MAXIDEX 0.1 %w/v Eye Drops Suspension

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

DEXAMETHASONE

Saatavilla:

Novartis Pharmaceuticals UK Ltd

ATC-koodi:

S01BA01

INN (Kansainvälinen yleisnimi):

DEXAMETHASONE

Annos:

0.1 %w/v

Lääkemuoto:

Eye Drops Suspension

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Corticosteroids, plain

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-05-05

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.
•
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.
DO NOT PASS IT ON TO OTHERS.
It may harm them, even if their symptoms are the same as yours.
•
IF ANY OF THE SIDE EFFECTS GET SERIOUS,
or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
WHAT MAXIDEX IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE MAXIDEX
3.
HOW TO USE MAXIDEX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MAXIDEX
6.
FURTHER 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.
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.
TAKE SPECIAL CARE...
•
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 corticosteroid-induced increased pressure in
the eye may be greater in
children and may occur earlier than in adults. The risk of increas

Valmisteyhteenveto

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: Contains 0.01% w/v Benzalkonium Chloride
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.
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