of NISAID is 50 mg to 200 mg daily divided in two to four equal doses and should be individually adjusted to the patient's response and tolerance.

In chronic rheumatic disorders, initiate therapy with low doses and increase gradually when necessary in order to produce maximum benefit. A dosage of 200 mg per day should not be exceeded.

In the treatment of acute gouty arthritis, the recommended daily dosage is 150 mg to 200 mg until symptoms and signs subside.

In primary dysmenorrhoea, 75 mg daily as a single dose or divided dose is recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
CENTRAL NERVOUS SYSTEM:
The most frequent Central Nervous System side-effects are headache, tinnitus, dizziness, drowsiness, vertigo, light-headedness and mental confusion.
Depression, psychosis and hallucinations may occur.
Should dizziness, and drowsiness occur, patients should not operate machinery or drive motor vehicles.
Insomnia, psychiatric disturbances, syncope, convulsions and peripheral neuropathy may also occur.

GASTROINTESTINAL:
Vomiting, nausea, anorexia, stomatitis, abdominal pain, diarrhoea and single or multiple ulceration of the upper gastrointestinal tract may occur with perforation and haemorrhage. Occult blood loss may lead to anaemia in the absence of ulceration. Acute pancreatitis has also been reported. If gastrointestinal bleeding occurs, discontinue NISAID.

HYPERSENSITIVITY:
This is manifested in rashes, pruritis (itching), urticaria, acute attacks of asthma and rapid fall in blood pressure. Patients allergic to Aspirin may exhibit a cross-reaction to indomethacin. Alopecia may occur.

HEPATIC REACTIONS:
Fatal cases of hepatitis and jaundice have been reported.

EYE REACTIONS:
Blurred vision, corneal opacities, visual-field changes and pallor of the optic disc have occurred.

HAEMOPOIETIC REACTIONS:
Consist of neutropenia, leucopenia, purpura, haemolytic anaemia, agranulocytosis, thrombocytopenia and aplastic anaemia. Occult gastrointestinal bleeding may lead to anaemia, therefore appropriate blood tests are recommended. Epistaxis and vaginal bleeding have also been reported.

RENAL FUNCTION:
Should be used with caution in patients with impairment of renal function. Elderly patients may be specially susceptible to the toxic effects of indomethacin. Renal failure and haematuria may occur.

OTHERS:
Oedema, mass gain, hypertension, hyperglycaemia and hyperkalaemia may also occur.

DRUG INTERACTIONS
Concurrent administration of NISAID/indomethacin with probenecid increases the risk of gastrointestinal bleeding; probenecid inhibits the tubular secretion of NISAID/indomethacin and thereby increases its plasma level and risk of systemic toxicity.
Concurrent administration with oral anticoagulant agents increases the risk of gastrointestinal bleeding.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastrointestinal upset, Central Nervous System effects (eg. headache, dizziness, vertigo) and tinnitus. Treatment is supportive and symptomatic.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
NISAID 25 capsules contain dry white powder in an opaque grey/pink (cap/body respectively) No. 3 hard gelatin capsule.

PRESENTATION:
NISAID 25 capsules are supplied in packs of 30's, 100's and 500's.

STORAGE INSTRUCTIONS:
Store in a dry place, below 25° C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
NISAID 25 capsules : X/3.1/323

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABS. LIMITED
Co. Reg. No. 77/3056/06
Needham Park
1 Manchester Road
Wadeville
2091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 April 1990
        PSO-532-4/92

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998