PONAC Suspension Ref.[115253] Active ingredients: Mefenamic acid

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Pharmacorp (Pty) Ltd, 29 Victoria Link, Route 21 Corporate Park, Irene, 0178, Pretoria

Therapeutic indications

PONAC SUSPENSION is indicated for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of five (5) days. PONAC SUSPENSION is also indicated as treatment of primary dysmenorrhoea, subject to a maximum daily dose of 500 mg three (3) times a day for a maximum of three (3) days.

Posology and method of administration

Posology

Adults

Use the lowest effective dose for the shortest possible duration of treatment.

PONAC SUSPENSION must be taken with meals.

Relief of mild to moderate pain: 500 mg three (3) times a day.

Acute pain: an initial dosage of 500 mg, thereafter 250 mg every six (6) hours for a maximum treatment period of five (5) days.

Primary dysmenorrhoea: a maximum daily dose of 500 mg three (3) times a day and a maximum treatment period of three (3) days.

Paediatric population

The dosage for children is 25 mg per kg body weight daily in divided doses.

The following dose may be repeated as necessary, up to three (3) times daily:

6 months to 1 year: One (1) measureful (5 ml).

2 years to 4 years: Two (2) measureful (10 ml).

5 years to 8 years: Three (3) measureful (15 ml).

9 years to 12 years: Four (4) measureful (20 ml).

Method of administration

Oral use only.

Overdose

Mefenamic acid such as in PONAC SUSPENSION has a marked tendency to induce tonic- clonic (grand mal) convulsions in overdosage. Dyskinesia, acute renal failure and coma have been reported. Overdose has led to fatalities.

Prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalised weakness (see section 4.4 and section 4.8).

Treatment is symptomatic and supportive. Following accidental overdosage, the stomach should be emptied immediately by inducing emesis followed by administration of activated charcoal. Vital functions should be monitored and supported. Haemodialysis is of little value since mefenamic acid and its metabolites are firmly bound to plasma proteins.

Shelf life

24 months.

Special precautions for storage

Store in a cool dry place at or below 25°C.

Keep in the original container.

Protect from light.

Nature and contents of container

Amber glass bottles containing 100 ml or 200 ml of suspension. Amber PVC bottles containing 100 ml or 200 ml of suspension. The bottles are packed into outer cardboard carton.

Not all packs and pack sizes may be marketed.

Special precautions for disposal and other handling

No special precautions are required.

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