RULIDE D roxithromycin 50mg tablet for suspension blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

roxithromycin, Quantity: 50 mg

זמין מ:

Sanofi-Aventis Australia Pty Ltd

INN (שם בינלאומי):

Roxithromycin

טופס פרצבטיות:

Tablet, dispersible

הרכב:

Excipient Ingredients: sodium lauryl sulfate; purified talc; fumaric acid; crospovidone; microcrystalline cellulose; methacrylic acid copolymer; colloidal anhydrous silica; triethyl citrate; macrogol 6000; saccharin sodium; sodium hydroxide; magnesium stearate; Flavour

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

10 tablets, 4 tablets, 20 tablets, 2 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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 tonsilitis and impetigo. Appropriate culture and sensitivity tests should be performed when necessary to determine an organism's susceptibility and thus treatment suitability. Therapy may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

leaflet_short:

Visual Identification: Practically white cylindrical tablets, 8mm in diameter with a breakline (score); Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

1996-05-30

עלון מידע

RULIDE
® D TABLETS
R
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i
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®
D
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 D?
Rulide D contains the active ingredient roxithromycin. Rulide D is
mainly used to treat respiratory tract infections, and skin and soft
tissue infections. For more information, see Section 1. Why am I using
Rulide D? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RULIDE D?
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 D? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rulide D 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 D?
•
For children weighing less than 40 kg, the dosage can range from one
half a tablet, one tablet or two tablets twice a day.
•
Your doctor will tell you the correct number of tablets to give your
child
More instructions can be found in Section 4. How do I use Rulide D? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RULIDE D?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that your child is taking
Rulide D.
•
If symptoms of your child's infection do not improve with a few days,
or if they become worse, tell your
doctor.
•
If your child is about to start taking any new medicine, tell your
doctor or pharmacist that they are taking
Rulide D
THINGS YOU
SHOULD NOT DO
•
Rulide D has been prescribed for your child. Do not give to anyone
else, even if they have the same
condition as your child.
•
Do not use Rulide D to treat any other complaints unless your doctor
tells you to
LOOKING AF

מאפייני מוצר

rul-rul-d-ccdsv7-piv9-23sep20
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