BROLENE ANTIBIOTIC

For ocular use. The recommended dosage for adults (including the elderly) and children aged 2 years and over is one drop to be applied to the affected eye every two hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only.

Treatment should continue for 5 days, even if symptoms improve.

Eye disorders:

Chloramphenicol eye drops may cause transient stinging and irritation when applied to the eye.

Blood and lymphatic system disorder:

Bone marrow depression, including irreversible and fatal 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.

Immune system disorders:

Hypersensitivity reactions including angioedema. 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.

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Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. 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 If this product is used following advice from a contact lens practitioner or doctor, contact lenses should not be worn during the course of treatment.

Soft contact lenses should not be replaced for 24 hours after completing treatment. The labels will state: • If symptoms do not improve within 48 hours talk to your doctor. • Seek further immediate medical advice at any time if symptoms worsen.

• Discard any remaining eye drops after the five day course of treatment. • Do not use if you are allergic to chloramphenicol or any of the other ingredients.

Chloramphenicol eye drops should not be administered to patients hypersensitive to chloramphenicol or any other ingredients in the formulation, or given to those with a known personal or family history of blood dyscrasias including aplastic anaemia.