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DROPODEX 0.1% W/V EYE DROPS SOLUTION

Active substance(s): 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.

What is in this leaflet:
1. What Dropodex® Eye Drops are and what it is 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
®

1. WHAT DROPODEX EYE DROPS ARE AND
WHAT IT IS USED FOR
Every Dropodex® single-dose unit contains the active ingredient
Dexamethasone phosphate (as dexamethasone sodium phosphate) at a
concentration of 0.1% w/v (1mg/ml). Each Dropodex® sterile, single-dose
unit holds approximately 0.4 ml of solution. Dropodex® belongs to the
group of corticosteroids that suppresses inflammation.
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.

Children and adolescents
Use of Dropodex 0.1% w/v eye drops solution in children and adolescents
must be restricted. In children, continuous, long term use of corticosteroid eye
drops should be avoided.
Other medicines and Dropodex®
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
prescription.
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®.
If you are using more than one sort of eye drops leave five minutes
between applications.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant, or are
planning to have a baby, you should 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.

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU
®
USE DROPODEX

3. HOW TO USE DROPODEX

Do not use Dropodex®:
• If you are allergic (hypersensitive) to Dexamethasone sodium
phosphate or any of the other ingredients of Dropodex® (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:
If any of the following apply to you then inform your doctor or
eye specialist before starting treatment:
• 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 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).

®

Always use Dropodex® exactly as your doctor has told you. If your
eye problem is severe, you may be asked to use this eye drop 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 unit 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 unit, keep
the tip of the container away from contact with any surface.
The solution from one individual single-dose unit of Dropodex® is to
be used immediately after opening for administration to the affected
eye(s). Since sterility cannot be maintained after the individual singledose unit is opened, a new single-dose unit must be opened prior to
each use and must be discarded immediately after administration.

How to use Dropodex®:
1. Wash your hands thoroughly before
(Figure 1)
using the drops. Open the foil sachet
if required.
2. Break off one single-dose unit from
the strip.
3. Open the single-dose unit by


(Figure 2)
bending/twisting the tab. (Figure 1).
4. Tilt your head backwards.
5. Gently pull down the lower lid with your
other hand to form a pouch. (Figure 2).
6. Place the dropper tip close to your
(Figure 3)
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).
7. Close your eyelid and gently press
(Figure 4)
the corner of your eye with your
forefinger for one minute. (Figure 4).
8. Some drops may roll down your face. This is normal. Wipe away
excess solution with a clean tissue. If the drop of Dropodex® is not
retained for any reason, another drop should be instilled in the eye.
9. After instillation, discard the used single-dose unit even if there is
solution remaining.
10. Repeat instructions 2-9 for the other eye.
11. Store the remaining single-dose units in the foil sachet. After

opening the sachet, the unopened ampoules can be stored for 28 days.
Follow these instructions carefully. Consult your doctor or pharmacist
if there is anything you do not understand.
If you use more Dropodex® 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® is accidentally swallowed, tell your doctor
immediately or go to your nearest hospital casualty department.
Take your medicine with you.
If you forget to use Dropodex®
Do not administer a double dose to make up for a forgotten dose. If
you forget to administer a dose of Dropodex®, use it as soon as you
remember and then carry on as before.

4. POSSIBLE SIDE EFFECTS
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.
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 you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

®

5. HOW TO STORE DROPODEX

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 units and on the carton. The expiry date can be
found after the abbreviation ‘EXP’. The expiry date refers to the last
day of that month shown.
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.
The Dropodex® single-dose unit 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.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Dropodex® looks like and contents of the pack
Each single-dose unit contains 0.4 ml Dropodex® Eye Drops, solution
without preservative. There are five single-dose units per sachet. Each
carton contains four sachets.
Each individual single-dose unit contains 0.4 mg of
Dexamethasone phosphate (as dexamethasone sodium phosphate) in
0.4 ml of solution.
Dropodex® Eye Drops, solution also contain sodium chloride, disodium
edetate, disodium phosphate dodecahydrate (E339) and purified water.
Marketing Authorisation Holder:
Moorfields Pharmaceuticals, 34 Nile Street, London, N1 7TP,
United Kingdom.
Tel: 0207 684 9090
Manufacturer:
NOVOCAT FARMA, S.A.
Av. De les Flors, 29
L7. 08191 Rubí.
Barcelona, Spain.
This leaflet was last revised in 01/2013.

To get this leaflet in large print, braille or as
an audio CD, call the RNIB Medicine Leaflet
line on 0800 198 5000

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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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