OCUFRESH INFECTED

Administration:

For topical ocular use only.

Adults, children aged 2 years and over, and elderly:

The recommended dose is to apply about 1 cm of ointment to the affected eye(s). If using chloramphenicol eye drops during the day, apply the ointment at night. If using the eye ointment alone, apply 3 to 4 times a day. Your doctor, pharmacist or nurse will advise on the most suitable treatment.

The course of treatment is 5 days; treatment should continue for 5 days even if symptoms improve.

Transient burning or stinging sensations may occur. Serious side effects include hypersensitivity reactions that may manifest as angioneurotic oedema, anaphylaxis, urticaria, fever, and vesicular and maculopapular dermatitis and are causes for immediate discontinuation.

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 infections 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 the treatment, the patient should be referred to the doctor. 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, pharmacist or nurse. The label will convey the following information: • If you do not get better within 48 hours, talk to your doctor • If your eye gets worse see your doctor straight away • Do not use this ointment if you are allergic to chloramphenicol or anything else in the ointment • After five days, throw away any eye ointment left, unless a longer course of treatment has been advised by your doctor, pharmacist or nurse • For Ocular use only.

Patients should be referred to a doctor if any of the following apply: • Disturbed vision • Any significant 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 If you wear contact lenses, seek advice either from your optometrist, contact lens practitioner 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 ointment.

3 Contra-indications Known hypersensitivity to chloramphenicol or to any of the excipients. Family or personal history of blood dyscrasias including myelosuppression and aplastic anaemia.