Consumer medicine information

1. Why am I using CIPROFLOXACIN-WGR?

CIPROFLOXACIN-WGR contains the active ingredient ciprofloxacin (as hydrochloride). CIPROFLOXACIN-WGR is used to treat certain infections of the lungs, skin, bones and joints, kidney and bladder, prostate and bowel.
For more information, see Section 1. Why am I using CIPROFLOXACIN-WGR? in the full CMI.

2. What should I know before I use CIPROFLOXACIN-WGR?

Do not take if you have ever had an allergic reaction to ciprofloxacin, other quinolone antibiotics including nalidixic acid, moxifloxacin, 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 CIPROFLOXACIN-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CIPROFLOXACIN-WGR 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 CIPROFLOXACIN-WGR?

Your doctor will tell you how much and how often you should take CIPROFLOXACIN-WGR. This will depend on the type of infection and any medical conditions you have. More instructions can be found in Section 4. How do I use CIPROFLOXACIN-WGR? in the full CMI.

5. What should I know while using CIPROFLOXACIN-WGR?

6. Are there any side effects?

Less serious side effects: nausea or vomiting, diarrhoea. Serious side effects: severe skin rashes, peeling of the skin, yellowing of the skin and eyes also called jaundice, severe watery or bloody diarrhoea, nightmares, hallucinations and psychotic reaction, fast or irregular heartbeats, visual disturbances, abdominal pain/cramps, pain, burning, tingling, numbness and/or weakness in your limbs. This is not a complete list of all possible 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.

Boxed Warnings

Serious disabling and potentially irreversible adverse reactions. Fluoroquinolones, including ciprofloxacin, 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, Effects on the CNS), musculoskeletal system (see Section 4.4, Effects on tendons) and psychiatric effects (see Section 4.4, Psychiatric reactions).

1 Name of Medicine

Ciprofloxacin hydrochloride.

2 Qualitative and Quantitative Composition

Ciprofloxacin-WGR tablets come in three strengths and contain 250 mg, 500 mg or 750 mg of ciprofloxacin (as the hydrochloride).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ciprofloxacin-WGR 250. Tablets, 250 mg (white to off white, round, convex, scored film-coated tablet, debossed CR/250 on one face and plain on the other side).
Ciprofloxacin-WGR 500. Tablets, 500 mg (white to off white, oblong, biconvex, scored film-coated tablet, debossed CR/500 on one face and plain on the other side).
Ciprofloxacin-WGR 750. Tablets, 750 mg (white to off white, oblong, biconvex, unscored film-coated tablet, debossed CR 750 on one face and plain on the other side).

4 Clinical Particulars

4.9 Overdose

Information on overdosage in humans is not available. In the event of serious toxic reactions from overdosage, haemodialysis or peritoneal dialysis may aid in the removal of ciprofloxacin from the body, particularly if renal function is compromised.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ciprofloxacin was mutagenic in the mouse lymphoma assay and the rat primary hepatocyte culture/DNA repair assay in vitro, but not in other mammalian systems in vitro or in microbial systems.
In a small study on the chromosomal effects of ciprofloxacin on white blood cells, the drug did not exhibit any cytogenetic effect.
Carcinogenicity. Carcinogenicity studies in mice (oral doses up to 1090 mg/kg/day and 1455 mg/kg/day in males and females, respectively) and rats (241 mg/kg/day and 328 mg/kg/day in males and females, respectively) showed no evidence of carcinogenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ciprofloxacin hydrochloride is a synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity.
Ciprofloxacin hydrochloride is a faintly yellowish to yellow crystalline substance that is sparingly soluble to soluble in water.
Chemical structure. It is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCIPHYD.gif C₁₇H₁₈FN₃O₃.HCl.H₂O. Molecular weight: 385.8.
CAS number. 86393-32-0.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

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