PACKAGE LEAFLET: INFORMATION FOR THE USER

DEXAMONO

1 mg/ml, eye drops, solution in single-dose containers
Dexamethasone sodium phosphate
Please read this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DEXAMONO is and what it is used for
What you need to know before using DEXAMONO
How to use DEXAMONO
Possible side effects
How to store DEXAMONO
Contents of the pack and other information

1. WHAT DEXAMONO IS AND WHAT IT IS USED FOR

DEXAMONO is an ophthalmic solution in single-dose containers containing a substance called dexamethasone. This substance is a corticosteroid that inhibits inflammatory symptoms.
DEXAMONO is indicated for:

The treatment of eye inflammation. The eye must not be infected (red eye, discharge, tearing); otherwise, specific treatment of the infection must be added (see section 2).

2. WHAT YOU SHOULD KNOW BEFORE USING DEXAMONO

Do not use DEXAMONO:

If you have an ocular infection, such as bacterial infections (including acute purulent infections), fungal infections, viral infections (e.g. Herpes simplex, vaccinia virus, varicella-zoster) or amoebic infections,
in the presence of corneal damage (perforation, ulceration, and corneal injury with incomplete epithelialization),
in case of known glucocorticoid-induced ocular hypertension (glucocorticoids being part of the corticosteroid family),
if you are allergic (hypersensitive) to dexamethasone sodium phosphate or to any of the excipients of DEXAMONO.

Warnings and precautions
Talk to your doctor or pharmacist before using DEXAMONO.
DO NOT INJECT, DO NOT INGEST.
Avoid contact between the tip of the container and the eye or eyelids.

If you use DEXAMONO, you must have regular ophthalmic examinations, in any case and particularly:
In children and elderly patients, more frequent ophthalmic checks are required,
If you have an ocular infection. You may use DEXAMONO only if the infection is controlled by an anti-infective treatment,
If you have corneal ulceration. You should not use topical dexamethasone treatment, or use DEXAMONO, unless inflammation is the main cause of delayed healing,
If you have pre-existing elevated intraocular pressure. If you previously experienced an increase in intraocular pressure following topical steroid treatment, you are at risk of developing increased intraocular pressure when treated with DEXAMONO,
If you have glaucoma.
Children: Long-term, uninterrupted therapy should be avoided.
Severe allergic conjunctivitis: If you have severe allergic conjunctivitis unresponsive to standard therapy, DEXAMONO may be used only for a short period.
Diabetes: If you are diabetic, inform your ophthalmologist.
Red eye: If you have a red eye without a confirmed diagnosis, do not use DEXAMONO.
Contact lenses: You must not wear contact lenses during treatment with DEXAMONO.

Other medicines and DEXAMONO
If you are using another eye drop at the same time, separate the administrations by 15 minutes.
Calcium phosphate precipitations on the corneal surface have been reported during concomitant topical therapy with steroids and beta-blockers.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

There is insufficient data on the use of DEXAMONO during pregnancy to assess potential harmful effects. For this reason, the use of DEXAMONO during pregnancy is not recommended.
It is not known whether this medicine is excreted in breast milk. However, the total dose of dexamethasone is low. Therefore, DEXAMONO may be used during breastfeeding. If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and use of machines
As with other eye drops, temporary blurred vision or other visual disturbances may affect your ability to drive vehicles or operate machinery. Do not drive or use machinery until your vision is clear.

3. HOW TO USE DEXAMONO

Dosage
Use this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop administered 4 to 6 times daily into the affected eye. In severe cases, treatment should begin with 1 drop every hour, reducing to 1 drop every 4 hours once a favorable response is observed. A gradual reduction of the dosage is recommended to avoid relapse.

No dosage adjustment is required in elderly patients.
In children, long-term and uninterrupted therapy should be avoided.

Method of administration
Ophthalmic use: this medicine is intended for administration into the eyes.

