NAFASOL®-250 TABLETS; NAFASOL®-500 TABLETS

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

NAFASOL®-250 TABLETS
NAFASOL®-500 TABLETS

SCHEDULING STATUS:
S3
S2 (See Indications below)

PROPRIETARY NAME
(and dosage form):

NAFASOL^®-250 TABLETS
NAFASOL^®-500 TABLETS

COMPOSITION:
Nafasol-250 Tablets: Each tablet contains 250 mg naproxen.
Nafasol-500 Tablets: Each tablet contains 500 mg naproxen.

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

PHARMACOLOGICAL ACTION:
Naproxen is an analgesic, antipyretic and non-steroidal anti-inflammatory. Naproxen inhibits prostaglandin synthetase, however, the exact mechanism of its anti-inflammatory action is not known.

INDICATIONS:
Schedule 3:
Naproxen is used in the treatment of rheumatoid arthritis, osteo-arthritis, ankylosing spondylitis, mild to moderate pain associated with dysmenorrhoea, musculoskeletal disorders (such as sprains and strains, cervical spondylitis and tendinitis) and in gout.

Schedule 2:
Emergency treatment of acute gout attacks. Treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days.

CONTRA-INDICATIONS:
A history of or active gastro-intestinal bleeding or peptic ulceration.
Pregnancy and lactation.
Patients who are sensitive to aspirin or other non-steroidal anti-inflammatory agents, since the potential for cross-sensitivity exists.
Not to be used in children under the age of 16 years except when used in juvenile rheumatoid arthritis.

DOSAGE AND DIRECTIONS FOR USE:
Antirheumatic (anti-inflammatory):
Adults: Usual dose is 500 mg to 1 g of naproxen daily in 2 divided doses.

Juvenile Rheumatoid Arthritis:
Children over 5 years: A dose of 10 mg/kg body-weight daily of naproxen in 2 divided doses.

Analgesic:
Adults: Usual initial dose is 500 mg naproxen followed by 250 mg every 6 or 8 hours.

Anti-gout agent:
Adults: Initial dose of 750 mg naproxen followed by 250 mg every 8 hours.

The tablets should be taken with food.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects which may occur include nausea, vomiting, dyspepsia, constipation, peptic ulceration, gastro-intestinal haemorrhage, insomnia or drowsiness, depression, headache, nervousness, dizziness, tinnitus, pruritus, skin eruptions and angio-oedema, visual disturbances and an increase in bleeding time.
Hypersensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been observed.
In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Naproxen should be given with care to patients with asthma, bronchospasm, bleeding disorders, cardiovascular disease, renal failure and in those who are receiving coumarin anticoagulants (due to naproxen being extensively bound to plasma proteins, an overdosage of coumarin can occur).

Interactions:
Naproxen may inhibit the clearance of lithium, leading to increasing lithium concentrations; Naproxen may inhibit the diuretic and hypotensive effect of furosemide; Naproxen may reduce the secretion of methotrexate, leading to toxicity with methotrexate; Naproxen may interfere with some tests for 17-ketogenic steroids.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms: Refer to “Side-effects”.
Treatment is symptomatic and supportive.

IDENTIFICATION:

Nafasol-250 Tablets:	A yellow, round, biconvex tablet engraved with a mortar and pestle on one side.
Nafasol-500 Tablets:	A yellow, flat bisected tablet with bevelled edges engraved with a mortar and pestle on one side and “NAFASOL 500” on the bisected side.

PRESENTATION:

Nafasol-250 Tablets:	Blister packs of 30 tablets and Securitainers of 250 tablets.
Nafasol-500 Tablets:	Securitainers of 30 and 100 tablets.

STORAGE INSTRUCTIONS:
Protect from light and moisture.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Nafasol-250 Tablets: M/3.1/518
Nafasol-500 Tablets: U/3.1/74

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

19/09/1991

G258B