Dexamethasone phosphate 1 mg/ml eye drops, solution, preservative free
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
12-08-2017
Summary of Product characteristics
(SPC)
12-08-2017
Active ingredient:
Dexamethasone sodium phosphate
Available from:
Alissa Healthcare Research Limited
ATC code:
S01BA; S01BA01
INN (International Name):
Dexamethasone sodium phosphate
Dosage:
1.0 milligram(s)/millilitre
Pharmaceutical form:
Eye drops, solution
Administration route:
Eye solution use
Units in package:
Pack size: 20 single dose containers
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
Farma Mediterrània S.L, Novocat Farma S.A.
Therapeutic group:
Corticosteroids, plain
Therapeutic area:
Corticosteroids, plain; dexamethasone
Therapeutic indications:
For treatment of non-infectious inflammatory conditions affecting the anterior segment of the eye
Authorization status:
Not marketed
Authorization date:
2015-03-13
Patient Information leaflet
Alissa Healthcare Research Limited
UK/H/5450/01/IB/006
Variation to updated in line with PRAC
1
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
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone phosphate 1 mg/ml eye drops, solution, preservative free
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 1 mg of dexamethasone phosphate as
dexamethasone sodium phosphate.
Each individual single-dose unit contains 0.4 mg 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.
Single-use, unpreserved sterile eye drops.
A colourless solution when examined under suitable conditions of
visibility, practically clear and practically free from
particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For treatment of non-infectious inflammatory conditions affecting the
anterior segment of the eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dexamethasone phosphate 1 mg/ml eye drops, solution, preservative free
is for ocular use only.
This product should be used only under close ophthalmic supervision.
_Posology_
The usual posology is of 1 drop 4 to 6 times daily in the affected
eye.
In severe cases, treatment may be started with 1 drop every hour but
dosage should be reduced to one drop every 4
hours when 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
recommendations 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-term continuous corticosteroid therapy should be
avoided due to possible adrenal suppression (see
section 4.4).
METHOD OF ADMINISTRATION
Dexamethasone is a sterile solution that does not contain a
preservative. The solution from one individual single dose
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