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DEXAMETHASONE PHOSPHATE 1MG/ML (AS SODIUM PHOSPHATE) EYE DROPS SOLUTION IN A SINGLE-DOSE CONTAINER

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE

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2. What you need to know before you use
Dexamethasone Phosphate Eye Drops
Do not use Dexamethasone Phosphate Eye Drops
• if you are suffering from an eye infection that you
are not using a medicine for
• 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
• if you are allergic (hypersensitive) to
dexamethasone 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.
Talk to your doctor, pharmacist or nurse before
using Dexamethasone Phosphate Eye Drops if the
following apply to you, as close monitoring is needed:
- for 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 (e.g. herpes). Only use
Dexamethasone Phosphate 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
Phosphate 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 Phosphate 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 Phosphate Eye Drops for a short
period of time.
• If you are diabetic, tell your ophthalmologist
or optician that you are using Dexamethasone
Phosphate Eye Drops.

Tell your doctor if you are using ritonavir or cobicistat,
as this may increase the amount of dexamethasone in
the blood.
Pregnancy and breast feeding
There is not enough information on the use of
Dexamethasone Phosphate Eye Drops during
pregnancy to know the possible side effects.
For this reason, the use of Dexamethasone Phosphate
Eye Drops during pregnancy is not recommended.
It is not known if this medicine is present in breast
milk. However, the dose of Dexamethasone
Phosphate Eye Drops is low. Dexamethasone
Phosphate Eye Drops 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 Dexamethasone Phosphate
Eye Drops
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 reduce the
dose gradually in order to avoid the condition
worsening again after you stop your medication.
- 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.
1. Wash your hands well before using these drops.
2. Look upwards and pull the lower eyelid down
with your finger. Put one drop into the eye to
be treated.
3. 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.
4. Throw away the single-dose container after use.
Do not keep it to use again.

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09/01/2017

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Date

Artwork No.

815560

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n/a

Dexamethasone sodium phosphate 1mg-ml Eye Drops LFT

Description

Keyline (non-printing)

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

• Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
• Some medicines may increase the effects of
Dexamethasone Phosphate Eye Drops and your
doctor may wish to monitor you carefully if you
are taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Dexamethasone Phosphate Eye Drops contains
dexamethasone, which is a corticosteroid used to
stop inflammatory symptoms (such as pain, heat
swelling and redness).
Dexamethasone Phosphate Eye Drops 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 Dexamethasone Phosphate Eye
Drops. See Section 2.

Using eye drops containing steroids and eye drops
containing beta-blockers (to treat high pressure in
the eye) together may rarely cause calcium crystals
to form on the surface of the eye.

artwork.leicester@cirrus-artwork.com

1. What Dexamethasone Phosphate Eye
Drops are and what it is used for

Other medicines and Dexamethasone
Phosphate Eye Drops
If you are using any other eye medicine, wait
15 minutes between using each medicine.

Wockhardt UK Limited

What is in this leaflet:
1. What Dexamethasone Phosphate Eye Drops are
and what it is used for
2. What you need to know before you use
Dexamethasone Phosphate Eye Drops
3. How to use Dexamethasone Phosphate Eye Drops
4. Possible side effects
5. How to store Dexamethasone Phosphate Eye Drops
6. Contents of the pack and other information

Talk to your doctor 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 longterm or intensive treatment with Dexamethasone
Phosphate 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 ritonavir or cobicistat.

Customer

The name of your medicine is Dexamethasone
Phosphate 1mg/ml (as sodium phosphate) Eye Drops,
Solution in a single-dose container. Throughout the
rest of this leaflet it is referred to as Dexamethasone
Phosphate Eye Drops.

• If you have a red eye that has not been diagnosed,
do not use Dexamethasone Phosphate Eye Drops.
• If you usually wear contact lenses: avoid
wearing contact lenses while you are using
Dexamethasone Phosphate Eye Drops.

Measure bar should be 150mm at 100% scale

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.

Colours Used

Dexamethasone Phosphate 1mg/ml (as sodium phosphate)
Eye Drops, Solution in a single-dose container

Process Black

Package leaflet: Information for the user

Hormone problems:
Not known: frequency cannot be estimated from
the available data
• 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”).
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
• changes in the thickness of the surface of the eye,
• ulcer on the surface of the eye causing pain,
watering, redness, and vision loss,
• perforation of the surface of the eye (the cornea).

Each individual single-dose unit contains 0.4 mg of
Dexamethasone phosphate (as sodium phosphate)
in 0.4 ml of solution.
Dexamethasone Phosphate Eye Drops, solution
also contain sodium chloride, disodium edetate,
disodium phosphate dodecahydrate (E339) and
purified water.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK
Manufacturer
Novocat Farma S.A, Avda de la Flores, Barcelona,
Spain.
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the following information:
Product name

Reference number

Dexamethasone
Phosphate 1mg/ml
(as sodium phosphate)
Eye Drops, Solution in a
single-dose container

PL 29831/0589

This is a service provided by the Royal National
Institute of Blind People.
For patients in the Republic of Ireland please call
+44 1978 669272
This leaflet was last revised in 01/2017
This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK & Ireland: Dexamethasone Phosphate
1mg/ml (as sodium phosphate) Eye Drops,
Solution in a single-dose container

General conditions:
Uncommon (may affect up to 1 in 100 people):
• if used for prolonged periods, the production of
certain hormones may be reduced. Signs of this
could include 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the national reporting
systems listed below:
United Kingdom:
Yellow Card Scheme
Website: http://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.

107386/2

9.75pt (Main Body) / 9pt (Variables)

UK

England

Market

Language

1

09/01/2017

Proof No.

Date

Artwork No.

815560

MPI
Proof By

Pharma
Code

n/a
180 x 445mm

Min. Point Size

Process Black

Keyline (non-printing)

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Like all medicines, this medicine can cause side
effects, although not everybody gets them:

Each single-dose unit contains 0.4 ml
Dexamethasone Phosphate Eye Drops, solution
without preservative. There are five single-dose
units per sachet. Each carton contains four sachets.

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

4. Possible side effects

What Dexamethasone Phosphate Eye Drops
looks like and contents of the pack

Size

If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

6. C
 ontents of the pack and other
information

artwork.leicester@cirrus-artwork.com

Do not stop using this medicine suddenly. Always
tell your doctor if you are thinking about stopping
the treatment.

As per uploaded pdf

If you stop using Dexamethasone Phosphate Eye
Drops

Profile

Do not use a double dose to make up for a forgotten
dose.

107386/2

If you forget to use Dexamethasone Phosphate
Eye Drops

Item Code

Immediately tell your doctor or pharmacist.

Dexamethasone sodium phosphate 1mg-ml Eye Drops LFT

Rinse the eye with sterile water if you have put too
much medicine in your eye and your eye feels sore.

Description

If you use more Dexamethasone Phosphate Eye
Drops than you should

Colours Used

You will usually need to use your drops for a few
days and for no longer than 14 days.

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.
Do not store above 25°C. Store in the original
package. Keep the single-dose containers in their
sachet to protect them from light.
After first opening the sachet, use the single-dose
containers within 28 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.

Wockhardt UK Limited

Duration of treatment

5. H
 ow to store Dexamethasone Phosphate
Eye Drops

Customer

As recommended by your doctor. Usually 4 to 6
times a day.

Measure bar should be 150mm at 100% scale

Frequency of use

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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