Chloramphenicol Eye Drops 0.5% (5 mg/mL) 0.4 mL

● Treatment of acute bacterial conjunctivitis in adults and children aged 2 years and over (OTC reference) [1] ● As a topical antibacterial for superficial ocular infections in adults and children (single-dose reference) [2]

● For ocular use only; instil into the conjunctival sac of the affected eye [1][2] ● Wash hands before and after use; do not touch the dropper with your fingers, ensure the nozzle does not touch the eye or skin, and replace the cap immediately after use [3] ● Single-dose units are for single use; discard after each application [2] ● Do not wear contact lenses during treatment; soft lens wearers should wait 24 hours after the last dose before reinserting their lenses [1][2][3] ● Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for about a minute during and after instillation — especially advisable in children [2][3]

The table below refers to registered chloramphenicol 0.5% eye-drop products; for the single-dose presentation, instil per the approved label [1][2]. ● Use the drops for 5 days even if the eye seems better; do not use for longer than 5 days unless told to do so [3] ● Speak to a pharmacist or doctor if there is no improvement after 2 days of use, or if symptoms get worse at any time [3]

● Contraindicated in hypersensitivity to chloramphenicol or any component, in myelosuppression during previous exposure, and in a family or personal history of blood dyscrasias including aplastic anaemia [1] ● Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported [1] ● Aplastic anaemia has, rarely, followed topical use of chloramphenicol eye drops — bear this uncommon hazard in mind when assessing the benefits; pale skin, weakness, increased heart rate, shortness of breath, headache, pain, fever, infection or bruises may be signs of a severe blood disorder [1][2] ● In severe bacterial conjunctivitis, or where the infection is not confined to the conjunctivae, topical use should be supplemented by appropriate systemic treatment and the patient referred for medical advice [1][2] ● Prolonged or frequent intermittent use should be avoided as it may increase sensitisation and the emergence of resistant organisms; do not use for more than 5 days without consulting a doctor (OTC reference); maximum 10–14 days (single-dose reference) [1][2][3] ● Overgrowth of non-susceptible organisms, including fungi, may occasionally occur; refer to a doctor if any new infection appears during treatment [1] ● Seek immediate medical advice if symptoms worsen at any time, and consult a doctor if the eye infection does not start to improve within 48 hours [1] ● Referral criteria include disturbed vision, severe pain within the eye, photophobia, eye inflammation with a rash on the scalp or face, glaucoma, a cloudy eye, an unusual pupil or a suspected foreign body; also refer patients with recent conjunctivitis, glaucoma, dry eye syndrome, eye surgery or laser treatment within the last 6 months, eye injury, current use of other eye drops or ointment, or contact lens use [1] ● Concomitant use with other drugs liable to depress bone marrow function should be avoided [1] ● Pregnancy: safety has not been established and the OTC product is not recommended during pregnancy; breast-feeding: avoid use as chloramphenicol may appear in breast milk [1]; the single-dose reference: use in pregnancy and lactation only when considered essential by the physician [2] ● Driving: transient blurring of vision may occur; do not drive or operate hazardous machinery unless vision is clear [1][2] ● Adverse reactions: local — transient irritation, burning, stinging, itching and dermatitis; hypersensitivity — angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis (discontinue immediately); blood — bone marrow depression, including idiosyncratic irreversible fatal aplastic anaemia, reported with topical use [1][2] ● Storage: multi-dose reference — store upright at 2–8 °C, do not freeze, protect from light, discard after the 5-day course (unopened shelf life 24 months; 28 days once opened) [1]; single-dose reference — store at 2–8 °C, do not freeze, protect from light, may be kept at up to 25 °C for 1 month [2]; NHS — store the eye drops in a fridge and use within 4 weeks of opening [3] ● Keep all medicines out of the sight and reach of children [1] For full prescribing information, refer to the approved product label / Summary of Product Characteristics of the product concerned [1][2][3].