DAPSONE Tablet Ref.[8269] Active ingredients: Dapsone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

DAPSONE TABLETS BP 50mg.

Pharmaceutical Form

White uncoated tablets.

White, circular, biconvex uncoated tablets impressed “C” on one face and the identifying letters “DP” on either side of a central division line on the reverse.

Qualitative and quantitative composition

Each tablet contains 50mg Dapsone PhEur.

Active Ingredient Description
Dapsone

Dapsone is a sulfone active against a wide range of bacteria. Dapsones mechanism of action is probably similar to that of the sulfonamides which involves inhibition of folic acid synthesis in susceptible organisms.

List of Excipients

Also contains:

Lactose
Magnesium stearate
Maize starch
Sodium lauryl sulfate

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250ยตm white rigid PVC. (ii) Surface printed 20ยตm hard temper aluminium foil with 5-7g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 7s, 10s, 14s, 21s, 28s, 30s, 56s, 60s, 84s, 100s, 112s, 250s, 500s, 1000s, 5000s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 200,000.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/6609 R

November 1988; November 1993
Renewed: 17.11.93, 28.1.99

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