Zithromax Capsules 250 mg

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 250 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

AZITHROMYCIN 250 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-02-06

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZITHROMAX
®
CAPSULES 250 MG
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 are allergic to azithromycin or any other macrolide antibiotic
such as erythromycin or
clarithromycin 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 before taking Zithromax if you have
or have had any of the
following conditions:

kidney problems

heart conditions

liver problems: your doctor may need to monitor your liv

Summary of Product characteristics

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zithromax Capsules 250 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Azithromycin dihydrate equivalent to 250 mg azithromycin.
Excipients with known effect:
Each capsule contains 151.55 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
White, hard gelatin capsules marked ‘Pfizer’ and ‘ZTM 250’.
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.
In common with many other antibiotics Zithromax Capsules should be
taken at least
one hour before or 2 hours after 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 18
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.
PAEDIATRIC POPULATION
IN CHILDREN UNDER 45 KG BODY WEIGHT:
Zithromax Capsules are not suitable for children under 45 kg.
THE ELDERLY