Rozidal Tablets 3mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

RISPERIDONE

Available from:

RANBAXY (MALAYSIA) SDN. BHD.

INN (International Name):

RISPERIDONE

Units in package:

100Tablet Tablets; 100Tablet Tablets; 60 Tablet Tablets

Manufactured by:

RANBAXY (MALAYSIA) SDN. BHD.

Summary of Product characteristics

_For the use only of a Psychiatrist _
_ _
PRESCRIBING INFORMATION
ROZIDAL TABLETS / ZESPERONE MD TABLETS
(RISPERIDONE TABLETS 1/2/3 MG & RISPERIDONE MOUTH DISSOLVING TABLETS
1/2MG)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE
AT AN INCREASED RISK OF DEATH. RISPERIDONE IS NOT APPROVED FOR THE
TREATMENT OF
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (SEE WARNINGS AND
PRECAUTIONS)
COMPOSITION
ROZIDAL TABLETS 1 MG
Each tablet contains
Risperidone ……………1 mg
ROZIDAL TABLETS 2 MG
Each tablet contains
Risperidone ……………2 mg
ROZIDAL TABLETS 3 MG
Each tablet contains
Risperidone ……………3 mg
_EXCIPIENTS: _
Lactose
Monohydrate,
Pregelatinised
Starch,
Microcrystalline
Cellulose,
Sodium Lauryl Sulphate, Croscarmellose Sodium, Colloidal Silicon
Dioxide, Magnesium
Stearate, Opadry White, Opadry Orange, Opadry Yellow, Purified Water
ZESPERONE MD TABLETS 1 MG
Each orodispersible tablet contains:
Risperidone ……………1 mg
ZESPERONE MD TABLETS 2 MG
Each orodispersible tablet contains:
Risperidone ……………2 mg
_EXCIPIENTS: _Magnesium Stearate, Ferric Oxide (Red), Mannitol,
Saccharin sodium, Heavy
magnesium carbonate, Flavour Peppermint 517 (spray dried), Colloidal
Anhydrous Silica,
Levomenthol,
Aspartame,
Croscarmellose
Sodium,
Low
substituted
hydroxypropyl
cellulose, Purified Talc.
PRODUCT DESCRIPTION
ROZIDAL TABLETS 1 MG
White capsule shaped, biconvex film coated tablets debossed with
‘RA85’ on one side
and plain on the other side.
ROZIDAL TABLETS 2 MG
Orange coloured, capsule shaped, biconvex film coated tablets debossed
with ‘RA86’ on
one side and plain on the other side.
ROZIDAL TABLETS 3 MG
Yellow coloured, capsule shaped, biconvex film coated tablets debossed
with ‘RA87’ on
one side and plain on the other side.
ZESPERONE MD TABLETS 1 MG
Pink coloured, peppermint flavoured, mottled, circular, flat beveled
tablets, debossed
with ‘R’ on one side and ‘1’