DEXAFREE 1 MG/ML EYE DROPS SOLUTION
Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE / DEXAMETHASONE SODIUM PHOSPHATE / DEXAMETHASONE SODIUM PHOSPHATE
Eye drops, solution in single-dose container
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See Section 4.
What is in this leaflet:
1. What Dexafree is and what it is used for
2. What you need to know before you use Dexafree
3. How to use Dexafree
4. Possible side effects
5. How to store Dexafree
6. Contents of the pack and other information
1. WHAT DEXAFREE IS AND WHAT IT IS USED FOR
Dexafree contains dexamethasone, which is a corticosteroid used
to stop inflammatory symptoms (such as pain, heat swelling and
Dexafree is used to treat inflammation of your eyes.
If you have an infected eye (red eye, tears and mucous), you will
be given another medicine to take at the same time as Dexafree.
See Section 2.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
Do not use Dexafree
• if you are suffering from an eye infection that you are not using
a medicine for,
• if you have damage on the surface of the eye (small holes,
ulcers or injury which have not healed properly),
• if you have high pressure in the eye known to be caused by
glucosteroids (family of corticosteroid medicines),
• if you are allergic (hypersensitive) to dexamethasone sodium
phosphate, or any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Tell your doctor, pharmacist or nurse before using Dexafree.
DO NOT INJECT, DO NOT SWALLOW.
Avoid contact between the dispenser tip and the eye or eyelids.
• close monitoring of the eye is needed during the use of
Dexafree and in particular:
- for children and the elderly. More frequent monitoring is
- if you have an eye infection. Only use Dexafree if you are
using an anti-infective medicine,
- if you have a corneal ulcer, an open sore on the surface of the
eye with sometimes extreme pain, tears, squinting and loss of
vision. Do not use Dexafree, unless inflammation is the main
cause of delayed healing,
- if you suffer from high pressure in the eye. If you have already
had high pressure in the eye after using an eye steroid
medicine, you are at risk of having this again if you use
- if you have glaucoma, a condition which can cause damage to
the optic nerve and may cause loss of sight.
• children: do not use for long-term treatment without a break.
• if you have severe allergic conjunctivitis (redness, swelling,
itching and tears in the eye) that another medicine has not been
able to treat, only use Dexafree for a short period of time.
• diabetic: if you are diabetic, tell your ophthalmologist or optician.
• if you have a red eye that has not been diagnosed, do not use
• contact lenses: do not wear contact lenses when you are using
Other medicines and Dexafree
If you are using any other eye medicine, wait 15 minutes between
using each medicine.
Using eye drops containing steroids and eye drops containing betablockers (to treat high pressure in the eye) together may cause
settling of calcium phosphate on the surface of the eye.
Tell your doctor or pharmacist if you are using or have recently
used or might use any other medicines.
Pregnancy and breast feeding
There is not enough information on the use of Dexafree during
pregnancy to know the possible side effects.
For this reason, the use of Dexafree during pregnancy is not
It is not known if this medicine is present in breast milk. However,
the dose of Dexafree is low. Dexafree can be used when breast
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before using this medicine.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them:
Very common (may affect more than 1 in 10 people):
• high pressure in the eye after 2 weeks of using the drops.
Common (may affect up to 1 in 10 people):
• discomfort, irritation, burning, stinging, itching and blurred vision
after use. These are usually mild and do not last long.
Uncommon (may affect up to 1 in 100 people):
• signs of an allergic reaction,
• healing which takes longer than expected,
• cloudy lens (cataract),
• high pressure in the eye (glaucoma).
Very rare (may affect up to 1 in 10,000 people):
• inflamed surface of the eye giving red eye, tears and irritation
• wide pupil (mydriasis),
• swelling of the face (facial oedema),
• drooping eyelids (ptosis),
• inflammation of the eye which causes pain and redness
• settling of calcium on the surface of the eye (calcification of the
• inflamed surface of the eye giving blurred vision, dry eyes,
sensitivity to light, burning, tears and a sandy sensation in your
eye (crystalline keratopathy),
• changes in the thickness of the surface of the eye,
• swelling of the surface of the eye (corneal oedema),
• ulcer on the surface of the eye causing pain, tears, squinting and
• small holes on the surface of the eye (perforation of the
Uncommon (may affect up to 1 in 100 people):
• if used often, the kidneys may not produce enough hormones
(suppression of corticoadrenal function). This could be shown by
low blood sugar, dehydration, weight loss and feeling confused
about where you are.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the national reporting system:
Yellow Card Scheme
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE DEXAFREE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the single-dose container after EXP. The expiry date refers to the
last day of that month.
Keep the single-dose containers in their sachet to protect them
After first opening the sachet, use the single-dose containers within
After opening of the single-dose container: use immediately and
throw away the single-dose container after use.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away any medicines you
no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND
Driving and using machines
You may have blurred vision for a short time after using your drops.
Wait until your vision is normal before you drive or use machines.
- The active substance is dexamethasone sodium phosphate.
Each millilitre of solution contains 1 mg of dexamethasone
3. HOW TO USE DEXAFREE
phosphate (as dexamethasone sodium phosphate).
- The other ingredients are disodium edetate, disodium phosphate
dodecahydrate, sodium chloride and water for injections.
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
What Dexafree looks like and contents of the pack
The usual dose is 1 drop, 4 to 6 times a day in the eye to be
Dexafree is a clear colourless to slightly brown eye drops solution
treated. If your condition is more serious, you may be told to start supplied in single-dose containers.
with 1 drop every hour and then change to 1 drop every 4 hours, Each single-dose container contains 0.4 ml of solution. A pack
after the medicine has started to work. It is important to lower the contains 10, 20, 30, 50 or 100 single-dose containers packed in
dose slowly to stop the condition getting worse again.
- In elderly people: there is no need to adjust the dose.
- In children: do not use for long-term treatment without a break. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Method of administration
Ocular use: this medicine is eye drops to be used in the eye.
12, rue Louis Blériot
Wash your hands well before using these drops.
63017 Clermont-Ferrand Cedex 2
Look upwards and pull the lower eyelid down with your finger.
Put one drop into the eye to be treated.
Immediately after you have put the eye drop in, press lightly with Manufacturer
your finger on the inside corner of your eye, nearest your nose
for few minutes. This helps to stop the eye drops spreading into ZI de la Guérie
50211 Coutances Cedex
the rest of your body.
Throw away the single-dose container after use. Do not keep it
to use again.
This medicine is authorised in the Member States of the EEA
Frequency of use
under the following names:
4 to 6 times a day.
Bulgaria, Cyprus, France, Greece,
Ireland, Poland, Portugal, Spain,
Duration of treatment
Sweden and United Kingdom...................................................... DEXAFREE
You will usually need to use your drops for a few days and no
Belgium, Luxembourg and the Netherlands................................................
longer than 14 days.
If you use more Dexafree than you should
Austria and Germany......................................................................MONODEX
Rinse the eye with sterile water if you have put too much medicine Italy and Slovenia .......................................................................... DEXAMONO
in your eye and your eye feels sore.
Denmark, Finland and Norway ................................................... MONOPEX
Immediately tell your doctor or pharmacist.
This leaflet was last revised in 01/2015.
If you forget to use Dexafree
Do not use a double dose to make up for a forgotten dose.
If you stop using Dexafree
Do not stop using this medicine suddenly. Always tell your doctor if
you are thinking about stopping the treatment.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.