Patient Information Leaflet: Information for the User

USOLDEC 0.15% Eye Drops, solution

Dexamethasone sodium phosphate
Equivalent medicinal product
Please read all of 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What USOLDEC is and what it is used for

USOLDEC contains the active substance dexamethasone, a corticosteroid with anti-inflammatory activity.
USOLDEC is used to treat inflammation of certain parts of the eye (conjunctiva, eyelid, cornea, sclera, uvea), including inflammation due to allergies (e.g. vernal conjunctivitis, allergic conjunctivitis, allergic blepharitis and blepharoconjunctivitis, allergic keratoconjunctivitis, scleritis and episcleritis, uveitis).

2. What you should know before taking USOLDEC

Do not take USOLDEC

if you are allergic to dexamethasone or to any of the other ingredients of this medicine (listed in section 6);
if you have elevated pressure inside the eye (intraocular hypertension);
if you have eye infections caused by the Herpes simplex virus;
if you have acute ulcerative viral infections of the cornea;
if you have conjunctival inflammation (conjunctivitis) and corneal lesions (ulcerative keratitis), even in the early stage (positive fluorescein test);
if you have tuberculosis or fungal infections (mycoses) affecting the eye;
if you have purulent eye infections (acute purulent ophthalmia, purulent conjunctivitis, purulent and herpetic blepharitis);
if you have a stye (an infection of the eyelid characterized by a pimple-like swelling or abscess);
if you have corneal lesions or abrasions;
if the patient is a child under three years of age;
if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking USOLDEC.
Prolonged use of corticosteroids may lead to increased intraocular pressure.
If you use USOLDEC for more than two weeks, your doctor may prescribe a clinical examination to monitor intraocular pressure.
Do not use USOLDEC for long periods, as corticosteroid use may promote the development of cataracts (a condition in which the lens becomes cloudy), which may become irreversible, especially in the presence of viral infections (see “Do not take USOLDEC”).
Your doctor will prescribe USOLDEC with great caution if you suffer from conditions associated with corneal thinning.
If you have viral herpes-related corneal inflammation (herpetic keratitis), USOLDEC will be prescribed only under strict ophthalmologist supervision.
The administration of USOLDEC in cases of conjunctivitis (inflammation of the conjunctiva) caused by bacteria, viruses, or fungi may mask signs of worsening infection.
The use of USOLDEC in the presence of corneal lesions delays healing and may promote the onset and spread of infections.
Contact your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with USOLDEC. Consult your doctor before stopping treatment on your own. These risks are particularly significant in children and in patients treated with the medicines ritonavir or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
USOLDEC is contraindicated in children under 3 years of age.
If your child is between 3 and 12 years old, your doctor may prescribe USOLDEC only if strictly necessary and under direct supervision.

Other medicines and USOLDEC
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other ophthalmic products or other medicines, including over-the-counter medicines.
Talk to your doctor if you are taking ritonavir or cobicistat, as these may increase dexamethasone levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will prescribe USOLDEC during pregnancy only if strictly necessary and under direct supervision.

Driving and using machines
USOLDEC does not affect the ability to drive or operate machinery.
However, as with any eye medication, if transient blurred vision occurs during use, wait until vision clears before driving or operating machinery.

USOLDEC multidose bottle contains benzalkonium chloride
This medicine contains 0.04 mg of benzalkonium chloride per dose, equivalent to four drops of eye drops.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the eye’s outermost transparent layer). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.

USOLDEC contains phosphate buffer
This medicine contains 0.2 mg of phosphate buffer per drop, equivalent to 3.93 mg/ml.
If you have severe damage to the eye’s outermost transparent layer (the cornea), phosphates may, in very rare cases, cause calcium deposits leading to opaque corneal spots during treatment.

3. How to take USOLDEC

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is: one drop of eye drops solution instilled into the conjunctival fornix three to four times daily, or as prescribed by your doctor.
Use in children and adolescents
USOLDEC should be administered to children aged 3 to 12 years only when strictly necessary and under direct medical supervision.
Instructions for use
Eye drops, solution in multidose container:

Remove the cap (stopper) from the bottle by gently rotating it.
If you wear contact lenses, remove them before instilling the eye drops and reinsert them only after 15 minutes.
Turn the bottle upside down and instill the drop by gently pressing; avoid letting the tip of the container touch the eye or any other surface.
Screw the cap back on tightly.
Eye drops, solution in single-dose containers:

Make sure the single-dose vial is intact.
Detach the single-dose vial from the strip.
Open by rotating the tab until the container opens.
Turn the vial upside down and instill by gently pressing.
Place the tip of the vial close to the eye without touching it.
Discard the vial and any remaining content immediately after use.

If you use more USOLDEC than you should
In case of overdose, temporarily and gradually discontinue the use of USOLDEC to avoid irritation, lesions or sudden increase in intraocular pressure (acute glaucoma). Contact your doctor or pharmacist immediately.
If you accidentally ingest the product, inform your doctor immediately or go to the nearest hospital and drink fluids to dilute it.
If you forget to take USOLDEC
Do not take a double dose to make up for the missed dose.
If you stop using USOLDEC
Do not stop treatment without first consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur with the use of USOLDEC:
Systemic reactions:

Allergic reactions (hypersensitivity)

The following side effects have been reported with medicines belonging to the same class as USOLDEC (corticosteroids):
Ocular side effects:

Clouding of the lens affecting vision (subcapsular cataract)
Eye infection (including bacterial, fungal, and viral infections)
Eye irritation
Perforation of the eye (scleral or corneal perforation)
Increased intraocular pressure
Eye disease due to increased pressure inside the eye (glaucoma)
Burning sensation in the eye
Blurred vision (frequency not known)

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (cornea) have developed opaque spots on the cornea due to calcium accumulation during treatment.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling with weight gain in the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).
In all of these cases, your doctor will discontinue your treatment and prescribe appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store USOLDEC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of that month.
Do not store the medicine above 25 °C.
Eye drops - Multi-dose bottle
The eye drops in the multi-dose bottle must be used within 28 days after first opening the bottle; after this period, any remaining medicine must be discarded.
Eye drops - Single-dose containers
The eye drops in single-dose containers must be used immediately after opening the container; any remaining medicine must be discarded.
After opening the aluminium pouch, the containers must be used within 28 days: after this period, any remaining containers must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What USOLDEC contains
USOLDEC 0.15% Eye Drops, solution in multidose container
1 ml of solution:

The active substance is: dexamethasone sodium phosphate 1.5 mg;
The other components are: Trisodium citrate dihydrate, Sodium dihydrogen phosphate dihydrate, Disodium hydrogen phosphate dihydrate, benzalkonium chloride, water for injections.

USOLDEC 0.15% Eye Drops, solution in single-dose container
1 ml of solution:

The active substance is: dexamethasone sodium phosphate 1.5 mg;
The other components are: Trisodium citrate dihydrate, Sodium dihydrogen phosphate dihydrate, Disodium hydrogen phosphate dihydrate, water for injections.

Description of the appearance of USOLDEC and contents of the pack
Eye drops, solution.
Carton pack containing one 5 ml bottle.
Carton pack containing 20 single-dose units of 0.3 ml each; each strip of 5 units is packaged in an aluminum pouch.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bionativa S.p.A.
Via Raffaello 15
Loc. Sambuca V.P.
50028 Florence
Italy
Manufacturer
Genetic S.p.A. – Contrada Canfora - Fisciano (SA)

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