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DROPODEX 0.1% W/V EYE DROPS SOLUTION

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

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Package leaflet: Information for the user

Dropodex 0.1% w/v Eye Drops, solution
®

Dexamethasone phosphate (as dexamethasone sodium phosphate)

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, or pharmacist.
• 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, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Dropodex® Eye Drops are and what they are used for
2. What you need to know before you use Dropodex®
3. How to use Dropodex®
4. Possible side effects
5. How to store Dropodex®
6. Contents of the pack and other information

Children and adolescents
Use of Dropodex® 0.1% w/v eye drops in children and adolescents must be
restricted. In children, continuous, long term use of corticosteroid eye drops
should be avoided.

1. What Dropodex® Eye Drops are and what they
are used for

If you are already using eye drops to treat glaucoma it is possible that
the dose may need to be adjusted if you are prescribed Dropodex®.

Each Dropodex® single-dose container contains the active ingredient
dexamethasone phosphate (as dexamethasone sodium phosphate), at a
concentration of 0.1% w/v (1 mg/ml). Each Dropodex® sterile single-dose
container holds approximately 0.4 ml of solution. Dropodex® belongs
to the group of corticosteroids that suppresses inflammation.

Tell your doctor if you are using ritanovir or cobicistat as this may
increase the amount of dexamethasone in the blood.

Dropodex® is used for:
• Certain cases of inflammation in the front of the eye such as the
inflammation of the cornea, conjunctiva and iris and connective tissue.
• Hypersensitive reaction of the conjunctiva not responding to
standard treatments.
• Treatment of inflammation of the eye, as long as the eye is not infected.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or eye specialist for advice
before taking this medicine. There is insufficient information available
to determine the potential harmful effects on pregnancy. Dropodex®
should not be used during pregnancy and breast-feeding unless
considered appropriate by your doctor or eye specialist.

Your doctor may sometimes use other drugs at the same time as
Dropodex® to make sure that your eye is treated effectively.

2. What you need to know before you use
Dropodex® Eye Drops
Do not use Dropodex® Eye Drops:
• If you are allergic to dexamethasone sodium phosphate or any of the
other ingredients of this medicine (listed in section 6).
• In case of bacterial eye infections (such as: acute purulent bacterial
infections), fungal infections, viral diseases (for example: Herpes
simplex, vaccinia, varicella zoster), or amoebiasis.
• In case of tuberculosis.
• In cases of damaged cornea (such as: perforation of the cornea),
ulceration, lesions with incomplete formation of the covering tissue.
• In cases of increased intraocular pressure caused by
glucocorticosteroids (these belong to the group of corticosteroids).
Warnings and precautions
Talk to your doctor or eye specialist before using Dropodex®
Eye Drops:
• If you have an eye infection.
• If you have increased pressure within the eye (glaucoma), or are at risk
of developing glaucoma. Your doctor will check for this.
• If you experience swelling and weight gain around the trunk and in
the face as these are usually the first manifestations of a syndrome
called Cushing’s syndrome. Suppression of the adrenal gland
function may develop after stopping a long-term or intensive
treatment with Dropodex® Eye Drops. Talk to your doctor before
stopping the treatment by yourself. These risks are especially
important in children and patients treated with a drug called ritanovir
or cobicistat.
• If you are using any other eye drops.
Wearing of contact lenses during treatment with corticosteroid eye
drops must be avoided.
Long term, frequent use of corticosteroids can lead to the formation of
cataracts (clouding of the lens in the eye).

Other medicines and Dropodex® Eye Drops
Tell your doctor or pharmacist if you are using, have recently used, or
might use any other medicines, including medicines obtained without
prescription.

If you are using more than one sort of eye drops leave five minutes
between applications.

Driving and using machines
Your eyesight may become blurred for a short time following the use
of Dropodex®. You must not drive or operate hazardous machinery
until your eyesight has returned to normal.

3. How to use Dropodex® Eye Drops
Always use this medicine exactly as described in this leaflet, or as your
doctor has told you. Check with your doctor if you are not sure.
If your eye problem is severe, you may be asked to use these eye drops
more frequently at first. The frequency can then be reduced as the eye
gets better. More detailed instructions will be given to you by your
doctor or pharmacist. Make sure you follow these instructions carefully.
Usual Dose
The recommended dose is 1 drop in one or both eyes, 4 to 6 times
a day in the affected eye. In severe cases, treatment may be started
with 1 drop every hour at the start of the therapy but dosage should
be reduced to 1 drop every 4 hours when a favourable response is
observed. Do not stop using the treatment abruptly. Gradual tapering
off is recommended in order to avoid a relapse. The duration of
treatment will generally vary from a few days to a maximum of 14 days.
Use in children and adolescents
Follow the instructions given by your doctor because the dose may vary.
Do not allow the tip of the single-dose container to touch your eye or
areas around your eye. It may become contaminated with bacteria that
can cause eye infections leading to serious damage to the eye, even loss
of vision. To avoid possible contamination of the single-dose container,
keep the tip of the container away from contact with any surface.
The solution from one individual single-dose container of Dropodex®
is to be used immediately after opening for administration to the
affected eye(s). Since sterility cannot be maintained after the individual
single-dose container is opened, a new single-dose container must be
opened prior to each use and must be discarded immediately after
administration.

Instructions for use of Dropodex® Eye Drops:
1. Break off one single-dose container from
(Figure 1)
the strip.
2. Open the single-dose container by
bending/ twisting the tab (Figure 1)
3. Tilt your head backwards
4. Gently pull down the lower lid to form
(Figure 2)
a pouch (Figure 2).
5. Place the dropper tip close to your eye, but
do not touch the eye or lid, and gently
squeeze the single-dose container to release
one drop into your eye. (Figure 3).
(Figure 3)
6. Close the eye for about 30 seconds and at
the same time gently press a finger against
the corner of the closed eye,nearest the
nose. (Figure 4).
7. Some drops may roll down your face. This
(Figure 4)
is normal. The eye holds less than one drop.
Wipe away the excess with a clean tissue.
If the drop of medication is not retained for any reason, another
drop should be dropped into the eye pouch.
8. If you use more than one type of eye medicine, wait five minutes before
putting in the next one. This prevents the first drop from being
washed away. Eye ointments should be applied last.
9. Repeat instructions 3-8 for the other eye.
10. After instillation, discard the used single-dose container even if
there is solution remaining.
11. Store the remaining single-dose containers in the foil sachet. After
opening the sachet, the unopened ampoules can be stored for 28 days.

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:

Follow these instructions carefully. Consult your doctor or pharmacist
if there is anything you do not understand.

Store in original package. After opening the sachet, the unopened
ampoules can be stored for 28 days. Do not store above 25°C. Do not
refrigerate or freeze.

If you use more Dropodex® Eye Drops than you should
If you put too much Dropodex® into your eye(s), close your eyes and
rinse off any excess with warm water.
If the contents of Dropodex® are accidentally swallowed, tell your
doctor immediately or go to your nearest hospital casualty
department. Take your medicine with you.

The Dropodex® single-dose container should be discarded immediately
after use, even if some solution remains. Do not throw away any
medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will
help protect the environment.

If you forget to use Dropodex® Eye Drops
Do not use a double dose to make up for a forgotten dose. If you
forget to use a dose of Dropodex®, use it as soon as you remember
and then carry on as before.

6. Contents of the pack and other information

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971; Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Dropodex® Eye Drops
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
sachet, single-dose containers and on the carton. The expiry date can
be found after ‘EXP’. The expiry date refers to the last day of that
month.

What Dropodex® Eye Drops contain
The active substance is dexamethasone sodium phosphate.
The other ingredients are: sodium chloride, disodium edetate, disodium
phosphate dodecahydrate (E339) and purified water.
What Dropodex® Eye Drops look like and contents of the pack
Each single-dose container contains 0.4 ml Dropodex® Eye Drops,
solution without preservative. There are five single-dose containers per
sachet. Each carton contains four sachets.

Most people who are treated with these eye drops do not suffer
from any unwanted side effects. Occasionally this medicine may cause
temporary stinging, burning, redness or watering of the eyes.

Each individual single-dose container contains 0.4 mg of dexamethasone
phosphate (as dexamethasone sodium phosphate) in 0.4 ml of solution.

In very rare cases, some patients with severe damage to the clear layer
at the front of the eye (the cornea) have developed cloudy patches on
the cornea due to calcium build-up during treatment.

Marketing Authorisation Holder:
Moorfields Eye Hospital NHS Foundation Trust trading as Moorfields
Pharmaceuticals, 25 Provost Street, London, N1 7NH, United Kingdom.
Tel: 0207 684 9090

Topical corticosteroids should not be used for longer than one week
except under ophthalmic supervision. You should consult your doctor
if you become aware of any changes in your eyesight.
It is possible that some of the solution may be absorbed into the
general circulation of the body following administration to the eye.
It is unlikely, however, that this will have any unwanted effect on the
body because so little of the eye drop is absorbed through the eye.The
action of pressing on the inner part of the eye when adding the drops
will also help to reduce this absorption even further.
If it does happen, it can cause hormone problems: growth of extra
body hair (particularly in women), muscle weakness and wasting, purple
stretch marks on body skin, increased blood pressure, irregular or
missing periods, changes in the levels of protein and calcium in your
body, stunted growth in children and teenagers and swelling and weight
gain of the body and face (called ‘Cushing’s syndrome’) (see section 2,
“Warnings and Precautions”).
30M005

Marketing Authorisation Holder and Manufacturer:

Manufacturer:
Unolab Manufacturing S.L.
Avda. de las Flores, 6
28970 Humanes de Madrid
Madrid
Spain
This leaflet was last revised in November 2016.

For package information leaflet in large font
please go to www.xpil.medicines.org.uk
For large print, audio or braille versions
contact the RNIB on the Medicine Leaflet
Line 0800 198 5000.

Non-printed information
Artwork details
• Ref:
PCS-PIL2011
• Issue: 24
• Date: 29 November 2016
Specification details
• Origination: 10 November 2011 - (as Issue 01)
• PIL dimensions: 210 x 297 mm
• PIL border: 10 mm
Font details
• Main heading — Frutiger 65 Bold: 22 pt
• Sub-titles
— Gill Sans Bold: 11 pt
• Body copy
— Gill Sans: 9 pt

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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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