Friday 27 July 2012

Vexol 1%






VEXOL 1% (10 mg/ml)


EYE DROPS, SUSPENSION

Rimexolone




Read all of this leaflet carefully before you start using this medicine.


  • This medicine has been prescribed for you personally. You should not pass it on to other people. It may harm them, even if their symptoms are the same as yours.


  • Keep this leaflet. You may need to read it again. If you still have questions after reading it, please ask your doctor or your pharmacist.



The active substance is rimexolone 10 mg/ml.



Other ingredients: benzalkonium chloride 0.1 mg/ml as a preservative, mannitol, carbomer, polysorbate 80, disodium edetate, sodium chloride and purified water. Very small amounts of hydrochloric acid and/or sodium hydroxide may have been added to regulate the acidity/alkalinity of the product to ensure comfort in the eye.



The marketing authorisation holder for VEXOL is




Alcon Laboratories (UK) Ltd.

Boundary Way

Hemel Hempstead

Herts

HP2 7UD

United Kingdom


The manufacturer of VEXOL is




Alcon-Couvreur NV

Rijksweg 14

B-2870 Puurs

Belgium




What Vexol Is And What It Is Used For


Vexol 1% (10 mg/ml) eye drops contain a substance called rimexolone, which is a type of substance known as an anti-inflammatory corticosteroid. Anti-inflammatory corticosteroids are types of medicines that help prevent or reduce redness, swelling and soreness in your eye.


If you have been prescribed this medicine then you will be suffering from inflammation (redness, soreness or swelling) in your eye. This inflammation may be caused as a result of an operation on your eye or it may be caused by an infection or by something entering into your eye. Vexol helps to prevent or reduce this inflammation.


Vexol 1% (10 mg/ml) is supplied as a white to off-white suspension in plastic dropper bottles containing 3 ml, 5 ml or 10 ml of solution.




Before You Use Vexol


In some circumstances, this medicine may not be suitable for you and your doctor may wish to give you a different medicine. If your doctor is unaware that you suffer from any of the following conditions please inform your doctor before starting to take this medicine.


  • If you have an infection in your eye caused by a virus, fungi or mycobacteria.

  • If you have a red eye where the cause is not known or an amoebic infection.

  • If you have a severe eye infection.

  • If you have kidney or liver problems.

  • If you have ever had to stop taking a medicine because you were allergic to it.

  • If you are pregnant or intending to become pregnant.

  • If you are breast feeding a baby.

Vexol has not been shown to have any effects on any other medicines that you may also be taking, however, you should make sure your doctor knows what other medicines you are taking before using Vexol.


  • Since the product contains benzalkonium chloride as a preservative, which has been known to discolour soft contact lenses, you must not wear soft contact lenses while using this medicine.

  • If your sight is affected in any way following the use of Vexol you should not drive or operate machinery.



How To Use Vexol


The normal dosage i.e. how often you should use Vexol, will depend on the cause of your inflammation. The normal dosage instructions for each condition for which Vexol is prescribed are listed below.


Your own dosage instructions will be specified on the label attached to the outer carton of your medicine. If they are not, or you are not sure, then ask your doctor or pharmacist. It is important that you use Vexol as instructed by your doctor.



Adults and elderly:



Post-operative inflammation


Apply one drop in the affected eye four times daily, beginning 24 hours after your operation and continuing throughout the first 2 weeks following your operation.



Steroid responsive inflammation


Apply one drop in the affected eye four times daily or more often (as indicated by your doctor).



Uveitis



  • First Week

  • Apply one drop in the affected eye every hour during the daytime.


  • Second Week

  • Apply one drop every two hours during the daytime.


  • Third Week

  • Apply one drop four times daily.


  • Fourth Week

  • Apply one drop twice daily for the first four days and then apply one drop once daily for the last three days.



Children:


The safe use of this medicine in children has not been demonstrated. Therefore, Vexol is not recommended for use in children.



Only use Vexol for dropping in your eyes.




How to put the drops in your eye


By following the 10 steps listed below, you will ensure that your eye drops are being used correctly and to the best effect.




  • 1. Wash your hands before using Vexol.


  • 2. Sit down in front of a mirror so that you can see what you are doing.


  • 3. Shake the bottle well and then remove the cap from the bottle.


  • 4. Make sure the dropper tip does not touch anything as this may contaminate the contents.


  • 5. Hold the bottle upside down in one hand between your thumb and middle finger.


  • 6. Using the forefinger of your other hand, gently pull down the lower eyelid of the affected eye.


  • 7. Place the dropper bottle tip close to, but not touching, your eye and gently tap the base of the bottle with your forefinger so that one drop falls into the gap between the eye and the lower lid.


  • 8. Now release the lower eyelid, and blink a few times to make sure the whole of the eye is covered by the liquid.


  • 9. Repeat steps 5 to 8 above, for the other eye, if necessary.


  • 10. Replace and tightly close the cap on the dropper bottle.



What you should do if you miss a dose of Vexol


If you miss a dose, DO NOT WORRY. Just put in the next dose when it is due.




What you should do if you put too much Vexol in your eye


If you put too much of this medicine in your eye(s), it can be washed out with warm water.





Vexol 1% Side Effects


  • You may experience some or all of the following reactions in your eye(s) :

    • Common (may affect 1-3% of people):

      • Blurred vision - Discharge - Discomfort - Pain - Increased pressure in your eye - Foreign body (gritty) sensation.
    • Uncommon (may affect less than 1% of people) :

      • Redness of the eye or inside the eyelid - Itching - Sticky sensation - Dryness - Swelling - Increased tear production - Sensitivity to light - Irritation - Staining or inflammation of the cornea.

  • You may also experience reactions in other areas of your body including:

    • Uncommon (may affect less than 1% of people) :

      • Eyebrow ache - Headache - Low blood pressure - Inflamed/blocked nose - Inflamed/sore throat - Bad taste in your mouth.

  • If you experience any of the reactions listed above, or any others not listed, after using Vexol, tell your doctor and follow his/her advice.



Storing Vexol


  • Keep Vexol in a safe place out of the reach and sight of children.

  • Do not store above 30°C. Do not freeze.

  • Do not use this medicine after the expiry date shown as "EXP" on the bottle and carton.

  • Once the bottle has been opened then the eye drops must be discarded one month after first opening.

This leaflet was last changed January 2001.


VEXOL is a registered trademark of N.V. Organon.




Further information


If you have any other questions about your medicines you should ask a doctor or pharmacist.







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