Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

General:
• For ocular or otic use only. Do not inject or swallow.
• Serious and occasionally fatal (anaphylactic) hypersensitivity reactions, some following the first dose, have been observed in patients receiving treatment based on systemically administered CIL API OCT21 V3                                           Belgium update Oct 2020 quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema, dyspnoea, urticaria and itching. Only a few patients had a history of hypersensitivity reactions.

• Serious acute hypersensitivity reactions to ciprofloxacin may require immediate emergency treatment.
Oxygen administration and airway clearance should be undertaken if clinically required.
• Ciprofloxacin should be discontinued at the first appearance of skin rash or any other sign of a hypersensitivity reaction.
• As with all antibacterial preparations, prolonged use may lead to proliferation of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate treatment should be initiated.
• Tendon inflammation and rupture may occur during systemic treatment with fluoroquinolones, including ciprofloxacin, especially in elderly patients and those treated concurrently with corticosteroids. Therefore, treatment with CILOXAN eye and ear drops should be discontinued at the first sign of tendon inflammation (see section 4.8 Undesirable effects).

Ocular use:
• Clinical experience is very limited in children under 1 year old, particularly neonates.
• The use of CILOXAN eye drops in neonates with ophthalmia neonatorum caused by gonococci or chlamydia 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, the risk of rhinopharyngeal passage, which may contribute to the development and spread of bacterial resistance, should be taken into account.
• The patient should be examined with a slit lamp whenever this is indicated by the clinical evaluation.
• A white topical ocular precipitate (medication residue) was observed in corneal ulcer patients who frequently used CILOXAN eye drops. This resolved after further administration of CILOXAN eye drops. This precipitate does not preclude continued use of CILOXAN, nor does it adversely effect the further course of the recovery process.
• The wearing of contact lenses is not recommended during treatment of an eye infection. Patients should therefore be advised not to wear contact lenses during treatment with CILOXAN eye drops.
• This medicine contains 0.3 mg of benzalkonium chloride in each 5 ml, equivalent to 0.06 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the lenses. In case patients are allowed to wear contact lenses, they should be instructed to remove them before applying CILOXAN eye drops and to wait at least 15 minutes before reinserting them.
Benzalkonium chloride can also cause eye irritation, particularly if the patient has dry eyes or a corneal disorder.
• If CILOXAN is used in the eye, the following measures are useful for reducing systemic absorption after application of the eye drops:
– Keep the eyelid closed for 2 minutes.
– Press on the tear duct with a finger for 2 minutes.

Otic use:
• Efficacy and safety in children under 1 year old have not been established. The safety and efficacy of this product in children aged 1 year and above have been established in controlled clinical trials.
Although very limited data are available in children under 1 year old treated for acute otitis externa, there are no differences in the disease process in this patient population that would preclude the use of this product in patients under 1 year old. Based on these very limited data, the treating physician should weigh the clinical benefits of use against the known and possibly unknown risks when prescribing the product for children under 1 year old.
• Careful and frequent medical surveillance is required during otic use in order to identify a possible need for other therapeutic measures in timely fashion.
CIL API OCT21 V3                                         Belgium update Oct 2020 • CILOXAN ear drops contain benzalkonium chloride, which may be irritant and cause skin reactions.

Effects on Driving

4.7 Effects on ability to drive and use machines

CILOXAN has no or negligible influence on the ability to drive and use machines.
As with all eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs following application, the patient must wait until the vision clears before driving or operating machinery.

There are no known effects of CILOXAN ear drops on the ability to drive and use machines.