CHLORAMPHENICOL

Posology Adults (including the elderly) and children aged 2 years and over: • Put one drop into the affected eye(s) every 2 hours for the first 48 hours and 4 hourly thereafter. • To be used during waking hours only • The course of treatment should be 5 days.

Method of administration For ocular use.

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.

Treatment must be discontinued immediately in such cases. Blood and lymphatic system disorders Bone marrow depression, including the idiosyncratic type of irreversible and fatal aplastic anaemia that is recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.

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.

8). In severe bacterial conjunctivitis and in cases where infection is not confined to the conjunctivae, the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. Therefore, the patient should be referred to seek medical advice.

The use of topical chloramphenicol may occasionally result in overgrowth of non-susceptible organisms including fungi. If any new infection appears during treatment, the patient should be referred to the doctor. Prolonged use of chloramphenicol eye drops is not advisable.

Prolonged or frequent intermittent topical application of chloramphenicol should be avoided since it may increase the likelihood of sensitisation and emergence of resistant organisms. Do not use for more than 5 days without consulting your doctor.

The label will state: • Seek further immediate medical advice any time if symptoms worsen. • Consult your doctor if your eye infection does not start to improve within 48 hours. • Discard the medicine after a 5 day course of treatment.

• Do not use if you are allergic to chloramphenicol or any of the ingredients. • For external use/use in the eye only • Keep all medicines out of the sight and reach of children. Patients should be referred to a 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 patient has glaucoma • 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 If this product is used following advice from a contact lens practitioner or doctor, contact lenses should not be worn during the period of treatment Soft contact lens wearers should wait 24 hours after completing a course of treatment before starting to use their lenses again.

1. • Myelosuppression during previous exposure to chloramphenicol. • Family or personal history of blood dyscrasias including aplastic anaemia.