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

Administration route:

Oral

Units in package:

10, 2 tablets (sample)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ADULTS: 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 CHILDREN: 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.

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:

1992-06-18

Patient Information leaflet

RULIDE
® TABLETS
R
u
l
i
d
e
®
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 RULIDE?
Rulide contains the active ingredient roxithromycin. Rulide is used to
treat infections in different parts of the body caused by
bacteria. For more information, see Section 1. Why am I using Rulide?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RULIDE?
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 Rulide? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rulide 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 RULIDE?
•
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 Rulide? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RULIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Rulide.
•
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 Rulide has been stopped.
•
If you get a sore, white mouth or tongue while taking, or soon after
stopping Rulide, 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
Rulide
THINGS YOU
SHOULD

Summary of Product characteristics

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Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – RULIDE
® & RULIDE
® D
(ROXITHROMYCIN)
1
NAME OF THE MEDICINE
Roxithromycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rulide 300 mg and 150 mg tablets contain 300 mg and 150 mg of
roxithromycin per tablet
respectively.
Rulide D tablets contain 50 mg of roxithromycin per tablet.
Tablets also contain saccharin sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Rulide 300mg Tablets: white, biconvex, cylindrical, 11mm diameter,
film-coated tablets, debossed
on one side with 164J.
Rulide 150mg Tablets: white, biconvex, cylindrical, 9 mm diameter,
film-coated tablets, debossed on
one side with 164.
Rulide D 50mg Tablets for Suspension: practically white, scored,
cylindrical tablets, 8mm in
diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Rulide 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
rul-rul-d-ccdsv7-piv9-23sep20
Page 2 of 14
CHILDREN
Rulide D 50mg tablets and Rulide 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 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
before results of these tests are known; once results become
available, appropriate therapy should be
continued.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Rulide should be taken a