United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 1% w/w Eye Ointment
Golden Eye Antibiotic 1% w/w Eye Ointment
Optrex Bacterial conjunctivitis 1% w/w Eye ointment
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 10 mg Chloramphenicol (1% w/w)
For the full list of excipients, see section 6.1
For the treatment of acute bacterial conjunctivitis in adults and children aged 2 years
Posology and method of administration
Topical administration to the eye only.
Adults, children aged 2 years and over and elderly
The recommended dose is a small amount of ointment (~ 1cm) to be applied to the
affected eye(s). The ointment should be applied either at night if eye drops are used
during the day, or 3 to 4 times a day if eye ointment is used alone
The pharmacist will advise on the most suitable treatment. Treatment should continue
for 5 days even if symptoms improve.
Hypersensitivity to chloramphenicol or any of the excipients listed in section 6.1.
Patients who have experienced myelosuppression during previous exposure to
Patients with a family history of blood dyscrasias.
Special warnings and precautions for use
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
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
Do not use for more than 5 days without consulting your doctor.
The label will convey the following information:
If you do not get better within 48 hours talk to a doctor.
If your eyes get worse see a doctor straight away.
Do not use this ointment if you are allergic to chloramphenicol or anything
else in the ointment.
After 5 days, throw away any ointment left.
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:
Any significant pain within the eye
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
Dry eye syndrome
Eye surgery or laser treatment in the last 6 months
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
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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.
Interaction with other medicinal products and other forms of interaction
Bone marrow depressant drugs.
Fertility, pregnancy and lactation
Safety for use in pregnancy and lactation has not been established. Therefore, use
only when considered essential by the physician.
Effects on ability to drive and use machines
Transient blurring of vision may occur immediately after use and patients should be
warned that driving or using machinery should not occur until the vision is clear.
SUMMARY OF PRODUCT CHARACTERISTICS
Transient burning or stinging sensations may occur. More serious side effects include
bone marrow depression and rarely aplastic anaemia, angioneurotic oedema,
anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have
been reported and are causes for discontinuation.
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 the Yellow Card Scheme
Accidental ingestion of the eye ointment is unlikely to cause systemic toxicity due to
the low content of the antibiotic in the product. If irritation, pain, swelling,
lacrimation or photophobia occur after undesired eye contact, the exposed eye(s)
should be irrigated for at least 15 minutes. If symptoms persist after this, an
ophthalmological examination should be considered.
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ATC CODE(S): S01AA01. Sensory. Ophthalmologicals. Antiinfectives. Antibiotics.
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is
effective against a wide range of gram-negative and gram-positive organisms.
Chloramphenicol enters the aqueous humour following topical application.
Chloramphenicol is widely distributed in body tissues and fluids: it enters the CSF,
giving concentrations of about 50% of those existing in the blood even in the absence
of inflamed meninges; it diffuses across the placenta into the fetal circulation, into
breast milk, and into the aqueous and vitreous humour of the eye. Up to about 60% in
the circulation is bound to plasma protein. The half-life of chloramphenicol has been
reported to range from 1.5 to 4 hours; the half-life is prolonged in patients with severe
hepatic impairment and is also much longer in neonates. Renal impairment has
relatively little effect on the half-life of the active drug, due to its extensive
metabolism, but may lead to accumulation of the inactive metabolites.
Chloramphenicol is excreted mainly in urine.
The absorption, metabolism, and excretion of chloramphenicol are subject to
considerable interindividual variation, especially in infants and children, making
monitoring of plasma concentrations necessary to determine pharmacokinetic in a
Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to
those already included in other sections of the SmPC.
List of excipients
Contents are sterile until opened.
Although the shelf life once opened is 28 days, patients should be advised to discard
the medicine after a 5 day course of treatment.
Special precautions for storage
Do not store above 25ºC
Nature and contents of container
4g aluminium tube and polyethylene cap.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Medicom Healthcare Ltd
Lynton House, 7-12 Tavistock Square,
Kings Cross, London,
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Level: 1 + Numbering Style: 1,
2, 3, … + Start at: 7 +
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Indent at: 0.84 cm, Tabs: Not
at 1.48 cm
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT