Levofloxacin Krka 500 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levofloxacin hemihydrate

Available from:

KRKA, d.d., Novo mesto

ATC code:

J01MA; J01MA12

INN (International Name):

Levofloxacin hemihydrate

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

oral use

Units in package:

1, 5, 7, 10 or 14 film-coated tablets in a box

Prescription type:

Product subject to prescription which may not be renewed (A)

Manufactured by:

PHARMATHEN S.A.

Therapeutic group:

quinolone antibacterials, fluoroquinolones

Therapeutic area:

Fluoroquinolones; levofloxacin

Therapeutic indications:

It is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): - Acute bacterial sinusitis. - Acute exacerbations of chronic bronchitis. - Community-acquired pneumonia. - Complicated skin and soft tissue infections

Authorization status:

Marketed

Authorization date:

2015-03-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levofloxacin Krka 250 mg film-coated tablets
Levofloxacin Krka 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 Krka is and what it is used for
2.
What you need to know before you take Levofloxacin Krka
3.
How to take Levofloxacin Krka
4.
Possible side effects
5.
How to store Levofloxacin Krka
6.
Contents of the pack and other information
1.
WHAT LEVOFLOXACIN KRKA IS AND WHAT IT IS USED FOR
The name of your medicine is Levofloxacin Krka tablets. Levofloxacin
Krka 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 KRKA 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’
In some special situations, Levofloxacin Krka tablets may be used to
lessen the chances of getting a
pulmonary disease named anthrax or worsening of the disease after you
are exposed to the bacteria
causing anthrax.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOFLOXACIN KRKA
DO NOT TAKE LEVOFLOXACIN KRKA AND TELL YOUR DOCTOR:
-
if you are allergic to levofloxacin, any other quinolone anti

Summary of Product characteristics

Health Products Regulatory Authority
07 February 2024
CRN00F09T
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin Krka 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg levofloxacin as levofloxacin
hemihydrate.
Excipient with known effect:
Sunset yellow FCF (E110) 0.038 mg (mg/tablet)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
500 mg film-coated tablets are orange, oblong, biconvex, tablets with
a scoreline and dimensions 19.3 mm x 7.8 mm and
thickness 5.0 mm. The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levofloxacin Krka 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: post exposure prophylaxis and curative treatment
(see section 4.4)
In the below-mentioned infections Levofloxacin Krka should be used
only when it is considered inappropriate to use other
antibacterial agents that are commonly recommended for the 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 Krka 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 Krka 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.
Health Products Regulatory Authority
07 February 2024
CRN00F09T
Page 2 o