Consumer medicine information

Metronidazole Noridem 500 mg/100 mL Solution for infusion

Metronidazole

BRAND INFORMATION

Brand name

Metronidazole Noridem

Active ingredient

Metronidazole

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Metronidazole Noridem 500 mg/100 mL Solution for infusion.

1. Why am I being given METRONIDAZOLE NORIDEM?


METRONIDAZOLE NORIDEM contains the active ingredient metronidazole. METRONIDAZOLE NORIDEM is used to treat serious infections caused by bacteria and other organisms and prevent certain infections that may occur during surgery.
For more information, see Section 1. Why am I being given METRONIDAZOLE NORIDEM? in the full CMI.

2. What should I know before I am given METRONIDAZOLE NORIDEM?


Do not use if you have ever had an allergic reaction to METRONIDAZOLE or any of the ingredients listed at the end of the CMI, or have Cockayne syndrome.
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 am given METRONIDAZOLE NORIDEM? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with METRONIDAZOLE NORIDEM 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 is METRONIDAZOLE NORIDEM given?


METRONIDAZOLE NORIDEM is given as injection into a vein. METRONIDAZOLE NORIDEM should only be given by a doctor or nurse.
More instructions can be found in Section 4. How is METRONIDAZOLE NORIDEM given? in the full CMI.

5. What should I know while being given METRONIDAZOLE NORIDEM?

Things you should doTell any doctor, dentist or pharmacist you visit that you are being given METRONIDAZOLE NORIDEM, especially if the following apply:-
  • If you become pregnant while you are being treated with METRONIDAZOLE NORIDEM.
  • If the symptoms of your infection do not improve or if they become worse.
  • If you get severe diarrhoea. Do this even if it occurs several weeks after METRONIDAZOLE NORIDEM has been stopped.
  • If you get a sore white mouth or tongue while using or soon after stopping METRONIDAZOLE NORIDEM.
  • If you get vaginal itching or discharge.
  • If you are using METRONIDAZOLE NORIDEM for 10 days or longer, make sure you have any tests of your blood and nervous system that your doctor may request.
  • If you need to have any blood tests.
Driving or using machines
  • METRONIDAZOLE NORIDEM may cause dizziness, confusion, hallucination (hearing or seeing strange or unusual things), convulsions (“fits”) or affect how you see things. If affected to do drive or operate machinery.
Drinking alcohol
  • Do not drink any alcohol or any alcoholic drinks while being treated with METRONIDAZOLE NORIDEM and for at least three days after stopping METRONIDAZOLE NORIDEM.
Looking after your medicine
  • METRONIDAZOLE NORIDEM will usually be stored in the pharmacy or on the ward. The infusion is kept in a cool dry place, protected from light, where the temperature stays below 30°C.

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

6. Are there any side effects?


Some common side affects you might experience include nausea, vomiting, abdominal cramps, joint pains, oral or vaginal thrush, constipation or diarrhoea. More serious side effects may include hypersensitivity reactions which may include rash, swelling of face, lips or mouth. Other effects that may occur are watery or severe diarrhoea which may also be bloody; signs of frequent infections with fever, severe chills, sore throat or mouth ulcers; severe blisters and bleeding in the lips, eye, mouth, nose or genitals; tingling or numbness of hands or feet, pins and needles or muscle weakness.
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

Metronidazole Noridem

Active ingredient

Metronidazole

Schedule

S4

 

1 Name of Medicine

Metronidazole.

2 Qualitative and Quantitative Composition

Metronidazole Noridem Intravenous Infusion contains metronidazole 5 mg/mL.
Metronidazole Noridem Intravenous Infusion is a sterile, isotonic, preservative-free, ready to use solution. Each mL contains 0.135 mmoles sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Intravenous infusion. Clear, almost colourless to pale yellow sterile, isotonic solution.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. Overdosage with metronidazole appears to be associated with very few abnormal signs or symptoms. Disorientation, ataxia and vomiting may occur, especially after ingestion of large amounts. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
Recommended treatment. There is no specific antidote for metronidazole overdosage. In cases of suspected overdosage, a symptomatic and supportive treatment should be instituted.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. See Section 4.4 Special Warnings and Precautions for Use, Carcinogenicity/mutagenicity.
Carcinogenicity. See Section 4.4 Special Warnings and Precautions for Use, Carcinogenicity/mutagenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETRON.gif Chemical name: 2-(5-nitro-2-methylimidazol-1-yl) ethanol.
Molecular Formula: C6H9N3O3.
Molecular Weight: 171.2.
CAS number. 443-48-1.

7 Medicine Schedule (Poisons Standard)

Prescription-only medicine (S4).

Summary Table of Changes

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