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

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

DEXAMETHASONE PHOSPHATE

Fáanlegur frá:

Wockhardt UK Limited

ATC númer:

S01BA; S01BA01

INN (Alþjóðlegt nafn):

DEXAMETHASONE PHOSPHATE

Skammtar:

1 milligram(s)/millilitre

Lyfjaform:

Eye drops, solution in single-dose container

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Corticosteroids, plain; dexamethasone

Leyfisstaða:

Not marketed

Leyfisdagur:

2014-12-12

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE PHOSPHATE 1MG/ML (AS SODIUM PHOSPHATE) EYE DROPS,
SOLUTION IN A
SINGLE-DOSE CONTAINER
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.
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.
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
1. WHAT DEXAMETHASONE PHOSPHATE EYE DROPS ARE AND WHAT IT IS USED FOR
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.
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),

Vara einkenni

Health Products Regulatory Authority
22 January 2019
CRN008RV8
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone Phosphate 1mg/ml (as sodium phosphate) Eye Drops
Solution in a
single dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone sodium phosphate equivalent to 0.1% w/v dexamethasone
phosphate
Each ml of solution contains 1mg of dexamethasone phosphate (as
dexamethasone
sodium phosphate).
Each individual single-dose unit contains 0.4mg dexamethasone
phosphate (as
dexamethasone sodium phosphate) in 0.4 ml of solution.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in a single container.
Single use eye drops which are sterile and preservative free.
A colourless solution when examined under suitable conditions of
visibility, which is
clear and free from particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of non-infectious inflammatory conditions affecting
the anterior
segment of the eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dexamethasone phosphate 1mg/ml (a sodium phosphate) Eye Drops,
solution in a
single-dose container is for ocular use only. This product should be
used under close
ophthalmic supervision.
Posology
The usual dose is 1 drop, 4 to 6 times daily in the affected eye.
Health Products Regulatory Authority
22 January 2019
CRN008RV8
Page 2 of 9
In severe cases, treatment may be started with 1 drop every hour but
dosage should
be reduced to 1 drop every 4 hours when a favourable response is
observed. 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.
Elderly patients
There has been wide experience with the use of dexamethasone eye drops
in elderly
patients. The dosage recommendation given above reflect the clinical
data derived
from this experience.
_Paediatric population_
Efficacy and safety has not been established in the paediatric
population.
In children, long-t