ROXITHROMYCIN SANDOZ roxithromycin 300mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin, Quantity: 300 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Roxithromycin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: silicon dioxide; titanium dioxide; hypromellose; lactose monohydrate; croscarmellose sodium; poloxamer; magnesium stearate; microcrystalline cellulose; povidone; macrogol 4000

Administration route:

Oral

Units in package:

5 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Roxithromycin Sandoz is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible microorganisms. Upper respiratory tract infection: acute pharyngitis, tonsilitis and sinusiti. Lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. Skin and skin structure infections. Nongonococcal urethritis. Children Roxithromycin Sandoz 150mg 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 tonsilitis. Impetigo. Appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be inititiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Product summary:

Visual Identification: White, round, convex film-coated tablets, scored on one face, embossment on other side: R300; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-07-11

Patient Information leaflet

ROXITHROMYCIN SANDOZ
®
1
ROXITHROMYCIN SANDOZ
®
_roxithromycin film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Roxithromycin
Sandoz.
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
SANDOZ 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)
•
exacerbation 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).
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 Sandoz
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
SANDOZ
_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,
clarithromycin or erythromycin).
Som

Summary of Product characteristics

190206-Roxithromycin Sandoz-pi
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
ROXITHROMYCIN SANDOZ
® (ROXITHROMYCIN) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Roxithromycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Roxithromycin Sandoz 150 mg film-coated tablets contains 150 mg
roxithromycin.
Each Roxithromycin Sandoz 300 mg film-coated tablets contains 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 Sandoz 150 mg film-coated tablets: white, round, convex
film-coated tablets,
scored on one face, embossment R 150.
Roxithromycin Sandoz 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 Sandoz 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 Sandoz 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
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.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
190206-Roxithromycin Sandoz-pi
Page 2 of 12
The recommended dosage is 300 mg per day, which may be take