Levofloxacin 500 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levofloxacin

Available from:

Chanelle Medical

ATC code:

J01MA; J01MA12

INN (International Name):

Levofloxacin

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Fluoroquinolones; levofloxacin

Authorization status:

Not marketed

Authorization date:

2020-07-03

Patient Information leaflet

ID: PL201M (IE)
Version: 03
Revision Date: 16/03/2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN 500 MG FILM-COATED TABLETS
LEVOFLOXACIN
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Levofloxacin Tablets are and what they are used for
2. What you need to know before you take Levofloxacin Tablets
3. How to take Levofloxacin Tablets
4. Possible side effects
5. How to store Levofloxacin Tablets
6. Contents of the pack and other information
1.
WHAT LEVOFLOXACIN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Levofloxacin Tablets. Levofloxacin
Tablets contain a medicine
called levofloxacin. This belongs to a group of medicines called
antibiotics. Levofloxacin is a
‘quinolone’ antibiotic. It works by killing the bacteria that
cause infections in your body.
LEVOFLOXACIN TABLETS CAN BE USED TO TREAT INFECTIONS OF THE:

Sinuses

Lungs, in people with long-term breathing problems or pneumonia

Urinary tract, including your kidneys or bladder

Prostate gland, where you have a long lasting infection

Skin and underneath the skin, including muscles. This is sometimes
called ‘soft
tissue’.
For the treatment of sinusitis, exacerbation of chronic obstructive
pulmonary disease,
bronchitis and uncomplicated cystitis, levofloxacin should only be
used when it is not
possible to use the antibiotics normally used for the initial
treatment of these infections.
In some special situations, Levofloxacin Tablets may be used to lessen
the chances of getting
a

Summary of Product characteristics

Health Products Regulatory Authority
26 April 2022
CRN00CV8L
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of levofloxacin as
levofloxacin hemihydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Light orange coloured, oval shaped, film-coated tablets with ‘500’
debossed on one side and ‘n’ debossed on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levofloxacin is indicated in adults for the treatment of the following
infections (see sections 4.4 and 5.1).

Acute pyelonephritis and complicated urinary tract infections (see
section 4.4)

Chronic bacterial prostatitis

Inhalation Anthrax: postexposure prophylaxis and curative treatment
(see section 4.4)
For the below-mentioned infections Levofloxacin Tablets should be used
only when it is considered inappropriate to use
other antibacterial agents that are commonly recommended for the
initial treatment of these infections.

Acute bacterial sinusitis

Acute exacerbations of chronic obstructive pulmonary disease including
bronchitis

Community-acquired pneumonia

Complicated skin and soft tissue infections

Uncomplicated cystitis (see section 4.4)
Levofloxacin Tablets may also be used to complete a course of therapy
in patients who have shown improvement during initial
treatment with intravenous levofloxacin.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Levofloxacin Tablets are administered once or twice daily. The dosage
depends on the type and severity of the infection and
the susceptibility of the presumed causative pathogen.
Levofloxacin Tablets may also be used to complete a course of therapy
in patients who have shown improvement during initial
treatment with intravenous levofloxacin; given the bioequivalence of
the parenteral and oral