SEDABARB Tablet Ref.[51216] Active ingredients: Phenobarbital

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: RANBAXY PHARMACEUTICALS (PTY) LTD, 14 LAUTRE ROAD, STORMILL EXT. 1, ROODEPOORT, 1724, SOUTH AFRICA

4.1. Therapeutic indications

SEDABARB is indicated for the prophylactic treatment of epilepsy of a convulsive type and as a general sedative.

4.2. Posology and method of administration

For Epilepsy: 1 tablet morning and at night.

For Hypnotic: 1 tablet to be taken one hour before bedtime.

For Sedative: 1 tablet to be taken three times a day.

4.9. Overdose

Barbiturate overdosage is a frequent cause of acute poisoning and death; the toxic effects of overdosage include prolonged coma, respiratory depression; and cardiovascular depression, with hypotension and shock leading to renal failure. Absent bowel sounds are a sign of severe poisoning, their return sometimes heralding further absorption of any remaining barbiturate in the gastro-intestinal tract, with resultant relapse. Hypothermia is common, with associated pyrexia during recovery. Characteristic erythematous or haemorrhagic blisters (bullae) may occur. Death is usually due to respiratory and circulatory failure. The aim in treating poisoning with Sedabarb is to prevent further absorption. Treatment is symptomatic and supportive.

6.3. Shelf life

100, 500, 5000, 1000 and 5000: 24 Months.

Patient ready packs: 15 months.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

Amber PVC containers of 100, 500, 1000 and 5000 tablets.

White polypropylene securitainers of 42, 100 and 1000 tablets.

Patient ready packs of different pack sizes.

6.6. Special precautions for disposal and other handling

Return all unused or expired medicines to your pharmacist for safe disposal.

Do not dispose of unused medicines in drains sewage systems (e.g. toilets).

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