Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
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 patien Read the complete document