OPTREX INFECTED

Posology Adults:

One drop instilled into the infected eye every 2 hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only. The course of treatment is 5 days. Treatment should continue for 5 days even if symptoms improve.

If symptoms persist or worsen after 48 hours, or have not resolved within 5 days, consult a healthcare professional.

Paediatric Population:

Children aged 2 years and over: As above for adults. Children under 2 years: this product is not recommended for children under 2 years of age.

Elderly:

No dosage adjustments are required for elderly Method of administration: For ocular use.

Adverse events which have been associated with topical chloramphenicol are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class Frequency Adverse Events Blood and Lymphatic System Disorders Not known Bone marrow failure1, aplastic anaemia1,2 Immune System Disorders Not known Hypersensitivity3 Eye Disorders Not known Vision blurred, eye pain, eye swelling, eye irritation Skin and Subcutaneous Tissue Disorders Not known Rash vesicular, rash maculo- papular Description of Selected Adverse Reactions: 1 Bone marrow failure, 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.

2 This can include neutropenia and thrombocytopenia. 3 This can include rashes, fever, angioedema, urticaria and anaphylaxis. Treatment must be discontinued immediately in such cases. 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

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 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. 8). The label 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 • Do not use if you are allergic to chloramphenicol or any of the ingredients • Discard any remaining eye drops after the five day course of treatment For external use only.

Keep all medicines out of the sight and reach of children. Phenylmercuric nitrate may cause allergic reactions. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy. 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 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.

Chloramphenicol eye drops must not be administered to: • Patients who have a history of hypersensitivity to chloramphenicol or to any other ingredient of the drops. • Patients with pre-existing bone-marrow depression or patients who have experienced myelosuppression during previous exposure to chloramphenicol.

• Patients with a family history of blood dyscrasias.