Floxaval 500mg film-coated tablets

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

levofloxacin (levofloxacin hemihydrate)

Fáanlegur frá:

Delorbis Pharmaceuticals Ltd

INN (Alþjóðlegt nafn):

levofloxacin (levofloxacin hemihydrate)

Skammtar:

500mg

Lyfjaform:

tablets film-coated

Gerð lyfseðils:

Prescription

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLOXAVAL 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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Floxaval is and what it is used for
2.
What you need to know before you take Floxaval
3.
How to take Floxaval
4.
Possible side effects
5.
How to store Floxaval
6.
Contents of the pack and other information
1.
WHAT FLOXAVAL IS AND WHAT IT IS USED FOR
The name of your medicine is Floxaval. Floxaval contains 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.
FLOXAVAL 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’
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLOXAVAL
DO NOT TAKE FLOXAVAL AND TELL YOUR DOCTOR IF:
•
You are allergic to levofloxacin, any other quinolone antibiotic such
as moxifloxacin, ciprofloxacin or
ofloxacin
or
any
of
the
other
ingredients
of
Floxaval
(listed
in
Section
6
below).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips,
face, throat or tongue
•
You have ever had epilepsy
•
You have ever had a problem with your tendons such as tendonitis that
was related

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Floxaval 500 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains levofloxacin hemihydrate equivalent
to 500 mg levofloxacin.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Peach, oblong coated tablet, scored on both sides.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Floxaval 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.
For the above mentioned-infections Floxaval should be used only when
it is considered inappropriate
to
use
antibacterial
agents that
are
commonly
recommended
for
the
initial
treatment
of
these
infections.
•
Pyelonephritis and complicated urinary tract infections (see section
4.4)
•
Chronic bacterial prostatitis
•
Uncomplicated cystitis (see section 4.4)
•
Inhalation Anthrax: post exposure prophylaxis and curative treatment
(see section 4.4)
Floxaval 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
2
Floxaval is administered once or twice daily. The dosage depends on
the type and severity of the
infection and the sensitivity of the presumed causative pathogen.
Floxaval 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 forms, the same dosage can be used.
_POSOLOGY _
The following dose recommendations can be given for Floxaval:
_DOSAGE IN PATIENTS WITH NORMAL RENAL FUNCTION _
(creatinine clearance> 50