Consumer medicine information

1. Why am I using APO-NORFLOXACIN?

APO-NORFLOXACIN contains the active ingredient norfloxacin. APO-NORFLOXACIN is an antibiotic used to treat some bacterial infections, such as:

• urinary tract infections

• infections of the stomach or intestines, such as traveller's diarrhoea.

2. What should I know before I use APO-NORFLOXACIN?

Do not use if you have ever had an allergic reaction to APO-NORFLOXACIN 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 APO-NORFLOXACIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-NORFLOXACIN 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 APO-NORFLOXACIN?

• The usual dose for APO-NORFLOXACIN tablets is one tablet twice a day.

• Your doctor will determine the duration of time that you take the tablets depending on your condition and whether you are taking any other medicines.

5. What should I know while using APO-NORFLOXACIN?

6. Are there any side effects?

Less serious side effects may include rash, headache, dizziness, tiredness, nausea, vomiting, stomach pain, vaginal thrush. Serious side effects may include fainting, seizures, depression, diarrhoea, tendon pain, swelling or rupture, pain, burning, numbness or tingling in the fingers or toes, eyesight problems, changes in mood or thoughts, skin reactions, blistering or peeling, and yellowing of the skin or eyes. 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.

Boxed Warnings

Serious disabling and potentially irreversible adverse reactions. Fluoroquinolones, including norfloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system (see Section 4.4, Nervous system), musculoskeletal system (see Section 4.4, Effect on tendons) and psychiatric effects (see Section 4.4, Psychiatric adverse reactions).

1 Name of Medicine

Norfloxacin.

2 Qualitative and Quantitative Composition

APO-Norfloxacin tablets contain 400 mg of norfloxacin.
Norfloxacin, a fluoroquinolone, is a synthetic antibacterial agent for oral administration.
Excipients with known effect. Contains soya beans.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO-Norfloxacin tablets are white, film-coated, convex, oval shaped scored tablet, embossed with "N/F" on one side and ">" on the other.

4 Clinical Particulars

4.9 Overdose

The acute oral LD₅₀ values in male and female mice and male and female rats were greater than 4 g/kg.
In the event of acute overdosage, absorption may be decreased by giving active charcoal. The patient should be observed carefully and given symptomatic and supportive treatment. Adequate hydration must be maintained.
Contact the Poison Information Centre on 13 11 26 (Australia) for advice on the management of overdosage.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Norfloxacin was tested for mutagenic activity in a number of in vivo and in vitro tests. Norfloxacin had no mutagenic effect in the dominant lethal test in mice and did not cause chromosomal aberrations in hamsters or rats at 500 to 1,000 mg/kg/day. Norfloxacin had no mutagenic activity in vitro in the Ames microbial mutagen test and V-79 mammalian cell assay. Although norfloxacin was weakly positive in the Rec-assay for DNA repair, all other mutagenic assays were negative including a more sensitive test (V-79).
Carcinogenicity. Information is not available at present on the carcinogenic potential of norfloxacin.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Norfloxacin is a white to pale yellow crystalline powder. It is freely soluble in glacial acetic acid, and slightly soluble in ethanol, methanol and water. Melting point: approximately 221°C.
Norfloxacin, a fluoroquinolone, differs from quinolones by having a fluorine atom at the 6 position and a piperazine moiety at the 7 position. Examples of antibacterial drugs which are quinolones include nalidixic acid and cinoxacin.
Chemical name: 1-ethyl-6-fluoro-1,4-dihydro-4-oxo- 7-(1-piperazinyl)-3-quinoline carboxylic acid.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSNORFLO.gif Molecular formula: C₁₆H₁₈FN₃O₃.
Molecular weight: 319.34.
CAS number. 70458-96-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4: Prescription Only Medicine.

Summary Table of Changes

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