Azithro-Denk 500mg tablets film-coated

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

azithromycin (azithromycin monohydrate)

Dostupno od:

Artesan Pharma GmbH & Co. KG

ATC koda:

J01FA10

INN (International ime):

azithromycin (azithromycin monohydrate)

Doziranje:

500mg

Farmaceutski oblik:

tablets film-coated

Jedinice u paketu:

(3/1x3/) in blister

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2019-11-14

Uputa o lijeku

Version 50001786/003
1
AZITHRO-DENK 500 MG
Film-coated tablet – oral use
Macrolide antibiotic
Active substance: Azithromycin
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 Azithro-Denk is and what it is used for
2.
What you need to know before you take Azithro-Denk
3.
How to take Azithro-Denk
4.
Possible side effects
5.
How to store Azithro-Denk
6.
Contents of the pack and other information
1. WHAT AZITHRO-DENK IS AND WHAT IT IS USED FOR
Azithromycin is one of a group of antibiotics called macrolides, which
prevents sensitive bacteria
from growing. It is used to treat infections caused by certain
bacteria and other micro-organisms,
which include:

Upper respiratory tract infections, including sinusitis, sore throat
(pharyngitis) and tonsillitis

Lower respiratory tract infections, including bronchitis and pneumonia

Ear infections (acute otitis media)

Skin and soft tissue infections

Uncomplicated genital infections caused by organisms called
_Chlamydia trachomatis _
or
_Neisseria _
_gonorrhoeae _
(non-multidrug-resistant strains).
When using antibiotics, the resistance status and official/local
guidelines on the appropriate use of
antibacterial agents must be considered.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZITHRO-DENK
DO NOT TAKE AZITHRO-DENK, IF

you are allergic to azithromycin, erythromycin or any antibiotic which
belongs to a group called
macrolide or ketolide antibiotics

you are allergic to any of the othe

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
Azithro-Denk 250 mg
Azithro-Denk 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: azithromycin
_ _
_Azithro-Denk 250 mg _
Each film-coated tablet contains 250 mg azithromycin (as azithromycin
monohydrate).
Excipient with known effect: Each film-coated tablet contains less
than 1 mmol sodium (23 mg).
_Azithro-Denk 500 mg _
Each film-coated tablet contains 500 mg azithromycin (as azithromycin
monohydrate).
Excipient with known effect: Each film-coated tablet contains less
than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_Azithro-Denk 250 mg _
White or off-white, oblong and biconvex film-coated tablet.
_Azithro-Denk 500 mg _
White or off-white, oblong and biconvex film-coated tablet with a
breaking score on both sides.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the following infections, when caused by
azithromycin-susceptible bacteria (see sections
4.4 and 5.1):
-
Upper respiratory tract infections (including and sinusitis,
pharyngitis and
tonsillitis)
-
Lower respiratory tract infections (including bronchitis and
pneumonia)
-
Acute otitis media
-
Skin and soft tissue infections
-
Uncomplicated genital infections due to _Chlamydia trachomatis_ or
_Neisseria gonorrrhoeae_ (non-
multiresistant strains).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Azithromycin differs from other antibiotics by its high tissue
affinity. Tissue concentrations exceed
serum levels by up to 50-fold, and the half-life in tissues ranges
from 2 to 4 days. For these reasons,
2
there is a difference between the dosing regimen of azithromycin and
that of other antimicrobial
substances.
Posology
ADOLESCENTS OVER 45 KG BODY WEIGHT AND ADULTS, INCLUDING ELDERLY
PATIENTS
For upper and lower respiratory tract infections, acute o