Floxaton tablets film-coated

Երկիր: Հայաստան

Լեզու: անգլերեն

Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ակտիվ բաղադրիչ:

levofloxacin (levofloxacin hemihydrate)

Հասանելի է:

Medochemie Ltd.

ATC կոդը:

J01MA12 վերարտադրված դեղ

INN (Միջազգային անվանումը):

levofloxacin (levofloxacin hemihydrate)

Դոզան:

500mg (10/1x10/) in blister

Դեղագործական ձեւ:

tablets film-coated

Միավորները փաթեթում:

500mg (10/1x10/) in blister

Ռեկվիզորի տեսակը:

Prescription

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2019-01-18

Տեղեկատվական թերթիկ

pillevo500fctabs2.0-AM
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLOXATON
Levofloxacin
500MG FILM-COATED TABLETS
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 Floxaton is and what it is used for
2.
What you need to know before you take Floxaton
3.
How to take Floxaton
4.
Possible side effects
5.
How to store Floxaton
6.
Contents of the pack and other information
1.
WHAT FLOXATON IS AND WHAT IT IS USED FOR
The name of your medicine is Floxaton. Floxaton 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. Floxaton
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, Floxaton 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 FLOXATON
DO NOT TAKE FLOXATON 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
reac

Ապրանքի հատկությունները

spclevo500fctabs2.0-AM
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Floxaton
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg levofloxacin as active
substance corresponding to 512.46 mg
of levofloxacin hemihydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Peach, cap-tab shape, convex, film coated-tablets, scored on one side,
embossed ”MC” on the other
side. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Floxaton is indicated in adults for the treatment of the following
infections (see sections 4.4 and 5.1):
•
Acute bacterial sinusitis.
•
Acute exacerbation of chronic obstructive pulmonary disease including
bronchitis.
•
Community-acquired pneumonia.
•
Complicated skin and soft tissue infections.
•
Uncomplicated cystitis (see section 4.4).
In the above-mentioned infections, Floxaton 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: post exposure prophylaxis and curative treatment
(see section 4.4).
Floxaton 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
Floxaton 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.
Floxaton 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 use