Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Chloramphenicol Eye Drops BP 0.5% W/V
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for Chloramphenicol belongs to a group of medicine called antibiotics. Chloramphenicol is used in both adults and children to treat bacterial conjunctivitis, which is an infection of the outer surfaces of the eye. The infected eye will probably be red, gritty or itchy. In the morning there will be a sticky discharge which may make it difficult to open the eye. When put in the eye, chloramphenicol works by helping kill the bacteria (germs) and allow the body to overcome the infection.
What you need to know before you take it
e chloramphenicol Do not use chloramphenicol • • •
If you are allergic (hypersensitive) to chloramphenicol or to any other ingredients of this medicine (see section 6 for more details) If you or someone in your family ever had a blood disorder or bone marrow disease including anemia (decrease in the number of red blood cells) when using chloramphenicol in the past. If you have a family history of "dyscrasias", a condition which can cause tiredness, bruising and an increased risk of infections
Take special care • •
If you develop a new eye infection during this treatment, you should stop using the drops and speak to your doctor. If you use chloramphenicol eye drops for a long time, your doctor may do some blood tests to check for any problems.
Warnings and precautions Talk to your doctor or pharmacist before using chloramphenicol •
if you have visual disturbances
•
if you have severe pain in the eye
•
if you are sensitive to light
•
if your eye is inflamed and you have a rash on the scalp or face
•
if your eye looks cloudy
•
if your black or coloured part of the eye looks unusual
•
if you have a foreign body in the eye
•
if you have an eye infection that keeps coming back
•
if you have glaucoma (raised pressure in the eye)
•
if you have dry eyes
•
if you have eye injury or eye surgery
•
if you are currently using any other eye drops or eye ointment
Other medicines and chloramphenicol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including using eye drops or eye ointment and medicines obtained without a prescription before you start to use this medicine. Your medicine may affect their action and could alter their effect. In particular, tell your doctor if you are taking any of the following: •
medicines for cancer such as methotrexate
•
medicines for the immune system such as azathioprine
Pregnancy and breast-feeding Chloramphenicol should not be used during pregnancy and breast-feeding unless considered essential by your doctor, as the effects are unknown. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines No effects on ability to drive and use machines have been reported. However do not drive or operate machines if you experience any visual disturbance after using the product. Wait until this clears before driving or using machines. Contact lenses Contact lenses should not be worn in an infected eye. Your doctor will ask you to remove your contact lenses prior to the administration of the drops. Do not wear contact lenses during treatment.
How to take it
chloramphenicol Always use Chloramphenicol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is two drops applied to the affected eye(s) every three hours. Use during waking hours only. Continue treatment at least 48 hours after the eye appears normal, or as directed by your doctor. Use in children: Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to immature metabolism and the risk of dose – related adverse effect .The maximum duration of treatment is 10-14 days If you are using in combination with another eye drop medicine, wait 5-15 minutes before applying the second eye drop. Instructions for use: (Please also refer to pictograms at the end of the leaflet) • •
First wash your hands Avoid touching the eye (or any other surface) with the tip of the bottle
•
These drops are supplied as a sealed bottle with a spiked cap. When using the bottle for the first time, screw the cap down tightly in order to pierce the tip of the bottle Tilt your head back and look at the ceiling Pull the lower eyelid gently downwards Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye Keep the affected eye closed and press your fingertip against the inside corner of the closed eye, and hold for 1 minute Repeat for the other eye if necessary Replace and tighten the cap immediately after use.
• • • • • •
Be careful not to touch the tip of the bottle on your eye or on any other surface.
Ocular solutions, if handled wrongly, can become contaminated by common bacteria and cause eye infections. If you do develop any other eye condition whilst using this product, see your doctor immediately. If you use more chloramphenicol than you should If you accidently apply too much drops, you should wash your eye with plenty of water, if any painful symptoms continue after this, you should tell your doctor immediately. If you forget to use Chloramphenicol Apply the drops as soon as you remember. However, if it is almost time for your next dose, do not double your dose and carry on with the normal schedule dose. If you stop using chloramphenicol To be effective chloramphenicol must be used every day. Do not stop using chloramphnicol until your doctor tells you so. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Chloramphenicol can cause side effects, although not everybody gets them. Some people find that their eyes sting or their sight is blurred immediately after using the drops. These effects should wear off after a short time. If prolonged irritation, swelling, watery eyes or sensitivity to light occurs, then exposed eye should be washed with water for 15 minutes. If the symptoms continue after this, an eye examination may be required. Stop using your medicine and tell your doctor or pharmacist immediately if you experience the following side effects: • •
Wheeziness (shortness of breath), fever, swelling of your face, lips or tongue, itching or rash with swelling of skin (the rash could be puffy (swollen) or blotchy, or look like little blisters. A sore throat, bruising or being unable to overcome an infection. On very rare occasions, patients using chloramphenicol have had changes in their blood cells causing severe tiredness or easy bruising.
