Azromax 250 mg film-coated tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Azithromycin dihydrate

Disponible des:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Codi ATC:

J01FA; J01FA10

Designació comuna internacional (DCI):

Azithromycin dihydrate

Dosis:

250 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Macrolides; azithromycin

Estat d'Autorització:

Marketed

Data d'autorització:

2010-06-04

Informació per a l'usuari

PAGE 1 OF 8
PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZROMAX 250MG FILM-COATED TABLETS
azithromycin
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 Azromax is and what it is used for
2.
What you need to know before you take Azromax
3.
How to take Azromax
4.
Possible side effects
5.
How to store Azromax
6.
Contents of the pack and other information
1. WHAT AZROMAX IS AND WHAT IT IS USED FOR
Azromax is one of a group of antibiotics known as macrolides. It is
used to treat bacterial infections caused
by microorganisms such as bacteria. These infections include:
•
Chest infections such as bronchitis and pneumonia
•
Infections in your sinuses, throat, tonsils or ears
•
Mild to moderate skin and soft tissue infections,
_e.g._
infection of the hair follicles (folliculitis), bacterial
infection of the skin and its deeper layers (cellulitis), skin
infection with shiny red swelling (erysipelas)
•
Infections caused by a bacterium called
_Chlamydia trachomatis_
. They can cause inflammation of the
tube that carries urine from your bladder (urethra) or where your womb
joins your vagina (cervix).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZROMAX
DO NOT TAKE AZROMAX:
•
if you are allergic to azithromycin, any other macrolide (such as
erythromycin or clarithromycin) or
ketolide antibiotic or any of the ingredients of this medicine (listed
in section 6). An allergic reaction may
cause skin rash or wheezing.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist

Fitxa tècnica

Health Products Regulatory Authority
27 May 2022
CRN00CVQS
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azromax 250 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg azithromycin (as azithromycin
dihydrate).
Excipient with known effect:
Each film-coated tablet contains 3.08 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Azithromycin 250 mg Film-coated Tablets are white to off-white, oblong
film-coated tablets and plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated for the treatment of the following
infections, when caused by microorganisms sensitive to
azithromycin (see section 4.4 and 5.1):
• Acute bacterial sinusitis (adequately diagnosed)
• Acute bacterial otitis media (adequately diagnosed)
• Pharyngitis, tonsillitis
• Acute exacerbation of chronic bronchitis (adequately diagnosed)
• Mild to moderately severe community acquired pneumonia
• Infections of the skin and soft tissues of mild to moderate
severity e.g. folliculitis, cellulitis, erysipelas
• Uncomplicated Chlamydia trachomatis urethritis and cervicitis
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Azithromycin tablets should be given as a single daily dose. The
duration of treatment in each of the infectious diseases is
given below.
_Adults, elderly, children and adolescents over 45 kg body weight_
The total dosage of azithromycin is 1500 mg which is spread over three
days (500 mg once daily).
Alternatively, the dosage can be spread over five days (500 mg as a
single dose on the first day and thereafter 250 mg once
daily).
In uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis the
dosage is 1000 mg as a single oral dose.
_For sinusitis_, treatment is indicated for adults and adolescents 16
years of age and over.
_Ch