ESPIRIDE Capsule Ref.[51228] Active ingredients: Sulpiride

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

Product name and form

ESPIRIDE (capsule).

ESPIRIDE ELIXIR.

Pharmaceutical Form

ESPIRIDE: A white powder encapsulated within a No. 3 off-white, opaque capsule, printed with a mortar and pestle and “Lennon” in blue ink.

ESPIRIDE ELIXIR: A clear, bright, yellowish-green solution.

Qualitative and quantitative composition

Each capsule of ESPIRIDE contains sulpiride 50 mg.

Excipients: Colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, purified talc, starch maize, titanium dioxide (C.I. 77891)

Contains sugar: Lactose monohydrate 112 mg

Each 5 ml of ESPIRIDE ELIXIR contains sulpiride 25 mg.

Excipients: Alcohol, disodium edetate, dye Lennon yellow (C.I. 47005), flavour lemon essence No.1, glycerol, saccharin sodium, sodium cyclamate, sorbitol (70%) solution, methyl hydroxybenzoate, propyl hydroxybenzoate, purified water

Preservatives:

Methyl hydroxybenzoate 0,08% m/v

Propyl hydroxybenzoate 0,02% m/v

Contains alcohol: 5,0% v/v

Contains sugar: Sorbitol 26,058 mg

Contains sweetener: Sodium cyclamate 55 mg, saccharin sodium 2,5 mg

Active Ingredient Description
Sulpiride

Sulpiride is a member of the group of substituted benzamides, which are structurally distinct from the phenothiazines, butyrophenones and thioxanthenes. One of the characteristics of sulpiride is its bimodal activity, as it has both antidepressant and neuroleptic properties. Schizophrenia characterised by a lack of social contact can benefit strikingly.

List of Excipients

ESPIRIDE: Colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, purified talc, starch maize, titanium dioxide (C.I. 77891)

ESPIRIDE ELIXIR: Alcohol, disodium edetate, dye Lennon yellow (C.I. 47005), flavour lemon essence No.1, glycerol, saccharin sodium, sodium cyclamate, sorbitol (70%) solution, methyl hydroxybenzoate, propyl hydroxybenzoate, purified water

Pack sizes and marketing

ESPIRIDE:

100 capsules are packed in a white cylindrical polypropylene securitainer with a white low density polyethylene cap with a tamper evident seal.

100 capsules are packed in a white hostalen polypropylene securitainer with a white low density polyethylene cap with a tamper evident seal.

100 capsules are packed in a white linear low density polyethylene securitainer with a white low density polyethylene cap with a tamper evident seal.

28 or 56 capsules are packed in a low density polyethylene Ziploc metallised lay-flat bags. The lay-flat bags are then grouped and packed into polyethylene bags.

ESPIRIDE ELIXIR:

100 ml is packed in an amber round polyvinyl chloride bottle together with a black urea formalin screw on cap with an expanded polyethylene liner. The bottle is placed in an outer cardboard carton.

100 ml is packed in an amber round glass bottle together with a black urea formalin screw on cap with an expanded polyethylene liner. The bottle is placed in an outer cardboard carton.

100 ml is packed in a clear high density polyethylene round bottle with a white low density polyethylene snap on cap. The bottle is placed in an outer cardboard carton.

100 ml is packed in a clear round polyvinylchloride bottle together with a white low density polyethylene snap on cap. The bottle is placed in an outer cardboard carton.

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

ESPIRIDE: Y/2.5/386
ESPIRIDE ELIXIR: W/2.5/36

Date of registration:

ESPIRIDE: 01 November 1993
ESPIRIDE ELIXIR: 17 December 1990

Drugs

Drug Countries
ESPIRIDE South Africa

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