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

Product name and form

SEDABARB.

Pharmaceutical Form

Tablet.

White normal biconvex tablet, with a breakline on one side, 5,5 mm in diameter.

Qualitative and quantitative composition

Each tablet contains:

Phenobarbitone 30 mg

Contains sugar: Lactose monohydrate 17,9 mg per tablet.

For full list of excipients, see section 6.1.

Active Ingredient Description
Phenobarbital

Phenobarbital has sedative effects and has some protective action against all varieties of human partial and generalised epilepsy, with the exception of absence seizures. Phenobarbital is also effective in preventing seizures in the corresponding experimental animal models of epilepsy.

List of Excipients

Flowlac 100
Magnesium stearate
Microcrystalline cellulose
Sodium starch glycolate

Pack sizes and marketing

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.

Marketing authorization holder

RANBAXY PHARMACEUTICALS (PTY) LTD, 14 LAUTRE ROAD, STORMILL EXT. 1, ROODEPOORT, 1724, SOUTH AFRICA

Marketing authorization dates and numbers

E/2.3/107 (South Africa)

19 June 1974

Drugs

Drug Countries
SEDABARB South Africa

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