TERRY WHITE ROXITHROMYCIN roxithromycin 150 mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin

Available from:

Apotex Pty Ltd

INN (International Name):

Roxithromycin

Authorization status:

Registered

Patient Information leaflet

TERRY WHITE CHEMISTS
ROXITHROMYCIN
_Roxithromycin_
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 roxithromycin. 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.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Roxithromycin is used to treat
different infections caused by
bacteria, which include:
•
acute pharyngitis (sore throat and
discomfort when swallowing)
•
tonsillitis
•
sinusitis
•
acute bronchitis (infection of the
bronchi causing coughing)
•
worsening of chronic bronchitis
•
pneumonia (lung infection
characterised by fever, malaise,
headache)
•
skin and soft tissue infections
•
non gonococcal urethritis
•
impetigo (bacterial infection
causing sores on the skin)
_HOW IT WORKS_
Roxithromycin is an antibiotic that
belongs to a group of medicines
called macrolides.
These antibiotics work by killing or
stopping the growth of the bacteria
that are causing your infection.
Roxithromycin, like other antibiotics,
does not work against viral infections
such as the 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.
This medicine is not recommended
for use in children

Summary of Product characteristics

Terry White Chemists Roxithromycin tablets
Page 1
1
AUSTRALIAN PRODUCT INFORMATION –TERRY WHITE CHEMISTS
ROXITHROMYCIN (ROXITHROMYCIN)
1
NAME OF THE MEDICINE
Roxithromycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Roxithromycin is a semi-synthetic macrolide antibiotic. Each
Roxithromycin film-coated tablet
contains either 150 mg or 300 mg of roxithromycin as the active
ingredient.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
150 MG TABLETS
White to off-white, round, convex and film-coated tablets.
300 MG TABLETS
White to off-white, round, convex and film-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Roxithromycin is indicated for the treatment of the following types of
mild to moderately
severe infections in adults caused by or likely to be caused by
susceptible microorganisms:
•
Upper respiratory tract infection: acute pharyngitis, tonsillitis and
sinusitis.
•
Lower respiratory tract infection: acute bronchitis and acute
exacerbations of chronic
bronchitis; community acquired pneumonia.
•
Skin and skin structure infections.
•
Non-gonococcal urethritis.
CHILDREN
Roxithromycin 150 mg tablets are indicated for the treatment of the
following mild to
moderately severe infections in children caused by or likely to be
caused by susceptible
microorganisms:
•
Acute pharyngitis
•
Acute tonsillitis
•
Impetigo.
Appropriate culture and sensitivity tests should be performed when
necessary to determine
an organism’s susceptibility and thus treatment suitability. Therapy
with roxithromycin may
be initiated before results of these tests are known; once results
become available,
appropriate therapy should be continued.
Terry White Chemists Roxithromycin tablets
Page 2
2
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral administration.
ADULTS
Roxithromycin should be taken at least 15 minutes before food or on an
empty stomach (i.e.
more than three hours after a meal).
The recommended dosage is 300 mg per day which may be taken according
to on