Consumer medicine information

Pharmacor Linezolid 600 mg Tablets

Linezolid

BRAND INFORMATION

Brand name

Pharmacor Linezolid

Active ingredient

Linezolid

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pharmacor Linezolid 600 mg Tablets.

1. Why am I using PHARMACOR LINEZOLID?


PHARMACOR LINEZOLID contains the active ingredient linezolid. It is used in the treatment of bacterial infections such as pneumonia, skin infections or blood infections. For more information, see Section 1. Why am I using PHARMACOR LINEZOLID? in the full CMI.

2. What should I know before I use PHARMACOR LINEZOLID?


Do not use if you or your child have ever had an allergic reaction to PHARMACOR LINEZOLID 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 PHARMACOR LINEZOLID? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with PHARMACOR LINEZOLID 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 PHARMACOR LINEZOLID?


Your doctor will give you instruction on how to take PHARMACOR LINEZOLID.
More instructions can be found in Section 4. How do I use PHARMACOR LINEZOLID? in the full CMI.

5. What should I know while using PHARMACOR LINEZOLID?

Things you should do
  • Tell your doctor if the symptoms of the infection do not improve within a few days, or if they become worse; you or your child have severe diarrhoea, a sore white mouth or tongue; you have vaginal itching or discharge; or if you are pregnant, or plan to become pregnant.
  • Tell any other doctor or dentist you visit that you or your child are using PHARMACOR LINEZOLID.
  • For more information on Things you should do can be found in Section 5 in the full CMI.
Things you should not do
  • Do not stop using this medicine or lower the dosage without checking with your doctor.
  • Do not use PHARMACOR LINEZOLID to treat any other medical complaints unless your doctor tells you to.
  • Do not start taking any other medicines without first telling your doctor or pharmacist.
Driving or using machines
  • Be careful driving or operating machinery until you know how PHARMACOR LINEZOLID affects you.
  • This medicine may cause dizziness and visual impairment in some people. Children should be careful performing activities requiring attention such as riding bicycles or climbing.
Drinking alcohol
  • Avoid drinking alcohol, especially draught beers and wine.
Looking after your medicine
  • Store PHARMACOR LINEZOLID in a cool dry place where the temperature stays below 25°C.
  • Do not store PHARMACOR LINEZOLID or any other medicines in a bathroom or near a sink.
  • Do not leave it in the car or on window sills.
  • Keep PHARMACOR LINEZOLID and all other medicines where children cannot reach them.

For more information, see Section 5. What should I know while using PHARMACOR LINEZOLID? in the full CMI.

6. Are there any side effects?


Side effects of this medicine may include headache; sore white mouth or tongue; vaginal itching or discharge; abdominal pain or bloating; nausea; vomiting; metallic taste; change in colour of tongue or teeth; difficulty concentrating; memory or visual impairment; confusion; tiredness; dizziness; rash, itching or hives or blisters on skin; numbness or weakness of arms or legs; shortness of breath; sweating; seizure; fainting; coma; swelling of face or lips; bleeding in lips, eyes, mouth, nose and genitals; painful red/purple spots with/without blisters and peeling of skin, may be accompanied by fevers, chills, aching muscles, dehydration, dark urine, reduced urine, no urine, joint pain, enlarged lymph nodes and generally feeling unwell. 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

Pharmacor Linezolid

Active ingredient

Linezolid

Schedule

S4

 

1 Name of Medicine

Linezolid.

2 Qualitative and Quantitative Composition

Each tablet contains 600 mg of linezolid.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Film coated tablets.
Pharmacor Linezolid 600 mg tablets. Linezolid 600 mg Film-coated tablets are white to off white capsule shape film coated tablet debossed with "LIN 600" on one side, plain on other side.

4 Clinical Particulars

4.9 Overdose

No specific antidote is known.
No cases of overdose have been reported. However, the following information may prove useful:
Supportive care is advised together with maintenance of glomerular filtration. Approximately 30% of a linezolid dose is removed during 3 hours of haemodialysis, but no data are available for the removal of linezolid by peritoneal dialysis or haemoperfusion. The two primary metabolites of linezolid are also removed to some extent by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. There was no evidence of genotoxicity in tests for gene mutations (bacteria and Chinese hamster ovary cells), chromosomal changes (human lymphocytes in vitro and mouse micronucleus assay in vivo) and DNA damage (unscheduled DNA synthesis in vitro).
Carcinogenicity. Lifetime studies in animals have not been conducted to evaluate the carcinogenic potential of linezolid.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Pharmacor Linezolid tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class with a. Linezolid is biologically active and is metabolised to form inactive derivatives. The aqueous solubility of linezolid is approximately 3 mg/mL, independent of pH between pH 3 to 9.
Chemical structure. The empirical formula of linezolid is C16H20FN3O4 and its chemical structure is represented below:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLINEZO.gif Chemical name. (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl) phenyl]-2-oxo-5-oxazolidinyl] methyl] acetamide.
CAS number. CAS-165800-03-3.
Molecular weight. 337.35.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription only medicine).

Summary Table of Changes

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