Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 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
CLINDAHEXAL150 (capsules).
CLINDAHEXAL 300 (capsules).
| Pharmaceutical Form |
|---|
|
CLINDAHEXAL 150: Opaque brown/red-brown hard gelatine capsules, size 1, filled with homogenous powder. CLINDAHEXAL 300: Opaque brown hard gelatine capsules, size 0, filled with homogenous powder. |
Each CLINDAHEXAL 150 capsule contains: clindamycin hydrochloride equivalent to 150 mg clindamycin base.
Each CLINDAHEXAL 300 capsule contains: clindamycin hydrochloride equivalent to 300 mg clindamycin base.
Each CLINDAHEXAL 150 mg capsule contains sugar (78,80 mg lactose monohydrate).
Each CLINDAHEXAL 300 mg capsule contains sugar (157,60 mg lactose monohydrate).
| Active Ingredient | Description | |
|---|---|---|
| Clindamycin |
Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes and a wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 50S subunit of the bacterial ribosome and inhibit the early stages of protein synthesis. |
| List of Excipients |
|---|
|
Lactose monohydrate, magnesium stearate, pregelatinised maize starch, talc. The hard gelatine capsules are composed of: Black iron oxide (E172), gelatine, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172). |
White opaque PVC/Aluminium blisters containing 10 capsules each. 2 (10) blister strips to be packed into a carton i.e. 20 capsules per carton or 10 (10) blister strips to be packed into a carton i.e. 100 capsules per carton, or
White Polypropylene securitainers containing 20 or 100 capsules.
Not all packs 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
CLINDAHEXAL 150: 32/20.1.1/0038
CLINDAHEXAL 300: 32/20.1.1/0039
Date of first authorisation:
CLINDAHEXAL 150 mg: 29 March 1999
CLINDAHEXAL 300 mg: 15 February 2000
| Drug | Countries | |
|---|---|---|
| CLINDAHEXAL | Germany, South Africa |
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