ROXITHROMYCIN AN roxithromycin 150mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin

Available from:

Sandoz Pty Ltd

INN (International Name):

Roxithromycin

Authorization status:

Registered

Patient Information leaflet

_ _
_Roxithromycin AN tablets – Consumer Medicine Information _
_ _
_Doc ID: 71.AN.M.1.0 _
_ _
_ _
_Page 1 _
ROXITHROMYCIN AN FILM-COATED TABLETS
_ROXITHROMYCIN _
CONSUMER MEDICINE INFORMATION
WHAT IS THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Roxithromycin AN.
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 risk of you taking
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
need
to
read it again.
WHAT ROXITHROMYCIN
AN IS USED FOR
This medicine is used to treat
various
infections
caused
by
bacteria such as:

acute
pharyngitis
(sore
throat and discomfort when
swallowing)

tonsillitis

sinusitis

acute bronchitis (infection of
the
bronchi
causing
coughing)

pneumonia
(lung
infection
characterised
by
fever,
malaise, headache)

skin
and
soft
tissue
infections

non gonococcal urethritis

impetigo (bacterial infection
causing sores on the skin).
It contains the active ingredient
roxithromycin.
Roxithromycin
belongs
to
a
group
of
medicines called macrolides.
It works by killing or stopping
the growth of the bacteria that
are causing the infection.
However,
Roxithromycin
AN
does
not
have
any
effect
on
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 it
for another reason.
This medicine is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
ROXITHROMYCIN AN
_ _
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE THIS MEDICINE IF
YOU HAVE AN ALLERGY TO:

roxithromycin,
the
active
ingredient, or to any of the
other
ingredients
listed
at
the end of this leaflet under
Product Description.

any
other
macrolide
antibiotic
(such
as
azithromycin,
clarith

Summary of Product characteristics

190206-Roxithromycin AN-pi
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
ROXITHROMYCIN AN (ROXITHROMYCIN) TABLETS
1.
NAME OF THE MEDICINE
Roxithromycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Roxithromycin AN 150 mg tablets contain 150 mg roxithromycin.
Each Roxithromycin AN 300 mg tablets contain 300 mg roxithromycin.
It is a white crystalline powder.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Roxithromycin AN 150 mg film-coated tablets: white, round, convex
film-coated tablets,
scored on one face, embossment R 150.
Roxithromycin AN 300 mg film-coated tablets: white, round, convex
film-coated tablets,
scored on one face, embossment R 300.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
_Adults_:
Roxithromycin AN 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.
•
Nongonococcal urethritis.
_Children: _
Roxithromycin AN 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
microoganisms.
•
Acute pharyngitis.
•
Acute tonsillitis.
•
Impetigo.
_ _
Appropriate culture and sensitivity tests should be performed when
necessary to determine
organism 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.
190206-Roxithromycin AN-pi
Page 2 of 12
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
The recommended dosage is 300 mg per day, which may be taken according
to one of the
following dosage regimens.
_Usual dosage: _
Roxithro