Levo-Denk 250 tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

levofloxacin (levofloxacin hemihydrate)

Available from:

Rottendorf Pharma GmbH

ATC code:

J01MA12

INN (International Name):

levofloxacin (levofloxacin hemihydrate)

Dosage:

250mg

Pharmaceutical form:

tablets film-coated

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-12-30

Patient Information leaflet

1
Version: 5506/003
LEVO-DENK 250
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 250 is and what it is used for
2.
What you need to know before you take Levo-Denk 250
3.
How to take Levo-Denk 250
4.
Possible side effects
5.
How to store Levo-Denk 250
6.
Contents of the pack and other information
1.
WHAT LEVO-DENK 250 IS AND WHAT IT IS USED FOR
The name of your medicine is Levo-Denk 250. Levo-Denk 250 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 250 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 250 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 250
DO NOT TAKE LEVO-DENK 250 AND TELL YOUR DOCTOR IF YOU:
•
are allergic to levofloxacin, any other quinolone antibiotic such as
mox

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levo-Denk 250
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: levofloxacin
Each film-coated tablet contains 250 mg levofloxacin, equivalent to
256.23 mg levofloxacin
hemihydrate.
Excipients with known effect:
Each film-coated tablet contains 3.6 mg of lactose monohydrate and
less than 1 mmol sodium (23 mg) per film-coated tablet.
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 250 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 250 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 250 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 250 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 250 tablets may also be used to complete a course of therapy
in patients who have shown
improvement during initial treatment wi