Dropodex 0.1% w/v eye drops, solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXAMETHASONE PHOSPHATE

Available from:

Rayner Pharmaceuticals Ltd 10 Dominion Way, Worthing, West Sussex, BN14 8AQ,, United Kingdom

ATC code:

S01BA01

INN (International Name):

DEXAMETHASONE PHOSPHATE 1 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

DEXAMETHASONE PHOSPHATE 1 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2013-01-28

Patient Information leaflet

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PACKAGE LEAFLET
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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. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Dropodex Eye Drops are and what they are 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 THEY ARE USED FOR
Each Dropodex single-dose container contains the active ingredient
dexamethasone phosphate (as
dexamethasone sodium phosphate), at a concentration of 0.1% w/v (1
mg/ml). Each Dropodex sterile
single-dose container 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. Your doctor may
sometimes use other drugs at the same time as Dropodex to make sure
that your eye is treated
effectively.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DROPODEX EYE DROPS
DO NOT USE DROPODEX EYE DROPS:
-
If you are allergic to dexamethasone sodium phosphate or any of the
other ingredients of this
medicine (listed in section 6).
-
In case of bacterial eye infections (

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dropodex 0.1% w/v Eye Drops, solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone sodium phosphate Ph Eur equivalent to 0.1% w/v
dexamethasone.
Each ml of solution contains 1 mg 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 eye drops which are sterile and preservative free.
A colourless solution when examined under suitable conditions of
visibility, clear and free
from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dropodex 0.1% w/v Eye Drops are indicated for inflammatory conditions
of the anterior
segment of the eye, such as marginal keratitis, stromal oedema in
keratitis, anterior uveitis,
episcleritis (if NSAIDs are contraindicated or insufficient),
scleritis, acute phase of severe
allergic conjunctivitis not responding to standard therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly) _
The usual dose in adults, including the elderly, is 1 drop, 4 to 6
times daily.
In severe conditions, the treatment can be used more frequently at
first (1 drop every hour),
and
then
reduced
to
1
drop
every
4
hours
as
the
eye
inflammation
subsides.
Dexamethasone sodium phosphate dosage should be progressively reduced.
_Paediatric population _
Use of Dropodex 0.1% w/v Eye Drops, solution in children and
adolescents must be restricted.
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No data on safety and efficacy are available for children aged less
than 2 years. Currently
available data are described in sections 4.8, 5.1 and 5.2 but no
recommendation on a posology
can be made. In children, long-term continuous corticosteroid therapy
should be avoided due
to possible adrenal suppression (see section 4.4).
Method of administration
Ocular use.
4.3
CONTRAINDICATIONS
Hypersen