Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090 1 Company Reg. No.: 1990/001979/07
COXLEON 100 (capsules).
COXLEON 200 (capsules).
| Pharmaceutical Form |
|---|
|
100 mg: Blue capsule with white body, which contains white to slightly yellowish pellets. 200 mg: Orange capsule with white body, which contains white to slightly yellowish pellets. |
Each COXLEON 100 capsule contains 100 mg celecoxib.
Each COXLEON 200 capsule contains 200 mg celecoxib.
Excipient with known effect:
Each COXLEON 100 capsule contains sugar (7 mg lactose monohydrate).
Each COXLEON 200 capsule contains sugar (14 mg lactose monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Celecoxib |
Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily). No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in this dose range in healthy volunteers. |
| List of Excipients |
|---|
|
Carrageenan; lactose monohydrate; magnesium stearate; microcrystalline cellulose; sodium laurilsulfate. Body composition: gelatine; titanium dioxide. 100 mg cap composition: gelatine; indigo-carmine; titanium dioxide. 200 mg cap composition: gelatine; red iron oxide; titanium dioxide; yellow iron oxide. |
An outer carton containing transparent PVC/TE/PVDC/silver aluminium blisters.
Pack sizes: COXLEON 100 and COXLEON 200 are packed in 10’s, 30’s and 60’s.
Not all pack sizes may be marketed.
Sandoz SA (Pty) Ltd1, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090
1 Company Reg. No.: 1990/001979/07
COXLEON 100: 46/3.1/0704.702
COXLEON 200: 46/3.1/0705.703
Date of first authorization: 02 June 2017
| Drug | Countries | |
|---|---|---|
| COXLEON | South Africa |
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