Visucortex

Package leaflet: Information for the user

VISUCORTEX 1.5 mg/ml eye drops, solution

Dexamethasone sodium phosphate
Please 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 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, as it may 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:

1. What VISUCORTEX is and what it is used for
2. What you need to know before using VISUCORTEX
3. How to use VISUCORTEX
4. Possible side effects
5. How to store VISUCORTEX
6. Contents of the pack and other information

1. What VISUCORTEX is and what it is used for

VISUCORTEX contains a substance called dexamethasone. This substance is a corticosteroid, a hormone that performs numerous activities, with an important role in controlling inflammation.
VISUCORTEX belongs to a group of medicines called "Anti-inflammatory, Non-combined Corticosteroids".
VISUCORTEX is used to treat inflammation of certain parts of the eye (conjunctiva, eyelid, cornea, sclera, uvea), including inflammation due to allergies, such as: allergic vernal conjunctivitis, blepharitis and blepharoconjunctivitis, allergic keratoconjunctivitis, scleritis and episcleritis, uveitis.

2. What you need to know before using VISUCORTEX

Do not use VISUCORTEX:

• if you are allergic to dexamethasone or to any of the other ingredients of this medicine (listed in section 6);
• if you have high pressure inside the eye (ocular hypertension);
• if you have eye infections caused by viruses (infections due to Herpes simplex, corneal viral infections in the acute ulcerative phase);
• if you have conjunctival inflammation (conjunctivitis) with corneal ulceration, even in the early stage (positive fluorescein test);
• if you suffer from tuberculosis;
• if you have eye infections caused by fungi (fungal eye infections);
• if you have pus-containing eye infections (acute purulent ophthalmia, purulent conjunctivitis, purulent and herpetic blepharitis);
• if you have an eyelid infection characterized by a pimple-like swelling or abscess (sty);
• if you have corneal lesions or abrasions;
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

VISUCORTEX must not be used in children under three years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using VISUCORTEX.
The use, especially if prolonged, of corticosteroids such as dexamethasone may lead to increased pressure inside the eye.
If you use VISUCORTEX for more than two weeks, your doctor will monitor your eye pressure.
Do not use VISUCORTEX for long periods, as corticosteroid use may promote the development of cataracts (a condition in which the lens becomes cloudy), which may become irreversible in the presence of viral infections (see “Do not use VISUCORTEX”).
Your doctor will prescribe VISUCORTEX with great caution if you suffer from conditions associated with corneal thinning.
If you suffer from corneal inflammation caused by Herpes virus (herpetic keratitis), VISUCORTEX will be prescribed only under strict ophthalmologist supervision.
The use of VISUCORTEX in cases of conjunctivitis (caused by bacteria, viruses or fungi) may mask signs of worsening infection.
The use of VISUCORTEX in the presence of lesions may delay healing and promote the onset and spread of possible infections.
If you suffer from dry eyes and use VISUCORTEX frequently or for prolonged periods, or if you have compromised cornea, your doctor will perform careful monitoring.
Contact your doctor if you experience blurred vision or other visual disturbances.
Contact your doctor if you notice 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 occur after discontinuation of prolonged or intensive treatment with VISUCORTEX. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with a medicine called ritonavir or cobicistat.
Children
In children aged 3 to 12 years, this medicine should be administered only when strictly necessary and under direct medical supervision.
Other medicines and VISUCORTEX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor if you are taking ritonavir or cobicistat, as they may increase the level of dexamethasone in the blood.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, your doctor will prescribe VISUCORTEX only if clearly needed and under close medical supervision.
Driving and using machines
VISUCORTEX does not affect the ability to drive or operate machinery. However, as with any eye medicine, if transient blurred vision occurs during treatment, wait until your vision clears before driving or operating machinery.
VISUCORTEX multidose eye drop bottle contains benzalkonium chloride
VISUCORTEX eye drops, solution in multidose container contains benzalkonium chloride 0.2 mg per 1 ml equivalent to 1 mg/ml, which may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience an unusual sensation, burning or pain in the eye after using this medicine, speak with your doctor.
Benzalkonium chloride has been reported to cause certain eye disorders (punctate keratopathy and/or toxic ulcerative keratopathy).
VISUCORTEX multidose eye drop bottle contains phosphate buffer.
VISUCORTEX eye drops, solution in multidose container contains monobasic sodium phosphate dihydrate 1.656 mg per 1 ml equivalent to 8.283 mg in 5 ml and dibasic sodium phosphate dihydrate 4.97 mg per 1 ml equivalent to 24.850 mg per 5 ml.
VISUCORTEX single-dose eye drops contain phosphate buffer.
VISUCORTEX eye drops, single-dose solution contains monobasic sodium phosphate dihydrate 1.656 mg per 1 ml equivalent to 0.497 mg in 0.3 ml and dibasic sodium phosphate dihydrate 4.97 mg per 1 ml equivalent to 1.491 mg per 0.3 ml.

