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DEXAMETHASONE PHOSPHATE 0.1% W/V EYE DROPS SOLUTION PRESERVATIVE FREE

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE

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Package leaflet: Information for the user

Dexamethasone phosphate 1 mg/ml eye drops, solution, preservative free
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 Dexamethasone eye drops is and what it is used for
2. What you need to know before you use Dexamethasone eye drops
3. How to use Dexamethasone eye drops
4. Possible side effects
5. How to store Dexamethasone eye drops
6. Contents of the pack and other information
The full name of your medicine is Dexamethasone phosphate 1 mg/ml
eye drops, solution, preservative free which is presented in single-dose
containers. In this leaflet the shorter name Dexamethasone eye drops is
used.
1. What Dexamethasone eye drops is
and what it is used for

Dexamethasone eye drops contains dexamethasone, which is a
corticosteroid used to treat inflammatory symptoms (such as pain,
swelling and redness).
Dexamethasone eye drops is used to treat inflammatory conditions
affecting the front part of the eye that are not caused by infections.
2. What you need to know before
you use Dexamethasone eye drops

Do not use Dexamethasone eye drops:
- if you are allergic to dexamethasone sodium phosphate or any of the
other ingredients of this medicine (listed in section 6)
- if you are suffering from an eye infection that is untreated
- if you have damage to the surface of the eye (including, ulcers
or injuries which have not healed properly), unless otherwise
recommended by your ophthalmologist
- if you have high pressure in the eye known to be caused by steroids,
unless otherwise recommended by your ophthalmologist.
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.
Talk to your doctor or pharmacist before using Dexamethasone eye drops
if the following apply to you, as close monitoring is needed:
- children and the elderly. More frequent monitoring is advised. If
Dexamethasone eye drops is to be used by a child, do not use for a long
time without a break.
- if you have an eye infection, or have had viral eye infections in the past
(eg, herpes). Only use Dexamethasone eye drops if you are using an
anti-infective medicine, and are under the care of an ophthalmologist.
- if you have a corneal ulcer, an open sore on the surface of the eye. Do
not use Dexamethasone eye drops, unless you are under the care of an
ophthalmologist

- if you suffer from high pressure in the eye, or you have glaucoma (a
condition which can cause damage to the optic nerve and may cause
loss of sight). 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 Dexamethasone eye drops. 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 Dexamethasone eye drops for a
short period of time.
• If you are diabetic, tell your ophthalmologist or optician that you are
using Dexamethasone eye drops.
• If you have a red eye that has not been diagnosed, do not use
Dexamethasone eye drops.
• If you usually wear contact lenses, avoid wearing contact lenses while
you are using Dexamethasone eye drops.
Children
Use of Dexamethasone eye drops solution in children must be restricted.
In children, continuous, long term use of corticosteroid eye drops should
be avoided.
Other medicines and Dexamethasone eye drops
Tell your doctor or pharmacist if you are using, have recently used or
might use any other medicines.
If you are using any other eye medicines, wait 15 minutes between using
each medicine.
Using eye drops containing steroids together with certain other eye drops
(e.g. those containing beta-blockers to treat high pressure in the eye) may
rarely cause calcium crystals to form on the surface of the eye.
Pregnancy, breast-feeding and fertility
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
taking this medicine.
There is not enough information on the use of Dexamethasone eye drops
during pregnancy to know the possible side effects.
For this reason, the use of Dexamethasone eye drops during pregnancy is
not recommended.
It is not known if this medicine is present in breast milk. Dexamethasone
eye drops should be used with caution whilst breast feeding.
Driving and using machines
You may have blurred vision for a short time after using your drops. Do not
drive or use machines until normal vision has returned.
3. How to use Dexamethasone eye drops

Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
This medicine should only be used in the eye (ocular use)
Recommended dose:
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 reduce the dose gradually in order to
avoid the condition worsening again after you stop your medication.
Use in elderly people:
There is no need to adjust the recommended dose.
Use in children:
Do not use for long-term treatment without a break.

Method of administration
1. Open the foil sachet which contains 5 single dose
containers. Write the date of first opening on the
sachet. Discard any unused single dose container 28
days after opening the sachet.
2. Wash your hands well before using these drops.
3. Break off one single dose container from the strip and
twist open the top of the single dose container (Figure
1).
4. Tilt your head back and pull your lower eyelid down
slightly to form a pocket between your eyelid and eye
(Figure 2). Put one drop into the eye to be treated. Do
not allow the container to touch your eye or any area
around your eye (Figure 3).
5. 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 2 minutes (Figure 4). This helps to
stop the eye drops spreading into the rest of your body.
6. Throw away the single-dose container after use. Do not
keep it to use again.

Figure 1

Figure 2

Figure 3

Figure 4

Frequency of use
As recommended by your doctor. Usually 4 to 6 times a day.
Duration of treatment
You will usually need to use your drops for a few days and for no longer
than 14 days.
If you use more Dexamethasone eye drops 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 Dexamethasone eye drops
Do not use a double dose to make up for a forgotten dose.
If you stop using Dexamethasone eye drops
Do not stop using the treatment abruptly. 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 or pharmacist.
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):
- increased pressure in the eye.
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):
- allergic reactions
- prolonged healing of wounds
- cataract (clouding of the lens inside the eye)
- infections
- glaucoma (caused by high pressure in the eye).
Very rare (may affect up to 1 in 10,000 people):
- conjunctivitis (inflammation of the surface of the eye, causing redness,
watering and irritation)
- increase in the size of the pupil
- swelling of the face
- drooping eyelids
- inflammation inside the eye which causes pain and redness (uveitis)
- formation of calcium crystals on the surface of the eye
- swelling of the surface of the eye (the cornea)
- ulcers on the surface of the eye causing pain, watering, redness and
vision loss perforation of the surface of the eye (the cornea).

General conditions:
Uncommon (may affect up to 1 in 100 people):
- if used for prolonged periods the production of certain hormones may
be reduced
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.
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:
UK: 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 Dexamethasone 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
overwrap of each unit and on the carton after EXP. The expiry date refers
to the last day of that month. After opening the sachet, the unopened
single-dose container can be stored for 28 days.
Do not store above 25°C. Store in original package in order to protect from
light.
Do not refrigerate or freeze.
Opened single-dose containers 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 Dexamethasone eye drops contains
- The active substance is dexamethasone sodium phosphate. Each
individual single-dose unit contains 0.4 mg of dexamethasone
phosphate (as dexamethasone sodium phosphate) in 0.4 ml of solution.
- Dexamethasone phosphate 1 mg/ml eye drops, solution, preservative
free also contains sodium chloride, disodium edetate, disodium
phosphate dodecahydrate (E339) and purified water.
What Dexamethasone eye drops looks like and contents of the pack
Each single-dose unit contains 0.4 ml Dexamethasone eye drops without
preservative. There are five single-dose units per sachet. Each carton
contains either four sachets (20 pack) or six sachets (30 pack). Not all
pack sizes may be marketed.
Marketing Authorisation Holder:
Alissa Healthcare Research Limited
Unit 5, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire,
United Kingdom, PO15 7FE
Manufacturer:
Farma Mediterrània S.L
C/Sant Sebastià s/n
08960 Sant Just Desvern
(Barcelona)
SPAIN

Novocat Farma S.A.
Avda. de les Flors, 29, Local 7
Rubi-Barcelona
Spain
08191

This medicinal product is authorised in the Member States of the EEA
under the following names:
Ireland & United Kingdom: Dexamethasone phosphate 1 mg/ml eye drops,
solution, preservative free
This leaflet was last revised in: 08/2015

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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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