ROXIMYCIN roxithromycin 150mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin, Quantity: 150 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; hyprolose; maize starch; poloxamer; colloidal anhydrous silica; purified talc; magnesium stearate; glucose; titanium dioxide; hypromellose; propylene glycol

Administration route:

Oral

Units in package:

10 tablets, 100 tablets, 20 tablets, 5 tablets

Prescription type:

(S4) Prescription Only Medicine

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 micro-organisms: Upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. Lower respiratory tract infection: acute bronchitis and acute exacerbation 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 weighing greater than 40 kg caused by or likely to be caused by susceptible micro-organisms: Acute pharyngitis. Acute tonsillitis. Impetigo. Appropriate culture and sensitivity tests should be performed when necessary to determine an organisms 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.

Product summary:

Visual Identification: Normal convex, white, film coated tablet, debossed 150 R on one side and G on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-03-30

Patient Information leaflet

ROXIMYCIN
_Roxithromycin film coated tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ROXIMYCIN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ROXIMYCIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ROXIMYCIN IS
USED FOR
ROXIMYCIN is used to treat
infections in different parts of the
body caused by bacteria. For
example:
•
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)
ROXIMYCIN 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.
ROXIMYCIN, like other antibiotics,
does not work against viral infections
such as the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ROXIMYCIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
ROXIMYCIN for another reason.
This medicine is available only with
a doctor's prescription.
ROXIMYCIN is not addictive.
BEFORE YOU TAKE
ROXIMYCIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ROXIMYCIN IF:
1.
YOU HAVE AN ALLERGY TO:
•
roxithromycin or any other
macrolide antibiotic eg.
azithromycin (eg: Zithromax),
clarithromycin (eg. Klacid,
Kalixocin) or erythromycin (eg.
EES, E-Mycin)
•
any of the ingredients listed at the
end of this leaflet (see Product
description)
Some of the symptoms of an allergic
reaction may incl

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ROXIMYCIN
_Roxithromycin film coated tablets _
1
NAME OF THE MEDICINE
Roxithromycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Roxithromycin is a semi-synthetic macrolide antibiotic.
Each ROXIMYCIN film-coated tablet contains either 150 mg or 300 mg of
roxithromycin as the active
ingredient.
Excipients with known effect: Sulfites
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ROXIMYCIN 150 mg: The biconvex tablets are white, round, and embossed
with “150” “R” on one
side and “G” on the other.
ROXIMYCIN 300 mg: The biconvex tablets and are presented as white,
round embossed with “300”
“R” on one side and “G” on the other.
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
micro-organisms:
•
Upper respiratory tract infection:
acute pharyngitis, tonsillitis, 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 micro-organisms:
•
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
ROXIMYCIN – PRODUCT INFORMATION
2
before results of these tests are known; once results become
available, appropriate therapy should be
continued.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Roxithromycin should be taken at least 15 minutes before food or on an
empty stomach (i.e. more
than 3 hours after a meal).
The recommended dosage i