Floxaval tablets film-coated

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

levofloxacin (levofloxacin hemihydrate)

MAH:

Delorbis Pharmaceuticals Ltd

ATC_code:

J01MA12 վերարտադրված դեղ

INN:

levofloxacin (levofloxacin hemihydrate)

dosage:

500mg (10/1x10/) in blister

pharmaceutical_form:

tablets film-coated

units_in_package:

500mg (10/1x10/) in blister

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2019-12-20

PIL

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 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.
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’.
In some special situations, Floxaval 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 FLOXAVAL
DO NOT TAKE THIS MEDICINE 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 this medicine (listed in
section 6).

Signs of an allergic reaction include: a rash, sw

SPC

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 the 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 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 Floxaval 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)
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
Floxaval is administered once or twice daily. The dosage depends on
the type and severity of the
infection and the susceptibility of the presumed causative pathogen.
2
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