Zithromax Powder for Oral Suspension 200 mg/5 ml.

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AZITHROMYCIN

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

J01FA10

INN (International Name):

AZITHROMYCIN 200 mg/5ml

Pharmaceutical form:

POWDER FOR ORAL SUSPENSION

Composition:

AZITHROMYCIN 200 mg/5ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-02-06

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZITHROMAX
®
POWDER FOR ORAL SUSPENSION 200 MG/5 ML
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 Zithromax is and what it is used for
2.
What you need to know before you take Zithromax
3.
How to take Zithromax
4.
Possible side effects
5.
How to store Zithromax
6.
Contents of the pack and other information
1.
WHAT ZITHROMAX IS AND WHAT IT IS USED FOR
This medicine contains azithromycin, which is one of a group of
antibiotics called macrolides. It is
used to treat infections caused by certain bacteria and other
micro-organisms, which include:

chest, throat or nasal infections (such as bronchitis, pneumonia,
tonsillitis, sore throat
(pharyngitis) and sinusitis

ear infections

skin and soft tissue infections (such as an abscess or boil)

sexually transmitted diseases caused by organisms called chlamydia or
gonorrhoea.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZITHROMAX
DO NOT TAKE ZITHROMAX:

if you/your child are allergic to azithromycin or any other macrolide
antibiotic such as
erythromycin or clarithromycin or any of the ingredients listed in
section 6. An allergic
reaction may cause skin rash or wheezing.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zithromax if you/your
child have or have had any of
the following:

kidney problems

heart conditions

diabetes

liver problems: your doctor

Summary of Product characteristics

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zithromax Powder for Oral Suspension 200 mg/5 ml.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Following reconstitution as directed, each 5 ml of suspension contains
200 mg
azithromycin (as dihydrate).
Excipients with known effect
Also contains 3.87 g sucrose per 5 ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for Oral Suspension.
A dry white powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Azithromycin is indicated for the treatment of the following
infections when known
or likely to be due to one or more susceptible microorganisms (see
section 5.1):
- bronchitis
- community-acquired pneumonia
- sinusitis
- pharyngitis/tonsillitis (see section 4.4 regarding streptococcal
infections)
- otitis media
- skin and soft tissue infections
- uncomplicated genital infections due to _Chlamydia trachomatis_ and
_Neisseria _
_gonorrhoeae._
Considerations should be given to official guidance regarding the
appropriate use of
antibacterial agents.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Zithromax should be given as a single daily dose.
Zithromax Suspension can be taken with food.
CHILDREN OVER 45 KG BODY WEIGHT AND ADULTS, INCLUDING ELDERLY
PATIENTS: The total
dose of azithromycin is 1500 mg which should be given over three days
(500 mg once
daily).
Page 2 of 19
In uncomplicated genital infections due to _Chlamydia trachomatis,
_the dose is 1000
mg as a single oral dose. For susceptible _Neisseria gonorrhoeae_ the
recommended
dose is 2000 mg azithromycin as a single oral dose together with 500
mg ceftriaxone
intramuscularly as a single dose according to local clinical treatment
guidelines. For
patients who are allergic to penicillin and/or cephalosporins,
prescribers should
consult local treatment guidelines.
THE ELDERLY:
The same dosage as in adult patients is used in the elderly. However,
since elderly
patients can be patients with ongoing proarrhythmic conditions a
particular caution i