CLOROGEN Eye drops, solution Ref.[50229] Active ingredients: Chloramphenicol

Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported (see section 4.8).

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.

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.

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. Soft contact lenses should not be replaced for 24 hours after completing the treatment.

Phenylmercuric nitrate is irritant to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.

Bone marrow suppressant drugs.

Pregnancy

The safety of chloramphenicol eye drops during pregnancy and lactation has not been established. As this product is for sale without prescription it is not recommended for use during pregnancy.

Breast-feeding

In view of the fact that chloramphenicol may appear in breast milk, use of the product during lactation should be avoided.

Fertility

No fertility data are available.

Transient blurring of vision may occur immediately after use and driving or using machinery should not occur until the vision is clear.

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.