Maxidex 0.1% w/v Eye Drops, Suspension

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Dexamethasone

Saatavilla:

Novartis Ireland Limited

ATC-koodi:

S01BA; S01BA01

INN (Kansainvälinen yleisnimi):

Dexamethasone

Annos:

0.1 percent weight/volume

Lääkemuoto:

Eye drops, suspension

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Corticosteroids, plain; dexamethasone

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1984-01-05

Pakkausseloste

1
PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXIDEX® 0.1 %W/V EYE DROPS, SUSPENSION
dexamethasone
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 your 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 MAXIDEX is and what it is used for
2.
What you need to know before you use MAXIDEX
3.
How to use MAXIDEX
4.
Possible side effects
5.
How to store MAXIDEX
6.
Contents of the pack and other information
1.
WHAT MAXIDEX IS AND WHAT IT IS USED FOR
MAXIDEX
belongs to a group of medicines known as corticosteroids.
IT IS USED TO TREAT
allergy and
inflammation of the eye. It helps to relieve the symptoms of
inflammation such as redness, soreness
and swelling.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MAXIDEX
DO NOT USE MAXIDEX...
-
If you think that you have any type of infection, including viral,
fungal, untreated parasitic eye
infections and tuberculosis of the eye.
-
If you are
ALLERGIC
to dexamethasone or any of the other ingredients listed in section 6.
If any of these apply, ask your doctor for advice.
WARNINGS AND PRECAUTIONS
-
Only use MAXIDEX in your eye(s).
-
MAXIDEX is not recommended for use
IN CHILDREN UNDER 2 YEARS.
-
MAXIDEX should not be used for
MORE THAN ONE WEEK
, unless advised by your doctor. Use of
MAXIDEX for
LONG PERIODS OF TIME
, may cause:
o
INCREASED PRESSURE
in your eye(s). If you already have high pressure in your eye(s) or
an eye disease such as
GLAUCOMA
. You should have your eye pressure checked
regularly while using MAXIDEX. Ask your doctor for advice. This is
especially
important in paediatric patients, as the risk of
cort

Valmisteyhteenveto

Health Products Regulatory Authority
13 August 2021
CRN00CD9C
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxidex 0.1% w/v Eye Drops, Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone 0.1% w/v.
Excipients with known effect in suspension:
0.01% w/v Benzalkonium Chloride,
6.5 mg of phosphates in 5 ml, which is equivalent to 1.3 mg/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, suspension
Whitish suspension, free from flocculates.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated for the treatment of allergic and inflammatory conditions of
the eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, adolescents and children (2 years of age and above)
One drop instilled into the conjunctival sac every 30-60 minutes for
3-4 days or until a satisfactory response occurs.
Method of Administration
For ocular use only.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
Do not let the tip of the dropper touch the eye.
Nasolacrimal occlusion or gently closing the eyelid for 2 minutes
after administration is recommended. This may reduce the
systemic absorption of medicinal products administered via the ocular
route and result in a decrease in systemic adverse
reactions.
Paediatric patients
The safety of this product has not been established in children below
2 years of age.
Elderly population
No overall differences in safety or effectiveness have been observed
between elderly and younger patients.
Hepatic and renal impairment
The safety and efficacy of MAXIDEX in patients with hepatic or renal
impairment have not been established.
4.3 CONTRAINDICATIONS

Ocular viral infections such as vaccinia, varicella
Health Products Regulatory Authority
13 August 2021
CRN00CD9C
Page 2 of 6

Herpes simplex keratitis.

Fungal disease of ocular structures or untreated parasitic eye
infections and mycobacterial ocular infections.

Acute, untreated bacterial inf