AZITHROMYCIN ACTAVIS 500 Milligram Film Coated Tablet

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

AZITHROMYCIN DIHYDRATE

Prieinama:

Actavis Group PTC ehf

INN (Tarptautinis Pavadinimas):

AZITHROMYCIN DIHYDRATE

Dozė:

500 Milligram

Vaisto forma:

Film Coated Tablet

Recepto tipas:

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

Autorizacija statusas:

Authorised

Leidimo data:

0000-00-00

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER 

AZITHROMYCIN ACTAVIS 250 MG, FILM-COATED TABLETS 
AZITHROMYCIN ACTAVIS 500 MG, 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 Azithromycin Actavis is and what it is used for 
2. 
What you need to know before you take Azithromycin Actavis 
3. 
How to take Azithromycin Actavis 
4. 
Possible side effects 
5. 
How to store Azithromycin Actavis 
6. 
Contents of the pack and other information 

1. 
WHAT AZITHROMYCIN ACTAVIS IS AND WHAT IT IS USED FOR 

Azithromycin belongs to a group of medicines called macrolide
antibiotics. Antibiotics are used to 
treat infections caused by micro-organisms like bacteria. 

Azithromycin is used for the treatment of certain infections caused by
bacteria that are sensitive to it, 
such as: 
- 
chest, throat or nasal infections (such as bronchitis, pneumonia,
tonsillitis, sore throat 
(pharyngitis) and sinusitis)  
- 
ear infections  
- 
skin and soft tissue infections, with exception of infected burn
wounds e.g. - 
infection of 
the tube that carries urine from the bladder (urethra) or the neck
of the womb (cervix) caused 
by _Chlamydia trachomatis _(bacteria)_ _
_ _
2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZITHROMYCIN ACTAVIS  

DO NOT TAKE AZITHROMYCIN ACTAVIS IF: 
- you 
are 
ALLERGIC to azithromycin dihydrate, erythromycin or any macrolide or
ketolide 
an

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azithromycin Actavis 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Azithromycin Actavis 500 mg film-coated tablets contain 500 mg azithromycin (as dihydrate).
Excipients with known effect:
Each tablet contains 120 mg lactose anhydrous
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablet
White to off-white oval, 9.7 x 17.9 mm, biconvex film-coated tablets marked “500” on one side and plain on the other
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated for the following bacterial infections induced by micro-organisms susceptible to
azithromycin (see sections 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
Azithromycin Actavis should be given as a single daily dose. Duration of the treatment for the different infection
diseases is given below.
The tablets can be taken with or without food.
The tablets should be taken with ½ glass of water.
_Children and adolescents with a body weight above 45 kg, adults and the elderly:_
The total dose is 1500 mg, administered as 500 mg once daily for 3 days. Alternatively, the same total dose (1500 mg)
can be administered in a period of 5 days, 500 mg