Levofloxacin Bluefish 500 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levofloxacin

Available from:

Bluefish Pharmaceuticals AB

ATC code:

J01MA; J01MA12

INN (International Name):

Levofloxacin

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Fluoroquinolones; levofloxacin

Authorization status:

Marketed

Authorization date:

2011-02-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN BLUEFISH 250 MG FILM-COATED TABLETS
LEVOFLOXACIN BLUEFISH 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 Bluefish is and what it is used for
2.
What you need to know before you take Levofloxacin Bluefish
3.
How to take Levofloxacin Bluefish
4.
Possible side effects
5.
How to store Levofloxacin Bluefish
6.
Contents of the pack and other information
1.
WHAT LEVOFLOXACIN BLUEFISH IS AND WHAT IT IS USED FOR
The name of your medicine is Levofloxacin Bluefish tablets.
Levofloxacin Bluefish 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 BLUEFISH
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 Bluefish 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 BLUEFISH
DO NOT TAKE LEVOFLOXACIN BLUEFISH
2
-
if you are allergic to

Summary of Product characteristics

Health Products Regulatory Authority
26 August 2022
CRN00D0Q6
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin Bluefish 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains levofloxacin hemihydrate equivalent
to levofloxacin 500 mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Pink coloured, capsule shaped, biconvex, film coated tablet with
dimensions of 16 x 8 mm and break line on both sides.
Debossed ‘L’ and ‘V’ on either side of the break line on one
face.
The tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levofloxacin Bluefish 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 obstructive pulmonary disease
including bronchitis
- Uncomplicated cystitis (see section 4.4)
- Community-acquired pneumonia
- Complicated skin and soft tissue infections
For the above-mentioned infections Levofloxacin Bluefish 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 pyelonephritis and complicated urinary tract infections (see
section 4.4)
- Chronic bacterial prostatitis
- Inhalation Anthrax: postexposure prophylaxis and curative treatment
(see section 4.4)
Levofloxacin Bluefish 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 Bluefish 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 Bluefish tablets may also be used to complete a course of
therap