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

Logo NAFASOL* SUPPOSITORIES

SCHEDULING STATUS:
S2 : S3

PROPRIETARY NAME
(and dosage form):

NAFASOL* SUPPOSITORIES

COMPOSITION:
Each suppository contains 500 mg
naproxen.

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

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

INDICATIONS:
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.

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 and-anti-inflammatory agents, since the potential for cross-sensitivity exists.

DOSAGE AND DIRECTIONS FOR USE:
Adult dosage: Insert one suppository per rectum at bedtime.
Administered in conjunction with oral administration during the day.
Total daily dose administered orally and rectally must not exceed 1 gram per day.

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 products 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:
A large, white torpedo-shaped suppository.

PRESENTATION:
Packs of 10 suppositories.

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

REGISTRATION NUMBER:
Y/3.1/131

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19/09/1991 K864
  Len574053 Stop Press
Directions for removing suppository from wrapping {illustrated here}

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