PIROXICAM Capsule Ref.[7940] Active ingredients: Piroxicam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

PIROXICAM CAPSULES 10mg.

Pharmaceutical Form

Pink and turquoise hard gelatin capsules printed “C” and the identifying letters “YA” in black.

Qualitative and quantitative composition

Each capsule contains 10mg Piroxicam PhEur.

Excipient with known effect: 210.60mg lactose monohydrate per tablet

For the full list of excipients, see section 6.1.

Active Ingredient Description
Piroxicam

Piroxicam is a non-steroidal anti-inflammatory agent with analgesic and antipyretic activity. It is effective regardless of the aetiology of the inflammation.

List of Excipients

The capsules also contain:

Carmellose sodium
Lactose
Magnesium stearate
Maize starch
Polysorbate

The capsule shell contains:

Gelatin
Indigo Carmine (E132)
Erythrosine (E127)
Titanium Dioxide (E171)
Red Iron Oxide (E172)
Black Iron Oxide (E172)

The printing ink contains:

Shellac glaze
Iron oxide black (E172)
Propylene glycol

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. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

The product may also be supplied in blister packs and 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: 14s, 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s.

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: 25,000.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 0142/0285

13.8.90

Renewed 15.1.98

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