PHENOBARBITONE Tablet Ref.[9814] Active ingredients: Pentobarbital

Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: SPONSOR: PSM Healthcare Limited, t/a API Consumer Brands, 14-16 Norman Spencer Drive, PO Box 76 401, Manukau City, AUCKLAND 2241, Telephone 0508 776746

Product name and form

Phenobarbitone (PSM), Tablet, 15mg.
Phenobarbitone (PSM), Tablets, 30mg.

Pharmaceutical Form
Oral – tablet. Presentations Phenobarbitone (PSM) tablets 15 mg: ‘White normal convex 5.0 mm tablets’. Phenobarbitone (PSM) tablets 30 mg: ‘White normal convex 5.55 mm tablets’.

Qualitative and quantitative composition

Name and strength of the active substance: Phenobarbital 15mg, Phenobarbital 30mg.

Excipient(s) with known effect: For the full list of excipients, see section 6.1.

Active Ingredient	Description
Pentobarbital	Phenobarbital is a barbiturate used mainly for its antiepileptic properties. It induces liver enzymes and alters the metabolism of a number of other drugs. Sedation is common but tends to become less of a problem as phenobarbital antiepileptic treatment continues.

List of Excipients
Magnesium stearate Purified talc Wheat starch Lactose

Pack sizes and marketing

Blister packs of 500 tablets.

Marketing authorization holder

SPONSOR: PSM Healthcare Limited, t/a API Consumer Brands, 14-16 Norman Spencer Drive, PO Box 76 401, Manukau City, AUCKLAND 2241, Telephone 0508 776746

Marketing authorization dates and numbers

31/12/1969

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