Chloramphenicol 1%W/W Eye Ointment
PACKAGE LEAFLET: INFORMATION FORTHE USER
Antibiotic Eye Ointment
D02827
Read all the leaflet carefully 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What your medicine is and what it is used for
2. Before you use your medicine
3. How to use your medicine
4. Possible side effects
5. Storing your medicine
6. Further information
1. What your medicine 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 eye ointment is for simple eye infections called "acute bacterial conjunctivitis".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 your medicine
Do not use the ointment and talk to your doctor or pharmacist if:
• You are allergic to Chloramphenicol or anything else in the ointment. Everything in the ointment 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.
• The person needing to use the ointment is under 2 years of age.
Do not use the ointment 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.
• 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 thinktheremaybe 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 ointment.
Taking other medicines
Tell your doctor or pharmacist if you are
taking any other medicines, especially:
• Other eye ointments or eye drops
• Medicines which may affect your bone marrow
Pregnancy and breast-feeding
Do not use this medicine if you are pregnant, breast feeding or trying to become pregnant. If you become pregnant while using this ointment, stop using it and see your doctor.
Driving and using machinery
The ointment may cause blurred vision due to smearing or stinging.
• This will only happen fora 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 your medicine
Chloramphenicol eye ointment is used by placing a small amount (about 1cm) in the space between the lower eyelid and the eye. Always follow your pharmacist's instructions.
• Do not take it by mouth
• Do not use for children under 2 years of age.
Continued overleaf
Adults and children aged 2 years and over:
A course of treatment lasts 5 days:
• If the eye ointment is being used alone, squeeze a thin line of ointment inside the lower eyelid of each affected eye
3 to 4 times a day. This means that you should use it about every 4-6 hours.
• If you are using Chloramphenicol eye drops during the day and the eye ointment at night - apply the ointment at night, before going to bed.
Your pharmacist will advise which is the most suitable treatment for you.
When using the ointment
• Wash your hands before and after using the ointment
• Sit or stand in front of a mirror
• Take off the tube cap
• Tilt the head gently backwards
• Gently pull lower eyelid down
• Gently squeezing the tube, put about 1cm of ointment into the space between the lower eyelid and the eye
• Let go of the eyelid "j and blink a few times.This will
help spread the
ointment over the eye '
• Try not to touch the eye, eyelashes, or anything else with the tip of the tube
• Repeat for the other eye, if affected
• Replace the 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
• There is no improvement within 2 days
Do not repeat the course of treatment without consulting your doctor or pharmacist.
If you miss a dose, use the ointment as directed above and then continue your normal course of treatment.
Do not share your eye ointment with anyone else.
If the contents of this tube are swallowed, contact your doctor straight away or go to your nearest hospital casualty department. Take with you the tube and container so that the medicine can be identified.
4. Possible side effects
Like all medicines, Chloramphenicol Eye Ointment can cause side effects, although not everybody gets them. Most of these side effects affect only the eye and may not last very long. If you have any severe or persistent side effect you should stop the ointment and contact your doctor, pharmacist or nurse immediately.
If you notice any of the following side effects, you must stop using the ointment and contact your doctor, pharmacist or nurse, or the nearest hospital emergency department immediately. Very severe side effects:
• swelling of your face and neck
• difficulty in breathing
• a drop in blood pressure and unconsciousness
• high temperature
• rashes that may be red and raised and may blister.
Less severe side effects:
• allergic reactions that affect only the eyes and can cause redness and itching, with swelling of the eyelids.
When Chloramphenicol Eye Ointment is given by mouth or by injection, it may cause drops of the numbers of all types of blood cells leading to anemia, infections and easy bruising and bleeding. Very occasionally, these effects cannot be reversed and have been fatal. Although only very small amounts of chloramphenicol are absorbed from the eye ointment into your bloodstream, there have been reports of these severe effects even with eye ointment.
Tell your doctor immediately if you:
- notice that you are feeling generally weak and tried, or
- get another infection or
- notice easy bleeding or bruising during or shortly after using the drops.
Other local side effects:
- burning or stinging in and around the eye.
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. Storing your medicine
• Keep all medicines out of the reach and sight of children.
• Sterile until opened.
• Do not store above 25°C.
• Protect from light.
• Do not use it after the expiry date shown on the tube and carton.
• Discard any unused eye ointment after completing your 5 day course of treatment or return it to your pharmacist.
6. Further information
The name of this medicine is Chloramphenicol 1.0% w/w Antibiotic Eye Ointment.
This medicine contains the active ingredient Chloramphenicol 1.0 w/w.Other ingredients are Liquid Paraffin and Yellow Soft Paraffin.
Each tube contains 4 grams of smooth yellow eye ointment.
Manufacturer:
Tubilux Pharma S.P.A, Via Costarica, 20/22,
N/P - Pomenzia, Italy
Marketing Authorisation Holder:
Martindale Pharmaceuticals Ltd Bampton Road, Romford, RM3 8UG United Kingdom
Text revised September 2014
MARTINDALE PHARMA
Bampton Road, Harold Hill, Romford, RM3 8UG, UK D02827
