CHEMMART AZITHROMYCIN azithromycin (as dihydrate) 500 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

azithromycin dihydrate

Available from:

Apotex Pty Ltd

INN (International Name):

azithromycin dihydrate

Authorization status:

Registered

Patient Information leaflet

CHEMMART
AZITHROMYCIN TABLETS
_Azithromycin dihydrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about azithromycin. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Azithromycin is used to treat
infections in different parts of the
body caused by bacteria, such as
chlamydia. Azithromycin belongs to
a group of medicines called
macrolide antibiotics.
_HOW IT WORKS_
Azithromycin works by killing or
stopping the growth of bacteria
causing your infection. Azithromycin
will not work against viral infections
such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of azithromycin
tablets in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
azithromycin
•
macrolide antibiotics (e.g.
clarithromycin, erythromycin,
roxithromycin, telithromycin)
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expire

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
CHEMMART AZITHROMYCIN (AZITHROMYCIN
DIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Azithromycin dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg Azithromycin (as dihydrate)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White, oval, biconvex film coated tablets engraved “APO” on one
side and “AZ500” on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AZITHROMYCIN IS INDICATED FOR USE IN ADULTS FOR THE TREATMENT OF THE
FOLLOWING INFECTIONS
OF MILD TO MODERATE SEVERITY:
1.
Lower respiratory tract infections:
Acute bacterial bronchitis due to _ Streptococcus pneumoniae,
Haemophilus influenzae_ or
_Moraxella catarrhalis._
Community
acquired
pneumonia
due
to
_Streptococcus _
_pneumoniae_
or
_Haemophilus _
_influenzae_ in patients suitable for outpatient oral treatment.
Community acquired pneumonia caused by susceptible organisms in
patients who require
initial
intravenous therapy.
In
clinical
studies
efficacy
has
been demonstrated
against
_Chlamydia _
_pneumoniae, _
_Haemophilus _
_influenzae, _
_Legionella _
_pneumophilia, _
_Moraxella _
_catarrhalis, _
_Mycoplasma _
_pneumoniae, _
_Staphylococcus _
_aureus_
and
_Streptococcus _
_pneumoniae_.
2.
Upper respiratory tract infections:
Acute sinusitis due to _Streptococcus pneumoniae_ or _Haemophilus
influenzae_.
Acute streptococcal pharyngitis. Note: Penicillin is the usual drug of
choice in the
treatment of Streptococcus pyogenes pharyngitis, including the
prophylaxis of rheumatic
fever. Azithromycin appears to be almost as effective in the treatment
of streptococcal
pharyngitis. However, substantial data establishing the efficacy of
azithromycin in the
subsequent prevention of rheumatic fever are not available at present.
2
3.
Uncomplicated skin and skin structure infections:
Uncomplicated
infections
due
to
_Staphylococcus _
_aureus, _
_Streptococcus _
_pyogenes_
or
_Streptococcus agalactiae_. Abscesses usually require surgical
drainage.
4.
Sex