Patient leaflet - Chloramphenicol 0.5% w/v eye drops solution
1. WHAT CHLORAMPHENICOL EYE DROPS ARE AND WHAT THEY ARE USED FOR
Chloramphenicol Eye Drops contain an antibiotic called chloramphenicol. It is used 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 Eye Drops are 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORAMPHENICOL EYE DROPS
Chloramphenicol Eye Drops are recommended for use in children, in adults and the elderly.
Do not use this product if you:
- are allergic (hypersensitive) to Chloramphenicol or any of the ingredients of this medicine (listed in section 6).
- or someone in your family have ever had a blood disorder or bone marrow disease including anaemia (decrease in the number of red blood cells) when using chlorampheni-col in the past
- 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, pharmacist or nurse.
- 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, pharmacist or nurse before using chloramphenicol if
- your eyesight is affected (loss of sight, reduced vision, blurred vision or halos around lights)
- you have pain within the eye
- your eye has suffered a blow or other injury
- your eye is inflamed and you have a rash on the scalp or face
- the pupil of your eye looks unusual or your eye looks cloudy
- your eyes are sensitive to light
- you have (or think you have) a foreign body in your eye, which has not been removed
- you have recently had an eye infection
- you suffer from or have suffered from glaucoma or dry eye syndrome
- you wear contact lenses. If you wear contact lenses and your doctor, pharmacist or nurse has advised you to use this product, do not wear your lenses during the course of treatment. Wear your glasses instead. Soft contact lenses should not be used for 24 hours after completing treatment.
- you are using any other eye drops or eye ointment
- you have had eye surgery or laser treatment in the last 6 months
- you are taking any other medicines
- you suffer from any other eye problems.
Other medicines and Chloramphenicol Eye Drops
Tell your doctor, pharmacist or nurse 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, pharmacist or nurse if you are taking bone marrow depressant medicines (medicines which decrease the activity of the bone marrow, causing low blood cell counts) such as azathioprine or are receiving chemotherapy, seek the advice of your doctor, pharmacist or nurse before using this product.
Pregnancy and breast-feeding
Chloramphenicol should not be used during pregnancy and breast-feeding unless consid-ered essential by your doctor, pharmacist or nurse, 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, pharmacist or nurse for advice before using this medicine. Driving and using machines
After using the drops, you may temporarily get blurred vision. Do not drive or operate machinery until your vision is clear. If in doubt, talk to your doctor, pharmacist or nurse. Chloramphenicol Eye Drops contains phenylmercuric nitrate, boric acid and borax
Phenylmercuric nitrate may cause allergic reactions.
3. HOW TO USE CHLORAMPHENICOL EYE DROPS
Always use Chloramphenicol Eye Drops exactly as your doctor, pharmacist or nurse 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, pharmacist or nurse.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Leaflet Size 135 x 425 mm
Main Text 9pt News Gothic Std
HEADINGS 10PT News Gothic BOLD
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 drops medicine, wait 5-15 minutes before applying the second eye drop.
Instructions for use
To be used in the eye(s) only
- Check that the seal is not broken before the first use
- For safety reasons, remove and discard the tamper evident seal after first opening and before first use
- Wash and dry your hands
- Tilt your head back while seated or lie down on your back
- Gently pull the lower eyelid downwards and look up
- Place the tip of the bottle close to your eye. Squeeze the bottle and let one drop fall into the space between the lower eyelid and the eye. Take care that the tip of the bottle does not touch your eye, the skin around your eye or your fingers
- Blink a few times to ensure the drops are evenly spread into your eye and close your eye for a moment
- When both eyes are to be treated, repeat for the other eye
- Replace and tighten the cap immediately after use.
Whilst applying the drops, do not
- breathe on or touch the dropper nozzle
- touch the eyes or eyelids (or any other surface) with the tip of the bottle
- share your eye drops with anyone else.
Ocular solutions, if handled incorrectly, 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, pharmacist or nurse immediately.
If you use more chloramphenicol than you should, you should wash your eye with plenty of water. If any painful symptoms continue after this, you should tell your doctor, pharmacist or nurse immediately.
If you forget to use your drops
If you have only just missed a dose and it is a long time before the next dose is due, put in the missed dose of drops straight away. If it is nearly time for your next dose, skip the missed dose and just put in the next dose of drops at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop using your drops
To be effective chloramphenicol must be used every day. Do not stop using chlorampheni-col until your doctor, pharmacist or nurse tells you so. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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.
- Allergic reactions such as itching or rashes. If you get a severe reaction, with swelling or breathing problems tell your doctor, pharmacist or nurse immediately.
- Changes in the blood (anaemia) leading to severe tiredness or easy bruising. If you experience these effects, stop using the drops immediately and tell your doctor, pharmacist or nurse.
- Discolouration or clouding of the eye surface (cornea) or lens.
- The use of topical Chloramphenicol may occasionally result in the over growth of other non susceptible organisms including fungi. If any new infection appears during treatment you should tell your doctor, pharmacist or nurse.
- Blurred vision or mild burning or stinging when you put the drops in. These should subside quickly. If prolonged irritation, swelling, watery eyes or sensitivity to light occurs, then the exposed eye should be washed with water for 15 minutes. If the symptoms continue after this, an eye examination may be required.
- The preservative, phenylmercuric nitrate, may cause allergic reaction. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. HOW TO STORE CHLORAMPHENICOL EYE DROPS
Replace the cap securely after use. Store in a refrigerator (2ºC - 8ºC). This is the temperature of most domestic refrigerators.
Keep the bottle in the outer carton in order to protect from light.
Keep this and all medicines out of the sight and reach of children.
Do not use after the expiry date which is stated on the bottle and on the carton the bottle is packed in.
Dispose of any medicine left 4 weeks after opening the bottle.
Do not use 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 waste water or household waste. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Chloramphenicol Eye Drops contains
- The active substance is Chloramphenicol 0.5% w/v.
- The other ingredients are: borax (E285), boric acid (E284), phenyl mercuric nitrate (as preservative) 0.002% w/v and water for injections.
What Chloramphenicol Eye Drops looks like and contents of the pack
Each bottle contains 10 ml of drops.
The drops contain 0.5% w/v chloramphenicol, which is equivalent to 5 mg of chloramphenicol per millilitre.
The product is a bright, colourless to faint yellow aqueous solution supplied in bottles containing 10ml of the eye drops.
Marketing Authorisation Holder:
Blumont Pharma Ltd. 23 Moortown Close, Grantham, NG31 9GG, UK Manufacturer:
Farmigea S.p.A, Via G.B. Oliva, 6, 56121 Pisa, Italy
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This leaflet was last revised in September 2024 PL number: 31103/0029