RISPIDE Oral solution Ref.[115328] Active ingredients: Risperidone

Source: Health Products Regulatory Authority (ZA)  Publisher: Abex Pharmaceutica (Pty) Ltd, Suite C, Rubenstein Ridge, 617 Rubenstein Drive, Moreleta Park, 0181

Product name and form

RISPIDE 1 mg/ml oral solution.

Pharmaceutical Form

Oral solution.

The solution is clear and colourless.

Qualitative and quantitative composition

1 ml oral solution contains 1 mg of risperidone.

Excipient(s) with known effect: 1 ml oral solution contains 1,5 mg benzoic acid (E210) as preservative

For the full list of excipients, see section 6.1.

Active Ingredient

Risperidone is a selective monoaminergic antagonist with unique properties. Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics.

List of Excipients

Tartaric acid (E334)
Benzoic acid (E210) (as preservative)
Hydrochloric acid, concentrated (for pH adjustment)
Purified water

Pack sizes and marketing

Type III amber glass bottle with a plastic (polypropylene/LDPE) child resistant and tamper-evident cap. RISPIDE oral solution is presented in bottle sizes of 30 ml, 60 ml, 100 ml and 120 ml.

Additionally, a dosing pipette (syringe) is supplied in each pack consisting of a polystyrene plunger and a LDPE-barrel and piston.

Not all pack sizes may be marketed.

Marketing authorization holder

Abex Pharmaceutica (Pty) Ltd, Suite C, Rubenstein Ridge, 617 Rubenstein Drive, Moreleta Park, 0181

Marketing authorization dates and numbers

56/2.6.5/0424

Registration date: 08 August 2023

Drugs

Drug Countries
RISPIDE South Africa

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