CEFALEXIN Capsule, hard Ref.[7715] Active ingredients: Cefalexin

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

Cefalexin 500mg Capsules.

Pharmaceutical Form

Capsules, hard.

Size 0 grey/orange capsule containing white powder printed CHX 500.

Qualitative and quantitative composition

Each capsule contains 500 mg of Cefalexin (as monohydrate).

Excipient(s) with known effect: Each capsule contains 53.2 mg lactose.

For full list of excipients, see 6.1

Active Ingredient Description
Cefalexin

Cefalexin is an antibacterial agent of the cephalosporin class. Like other cephalosporins cefalexin exerts antibacterial activity by binding to and inhibiting the action of penicillin-binding proteins involved in the synthesis of bacterial cell walls. This leads to bacterial cell lysis and cell death.

List of Excipients

Lactose
Magnesium stearate
Capsule shell
Black iron oxide (E172)
Titanium dioxide (E171)
Erythrosin (E127)
Quinoline yellow (E104)
Gelatin

Pack sizes and marketing

Each container consists of a polypropylene tubular container with an open end equipped to accept a polyethylene closure, with a tamper-evident tear strip, or PVC/aluminium blisters, or PVDC coated PVC/ Aluminium blisters (60g/m² PVDC on 250μm PVC/20μm Al) of an appropriate size to accomodate 7, 14, 20, 21, 28, 30, 50, 56, 60, 100, or 500 capsules. 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 16363/0119

04/03/2009

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