FLUCLOXACILLIN Capsule Ref.[8147] Active ingredients: Floxacillin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom

Product name and form

Flucloxacillin 250mg Capsules BP.

Pharmaceutical Form

Capsules.

Hard gelatin size ‘2’ capsules with Caramel body and Black cap printed with ‘FLU250 MIL’ and filled with white to almost white granular powder.

Qualitative and quantitative composition

Flucloxacillin Sodium equivalent to 250mg Flucloxacillin per Capsule.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Floxacillin

Flucloxacillin is an isoxazolyl penicillin of the β-lactam group of antibiotics which exerts a bactericidal effect upon many Gram-positive organisms including β-lactamase-producing staphylococci and streptococci.

List of Excipients

Magnesium stearate (E572)
Colloidal anhydrous Silica

Capsule Shell Components:

Body:

Red iron oxide (E172)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin

Cap:

Black iron oxide (E172)
Titanium dioxide (E171)
Gelatin

Ink components:

Titanium dioxide (E171)
Shellac (E904)
Industrial methylated spirits
Soya lecithin
Dimethyl siloxane
Mono and di glycerides of fatty acids (E471)
Methyl cellulose
Polyethylene glycol stearate
Xanthan gum
Benzoic acid
Polyethylene glycol
Sorbic acid

Pack sizes and marketing

White polypropylene container with polyethylene lid: 14, 28, 100, 250, 500 and 1000 capsules.

Blister Strips: 14, 28 and 100 capsules.

The blister strips are packed in the carton along with the patient leaflet.

Or

Blister strips are packed in triple laminated bags along with a silica gel sachet and heat sealed. The bags are packed in the carton along with the patient leaflet.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0041

14/05/2002

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