Adiflox tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

levofloxacin (levofloxacin hemihydrate)

Available from:

ADIPHARM EAD

ATC code:

J01MA12

INN (International Name):

levofloxacin (levofloxacin hemihydrate)

Dosage:

500mg

Pharmaceutical form:

tablets film-coated

Units in package:

(7/1x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-06-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADIFLOX 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 symptoms 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 ADIFLOX is and what it is used for
2. What you need to know before you take ADIFLOX
3. How to take
ADIFLOX
4. Possible side effects
5. How to store ADIFLOX
6. Content of the pack and other information
1.
WHAT ADIFLOX IS AND WHAT IT IS USED FOR
The name of yours medicine is Adiflox. It contains levofloxacine,
broad - spectrum quinolone
antibiotic. It has antibacterial effect by stopping bacterial growth
of different bacteria species causing
infections in your body.
Your doctor has prescribed you Adiflox for treatment of some of the
following bacterial infections:
-
Infections of sinuses
-
Infections of lungs, respiratory tracks or pneumonia
-
Infections of urinary tract, including kidneys or bladder
-
Infections of prostate gland
-
Skin and soft-tissue infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADIFLOX
DO NOT TAKE ADIFLOX AND TELL YOUR DOCTOR:
-
If you are allergic (hypersensitive) to levofloxacin or any of the
ingredients of this medicine
(listed in section 6), or if you allergic to any other quinolone
antibiotic (ofloxacin, ciprofloxacin);
Signs of an allergic reaction can be: a rash, swallowing or breathing
problems, swelling of your lips,
throat or tongue
-
suffer epilepsy;
-
have had tendon problems and were treated with quinolone antibiotic;
-
you are pregnant, might become pregnant or planning pregnancy;
-
are breast – feeding, this medicine could harm your bab

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ADIFLOX 500 MG FILM-COATED TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg levofloxacin as levofloxacin
hemihydrate.
3. PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex orange film-coated tablets.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Levofloxacin is an antibacterial agent of the wide spectrum
fluoroquinolone group.
It is intended for treatment of the following infections in adults
(see sections 4.4 and 5.1):
- Acute bacterial sinusitis
-
Exacerbated chronic bronchitis
-
Community-acquired pneumonia
-
Complicated skin and soft tissue infections
Adiflox
should
be
used
for
the
abovementioned
infections
only
when
the
use
of
the
usually
recommended in these cases antibacterial products is considered
inappropriate.
-
Complicated infections of the urinary tract and pyelonephritis
-
Chronic bacterial prostatitis
-
Uncomplicated cystitis (see section 4.4)
-
Inhalation anthrax: prevention upon exposure and treatment (see
section 4.4)
Adiflox may be used for completion of treatment in patients who have
shown improvement upon
initial administration of intravenous levofloxacin.
When
prescribing
Adiflox,
the
formal
recommendations
for
appropriate
administration
of
antibacterial medicines should be considered.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
Adiflox film-coated tablets are administered once or twice daily
according to the infection type and
severity and the susceptibility of the causative agent to
levofloxacin.
If treatment with levofloxacin is initiated parenterally (in patients
in whom oral administration is
inappropriate), it is possible to switch to oral intake depending on
the patient’s condition. Equal oral
and parenteral doses may be administered due to the bioequivalence of
levofloxacin (see section 5.2).
_ _
_ _
_ _
2
_DURATION OF TREATMENT _
_ _
The therapy duration is determined by the course of the disease. As
with every antibiotic therapy, the
administration