2. How to use VISUCORTEX

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is: one drop of eye drops, three to four times a day, or as prescribed by
your doctor.
Apply the drop into the conjunctival sac (conjunctival fornix).
Instructions for use
Eye drops, solution in multidose container:

1. Remove the seal
2. Remove the cap from the bottle
3. If you wear contact lenses, remove them before applying the eye drops and reinsert them
   after 15 minutes
4. Invert the bottle and apply by pressing; avoid letting the tip of the container touch the eye or any other surfaces.
   Eye drops, solution in single-dose containers:
5. Make sure the single-dose unit is intact
6. Detach the single-dose unit from the strip
7. Open by twisting the tab until the container opens
8. Invert the container and apply by pressing.
   If you use more VISUCORTEX than you should
   Cases of overdose have not been reported.
   If VISUCORTEX is accidentally ingested or used for a prolonged period at excessive doses,
   toxic effects may occur. In case of accidental ingestion/overdose of VISUCORTEX, contact your doctor immediately or go to the nearest hospital.
   Any potential overdose requires temporary discontinuation of treatment to prevent irritative, ulcerative, or acute glaucoma symptoms. However, this discontinuation should be carried out gradually. If accidentally ingested, drink fluids to dilute.
   If you forget to use VISUCORTEX
   Do not use a double dose to make up for the missed dose.
   If you stop using VISUCORTEX
   If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects due to dexamethasone are:

• Increased pressure inside the eye after 15-20 days of application in people who are predisposed or affected by glaucoma.
• Clouding of the lens (cataract) following prolonged treatment.
• Eye irritation and eye perforation (scleral or corneal perforation), glaucoma, and blurred vision.
• Hypersensitivity reactions and development or worsening of infections caused by Herpes simplex or fungal or bacterial infections.
• Delayed healing.

In all these cases, your doctor will stop your treatment and prescribe an appropriate therapy.
Occasionally, this product may cause mild itching or burning.
Blurred vision has been reported with unknown frequency.
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 and weight gain in the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).
Adverse reactions reported with eye drops containing phosphates
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy spots on the cornea due to calcium accumulation during treatment.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VISUCORTEX

Keep this medicine out of the sight and reach of children.
Store below 25°C.
The multidose bottle eye drops must be used within 28 days after first opening the bottle; after this period, any remaining medicine must be discarded.
The single-dose container eye drops 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 unused containers must be discarded.
Do not use this medicine after the expiry date which is stated on the carton after “Exp.:”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VISUCORTEX contains
VISUCORTEX 1.5 mg/ml eye drops, solution in multidose container

• The active substance is: desamethasone sodium phosphate. 1 ml of solution contains 1.5 mg of desamethasone sodium phosphate.
• The other components are: Trisodium citrate dihydrate, Monosodium phosphate monohydrate, Disodium phosphate dihydrate, Benzalkonium chloride, Water for injections.

VISUCORTEX 1.5 mg/ml eye drops, solution in single-dose containers

• The active substance is: desamethasone sodium phosphate. 1 ml of solution contains 1.5 mg of desamethasone sodium phosphate.
• The other components are: Trisodium citrate dihydrate, Monosodium phosphate monohydrate, Disodium phosphate dihydrate, Water for injections.

Description of the appearance of VISUCORTEX and contents of the pack
VISUCORTEX is an eye drop solution.
The pack contents are:

• One 5 ml bottle in a carton;
• Carton containing 20 single-dose units of 0.3 ml; each strip of 5 units is packaged in an aluminium pouch.

Marketing Authorization Holder
Visufarma S.p.A.
Via Alberto Cadlolo, 21
00136 Rome
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)