AMESOL Film-coated tablet Ref.[28104] Active ingredients: Levofloxacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Amesol 250 mg film-coated tablets.

Amesol 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Amesol 250 mg film-coated tablets: Peach, round, convex, scored on one side, embossed “MC” on the other side film coated tablets. The tablet can be divided into equal doses

Amesol 500 mg film-coated tablets: Peach, cap-tab shape, convex, film coated-tablets, scored on one side, embossed “MC” on the other side. The tablet can be divided into equal doses.

Qualitative and quantitative composition

Amesol 250 mg film-coated tablets contain 250 mg levofloxacin as active substance corresponding to 256.23 mg of levofloxacin hemihydrate.

Amesol 500 mg film-coated tablets contain 500 mg levofloxacin as active substance corresponding to 512.46 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

Core:

Microcrystalline cellulose
Hypromellose
Crospovidone
Magnesium stearate

Coating:

Titanium dioxide (E171)
Hypromellose
Macrogol (Polyethylene glycol) 6000
Talc
Iron oxide red (E172)
Iron oxide yellow (E172)

Pack sizes and marketing

Amesol 250 mg film-coated tablets are packed in blisters of PVC/Alu of: 3, 5, 7, 10, 50, 90, 100, 200 and 300 tablets.

Amesol 500 mg film-coated tablets are packed in blisters of PVC/Alu of: 3, 5, 7, 10, 50, 80, 90, 200 and 300 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Amesol 250 mg film-coated tablets: 21561

Amesol 500 mg film-coated tablets: 21562

Amesol 250 mg film-coated tablets: 01/11/2012 / 01/11/2017

Amesol 500 mg film-coated tablets: 01/11/2012 / 01/11/2017

Drugs

Drug Countries
AMESOL Cyprus, Hong Kong, Malta

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