Source: Health Products Regulatory Authority (ZA) Publisher: Dr. Reddys Laboratories (Pty) Ltd, The Place, Third Floor, 1 Sandton Drive, Sandton, 2196
INIR 10 (capsule).
INIR 18 (capsule).
INIR 25 (capsule).
INIR 40 (capsule).
INIR 60 (capsule).
| Pharmaceutical Form |
|---|
|
Capsule. INIR 10: White to off-white powder filled in size ‘4’ hard gelatin capsules with opaque white coloured cap and opaque white coloured body imprinted “RDY” on cap and "519"on body with black ink. INIR 18: White to off-white powder filled in size ‘3’ hard gelatin capsules with opaque dark gold coloured cap and opaque white coloured body imprinted ‘RDY’ on cap and ‘520’ on body with black ink. INIR 25: White to off-white powder filled in size ‘3’ hard gelatin capsules with opaque dark blue coloured cap and opaque white coloured body imprinted ‘RDY’ on cap and ‘528’ on body with black ink. INIR 40: White to off-white powder filled in size ‘1’ hard gelatin capsules with opaque dark blue coloured cap and opaque dark blue coloured body imprinted ‘RDY’ on cap and ‘521’ on body with black ink. INIR 60: White to off-white powder filled in size ‘1’ hard gelatin capsules with opaque dark blue coloured cap and opaque dark gold coloured body imprinted ‘RDY’ on cap and ‘522’ on body with black ink. |
INIR 10: Each capsule contains atomoxetine hydrochloride equivalent to 10 mg atomoxetine.
INIR 18: Each capsule contains atomoxetine hydrochloride equivalent to 18 mg atomoxetine.
INIR 25: Each capsule contains atomoxetine hydrochloride equivalent to 25 mg atomoxetine.
INIR 40: Each capsule contains atomoxetine hydrochloride equivalent to 40 mg atomoxetine.
INIR 60: Each capsule contains atomoxetine hydrochloride equivalent to 60 mg atomoxetine.
The other ingredients are dimethicone and pregelatinised starch.
| Active Ingredient | Description | |
|---|---|---|
| Atomoxetine |
Atomoxetine is a highly selective and potent inhibitor of the pre-synaptic noradrenaline transporter, its presumed mechanism of action, without directly affecting the serotonin or dopamine transporters. |
| List of Excipients |
|---|
|
|
HDPE containers: The capsules will be packaged in white plastic containers with white plastic caps containing 30 or 500 capsules.
PVC-PVdC/Alu pack: The capsules are packed in blister strips of clear transparent PVC film coated with PVdC on one side and paper backed aluminium foil with heat seal coating on the other side. The blister strips will be packaged in a cardboard box containing 7, 10, or 14 capsules.
Dr. Reddy’s Laboratories (Pty) Ltd, The Place, Third Floor, 1 Sandton Drive, Sandton, 2196
INIR 10: 43/1.2/0809
INIR 18: 43/1.2/0810
INIR 25: 43/1.2/0811
INIR 40: 43/1.2/0812
INIR 60: 43/1.2/0813
25 November 2016
| Drug | Countries | |
|---|---|---|
| INIR | South Africa |
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