CEFADROXIL Capsules, hard Ref.[6563] Active ingredients: Cefadroxil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Sandoz Limited, Frimley Business Park, Frimley, Surrey GU16 7SR, United Kingdom

Product name and form

Cefadroxil 500 mg Capsules.

Pharmaceutical Form

Capsules, hard.

Description: White, opaque capsule containing white to slightly yellowish powder.

Qualitative and quantitative composition

One capsule contains 500 mg of cefadroxil (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cefadroxil

Cefadroxil is a cephalosporin for oral administration which inhibits bacterial wall synthesis of actively dividing cells by binding to one or more penicillin-binding proteins.

List of Excipients

Content:

Magnesium stearate
Sodium lauryl sulfate
Cellulose, microcrystalline

Shell:

Titanium dioxide (E-171)
Gelatine

Pack sizes and marketing

Single packs of 10, 12, 14, 16, 20, 30, 40 and 100 (100 × 1) capsules.

Hospital packs of 100 (10 × 10) and 1000 (100 × 10) capsules in polyvinylchloride/polyvinylidene (PVC/PVDC)-Alu-blister strips.

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Surrey GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 04416/0433

Date of first authorisation: 16 February 1995
Date of last renewal: 01 April 2005

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