Levo-Denk 500 tablets film-coated

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

levofloxacin (levofloxacin hemihydrate)

Dostępny od:

Rottendorf Pharma GmbH

Kod ATC:

J01MA12

INN (International Nazwa):

levofloxacin (levofloxacin hemihydrate)

Dawkowanie:

500mg

Forma farmaceutyczna:

tablets film-coated

Sztuk w opakowaniu:

(10/1x10/) in blister

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2020-12-30

Ulotka dla pacjenta

_ Levo-Denk 500_
Film-coated tablet – oral use
Antibiotic of the quinolone class
Active substance: levofloxacin
Package leaflet: Information for the patient
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
LEVO-DENK 500 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVO-DENK 500
3.
HOW TO TAKE LEVO-DENK 500
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LEVO-DENK 500
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Levo-Denk 500 is and what it is used for
The name of your medicine is
Levo-Denk 500.
Levo-Denk 500 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.
Levo-Denk 500 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,
Levo-Denk 500 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 Levo-Denk 500
Do not take
Levo-Denk 500 and tell your doctor if you:
•
are allergic to levofloxacin, any other quinolone antibiotic such as
moxifloxacin,
ciprof

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levo-Denk 500
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: levofloxacin
Each film-coated tablet contains 500 mg levofloxacin, equivalent to
512.46 mg levofloxacin
hemihydrate.
Excipients with known effect
: Each film-coated tablet contains 7.2 mg of lactose monohydrate and
less than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oblong, film-coated tablet with break marks on both faces.
The film-coated tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levo-Denk 500 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)
For the following indications Levo-Denk 500 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 exacerbation of chronic obstructive pulmonary disease including
bronchitis
-
Community acquired pneumonia
-
Complicated skin and soft tissue infections
-
Uncomplicated cystitis (see section 4.4)
Levo-Denk 500 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
Levo-Denk 500 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.
2
Levo-Denk 500 tablets may also be used to complete a course of therapy
in patients who have shown
improvement during initial treatment with intravenous levoflo