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:

2018-04-04

Patient Information leaflet

_Levo-Denk 250_
Film-coated tablets – oral use
Antibiotic of the quinolone class
Active ingredient: levofloxacin
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 doc-
tor or pharmacist. This includes any possi-
ble side effects not listed in this leaflet.
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 tablets 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.
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 mus-
cles. This is sometimes called ‘soft tissue’.
In some special situations, Levo-Denk 250 may
be used to lessen the chances of getting a pul-
monary disease named anthrax or worsening
of the disease after you are exposed to the bac-
teria causing anthrax.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE LEVO-DENK 250
DO NOT TAKE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
– You are allergic to levofloxacin, any other
quinolone antibiotic such as moxifloxacin,
cipro

Summary of Product characteristics

Trade name:
Generic name:
Applicant:
Levo-Denk 250
Levofloxacin 250 mg, film-coated tablet
DENK PHARMA GmbH & Co. KG
1/ 16
S
UMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levo-Denk 250
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 250 mg levofloxacin, equivalent to
256.23 mg levofloxacin hemihydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oblong, film-coated tablet with a breaking line on both sides.
The film-coated tablet can be divided into equal halves.
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 bacterial sinusitis
•
Acute exacerbations of chronic bronchitis
•
Community-acquired pneumonia
•
Complicated skin and soft tissue infections
For the above-mentioned infections Levo-Denk 250 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: postexposure prophylaxis and curative treatment
(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.
Levo-Denk 250 tablets 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,