Core Safety Profile. Pharmaceutical form(s)/strength: Eye drops, solution 3 mg/ml Ear drops, solution 3 mg/ml Eye ointment 3 mg/g

Transcription

1 Core Safety Profile Active substance: Ciprofloxacin Pharmaceutical form(s)/strength: Eye drops, solution 3 mg/ml Ear drops, solution 3 mg/ml Eye ointment 3 mg/g P - RMS: NO/H/PSUR/0010/001 Date of FAR:

2 4.3. Contraindications Hypersensitivity to the active substance or to any of the excipients 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 /.../ 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 /.../ 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.* When using /.../ 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 /.../ 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.* 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, 2/5

3 4.5. Interaction with other Medicinal Products and Other Forms of Interaction No interaction studies have been performed Fertility, Pregnancy and Lactation Pregnancy There are no adequate data from the use of /.../ in pregnant women. Animal studies do not indicate indirect 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 /.../ 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 /.../ is administered to a nursing woman Effects on Ability to Drive and Use Machines 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. There are no known effects of ciprofloxacin ear drops on the ability to drive and use machines Undesirable Effects The following adverse reactions have been observed with the use of topical ophthalmic ciprofloxacin. Frequency cannot be estimated from available data. System Organ Classification MedDRA Term (v. 13.0) Nervous system disorders dysgeusia Eye disorders eye pruritus 3/5

4 Eye Drops: 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.* exfoliative, Stevens-Johnson syndrome and urticaria occur very rarely.* In patients with corneal ulcer and frequent administration of /.../, white topical ocular precipitates (medication residue) have been observed which resolved after continued application of /.../. The precipitate does not preclude the continued use of /.../, nor does it adversely affect the clinical course of the recovery process. 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 /.../ 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.* Safety and effectiveness of /.../ 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.* Safety and efficacy of /.../ 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.* 4/5

5 4.9. Overdose In case of ocular overdose, ciprofloxacin eye drops/eye ointment can be rinsed from the eye with lukewarm tap water. 5/5