Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Ranbaxy Pharmaceuticals {Pty) Ltd, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa
BENIPROSIN SR (Capsule 0,4 mg).
| Pharmaceutical Form |
|---|
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Capsule. Brown, opaque cap/orange opaque body, of size ‘2’ imprinted with ‘R’ on cap and ‘TSN400’ on body in black edible ink, containing white to off-white granular beads. |
BENIPROSIN SR.
Each capsule contains tamsulosin hydrochloride 0,4 mg.
Sugar free.
For full list of excipients, see section 6.1.
| Active Ingredient |
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Tamsulosin binds selectively and competitively to post-synaptic α1-adrenoreceptors, prevailingly their subtypes designated α1A and α1D. Thus relaxation of smooth muscles of the prostate and urethra is achieved, which leads to a reduction of tonus and an improvement of the urinary flow. |
| List of Excipients |
|---|
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Tamsulosin hydrochloride beads: Magnesium stearate, methycrylic acid-ethyl acrylate copolymer (1:1) dispersion, microcrystalline cellulose (PH101) Enteric coating: Methycrylic acid-ethyl acrylate copolymer (1:1), sodium hydroxide, triacetin, talc, Extra granular: Talc Capsule Shell: Brown cap/Orange body size 2 Body composition: Brilliant blue (Cl No 42090), gelatin; poncrea 4R (Cl No 16255), quinolone yellow (Cl No 470005), sunset yellow (Cl No 15985), titanium dioxide (Cl No 77891) Cap Composition: Brilliant blue (Cl No 42090), carmosine (Cl No14720), gelatin, titanium dioxide (Cl 77891); yellow iron oxide (Cl No 77891) Printing Ink-1: Activated charcoal, alcohol (ethanol)#, isopropyl alcohol#, shellac Printing Ink-2 & 3: Tekprint SW-9007 or Tekprint SW-9008 Black iron oxide (E172), butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution # Used as solvent an lost during processing |
Cartons containing 10, 30 or 60 capsules packed in blister strips. The blister strip consists of clear, transparent film of PVC coated with PVdC with a backing of aluminium foil.
Ranbaxy Pharmaceuticals {Pty) Ltd, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa
A40/34/0211
09 December 2008
| Drug | Countries | |
|---|---|---|
| BENIPROSIN | South Africa |
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