Consumer medicine information

APX-Roxithromycin 300 mg Tablets

Roxithromycin

BRAND INFORMATION

Brand name

APX-Roxithromycin

Active ingredient

Roxithromycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APX-Roxithromycin 300 mg Tablets.

1. Why am I using APX-ROXITHROMYCIN?


APX-ROXITHROMYCIN contains the active ingredient roxithromycin. APX-ROXITHROMYCIN is used to treat infections in different parts of the body caused by bacteria. For more information, see Section 1. Why am I using APX-ROXITHROMYCIN? in the full CMI.

2. What should I know before I use APX-ROXITHROMYCIN?


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 APX-ROXITHROMYCIN? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with APX-ROXITHROMYCIN 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 APX-ROXITHROMYCIN?

  • 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 APX-ROXITHROMYCIN? in the full CMI.

5. What should I know while using APX-ROXITHROMYCIN?

Things you should do
  • Remind any doctor or dentist you visit that you are using APX-ROXITHROMYCIN.
  • 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 APX-ROXITHROMYCIN has been stopped.
  • If you get a sore, white mouth or tongue while taking, or soon after stopping APX-ROXITHROMYCIN, 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 APX-ROXITHROMYCIN.
Things you should not do
  • Do not take more than the recommended dose unless your doctor or pharmacist tells you to.
  • Do not give this medicine to anyone else, even if they have the same condition as you.
  • Do not use this medicine to treat any other complaints unless your doctor tells you to.
  • Do not stop taking your tablets because you are feeling better, unless advised by your doctor or pharmacist.
Driving or using machines
  • Make sure you know how APX-ROXITHROMYCIN affects you before driving or operating machinery.
Drinking alcohol
  • Tell your doctor if you drink alcohol
Looking after your medicine
  • Keep the medicine in a cool dry place where the temperature stays below 25°C.
  • Keep the tablets in the blister until it is time to take them

For more information, see Section 5. What should I know while using APX-ROXITHROMYCIN? in the full CMI.

6. Are there any side effects?


Common side effects include: rash; loss of appetite. Refer to the CMI for all side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

APX-Roxithromycin

Active ingredient

Roxithromycin

Schedule

S4

 

1 Name of Medicine

Roxithromycin.

2 Qualitative and Quantitative Composition

APX-Roxithromycin 150 mg tablets contain 150 mg of roxithromycin.
APX-Roxithromycin 300 mg tablets contain 300 mg 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 150 mg tablets are white to off white round biconvex film-coated tablet plain on both sides.
APX-Roxithromycin 300 mg tablets are white to off white round biconvex film-coated tablet plain on both sides.

4 Clinical Particulars

4.9 Overdose

In case of overdosage, symptomatic treatment should be provided as required. There is no specific antidote. For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Mutagenesis. Roxithromycin has shown no mutagenic potential in standard laboratory tests for gene mutation and chromosomal damage.
Carcinogenicity. Long term studies in animals have not been performed to evaluate the carcinogenic potential of roxithromycin.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical name for roxithromycin is (3R,4S,5S,6R,7R,9R,11S,12R,13S,14R)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-10-[(E)-[(2-methoxyethoxy)methoxy]imino]-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethyl amino)-β-d-xylo-hexopyranosyl]oxy]oxacyclotetradecan-2-one. The structural formula of roxithromycin is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSROXITH.gif C41H76N2O15. Molecular weight: 837.
CAS number. CAS No.: 80214-83-1.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APXROXST.gif