APX-ROXITHROMYCIN roxithromycin 150 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin, Quantity: 150 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

10 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 microorganisms: 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. Nongonococcal 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 susceptibility 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.

Product summary:

Visual Identification: White to off white round biconvex film-coated tablet plain on both side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-05-04

Patient Information leaflet

APX-ROXITHROMYCIN- Consumer Medicine Information
Page 1 of 4
APX-Roxithromycin
roxithromycin
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-
ROXITHROMYCIN.
It does not contain all of 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 APX-
ROXITHROMYCIN against the
benefits they expect it will have for
you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT APX-
ROXITHROMYCIN IS
USED FOR
APX-ROXITHROMYCIN is used to
treat infections in different parts of
the body 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-gonoccocal urethritis
•
impetigo (bacterial infection
causing sores on the skin).
APX-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.
APX-ROXITHROMYCIN, like other
antibiotics, does not work against
viral infections such as the flu.
Your doctor may have prescribed
APX-ROXITHROMYCIN for another
reason. Ask your doctor if you have
any questions about why APX-
ROXITHROMYCIN has been
prescribed for you.
This medicine is available only with
a doctor's prescription.
There is no evidence that APX-
ROXITHROMYCIN is addictive.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE THIS MEDICINE IF YOU
ARE ALLERGIC TO:
•
roxithromycin
•
any other macrolide antibiotic eg,
azithromycin, clarithromycin or
erythromycin
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may

Summary of Product characteristics

1
AUSTRALIAN PI – APX-ROXITHROMYCIN (ROXITHROMYCIN)
1
NAME OF THE MEDICINE
Roxithromycin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-ROXITHROMYCIN 150mg tablets contain 150mg of roxithromycin.
APX-ROXITHROMYCIN 300mg tablets contain 300mg of roxithromycin.
PHYSICAL AND CHEMICAL CHARACTERISTICS:
Roxithromycin is a white, crystalline powder. It is very slightly
soluble in water and freely soluble in
acetone, alcohol and methylene chloride.
EXCIPIENTS:
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APX-ROXITHROMYCIN 150mg tablets are white to off white round biconvex
film-coated tablet plain
on both sides.
APX-ROXITHROMYCIN 300mg tablets are white to off white round biconvex
film-coated tablet plain
on both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Adults.
Roxithromycin is indicated for the treatment of the following types of
mild to moderately severe
infections 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
exacerbations of chronic bronchitis;
community acquired pneumonia.
Skin and skin structure infections.
Non-gonococcal urethritis.
Children.
2
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
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
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 m