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

Logo FENAMIN-250 CAPSULES
FENAMIN-500 TABLETS
FENAMIN SUSPENSION

SCHEDULING STATUS:
S3
S2 (see indications below)

PROPRIETARY NAME
(and dosage form):

FENAMIN-250 CAPSULES
FENAMIN-500 TABLETS
FENAMIN SUSPENSION

COMPOSITION
Capsules containing 250 mg mefenamic acid
Film coated tablets containing 500 mg mefenamic acid
Suspension containing in each 5 mL 50 mg
mefenamic acid
Preservatives:
  Methylparaben 0,03% m/v
  Propylparaben 0,015% m/v
  Butylparaben 0,015% m/v
PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Antipyretic and anti-inflammatory analgesics

PHARMACOLOGICAL ACTION:
Fenamin has anti-inflammatory activity and also antipyretic and analgesic properties. In analgesia it has a central as well as a peripheral action. Fenamin appears to owe those properties to its capacity to inhibit cyclo-oxygenase. Also it appears to antagonise certain effects of prostaglandins.

INDICATIONS:
S3: The relief of mild to moderate pain arising from rheumatic conditions, soft-tissue injuries, other painful musculoskeletal conditions and dysmenorrhoea.
S2: Treatment of post traumatic conditions such as pain, swelling and inflammation for a maximum period of 5 days.
CONTRA-INDICATIONS:
Sensitivity to mefenamic acid and other non-steroidal anti-inflammatory agents, with prostaglandin synthetase inhibiting activity. The possibility of cross-sensitivity among non-steroidal anti-inflammatory agents exists.
Fenamin is contra-indicated in patients with ulceration or inflammation of the gastro-intestinal tract. Epileptics. Patients with impaired hepatic functions.
Safety in pregnancy and lactation has not been established.

WARNINGS
If diarrhoea or skin rash appear, use of Fenamin should be discontinued immediately.

DOSAGE AND DIRECTIONS FOR USE:
Fenamin must be taken with meals.
Fenamin should not be given for longer than 7 days.
Relief of mild to moderate pain: 500 mg three times a day.
Acute pain: An initial dosage of 500 mg, thereafter 250 mg every 6 hours.
Children
The dosage for children is 25 mg per kg body-weight daily, in divided doses.
6 months to 1 year: One medicine measureful (5 mL)
2 years to 4 years: Two medicine measuresful (10 mL).
5 years to 8 years: Three medicine measuresful (15 mL).
9 years to 12 years: Four medicine measuresful (20 mL).
The dose may be repeated as necessary, up to three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The commonest adverse effects occurring with Fenamin are gastro-intestinal disturbances. Peptic ulceration and gastro-intestinal bleeding have also been reported. Headache, drowsiness, dizziness, nervousness, visual disturbances, and slight elevations in blood-urea have been reported. Acute hypersensitivity reactions (urticaria, bronchospasm, anaphylaxis) have occurred. Asthma may be precipitated. Skin rashes occur. Reported haematological effects include haemolytic anaemia, agranulocytosis, pancytopenia, thrombocytopenic purpura, and bone-marrow aplasia.
Fenamin should be used with caution in patients with impaired renal or liver function. It may enhance the effects of coumarin anticoagulants.
Fenamin is best avoided in elderly patients with dehydration or pre-existing renal disease.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "side-effects and special precautions".
Mefenamic acid has a marked tendency to induce tonic-clonic (grand mal) convulsions in overdosage.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Capsules: Pale yellow body and turquoise cap.
Tablets: A pale yellow, film-coated bevelled biconvex tablet embossed with a pestle and mortar on one side.
Suspension: An off-white suspension.
PRESENTATION:
Capsules: 250 mg capsules in 'Securitainers' of 100's and 250's.
Tablets: 500 mg tablets in 'Securitainers’of 50's and 100's.
Suspension: In bottles of 100 mL, 200 mL and 2,5 litres.
STORAGE INSTRUCTIONS:
Store in a cool dry place below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Capsules: 27/2.7/0281
Tablets: 27/2.7/0282
Suspension: 27/2.7/0283
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
LENNON LIMITED
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15/03/1993
        G043
KOHLER C&P P.E.

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