GOLDEN

Adults (including the Elderly) and children The recommended dosage for adults and children is two drops to be applied to the affected eye every three hours. To be used during waking hours only. Treatment should be continued for at least 48 hours after eye appears normal.

Paediatric population Dosage adjustment may be necessary in new born infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days.

Method of Administration For ocular use only.

Eye disorders Transient irritation, burning, stinging and sensitivity reactions such as itching and dermatitis. Immune system disorders Hypersensitivity reactions including angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis.

Blood and lymphatic system disorders Bone marrow depression and rarely aplastic anaemia 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 this compound.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

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 chloramphenicol eye drops are 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 the 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. Chloramphenicol Eye Drops 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 Patients should also be referred to their doctor if any of the following in his/her medical history apply: • 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 Soft contact lenses should not be worn during treatment with chloramphenicol eye drops due to absorption of the preservative onto the lens which may cause damage to the lens.

•Should not be administered to patients hypersensitive to chloramphenicol or any of the ingredients of the drops. • Myelosuppression during previous exposure to chloramphenicol. • Known personal or family history of blood dyscrasias including aplastic anaemia.