Consumer medicine information

1. Why am I using CEQUA?

CEQUA contains the active ingredient ciclosporin. CEQUA is used to CEQUA is used to treat a condition known as 'keratoconjunctivitis sicca' which is also known as 'dry eye'.
For more information, see Section 1. Why am I using CEQUA? in the full CMI.

2. What should I know before I use CEQUA?

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

3. What if I am taking other medicines?

Some medicines may interfere with CEQUA 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 CEQUA?

One drop of CEQUA twice daily (about 12 hours apart) into each eye. You can use other artificial tears eye drops but you should wait at least 15 minutes after applying CEQUA.
More instructions can be found in Section 4. How do I use CEQUA? in the full CMI.

5. What should I know while using CEQUA?

6. Are there any side effects?

Common side effects include pain, stinging or itchiness in your eye that persists after you add the drops to your eyes; persistent red or bloodshot eyes. Serious side effects include light sensitivity and/or blurred vision; Urinary Tract Infection: a change in the amount of urine passed or in the number of times you urinate, pain or a burning sensation when urinating, bloody, smelly or cloudy urine, pain in the pelvis.
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.

1 Name of Medicine

Ciclosporin.

2 Qualitative and Quantitative Composition

Cequa contains ciclosporin 900 microgram/mL as the active ingredient. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops.
Cequa is a sterile, clear, colourless solution, practically free from visible particulates.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ciclosporin was not genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. An in vitro sister chromatid exchange (SCE) assay using human lymphocytes gave indications of a positive effect for ciclosporin at high concentrations.
Carcinogenicity. Systemic carcinogenicity studies were carried out in mice and rats. A 78-week mouse study, at oral doses of 1, 4, and 16 mg/kg/day, revealed a trend for increased incidences of lymphomas at the highest dose studied. In another study with ARK mice treated with ciclosporin at 150 mg/kg in the diet, ciclosporin accelerated the development of lymphomas.
In a 24-month rat study, conducted at oral doses of 0.5, 2, and 8 mg/kg/day, no significant increase in tumour incidence was observed. Adjusted for body surface area, the highest doses without tumourigenic effect in the mouse and rat are approximately 210 and 830 times higher than the maximum recommended ophthalmic dose of ciclosporin provided by Cequa therapy.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ciclosporin is a white powder that is insoluble in water and freely soluble in ethanol.
Chemical structure. Mol. Formula: C₆₂H₁₁₁N₁₁O₁₂.
Mol. Wt.: 1202.6.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCICLOS.gif CAS number. 59865-13-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

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