Wash your hands thoroughly before using the product.
Instill one drop into the affected eye, while looking upward and pulling down the lower eyelid with your finger.
Immediately after instillation, apply gentle pressure with your finger at the inner corner of the treated eye for several minutes (to reduce the possibility of systemic reactions and to optimally enhance medicine penetration into the eye).
Discard the single-dose container after use. Do not store the container for later use.

Frequency of administration
4 to 6 times daily.
Duration of treatment
Treatment duration generally ranges from a few days up to a maximum of 14 days.
If you use more DEXAMONO than you should
If you have instilled an excessive amount of the product into the eye and experience persistent irritation, rinse the eye with sterile water.
Contact your doctor or pharmacist immediately.
If you forget to use DEXAMONO
Do not use a double dose to make up for the missed dose.
If you stop using DEXAMONO
Do not stop treatment abruptly. Always consult your doctor before stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them:
Ocular disorders:
Very common (may affect more than 1 in 10 people):

increased intraocular pressure after 2 weeks of treatment.

Common (may affect less than 1 in 10 people):

discomfort, irritation, burning, stinging pain, itching, and blurred vision after instillation. These are usually short- to medium-term symptoms.

Uncommon (may affect less than 1 in 100 people):

allergic reactions and hypersensitivity to one of the components of the eye drops,
delayed wound healing,
lens clouding (cataract),
infections,
glaucoma.

Very rare (may affect less than 1 in 10,000 people):

inflammation of the eye membranes (conjunctivitis),
dilation of the pupil (mydriasis),
facial swelling (facial edema),
eyelid drooping (ptosis),
inflammation of the pigmented membrane of the iris (uveitis),
corneal calcification,
inflammation of the cornea (lens crystalline keratopathy),
changes in corneal thickness,
corneal edema,
corneal ulcer,
corneal perforation.

General disorders:
Uncommon (may affect less than 1 in 100 people):
Suppression of adrenal cortical function after frequent applications.
In very rare cases, patients with severe damage to the clear outer layer of the front of the eye (cornea) have developed areas of corneal opacification due to calcium accumulation during treatment.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist.
You can also report adverse reactions directly via the reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DEXAMONO

Keep this medicine out of the sight and reach of children.
Do not use DEXAMONO after the expiry date stated on the single-dose container, following the term "EXP." The expiry date refers to the last day of that month.
After first opening of the sachet: use the single-dose containers within 5 days.
After first opening of the sachet: use the single-dose containers within 10 days.
After first opening of the single-dose container: use immediately and discard the single-dose container with any remaining solution immediately after use.
Store the single-dose containers inside the pouch to protect them from light.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What DEXAMONO contains

The active substance is sodium dexamethasone phosphate. Each millilitre of solution contains 1 mg of dexamethasone phosphate (as sodium dexamethasone phosphate).
The excipients are disodium edetate, disodium phosphate dodecahydrate, sodium chloride, water for injections.

Description of the appearance of DEXAMONO and packaging contents
DEXAMONO is a transparent solution, colourless to light brown, supplied in single-dose containers.
Each single-dose container holds 0.4 ml of solution. The package contains 10, 20, 30, 50 or 100 single-dose containers packed in sachets.

Marketing Authorisation Holder
Laboratoires THEA,
12, rue Louis Blériot,
63017 Clermont-Ferrand, Cedex 2
FRANCE

Distributor
THEA FARMA S.p.A. Via Giotto, 36 – 20145 MILAN

Manufacturer
EXCELVISION,
Rue de la Lombardière,
07100 Annonay,
FRANCE
Laboratoire UNITHER
ZI de la Guérie
50211 COUTANCES CEDEX
FRANCE

This medicinal product is authorised in the EEA Member States under the following names:
France, Poland, Portugal and Spain DEXAFREE
Belgium, Luxembourg and the Netherlands MONOFREE DEXAMETHASONE
Austria and Germany MONODEX
Italy DEXAMONO

This leaflet was last updated in: December 2014
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency.