Dexavision

Package leaflet: Information for the user

Dexavision 1 mg/mL eye drops, solution

dexamethasone phosphate
Equivalent medicine
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Dexavision is and what it is used for

Dexavision contains dexamethasone, a corticosteroid used to stop inflammatory symptoms (such as
pain, heat, swelling, and redness).
Dexavision is used for the treatment of eye inflammation.
If the eye is infected (red eye, discharge, tearing), you will be given another medicine to use
together with Dexavision. See section 2.
Dexavision eye drops solution is a sterile solution that does not contain preservatives.

2. What you need to know before using Dexavision

Do not use Dexavision

• if you are allergic to dexamethasone phosphate or to any of the other ingredients of this medicine (listed in section 6),
• if you have an eye infection for which you are not using any medication,
• if you have damage to the surface of the eye (small perforations, ulcers or wounds that have not healed properly),
• if you have known steroid-induced ocular hypertension (glucocorticoid family).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Dexavision.

• Do not inject or swallow it.
• Avoid contact between the tip of the dispenser and the eye or eyelids.
• Careful monitoring of the eye is required during treatment with Dexavision, in particular:
  • for children and elderly patients. More frequent monitoring is advisable.
• if you have an eye infection. Use Dexavision only if you are also using an anti-infective medication.
• if you have a corneal ulcer, an open lesion on the surface of the eye sometimes accompanied by severe pain, tearing, squinting or vision loss. Do not use Dexavision unless inflammation is the main reason for delayed healing.
• if you have elevated intraocular pressure. If you previously experienced an increase in intraocular pressure during steroid eye treatment, you are at risk of this recurring with Dexavision use.
• if you have glaucoma, a condition that can cause damage to the optic nerve and vision loss.
  • If signs of corneal calcification appear, treatment must be discontinued and the patient should be treated with phosphate-free formulations.
  • Children: Do not use for long-term uninterrupted treatment.
  • If you have severe allergic conjunctivitis (redness, swelling, itching and tearing of the eye) that has not responded to other medications, use Dexavision only for a short period.
  • Diabetic patients: Inform your ophthalmologist or optician if you are diabetic.
  • Do not use Dexavision if you have a red eye without a confirmed diagnosis.
  • Contact lenses: Do not wear contact lenses during treatment with Dexavision.

If you have previously experienced contact hypersensitivity to silver, do not use this medicine.
Inform your doctor if you experience weight gain and swelling of the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Adrenal suppression may occur after long-term or intensive treatment with Dexavision. Inform your doctor before stopping treatment on your own. These risks are particularly important in children and in patients taking medications called ritonavir or cobicistat.

Other medicines and Dexavision
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using another eye medication, administer it at least 15 minutes apart from Dexavision.
Concomitant use of a steroid-containing eye drop and a beta-blocker-containing eye drop (used to treat high eye pressure) may cause calcium phosphate precipitation on the eye surface.
Inform your doctor if you are taking ritonavir or cobicistat, as these may increase the amount of dexamethasone in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
There is insufficient information on the use of dexamethasone during pregnancy to determine possible adverse effects. For this reason, the use of Dexavision during pregnancy is not recommended.
It is not known whether this medicine passes into breast milk. However, the dose of Dexavision is low. Dexavision may be used during breastfeeding.

Driving and using machines
You may experience blurred vision for a short time after using the eye drops. Wait until your vision returns to normal before driving or operating machinery.

Dexavision contains phosphate buffer
This medicine contains 1.976 mg of phosphates in each mL of solution, equivalent to 7.450 mg of disodium phosphate dodecahydrate.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Dexavision

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 1 drop, 4 to 6 times daily, into the affected eye. If your condition is more severe, you may be instructed to start with 1 drop every hour, then switch to 1 drop every 4 hours once a favorable response is observed. It is important to gradually reduce the dosage to avoid a recurrence of the condition.

Elderly patients
No dose adjustment is required.

Use in children
Do not use this medicine for long-term continuous treatment.

Method of administration
Ophthalmic use: this medicine is an eye drop solution to be administered into the eye.

Do not let the tip of the multidose container touch the eye or the surrounding area. This could cause eye injury. The eye drop solution may become contaminated with bacteria, which could lead to eye infections and potentially serious eye damage, including loss of vision. To avoid contamination of the multidose container, keep the tip of the container away from contact with any surface.

Before instilling the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medicine if you notice that the tamper-evident seal on the neck of the bottle is broken before first use.
• When using it for the first time, before administering a drop into the eye, practice using the dropper bottle by gently pressing it to release a drop into the air, away from the eye.
• Once you feel confident about administering a single drop, choose the position you find most comfortable for instillation (you may sit, lie on your back, or stand in front of a mirror).

Instillation:

1. Hold the bottle directly under the cap and twist to open. Do not touch anything with the tip of the bottle to avoid contaminating the solution.
2. Tilt your head backward and hold the bottle above the eye.
3. Pull down the lower eyelid and look upward. Gently press the center of the bottle to release one drop into the eye. Please note that there may be a delay of several seconds between pressing and the drop falling. Do not press too hard. If you are unsure how to administer the medicine, ask your doctor, pharmacist, or nurse.

4. Blink several times to help spread the drop across the eye.

5. After using Dexavision, press a finger against the corner of the eye near the nose for a few minutes. This helps prevent the eye drops from draining into the rest of the body.

6. Repeat steps 2–5 to administer a drop into the other eye, if your doctor has instructed you to do so. Sometimes only one eye requires treatment, and your doctor will tell you if this applies to you and which eye needs treatment.
7. After use and before replacing the cap, shake the bottle once and turn it upside down, without touching the dropper tip, to remove any residual liquid from the tip. This is necessary to ensure proper delivery of subsequent drops.

After using all prescribed doses, a small amount of Dexavision may remain in the bottle. This is not a cause for concern, as an excess amount of Dexavision has been added to ensure you receive the full prescribed amount. Do not attempt to use the remaining excess medicine left in the bottle after completing your treatment course.

Frequency of administration
4 to 6 times daily.

Duration of treatment
You should use the eye drops for several days and for no longer than 14 days.

If you use more Dexavision than you should
If you have instilled an excessive amount of medicine into the eye and it causes discomfort, rinse the eye with sterile water.
Contact your doctor or pharmacist immediately.

If you forget to use Dexavision
Do not use a double dose to make up for the missed dose.

If you stop using Dexavision
Do not stop treatment abruptly. Always consult your doctor if you are considering stopping treatment.

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Eye disorders:
Very common (may affect more than 1 in 10 people):

• increased intraocular pressure after 2 weeks of treatment.

Common (may affect up to 1 in 10 people):

• discomfort, irritation, burning, stinging pain, itching and blurred vision after instillation. These are usually mild symptoms and do not last long.

Uncommon (may affect up to 1 in 100 people):

• signs of allergic reaction,
• delayed wound healing,
• clouding of the lens (cataract),
• infections,
• high eye pressure (glaucoma).

Very rare (may affect up to 1 in 10,000 people):

• inflammation of the eye surface causing redness, tearing and irritation (conjunctivitis),
• dilation of the pupil (mydriasis),
• swelling of the face (facial edema),
• drooping of the eyelids (ptosis),
• inflammation of the eye causing pain and redness (uveitis),
• calcium deposits on the eye surface (corneal calcification),
• inflammation of the eye surface causing blurred vision, dry eyes, light sensitivity, burning, tearing and sensation of sand in the eye (keratopathy of the lens),
• changes in thickness of the eye surface,
• swelling of the eye surface (corneal edema),
• ulcer on the eye surface causing pain, tearing, squinting and loss of vision,
• small holes on the eye surface (corneal perforation).

General side effects:
Uncommon (may affect up to 1 in 100 people):

• if used frequently, the kidneys may not produce enough hormones (suppression of adrenal function). This may present as low blood sugar, dehydration, weight loss and confusion.

Frequency not known (frequency cannot be estimated from the available data):

• hormonal problems: excessive growth of body hair (especially in women), weakness and muscle loss, development of purple stretch marks on the skin, increased blood pressure, irregular or missed menstrual periods, changes in protein and calcium levels in the body, growth suppression in children and adolescents, and facial swelling and increased body weight (known as 'Cushing's syndrome') (see section 2, "Warnings and precautions"). Reporting of side effects If you experience any side effect, 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexavision

Keep this medicine out of the sight and reach of children.
Do not use the eye drops for more than 28 days after first opening the bottle. Write the date of opening
of the bottle in the space provided on the label of the bottle and on the carton.
Do not use this medicine after the expiry date stated on the carton and on the bottle after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dexavision contains:

• The active substance is dexamethasone phosphate. Each millilitre of solution contains 1 mg of dexamethasone phosphate as sodium dexamethasone phosphate.
• The other components are disodium phosphate dodecahydrate, sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Dexavision and contents of the pack
Dexavision eye drops, solution is presented as 6 ml of clear solution in an 11 ml opaque white LDPE bottle with a Novelia white dropper (HDPE and silicone) and a white HDPE cap.
Each carton contains 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
FB VISION S.r.l.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno, Italy (IT)

Manufacturer
Pharmathen S.A.
6 Dervenakion
15351 Pallini Attiki
Greece
or
EXCELVISION
27 st. La Lombardière, Zl La Lombardière,
ANNONAY 07100
France

This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Denmark Oratoria
Italy Dexavision
Cyprus Oratoria
Greece Oratoria
Poland Oratoria
Sweden Oratoria
Germany Oratoria 1 mg / ml Augentropfen, Lösung
France Oratoria
United Kingdom Eythalm