CHLOROMYCETIN Eye drops, solution Ref.[50418] Active ingredients: Chloramphenicol

Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure. Bone marrow hypoplasia, including aplastic anaemia and death, has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of the compound. Where Chloromycetin Redidrops is used on a long-term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect any haemopoietic abnormalities.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. If any new infection appears during treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only in infections for which it is specifically indicated.

Chloromycetin Redidrops does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

Do not use for more than 5 days without consulting a doctor.

Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time.

Patients should be referred to their doctor if any of the following apply:

• Disturbed vision
• Severe pain within the eye
• Photophobia
• Eye inflammation associated with a rash on the scalp or face
• The eye looks cloudy
• The pupil looks unusual
• Suspected foreign body in the eye

Chloramphenicol should be used with caution in patients with a history of:

• Previous conjunctivitis in the recent past
• Glaucoma
• Dry eye syndrome
• Eye surgery or laser treatment in the last 6 months
• Eye injury
• Current use of other eye drops or eye ointment
• Contact lens use

If you wear contact lenses, seek advice either from your contact lens practitioner (optician, optometrist) or doctor before you use this product. You should not wear your contact lenses during the course of treatment. If you wear soft contact lenses do not start wearing them for at least 24 hours after you have finished using the eye drops.

The packaging will convey the following information:

• If symptoms do not improve within 48 hours talk to your doctor.
• Seek further immediate medical advice at any time if symptoms worsen.
• Do not use if you are allergic to chloramphenicol or any of the ingredients.

Phenylmercuric nitrate is irritating to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.

Paediatric population

This medicine contains boron which has been shown to impair fertility in animals. While the potential for effect on fertility in humans is not known, it should be prescribed with particular caution to a child younger than 2 years, as the exposure to boron may exceed the established safety limit when used in line with the maximum recommended posology in this age group.

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.

The safety of topical chloramphenicol in pregnancy and lactation has not been established.

Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.

Chloramphenicol has a minor influence on the ability to drive and use machines. Blurring of vision can occur with the drops and patients should be warned not to drive or operate machinery unless their vision is clear.

Adverse reactions reported in clinical trials and in the post-marketing period are included in the table below. The frequencies correspond with:

^* Causes for discontinuation

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie.

Not applicable.