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

Logo PONAC CAPSULES
PONAC FORTE TABLETS
PONAC SUSPENSION

SCHEDULING STATUS:
S3
S2        See indications below

PROPRIETARY NAME
(and dosage form):

PONAC CAPSULES
PONAC FORTE TABLETS
PONAC 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:
Ponac has anti-inflammatory activity and also antipyretic and analgesic properties. In analgesia it has a central as well as a peripheral action. Ponac appears to owe these properties to its capacity to inhibit cyclo-oxygenase. Also it appears to antagonize 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.
Ponac 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.

WARNING:
If diarrhoea or skin rash appear, use of Ponac should be discontinued immediately.

DOSAGE AND DIRECTIONS FOR USE:
Ponac must be taken with meals.
Ponac 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 Ponac 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) has occurred. Asthma may be precipitated. Skin rashes occur. Reported haematological effects include haemolytic anaemia, agranulocytosis, pancytopenia, thrombocytopenic purpura, and bone-marrow aplasia.
Ponac should be used with caution in patients with impaired renal or liver function. It may enhance the effects of the comarin anticoagulants.
Ponac 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, the one section to be imprinted with “CE”and “PONAC-250” on the other section.
Film Tablets Round, pale yellow film-coated tablets with “CE”imprinted on one side, and “PONAC-500”imprinted on the other side.
Suspension An off-white suspension.

PRESENTATION:
Capsules 250 mg capsules in blister packs of 100's.
Film Tablets 500 mg tablets in blister packs of 50'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 NUMBERS:
Capsules         Y/2.7/157
Tablets         Y/2.7/158
Suspension         Y/2.7/192

NAME AND BUSINESS ADDRESS OF APPLICANT'
Continental Ethicals (Pty) Ltd, 7 Fairclough Road, PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13/12/1990

        K848
        Tradepak PE

First displayed on this site December 1995
Current: September 2004
Source: Pharmaceutical Industry

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