ZITHROMAX

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AZITHROMYCIN DIHYDRATE

Available from:

Primecrown 2010 Ltd

ATC code:

J01FA10

INN (International Name):

AZITHROMYCIN DIHYDRATE

Dosage:

250 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

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

Therapeutic area:

azithromycin

Authorization status:

Authorised

Authorization date:

2013-11-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER ZITHROMAX™ 250MG CAPSULES
azithromycin (as dihydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE

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. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.

If you get any side effects, or if you notice any side effects not
listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. WHAT ZITHROMAX IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE ZITHROMAX
3. HOW TO TAKE ZITHROMAX
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZITHROMAX
6. FURTHER INFORMATION
1. WHAT ZITHROMAX IS AND WHAT IT IS USED FOR
Zithromax 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 an organism called chlamydia.
2. BEFORE YOU TAKE ZITHROMAX
DO NOT TAKE ZITHROMAX IF:

you are allergic to Zithromax 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.

You are allergic to soya or peanut due to the risk of hypersensitivity
reactions from
the ingredient soya lecithin.

TAKE SPECIAL CARE WITH ZITHROMAX
Your doctor needs to know BEFORE you take 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 liver function or
stop the
treatment

myasthenia gravis (localised muscle weakness)



and if you are taking any ergot derivatives such as ergotamine (used
to tre

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zithromax 250mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains azithromycin dihydrate equivalent to 250 mg
azithromycin.
Also contains Lactose anhydrous and soya lecithin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, Hard
_Product imported from Spain:_
White, hard gelatin capsules with “Pfizer” and “ZTM 250”
printed in black.
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 Pharmacodynamic
properties):
bronchitis
community-acquired pneumonia
sinusitis
pharyngitis/tonsillitis (see section 4.4 Special warnings and
precautions for use, regarding streptococcal
infections)
otitis media
skin and soft tissue infections
uncomplicated genital infections due to_ Chlamydia trachomatis._
Considerations should be given to official guidance regarding the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
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).
In uncomplicated genital infections due to Chlamydia trachomatis, the
dose is 1000 mg as a single oral dose.
IN CHILDREN UNDER 45 KG BODY WEIGHT:
Zithromax Capsules are not suitable for children under 45 kg.
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