If any of the side effects gets serious, or if you notice any side effects 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 at 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.
How to store it
chloramphenicol Keep this medicine out of the sight and reach of children. Store in a refrigerator at a temperature between 2°C and 8°C. Protect from light. Discard the bottle 28 days after opening, even if there is solution remaining. Do not use Chloramphenicol after the expiry date which is stated on the carton and label after 'EXP'. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of pack and other information What Chloramphenicol contains The active substance is chloramphenicol 0.5% w/v. The other ingredients are borax, boric acid- and water for injection. What Chloramphenicol looks like and contents of the pack Each bottle contains 5ml or 10ml of Chloramphenicol Eye Drops. Your medicine is a bright, colourless to faint yellow aqueous solution. Marketing Authorisation Holder and Manufacturer FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE, United Kingdom PL number: 15872/0003 Hard to see or read the leaflet? Call + 44(0) 1489 565222 for help. This leaflet was last revised in: April 2023.
MODE OF USE
Frequently asked questions about Chloramphenicol Eye Drops BP 0.5% W/V
How do I take Chloramphenicol Eye Drops BP 0.5% W/V?
Chloramphenicol Eye Drops BP 0.5% W/V comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Chloramphenicol Eye Drops BP 0.5% W/V?
The active substance in Chloramphenicol Eye Drops BP 0.5% W/V is chloramphenicol.
Are there equivalent medicines to Chloramphenicol Eye Drops BP 0.5% W/V?
Medicines with the same active substance, strength and form include: Clorogen Eye Drops 0.5% w/v, Minims Chloramphenicol 0.5%, Eye drops solution, Optrex Infected Eye Drops. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Chloramphenicol Eye Drops BP 0.5% W/V, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Chloramphenicol Eye Drops BP 0.5% W/V without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: chloramphenicol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Chloramphenicol is a broad spectrum antibiotic indicated in both adults and children for the treatment of bacterial conjunctivitis caused by chloramphenicol susceptible organisms including: Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus haemolyticus, Morax-axenfeld, Klebsiella/Enterobacter species and others.
4.2. Posology and method of administration
Posology
Adults (including the Elderly) and children
The recommended dosage for adults and children is two drops to be applied to the affected eye every three hours. To be used during waking hours only. Treatment should be continued for at least 48 hours after eye appears normal.
Paediatric population
Dosage adjustment may be necessary in new born infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days
Method of Administration
For ocular use only.
4.3. Contraindications
• Hypersensitivity to the active substance, chloramphenicol or to any of the excipients listed in section 6.1
• Myelosuppression during previous exposure to chloramphenicol.
• Known personal or family history of blood dyscrasias including aplastic anaemia.
4.4. Special warnings and precautions for use
Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure.
Bone marrow hypoplasia, including aplastic anaemia and death, has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of the compound.
Where chloramphenicol eye drops are used on a long-term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect any haemopoietic abnormalities.
In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment.
Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. If any new infection appears during the treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only in infections for which it is specifically indicated.
Chloramphenicol Eye Drops does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.
Do not use for more than 5 days without consulting a doctor.
Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time.
Patients should be referred to their 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
Contact lenses should not be worn in an infected eye. Contact lenses should be removed during the period of treatment.
The packaging will convey the following information:
• 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
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant administration of Chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
4.6. Fertility, pregnancy and lactation
Pregnancy and Breast-feeding
The safety of topical use of chloramphenicol in pregnancy and lactation has not been established.
Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.
Fertility
No fertility data are available
4.7. Effects on ability to drive and use machines
Transient blurring of vision may occur immediately after use and driving or using machinery should not occur until the vision is clear.
4.8. Undesirable effects
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.
Blood and lymphatic system disorders
Bone marrow depression and rarely aplastic anaemia has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of this compound.
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.
4.9. Overdose
Accidental ingestion of the eye drops 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.
💬 Ask about this leaflet
Ask anything about Chloramphenicol Eye Drops BP 0.5% W/V. 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.
Medicines containing Chloramphenicol
- Brolene Antibiotic 0.5%w/v Eye Drops
- Chloramphenicol 1.0% w/w Antibiotic Eye Ointment
- Chloramphenicol 10% w/v Ear Drops
- Chloramphenicol 5% w/v Ear Drops
- Chloramphenicol 5% w/v Ear Drops (FAMAR)
- Chloramphenicol Antibiotic 0.5%w/v Eye Drops
- Chloramphenicol Capsules BP 250 mg
- Clorogen Eye Drops 0.5% w/v
- Eykappo (Chloramphenicol) 5mg/ml Eye Drops
- Minims Chloramphenicol 0.5%, Eye drops solution
- Mollifeye 5mg/ml Eye Drops, Solution
- Optrex Bacterial Conjunctivitis 1% w/w Eye ointment
- Optrex Infected Eye Drops