FML

FML


OPHTHALMIC, SUSPENSION

(Fluorometholone 0.1%)

in Liquifilm

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

If you have difficulty in reading this patient information leaflet and would like a large print version, please contact the technical information manager at Allergan in the UK on 01494 444722.

If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

• The active ingredient in FML is: fluorometholone 0.1% w/v.


• It also contains: Liquifilm (polyvinyl alcohol), edetate disodium, benzalkonium chloride, polysorbate 80, sodium phosphate, sodium chloride, purified water, and sodium hydroxide to adjust pH.


• FML is a sterile eye drop suspension and each bottle contains 5 ml or 10 ml of the medicine.


• FML contains fluorometholone, a steroid that reduces irritation, burning, redness and swelling of eye inflammation.

• PL holder [UK]:

• 
  
  
  

  Allergan Ltd

  
  

  Coronation Road

  
  

  High Wycombe

  
  

  Bucks

  
  

  HP12 3SH

  
  

  United Kingdom

  
  
  
  

• PA holder [Ireland]:

• 
  
  
  

  Allergan Pharmaceuticals (Ireland) Ltd.

  
  

  Westport

  
  

  County Mayo

  
  

  Ireland

  
  
  
  

• Manufacturer [UK and Ireland]:

• 
  
  
  

  Allergan Pharmaceuticals (Ireland) Ltd.

  
  

  Westport

  
  

  County Mayo

  
  

  Ireland

  
  
  
  

Uses

FML is used to treat eye inflammation in certain parts of the eye.

Before you use this medicine

Tell your doctor:

• (a) If you have ever suffered from any other eye problem, particularly infection, that required treatment from a doctor or specialist.


• (b) If you are pregnant or breastfeeding.


• (c) If you are taking any other medication, whether it has been purchased from a chemist or pharmacist, or prescribed for you by a doctor.


• (d) If you are allergic to the preservative benzalkonium chloride or any of the other ingredients, as FML should not be used.


• (e) If you wear soft (hydrophilic) contact lenses. (The preservative benzalkonium chloride can permanently damage this type of lens.)


• (f) If you are suffering from viral, fungal or severe bacterial eye infection or tuberculosis of the eye. In these cases FML should not be used. Please also tell your doctor if you have a history of these conditions.

The safety and effectiveness in children under 2 years of age have not been shown.

The pressure within your eye should be checked frequently while taking FML.

Dosage

One to two drops of FML are usually used two to four times daily. It should not normally be used for longer than one week without review by your doctor. During the first two days of treatment you may be asked to apply the drops every hour.

Follow the instructions on your prescription label carefully, and ask your doctor or pharmacist to explain anything that you do not understand.

Do not use this medicine more or less often, or for a longer period, than you are told to by your doctor or pharmacist. Do not stop using FML until your doctor tells you to.

FML is not recommended for use in children under 2 years of age.

How to use the product

FML comes as eye drops. Your prescription label tells you how many drops to use at each dose.

Apply your eye drops in the following way:

• 1. Shake the bottle well before use.


• 2. Tilt your head back and look at the ceiling.


• 3. Gently pull the lower eyelid down until there is a small pocket.


• 4. Squeeze the upturned dropper bottle to release a drop into your eye.


• 5. Release the lower lid, and close your eye for 30 seconds.

Avoid touching the dropper tip against your eye or anything else.

Replace and tighten the cap straight after use.

The proper application of your eye drops is very important.

If you have any questions ask your doctor or pharmacist.

Missed doses

If you forget to apply a dose apply it as soon as you remember and then apply any remaining doses for that day at evenly spaced intervals. If, however, it is almost time for your next dose, you should omit the missed dose altogether and then follow your normal routine.

Overdosage

If you accidentally place too many drops in your eye(s), wash the eye(s) with water.

The application of too many drops is, however, unlikely to lead to unwanted side-effects.

If the medicine is drunk by accident, contact your doctor.

Side-effects

As with all medicines, FML can cause unwanted effects in some users. You may experience mild stinging and/or burning when the drops are applied and temporary blurred vision. You may possibly experience thinning of the skin and the appearance of fine red lines on the face, formation of cataracts and poorer vision. You should see your doctor if these effects prove troublesome or if they are long-lasting.

If you experience pressure or pain in the eye you should see your doctor at once. Possible causes of pain and pressure in the eye are i.e. eye infection or glaucoma (raised pressure within the eye). You should also see your doctor if you experience any other unusual or unexpected effects.

Storage

Keep the bottle in a safe place out of the reach of children.

Do not store above 25°C (room temperature). Do not freeze.

Warnings

Do not use the product if the tamper-proof seal on the bottle is broken.

The product should not be used after the expiry date. (This is printed on both the label on the bottle and on the bottom of the carton that the bottle is packed in.)

Throw the bottle away 28 days after opening, even if there is solution remaining.

Prepared: February 2003

POM

PL 00426/0028

PA 148/7/1

This medicine is for your use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.

Important

This leaflet does not contain complete information about your medicine. If you have any queries, or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

70042GB34M