LEVOFLOXACIN Film-coated tablet Ref.[7251] Active ingredients: Levofloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4 HF, United Kingdom

Product name and form

Levofloxacin 250 mg Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

For 250 mg tablets: Pink coloured, capsule shaped, biconvex, film coated tablet with break line on both sides. Debossed ‘L’ and ‘F’ either side of the break line on one face.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film coated tablet contains 250 mg of levofloxacin as active substance corresponding to 256.23 mg of levofloxacin hemihydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levofloxacin

Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class. As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA – DNA-gyrase complex and topoisomerase IV.

List of Excipients

Tablet core:

Povidone
Crospovidone (Type-B)
Cellulose microcrystalline
Magnesium stearate
Silica colloidal anhydrous

Tablet coating:

Hypromellose E5 Talc
Titanium dioxide (E171)
Macrogol 400
Yellow ferric oxide (E172)
Red ferric oxide (E172)

Pack sizes and marketing

Tablets are packed in PVC/aluminium blisters.

For 250 mg, the tablets are provided in pack sizes of 1, 2, 3, 5, 7, 10, 30, 50 and 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4 HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0297

02/06/2011

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.