Decadron Oftalmico

Package leaflet: Information for the user

DECADRON OFTALMIC 1 mg/ml, eye drops, solution in single-dose containers

Dexamethasone phosphate
Equivalent medicine
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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What DECADRON OFTALMIC is and what it is used for

2. What you need to know before using DECADRON OFTALMIC

3. How to use DECADRON OFTALMIC

4. Possible side effects

5. How to store DECADRON OFTALMIC

6. Contents of the pack and other information

7. What DECADRON OFTALMIC is and what it is used for

DECADRON OFTALMIC contains dexamethasone, a corticosteroid used to relieve inflammatory symptoms (such as pain, heat, swelling and redness).
DECADRON OFTALMIC is used to treat inflammation of the eye.
The eye must not be infected (red eye, discharge, tearing); otherwise, specific treatment for the infection must be added (see section 2).

2. What you need to know before using DECADRON OFTALMICO

Do not use DECADRON OFTALMICO

• if you are allergic to dexamethasone sodium phosphate or to any of the other ingredients of this medicine (listed in section 6),
• 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 those caused by amoebae (parasites),
• if you have damage to the surface of the eye (small perforations, ulcerations or lesions that have not healed properly),
• if you have known steroid-induced ocular hypertension (glucocorticoid family).

Warnings and precautions
Talk to your doctor or pharmacist before using DECADRON OFTALMICO.
Do not inject or swallow this medicine.
Avoid contact between the tip of the single-dose container and the eye or eyelids.
Careful monitoring of the eye is required during treatment with DECADRON OFTALMICO, particularly:

• In children and elderly patients, more frequent ophthalmological examinations are recommended.
• If you have an ocular infection. You may use DECADRON OFTALMICO only if you are simultaneously receiving anti-infective treatment.
• If you have corneal ulceration, i.e. an open lesion on the surface of the eye, sometimes associated with severe pain, tearing, squinting or vision loss. You should not use DECADRON OFTALMICO unless inflammation is the main cause of delayed healing.
• If you suffer from elevated intraocular pressure. If you previously experienced an increase in intraocular pressure during steroid eye treatment, you are at risk of developing increased intraocular pressure again when using DECADRON OFTALMICO.
• If you have glaucoma, a condition that may cause damage to the optic nerve and vision loss.
• Children: long-term, uninterrupted therapy should be avoided.
• If you have severe allergic conjunctivitis (redness, swelling, itching and tearing of the eye) unresponsive to standard therapy, DECADRON OFTALMICO may be used only for a short period.
• Diabetic patients: if you are diabetic, inform your ophthalmologist or optician before using DECADRON OFTALMICO.
• If you have a red eye without a confirmed diagnosis, you should not use DECADRON OFTALMICO.
• Contact lenses: you must not wear contact lenses during treatment with DECADRON OFTALMICO.

Talk to your doctor if you experience weight gain and swelling of the trunk and face, as these are generally the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after long-term or intensive treatment with DECADRON OFTALMICO.
Do not stop treatment on your own without consulting your doctor first.
These risks are particularly important in children and in patients taking medicines called ritonavir or cobicistat (used in the treatment of HIV).
Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and DECADRON OFTALMICO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using another eye drop at the same time, wait at least 15 minutes between each instillation.
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 precipitations on the surface of the eye.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There is insufficient information on the use of dexamethasone during pregnancy to assess potential harmful effects. For this reason, the use of DECADRON OFTALMICO during pregnancy is not recommended.
It is not known whether this medicine passes into breast milk. However, the dose of DECADRON OFTALMICO is low. DECADRON OFTALMICO may be used during breastfeeding when clearly needed and under direct medical supervision.

Driving and using machines
After using this product, temporary blurred vision or other visual disturbances may occur. If this happens, do not drive or operate machinery until your vision is clear.

DECADRON OFTALMICO contains phosphates
This medicine contains 1.485 mg of phosphates in each mL of solution, equivalent to 5.600 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 corneal opacities due to calcium accumulation during treatment.

3. How to use DECADRON OFTALMICO

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, 4 to 6 times daily, instilled 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. A gradual reduction in dosage is recommended to
prevent the condition from worsening again.
Elderly
No dose adjustment is required.
Use in children
In children, long-term, uninterrupted therapy should be avoided.
Method of administration
This medicine is for ophthalmic use only. Do not inject or ingest this medicine.

1. Open the sachet containing the 5 single-dose containers
2. Wash your hands before opening the single-dose container
3. Detach one single-dose container from the strip and open it by twisting the top (Figure 1)
4. Tilt your head backward, pull down the lower eyelid with your finger (Figure 2). Instill
   one drop into the eye. Avoid contact between the tip of the container and the eye or eyelids
   (Figure 3)
5. Immediately after applying Decadron Oftalmico, press with your finger on the inner corner of the eye near the nose. This helps prevent the eye drops from being absorbed into the rest of the body (Figure 4)
6. Discard the single-dose container after use. Do not reuse it.
   Duration of treatment
   Treatment usually lasts for a few days. Do not use Decadron Oftalmico for more than
   14 days.
   If you use more Decadron Oftalmico than you should
   If you have instilled an excessive amount of the 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 Decadron Oftalmico
   Do not use a double dose to make up for the missed dose.
   If you stop using Decadron Oftalmico
   Do not stop treatment abruptly. Always consult your doctor if you are considering stopping treatment.
   If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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)

• allergic reactions and hypersensitivity to one of the components of the eye drops,
• delayed wound healing,
• clouding of the lens (cataract),
• eye infections,
• increased eye pressure (glaucoma),
• if used frequently, the kidneys may not produce enough hormones (suppression of adrenal cortical function). This condition may present as low blood sugar levels, dehydration, weight loss and confusion.

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 surface of the eye (corneal calcification),

• inflammation of the eye surface causing blurred vision, dry eyes, light sensitivity, burning, tearing and sensation of sand in the eye (crystalline keratopathy),

• changes in the thickness of the eye surface,

• swelling of the eye surface (corneal edema),

• ulcer on the eye surface causing pain, tearing, squinting and vision loss, small holes in the eye surface (corneal perforation).

• Frequency not known (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 and weight gain of the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).

• In very rare cases, patients with severe damage to the transparent layer at the front of the eye (cornea) have developed areas of corneal opacity 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DECADRON OFTALMICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the sachet after
Exp. The expiry date refers to the last day of that month.
Store the single-dose containers inside the sachet to protect them from light.
After first opening the sachet containing 5 single-dose containers: use the single-dose containers within
60 days.
After opening a single-dose container: discard any unused solution after administration.
Do not store above 30°C.
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 DECADRON OFTALMICO contains

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

Description of the appearance of DECADRON OFTALMICO and contents of the pack
Clear, colourless aqueous solution in single-dose containers.
Each single dose contains 0.3 ml of solution.
A pack contains 20 single doses.
Marketing Authorization Holder
I.B.N. Savio S.r.l., Via del Mare, 36 - 00071 Pomezia (RM)
Manufacturer
Farmigea S.p.A. – via G.B. Oliva 6/8 – 56121 Pisa - Italy