BIAXSIG roxithromycin 150mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin, Quantity: 150 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

2 tablets (sample), 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of mild to moderately severe infections in adults caused by or likely to be caused by susceptible micro-organisms in; Acute pharyngitis, tonsillitis, and sinusitis. Acute bronchitis and acute exacerbations of chronic bronchitis; Community acquired pneumonia (including atypical pneumonia). Skin and soft tissue infections and non-gonococcal urethritis

Product summary:

Visual Identification: A 9mm in diameter white, cylindrical and biconvex tablet debossed with number 164 on one side.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1994-06-03

Patient Information leaflet

BIAXSIG
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BIAXSIG?
Biaxsig contains the active ingredient roxithromycin. Biaxsig is used
to treat infections in different parts of the body caused by
bacteria. For more information, see Section 1. Why am I using Biaxsig?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BIAXSIG?
Do not use if you have ever had an allergic reaction to roxithromycin
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding. For more information, see Section 2. What should
I know before I use Biaxsig? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Biaxsig and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE BIAXSIG?
•
The recommended adult dosage is 300 mg per day
•
The recommended dosage for children more than 40 kg is one 150 mg
tablet twice daily.
More instructions can be found in Section 4. How do I use Biaxsig? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BIAXSIG?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Biaxsig.
•
If the symptoms of your infection do not improve within a few days, or
if they become worse, tell your
doctor.
•
If you get severe diarrhoea tell your doctor, pharmacist or nurse
immediately. Do this even if it occurs
several weeks after Biaxsig has been stopped.
•
If you get a sore, white mouth or tongue while taking, or soon after
stopping Biaxsig, tell your doctor or
pharmacist.
•
Tell your doctor or pharmacist if you get vaginal itching or
discharge.
•
If you are about to start taking any new medicine, tell your doctor
and pharmacist that you are taking
Biaxsig
T

Summary of Product characteristics

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Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION – BIAXSIG
®
(ROXITHROMYCIN)
1
NAME OF THE MEDICINE
Roxithromycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
300 mg and 150 mg tablets contain 300 mg and 150 mg of roxithromycin
per tablet
respectively.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Biaxsig 300 mg Tablets: white biconvex, cylindrical, 11 mm in
diameter, film-coated tablets.
Contains glucose (in film coating).
Biaxsig 150 mg Tablets: white biconvex, cylindrical, 9 mm in diameter,
film-coated tablets.
Contains glucose (in film coating).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Biaxsig 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 Infections: Acute pharyngitis, tonsillitis,
sinusitis
•
Lower Respiratory Tract Infections: Acute bronchitis and acute
exacerbations of
chronic bronchitis; community acquired pneumonia
•
Skin and skin structure infections
•
Non-gonococcal urethritis
CHILDREN
Biaxsig is 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
bia-ccdsv7-piv10-23sep20_ _
Page 2 of 13
•
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 Biaxsig may be
initiated before results of these tests are known; once results become
available, appropriate
therapy should be continued.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Biaxsig 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 for adults, the elderly and patients with
impaired renal function is
300 mg per day taken as either one 150 mg tablet twice daily, or as