DEXAFREE 1 MG/ML EYE DROPS SOLUTION

Active substance: DEXAMETHASONE SODIUM PHOSPHATE

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Dexafree 1 mg/ml,

Eye drops, solution
Dexamethasone phosphate
Read all of this leaflet carefully before you start using this medicine because it
contains important information.
- 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.
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 in the front part of the
eye; for example, the cornea and the
conjunctiva that cover the surface of
the eye, the coloured iris, and the tissue
under the conjunctiva,
- severe allergic reactions of the
conjunctiva (surface of the eye) that other
more usual medicines have not been
able to treat.
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 tuberculosis (lung infection),
• 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
DO NOT INJECT, DO NOT SWALLOW.
Avoid contact between the dispenser tip
and the eye or eyelids. Keep out of sight
and reach of children.
Tell your doctor, pharmacist or nurse before
using Dexafree:
• If the following apply to you as close
monitoring of the eye is needed during
the use of Dexafree:
- 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 are using Dexafree to treat
Herpes, a viral infection of the surface
of the eye causing redness, pain and
which reduces sight. If you have had
ocular viral infection before, only use
Dexafree together with medicine to
treat this kind of infection,
- 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.

• If Dexafree is to be used by a child: do
not use for a long-time 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.
• If you are diabetic, tell your
ophthalmologist or optician that you have
used Dexafree.
• If you have a red eye that has not been
diagnosed, do not use Dexafree.
• If you usually wear contact lenses: do not
wear contact lenses when you are using
Dexafree.
Other medicines and Dexafree
Tell your doctor or pharmacist if you are
using, have recently used or might use
any other medicines, including medicines
obtained without a prescription.
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.
Pregnancy
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before using this medicine.
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.
Breast feeding
It is not known if this medicine is present in
breast milk. Dexafree should be used with
caution when breast feeding.
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 Dexafree 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.

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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.
ƒ 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
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.

where you are.
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
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.
After first opening of the sachet: use the
single-dose containers within 5 days.
Throw away the single-dose container with
any remaining drops after use immediately.
Do not keep it to use again.
Keep the single-dose containers in the
sachet, to protect from light.
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 OTHER
INFORMATION
What Dexafree contains
- The active substance is dexamethasone
sodium phosphate. Each millilitre
of solution contains 1 mg of active
substance as dexamethasone phosphate
form.
- 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 singledose containers.
Each single-dose container contains 0.4 ml
of solution. A pack contains 10, 20, 30,
50 or 100 single-dose containers.
Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND Cedex 2
FRANCE

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).

Manufacturer
EXCELVISION
Rue de la Lombardière
07100 ANNONAY
FRANCE

This leaflet was last approved in
11/2012.

General conditions:
Uncommon (may affect up to 1 in
100 people):
• if used often, the body may not produce
enough of certain hormones (suppression
of corticoadrenal function). This could be
shown by low blood sugar, dehydration,
weight loss and feeling confused about
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N1915U30ASP/1112

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).

This medicine is authorised in the
Member States of the EEA under the
following names:
Bulgaria, Cyprus, France, Greece, Ireland,
Poland, Portugal, Spain
and United Kingdom ......................... DEXAFREE
Belgium, Luxembourg and
the Netherlands........................................................
........................... MONOFREE DEXAMETHASON
Austria and Germany........................MONODEX
Italy and Slovenia ............................DEXAMONO
Denmark, Finland, Norway
and Sweden ........................................ MONOPEX

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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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