RISPIDE Film-coated tablet Ref.[115330] Active ingredients: Risperidone

Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Abex Pharmaceutica (Pty) Ltd, Suite C, Rubenstein Ridge, 617 Rubenstein Drive, Moreleta Park, 0181

Product name and form

RISPIDE 0,5, film-coated tablets.

RISPIDE 1, film-coated tablets.

RISPIDE 2, film-coated tablets.

RISPIDE 3, film-coated tablets.

RISPIDE 4, film-coated tablets.

RISPIDE 6, film-coated tablets.

Pharmaceutical Form
Film-coated tablets. RISPIDE 0,5: Cream, round, biconvex tablets with a diameter of approximately 8,1 mm. RISPIDE 1: White, round, biconvex tablets with a diameter of approximately 8,1 mm. RISPIDE 2: Yellow, round, biconvex tablets with a diameter of approximately 8,1 mm. RISPIDE 3: Peach, round, biconvex tablets with a diameter of approximately 8,1 mm. RISPIDE 4: Green, round, biconvex tablets with a diameter of approximately 8,1 mm. RISPIDE 6: Light green, round, biconvex tablets with a diameter of approximately 8,1 mm.

Qualitative and quantitative composition

RISPIDE 0,5: Each film-coated tablet contains 0,5 mg risperidone.

RISPIDE 1: Each film-coated tablet contains 1 mg risperidone.

RISPIDE 2: Each film-coated tablet contains 2 mg risperidone.

RISPIDE 3: Each film-coated tablet contains 3 mg risperidone.

RISPIDE 4: Each film-coated tablet contains 4 mg risperidone.

RISPIDE 6: Each film-coated tablet contains 6 mg risperidone.

RISPIDE 1 contains sugar (1,6 mg lactose monohydrate per tablet).

RISPIDE 0,5, 2, 3, 4 & 6 are sugar free.

For the full list of excipients, see section 6.1.

Active Ingredient
Risperidone
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
Tablet core: Microcrystalline cellulose PH102 Pregelatinised starch Hypromellose (Methocel E50 LV) Magnesium stearate (vegetable grade) Film coating: RISPIDE 0,5: Hypromellose, propylene glycol, quinoline yellow, sunset yellow, talc and titanium dioxide RISPIDE 1: Hypromellose, lactose monohydrate, macrogol and titanium dioxide RISPIDE 2: Hypromellose, propylene glycol, quinoline yellow, talc and titanium dioxide RISPIDE 3: Hypromellose, propylene glycol, sunset yellow, talc and titanium dioxide RISPIDE 4: Hypromellose, indigotine, macrogol, quinoline yellow, talc and titanium dioxide RISPIDE 6: Hypromellose, indigotine, macrogol, propylene glycol, quinoline yellow, talc and titanium dioxide

Pack sizes and marketing

Packs of 30 tablets packed in opaque white PVC/PE/PVDC/Aluminium blisters in a cardboard carton.

Not all strengths are necessarily marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

RISPIDE 0,5: 44/2.6.5/0673
RISPIDE 1: 44/2.6.5/0674
RISPIDE 2: 44/2.6.5/0675
RISPIDE 3: 44/2.6.5/0676
RISPIDE 4: 44/2.6.5/0677
RISPIDE 6: 44/2.6.5/0678

Date of registration: 21 April 2016

Drugs

Drug	Countries
RISPIDE	South Africa

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