Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Chloramphenicol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for 2. What you need to know before you use Chloramphenicol Antibiotic Eye Drops 3. How to use Chloramphenicol Antibiotic Eye Drops 4. Possible side effects 5. How to store Chloramphenicol Antibiotic Eye Drops 6. Contents of the pack and other information
1. What Chloramphenicol Antibiotic Eye Drops is and what it is used for Chloramphenicol Antibiotic Eye Drops contains an antibiotic called chloramphenicol. It is used in both adults and children aged 2 years and over to treat bacterial infections that affect the front surfaces of the eye. The most common type of infection in this area is called acute bacterial conjunctivitis. When you have this condition, the white part of one or both of your eyes will be red and/or your eyelids will be red or swollen. There will be a sticky discharge, which can make the eye difficult to open in the morning and the eye may feel"gritty" or "irritated". Chloramphenicol Antibiotic Eye Drops is not suitable for treating eye infections that have spread to the deeper layers of the eye coverings or into the fluid within the eyeball. Antibiotic tablets or injections are needed to treat these deeper, more serious infections.
e Chloramphenicol Antibiotic Eye Drops Chloramphenicol Antibiotic Eye Drops is recommended for use in children aged 2 years and over, in adults and the elderly. A child below the age of 2 years with an eye infection should see a doctor due to necessary dosage adjustment. Do not use Chloramphenicol Antibiotic Eye Drops if
Chloramphenicol Antibiotic Eye Drops Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Contact lens users If you wear contact lenses they must be removed whilst you are using Chloramphenical Antibiotic Eye Drops. You should wait 24 hours after you take your last dose of Chloramphenicol Antibiotic Eye Drops before starting to use your lenses again. Instructions for use To be used in the eye(s) only
100mm Measurement Verification Bar
product. Take care not to touch the end of the nozzle
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people may get one or more of these side effects. Some effects happen straight away but do not last long, others may only happen after several days of use.
non-susceptible organisms including fungi. If any new infection appears during treatment you should tell your doctor.
get serious or if you experience any side effect not listed in this leaflet please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Chloramphenicol Antibiotic Eye Drops Keep out of the sight and reach of children. Do not use Chloramphenicol Eye Drops after the expiry date printed on the bottle label. The expiry date refers to the last day of that month. Once the bottle is opened use within 4 weeks. You are advised to dispose of the bottle once you have finished your 5 day course of treatment. This medicine needs to be stored upright between 2-8°C (in a refrigerator). Protect from light. Do not allow it to freeze. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
What Chloramphenicol Antibiotic Eye Drops contains: The active substance is chloramphenicol 0.5%w/v The other ingredients are borax, boric acid, phenylmercuric nitrate (as preservative) and purified water. What Chloramphenicol Antibiotic Eye Drops looks like and contents of the pack Chloramphenicol Antibiotic Eye Drops is a clear colourless solution supplied in plastic bottles. Each bottle contains 10ml of solution. Marketing Authorisation Holder and Manufacturer: Martindale Pharmaceuticals Ltd. Bampton Road, Harold Hill Romford Essex RM3 8UG United Kingdom Manufacturer: Famar S.A. 63, Agiou Dimitriou Street 174 56 Alimos – Athens, Greece If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address. This leaflet was last revised in March 2025 PL 00156/0109 D06446
D06446
PACKAGE LEAFLET: INFORMATION FOR THE USER
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Chloramphenicol Antibiotic 0.5%w/v Eye Drops comes as eye drops containing 0.5%. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Chloramphenicol Antibiotic 0.5%w/v Eye Drops is chloramphenicol.
Medicines with the same active substance, strength and form include: Brolene Antibiotic 0.5%w/v Eye Drops. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Chloramphenicol Antibiotic 0.5%w/v Eye Drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Chloramphenicol is broad spectrum antibiotic indicated in both adults and children aged 2 years and over for the treatment of acute bacterial conjunctivitis.
Posology
Adults (including the elderly) and children aged 2 years and over:
• Put one drop into the affected eye(s) every 2 hours for the first 48 hours and 4 hourly thereafter.
• To be used during waking hours only
• The course of treatment should be 5 days.
Method of administration
For ocular use.
Chloramphenicol eye drops must not be administered to patients who have:
• Hypersensitivity to the chloramphenicol or to any of the excipients listed in section 6.1.
• Myelosuppression during previous exposure to chloramphenicol.
• Family or personal history of blood dyscrasias including aplastic anaemia.
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 use of chloramphenicol eye drops is not advisable. 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:
• Seek further immediate medical advice any time if symptoms worsen.
• Consult your doctor if your eye infection does not start to improve within 48 hours.
• Discard the medicine after a 5 day course of treatment.
• Do not use if you are allergic to chloramphenicol or any of the ingredients.
• For external use/use in the eye 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 patient has glaucoma
• 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 period of treatment
Soft contact lens wearers should wait 24 hours after completing a course of treatment before starting to use their lenses again.
Phenylmercuric nitrate is irritant to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
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.
The use of the eye drops may cause transient blurring of vision. Patients should not drive or operate hazardous machinery unless 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.
Accidental ingestion of the drops is unlikely to cause systemic toxicity due to the low content of the antibiotic in the product.
In view of the relatively small amount of chloramphenicol in Chloramphenicol
Eye Drops, overdosage with this product is unlikely to constitute a hazard. No specific treatment would be required.
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.
Ask anything about Chloramphenicol Antibiotic 0.5%w/v Eye Drops. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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