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DEXAFREE 1 MG/ML EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINER

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE / DEXAMETHASONE SODIUM PHOSPHATE

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Dexafree® 1 mg/ml Eye drops,
solution in single-dose container

2906
01.04.17[3]

(dexamethasone sodium phosphate)
PATIENT INFORMATION LEAFLET
Read all of the 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.
This medicine is available using the above name but will be referred to as
Dexafree throughout the following leaflet.
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 redness).
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 DEXAFREE
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 advised,
- if you have an eye infection. Only use Dexafree if you are using an antiinfective 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 Dexafree,
- 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 Dexafree.
- contact lenses: do not wear contact lenses when you are using Dexafree.
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 beta-blockers
(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 recommended.

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 feeding.
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.
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.
3. HOW TO USE DEXAFREE
Dose
Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. The usual dose is 1 drop, 4 to
6 times a day in the eye to be treated. If your condition is more serious, you
may be told to start with 1 drop every hour and then change to 1 drop every
4 hours, after the medicine has started to work. It is important to lower the
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.
Method of administration
Ocular use: this medicine is eye drops to be used in the eye.
- Wash your hands well before using these drops.
- 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 your
finger on the inside corner of your eye, nearest your nose for few minutes.
This helps to stop the eye drops spreading into the rest of your body.
- Throw away the single-dose container after use. Do not keep it to use
again.
Frequency of use
4 to 6 times a day.
Duration of treatment
You will usually need to use your drops for a few days and no longer than
14 days.
If you use more Dexafree than you should
Rinse the eye with sterile water if you have put too much medicine in your
eye and your eye feels sore.
Immediately tell your doctor or pharmacist.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them:
Eye conditions:
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),
- infections,
- 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
(conjunctivitis),
- wide pupil (mydriasis),
- swelling of the face (facial oedema),
- drooping eyelids (ptosis),
- inflammation of the eye which causes pain and redness (uveitis),
- settling of calcium on the surface of the eye (calcification of the cornea),
- 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 vision
loss,
- small holes on the surface of the eye (perforation of the cornea).
General conditions:
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: United Kingdom
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
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 singledose 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 from light.
After first opening the sachet, use the single-dose containers within 5 days.
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.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dexafree contains
- The active substance is dexamethasone sodium phosphate.
Each ml of solution contains 1 mg of dexamethasone phosphate (as
dexamethasone sodium phosphate).
- The other ingredients are disodium edetate, disodium phosphate
dodecahydrate, sodium chloride and water for injections.
What Dexafree looks like and contents of the pack
Dexafree is a clear colourless to slightly brown eye drops solution supplied
in single-dose containers.
Each single-dose container contains 0.4 ml of solution.
A pack contains 20 or 30 single-dose containers packed in sachets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Excelvision, 27, rue de la Lombardière, ZI la Lombardière,
07100 Annonay, France.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

20636/2906

Leaflet revision and issue date (Ref) 01.04.17[3]
Dexafree is a trademark of Laboratoires Théa.

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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.

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