ZITHROMAX 200mg/5ml Anhyd mg/5ml Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AZITHROMYCIN DIHYDRATE

Available from:

Pfizer Limited

ATC code:

J01FA10

INN (International Name):

AZITHROMYCIN DIHYDRATE

Dosage:

200mg/5ml Anhyd mg/5ml

Pharmaceutical form:

Powder for Oral Suspension

Prescription type:

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

Therapeutic area:

Macrolides

Authorization status:

Authorised

Authorization date:

1992-02-18

Patient Information leaflet

Page 1 of 8
2016-0023201
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZITHROMAX
® POWDER FOR ORAL SUSPENSION
200 MG / 5 ML
azithromycin dihydrate
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

liv

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zithromax Powder for Oral Suspension 200mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Following reconstitution as directed, each 5 ml of suspension contains
200 mg azithromycin 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).
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.
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