Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
roxithromycin, Quantity: 50 mg
Sanofi-Aventis Australia Pty Ltd
Roxithromycin
Tablet, dispersible
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
Oral
10 tablets, 4 tablets, 20 tablets, 2 tablets
(S4) Prescription Only Medicine
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.
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
Licence status A
1996-05-30
RULIDE ® D TABLETS R u l i d e ® 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 Прочетете целия документ
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 Прочетете целия документ