Annex I : Final CSP with correction in 4.6, dated 22 February 2012
Proposed Core Safety Profile for
[Ciprofloxacin 3 mg/ml Eye Drops / Ear Drops
& Ciprofloxacin 3 mg/g Eye Ointment]
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4. Special Warnings and Precautions for Use
General:
 Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the
first dose, have been observed in patients receiving systemic quinolone therapy. Some
reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling,
pharyngeal or facial oedema, dyspnea, urticaria, and itching.
Only a few patients had a history of hypersensitivity reactions.*
 Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of
hypersensitivity reaction.
 As with all antibacterial preparation prolonged use may lead to overgrowth of nonsusceptible
bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.
Eye Drops:
 The clinical experience in children less than one year old, particularly in neonates is very
limited.*
 The use of CILOXAN eye drops in neonates with ophthalmia neonatorum of gonococcal or
chlamydial origin is not recommended as it has not been evaluated in such patients. Neonates
with ophthalmia neonatorum should receive appropriate treatment for their condition.*
 When using CILOXAN eye drops/eye ointment one should take into account the risk of a
rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial
resistance.*
Eye Ointment:
 When using CILOXAN eye drops/eye ointment one should take into account the risk of a
rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial
resistance.*
 There is no experience in children less than 1 year old.*
 The use of CILOXAN eye ointment in neonates with ophthalmia neonatorum is not
recommended as it has not been evaluated in such patients. Neonates with ophthalmia
neonatorum should receive appropriate treatment for their condition.*
Ear Drops:
 In otic use meticulous medical monitoring is required in order to be able to determine in a
timely manner the possible necessity of other therapeutic measures.*
 The safety and efficacy of this product have been established in paediatric patients 1 year and
older in controlled clinical trials. Although very limited data are available in patients less than
age 1 year treated for acute otitis externa, there are no differences in the disease process
itself, in this patient population, which would preclude use of this product in patients less than
one year of age. Based upon the very limited data, the prescribing physician should weigh the
clinical benefits of use against the known and possibly unknown risks when prescribing in
patients less than age 1 year.*
4.5. Interaction with other Medicinal Products and Other Forms of
Interaction
No interaction studies have been performed.
4.6. Fertility, Pregnancy and Lactation
Pregnancy
There are no adequate data from the use of CILOXAN in pregnant women. Animal studies do not
indicate direct harmful effects with respect to reproductive toxicity. Systemic exposure to ciprofloxacin
after topical use is expected to be low. As a precautionary measure, it is preferable to avoid the use of
CILOXAN during pregnancy, unless the therapeutic benefit is expected to outweigh the potential risk
to the fetus. .
Lactation
Oral ciprofloxacin had been traced in human breast milk. It is unknown whether ciprofloxacin is
excreted in human breast milk following topical ocular or otic administration. Caution should therefore
be exercised when CILOXAN is administered to a nursing woman.
4.7. Effects on Ability to Drive and Use Machines
Eye Drops/Eye Ointment:
Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines.
If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before
driving or using machinery.
Ear Drops:
There are no known effects of ciprofloxacin ear drops on the ability to drive and use machines.
4.8. Undesirable Effects
Eye Drops/Eye Ointment:
The following adverse reactions have been observed with the use of topical ophthalmic ciprofloxacin.
Frequency cannot be estimated from available data.
System Organ Classification
Nervous system disorders
Eye disorders
MedDRA Term (v. 13.0)
dysgeusia
eye pruritus
Eye Drops:
With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis exfoliative,
Stevens-Johnson syndrome and urticaria occur very rarely.
In isolated cases blurred vision, decreased visual acuity, and medication residue have been observed
with ophthalmic ciprofloxacin.*
Eye Ointment:
With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis exfoliative,
Stevens-Johnson syndrome and urticaria occur very rarely.*
In patients with corneal ulcer and frequent administration of CILOXAN, white topical ocular precipitates
(medication residue) have been observed which resolved after continued application of CILOXAN.
The precipitate does not preclude the continued use of CILOXAN, nor does it adversely affect the
clinical course of the recovery process.
Ear Drops:
With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis exfoliative,
Stevens-Johnson syndrome and urticaria occur very rarely.
In otic use the ingredients rarely are sensitizing. However as with any substance that is applied to the
skin, an allergic reaction to any of the ingredients of the preparation can always occur.
General:
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose,
have been reported in patients receiving systemic quinolone therapy. Some reactions were
accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial
oedema, dyspnoea, urticaria, and itching.
Paediatric population
Eye Drops:
Safety and effectiveness of CILOXAN 3 mg/ml eye drops were determined in 230 children between
the ages of 0 and 12 years of age. No serious adverse drug reaction was reported in this group of
patients.*
Eye Ointment:
Safety and effectiveness of CILOXAN 3 mg/g eye ointment were determined in 103 children between
the ages of one and 12 years of age. No serious adverse drug reaction was reported in these
patients.*
Ear Drops:
Safety and efficacy of CILOXAN 3 mg/ml ear drops was determined in 193 children between the ages
of one and 12 years of age. No serious adverse drug reaction was reported in this group of patients.*
4.9. Overdose
Eye Drops/Eye Ointment:
In case of ocular overdose, ciprofloxacin eye drops/eye ointment can be rinsed from the eye with
lukewarm tap water.