PHENERINE Sugar-coated tablet Ref.[51181] Active ingredients: Orphenadrine

Source: Health Products Regulatory Authority (ZA)  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

PHENERINE (sugar-coated tablet).

Pharmaceutical Form

A light yellow normal biconvex sugar-coated tablet.

Qualitative and quantitative composition

Each sugar-coated tablet of PHENERINE contains 50 mg of orphenadrine hydrochloride.

Excipients: Acacia powder, benzoic acid, cetyl palmitate, colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl hydroxybenzoate sodium, quinoline yellow (C.I. 47005), sodium benzoate, sodium ethyl parabenzoate, sodium methyl parahydroxybenzoate, starch maize, stearic acid, sucrose, talc purified, white colour dye Lennon (C.I. 77891)

Preservatives:

Benzoic acid 0,005% m/m

Propyl hydroxybenzoate sodium 0,00012% m/m

Sodium benzoate 0,00002% m/m

Sodium ethylparabenzoate 0,00004% m/m

Sodium methyl parahydroxybenzoate 0,00006% m/m

Contains sugar: Sucrose 50,42 mg, lactose monohydrate 20 mg.

Active Ingredient Description
Orphenadrine

Orphenadrine, which is a congener of diphenhydramine without sharing its soporific effect, is an anti-muscarinic agent. Orphenadrine is used as the hydrochloride in the symptomatic treatment of Parkinsonism.

List of Excipients

Acacia powder, benzoic acid, cetyl palmitate, colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl hydroxybenzoate sodium, quinoline yellow (C.I. 47005), sodium benzoate, sodium ethyl parabenzoate, sodium methyl parahydroxybenzoate, starch maize, stearic acid, sucrose, talc purified, white colour dye Lennon (C.I. 77891)

Pack sizes and marketing

100 tablets are packed in a white polypropylene container sealed with a white low-density polyethylene cap with vertical ridges on the side and a tamper evident seal, together with a white foam insert or rayon. The container is packed into an outer cardboard carton together with a leaflet.

28, 56 and 84 tablets are packed into pre-printed metallised polyester, laminated with opaque low-density polyethylene, patient ready packs and sealed with a low-density polyethylene ziploc and packed into polyethylene bags.

Not all packs and pack sizes are necessarily marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

L/5.4.1/234

Date of registration: 08 December 1978

Drugs

Drug Countries
PHENERINE South Africa

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