Friday, October 14, 2016

Chloramphenicol Eye Drops BP 0.5%w / v






CHLORAMPHENICOL EYE DROPS BP 0.5% w/v


Chloramphenicol 0.5% w/v


Please read this leaflet carefully before you start to take your medicine.


Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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.


The medicine will be called Chloramphenicol in this leaflet.



In this leaflet:



1. What Chloramphenicol is and what is it used for

2. Before you use Chloramphenicol

3. How to use Chloramphenicol

4. Possible side effects

5. How to store Chloramphenicol

6. Further information





What Chloramphenicol Is And What Is It Used For


Chloramphenicol belongs to a group of medicine called antibiotics.


Chloramphenicol is used to treat acute bacterial conjunctivitis, which is an infection of the outer surfaces of the eye.




Before You Use Chloramphenicol



Do not use:


  • If you are allergic (hypersensitive) to chloramphenicol or to any other ingredient of this medicine (see section 6.6 for more details)

  • If you have ever had problems with your bone marrow or blood 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 with Chloramphenicol



Please tell your doctor if you:


  • develop a new eye infection during this treatment

  • are wearing contact lenses



Taking other medicines


Please tell your doctor or pharmacist if you are applying any other type of eye drops or eye ointment before you start to use this medicine. Your medicine may affect their action and could alter their effect.


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without any prescription.




Pregnancy and breast-feeding


Ask your doctor or pharmacist for advice before taking any medicines.


Chloramphenicol should not be used during pregnancy and breast-feeding unless considered essential by your doctor.




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.





How To Use Chloramphenicol


Always use Chloramphenicol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


The usual dosage is two drops applied to the affected eye(s) every three hours for at least 48 hours, or as directed by your doctor.


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

  • If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting

  • 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 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.





Possible Side Effects


Like all medicines, Chloramphenicol can cause side effects, although not everybody gets them.


If you experience a rare (these may affect between 1 in 1,000 and 1 in 10,000 patients) but serious allergic reaction (difficulty breathing, closing of the throat, swelling of the lips, tongue, or face or hives) to chloramphenicol, stop using the medication and contact your doctor immediately.


Please tell your doctor if you notice any of the following side effects:


  • stinging, burning

  • eye irritation

  • blurring of vision.


Very rare possible side effects: (these may affect less than 1 in 10,000 patients)


  • anaemia (in particular very low numbers of blood cells)

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 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.




How To Store Chloramphenicol


Keep out of the reach and sight 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 bottle and on the carton the bottle is packed in.




Further Information



What Chloramphenicol contains


The active substance is chloramphenicol 0.50% w/v. It also contains Borax, Boric acid, Phenyl mercuric nitrate (as preservative) 0.002% w/v and purified water.




What Chloramphenicol look like and contents of the pack


Each bottle contains 5ml or 10ml of Chloramphenicol Eye Drops.


Your medicine is a clear colourless, sterile solution.




Marketing Authorisation Holder and Manufacturer



FDC International Ltd

At: Unit 6, Fulcrum 1

Solent Way

Whiteley

Fareham

Hampshire
PO15 7FE





PL number:15872/0003



Hard to see or read the leaflet? Call + 44(0) 1489 565222 for help.



This leaflet was last approved in: 09/2009



MODE OF USE


Bottle as received


Tighten the cap on the nozzle till the cap touches the shoulder.


The spike in the cap will pierce the tip of the bottle.


Tilt head backwards. Dispense drops with gentle pressure. Do not touch dropper tip to the surface of the eye.


Replace cap after every use, and screw the cap down


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