Chloramphenicol 0.5% W/V (5mg/Ml) Antibiotic Eye Drops Solution
Chloramphenicol 0.5% w/v Antibiotic Eye Drops Patient Information leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without a prescription. However, you still need to use it carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms get worse or do not improve.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Chloramphenicol 0.5% w/v Antibiotic Eye Drops is and what it is used for
2. Before you use Chloramphenicol 0.5% w/v Antibiotic Eye Drops
3. How to use Chloramphenicol 0.5% w/v Antibiotic Eye Drops
4. Possible side effects
5. How to store Chloramphenicol 0.5% w/v Antibiotic Eye Drops
6. Contents of the pack and other information
1. What Chloramphenicol 0.5% w/v Antibiotic Eye Drops is and what it is used for
Chloramphenicol belongs to a group of medicines called antibiotics. Antibiotics are used for infections caused by bacteria.
Chloramphenicol 0.5% w/v Antibiotic Eye Drops are for simple eye infections called "acute bacterial conjunctivitis” in both adults and children. This is sometimes known as "red eye” because the white part of the affected eye(s) will be red and/or the eyelid(s) will be red or swollen. There may also be a sticky discharge which can make the eye difficult to open in the morning, and the eye may feel ‘gritty’ or ‘irritated’.
2. Before you use Chloramphenicol 0.5% w/v Antibiotic Eye Drops Do not use the eye drops and talk to your doctor or pharmacist if:
• You are allergic to chloramphenicol or anything else in the eye drops. Everything in the eye drops is listed in Section 6 "Further Information”.
• You or a member of your family has had problems with their blood or bone marrow. These problems can include a severe reduction in red blood cells or lower than normal blood count.
Do not use the eye drops and talk to your doctor or pharmacist straight away if any of the following apply to you:
• Your eye is painful (rather than just feeling sore or gritty) or you have pain or swelling around the eye or face.
• Your sight is affected by loss of vision, reduced or blurred vision or you see halos around lights.
• It is too painful to open your eyes properly.
• Your pupil (the black circle in the centre of your eye) looks different. It may be torn, not round, very big or does not change size in the light.
• Your eye looks cloudy.
• Your eye is inflamed and you have a rash on the scalp or face._
• Your eyes are sensitive to light.
• You have had an eye infection in the past month.
• You have glaucoma (high pressure inside your eye).
• You have "dry eye syndrome”.
• You have injured your eye.
• You think there may be something in your eye or you have splashed something in your eye.
• You are already using other eye drops or eye ointment.
• You have had eye surgery or laser treatment in the last 6 months._
If you wear contact lenses, seek advice either from your contact lens practitioner (optician, optometrist) or doctor before you use this product.
• You should not wear your contact 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 the eye drops.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, especially:
• Other eye drops or eye ointments
• Medicines which may affect your bone marrow.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, breast-feeding or trying to become pregnant. If you become pregnant while using chloramphenicol eye drops, stop using and see your doctor.
Important information about some of the ingredients of this medicine
This medicine contains Phenylmercuric Nitrate which may cause allergic reactions.
Driving and using machinery
The eye drops may cause blurred vision due to smearing or stinging.
• This will only happen for a short period after it is put in your eye.
• If this happens do not drive or use machinery until you can see clearly.
3. How to use Chloramphenicol 0.5% w/v Antibiotic Eye Drops
Chloramphenicol 0.5% w/v Antibiotic Eye Drops are used by placing in the space between the lower eyelid and the eye, for the treatment of acute bacterial conjunctivitis.
Always follow your pharmacist’s instructions.
• Do not take it by mouth.
Adults, children, and the elderly:
A course of treatment lasts 5 days, to be used during waking hours only:
• One drop should be applied every 2 hours for the first 48 hours and thereafter every 4 hours. Your pharmacist will advise which is the most suitable treatment for you.
Paediatric population
Dosage adjustment may be necessary in newborn 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.
When using the eye drops
• Wash your hands before and after using the eye drops
• Sit or stand in front of a mirror
• T ake off the bottle cap
• Tilt head gently backwards
• Gently pull lower eyelid down
• Gently squeeze the dropper and put one drop into the space between the lower eyelid and the eye.
• Let go of the eyelid and blink a few times. This will help spread the eye drops over the eye
• Try not to touch the eye, eyelashes, or anything else with the tip of the dropper.
• Repeat for the other eye, if affected.
• Replace cap securely after use.
It is important to complete the course of treatment even if your eyes feel better.
Talk to your doctor immediately if:
• Your eyes get worse at any time or during the treatment
• Symptoms are not improving after 48 hours.
Do not repeat the course of treatment without consulting your doctor or pharmacist.
If you miss a dose, use the eye drops as directed above and then continue your normal course of treatment.
Do not share your eye drops with anyone else.
If the contents of this bottle are swallowed, contact your doctor straight away or go to your nearest hospital casualty department. Take with you the bottle and container so that the medicine can be identified.
4. Possible side effects
Like all medicines, Chloramphenicol 0.5% w/v Antibiotic Eye Drops can have side effects, although not everybody gets them.
Side effects that may occur include:
• allergic reactions such as itching or rashes. If you get a severe reaction with swelling or breathing problems, get medical help straight away.
Reactions on or around the eye which are mild:
• stinging or burning
• irritation or itching
• inflammation of the skin (dermatitis).
The following side effects are very rare (affect less than 1 person in 10,000):
Blood disorders including:
• severe reduction in red blood cells (also called aplastic anaemia), which may cause weakness or breathlessness
• lower than normal blood cell counts (bone marrow depression) which may cause fever, joint pain or repeated infections.
Grey baby syndrome in newborns and infants:
• low blood pressure
• vomiting
• blue colouring of the lips and pale "grey” skin.
• discolouration or clouding of the eye surface (cornea) or lens due to the preservative.
• the use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including fungi. If any new infection appears during treatment you should tell your doctor.
• irritation of the skin around the eyes, mercurialentis (brown discolouration of the lens) and atypical band keratopathy (appearance of calcium on the cornea). These may be due to the preservative on the drops called phenyl mercuric nitrate.
Reporting of 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Chloramphenicol 0.5% w/v Antibiotic Eye Drops
• Keep out of the sight and reach of children.
• Sterile until opened.
• Store upright, between 2°C and 8°C in a dry, dark place (e.g. fridge).
• Do not freeze.
• Do not use after the expiry date shown on the bottle and carton.
• Discard any unused eye drops after completing your 5 day course of treatment or return it to your pharmacist.
• Do not throw away any medicines via waste water 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 the pack and other information The active ingredient is: Chloramphenicol 0.5% w/v.
The other ingredients are: borax, boric acid, phenylmercuric nitrate 0.002% w/v, and purified water.
Each bottle contains 10ml of sterile liquid.
MA Holder: Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom. Manufacturer: Martindale Pharmaceuticals, Bampton Road, Romford, RM3 8UG,
England.
Leaflet revised: 09/2016
IF YOU WOULD LIKE A LEAFLET WITH LARGER PRINT PLEASE CALL 01226 779911