Desadoc

PATIENT LEAFLET: INFORMATION FOR THE USER

DESADOC 1.5 mg/ml eye drops, solution

Desamethasone sodium phosphate
Equivalent medicine
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 others, even if their symptoms are the same as yours, because it could be harmful.
• 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:

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

1. What DESADOC is and what it is used for

DESADOC is a corticosteroid anti-inflammatory drug (also known as a glucocorticoid)
indicated for the treatment of various types of ocular inflammation:

• Allergic and vernal conjunctivitis (inflammations of the conjunctiva of allergic origin);
• Allergic blepharitis and blepharoconjunctivitis (inflammations of the eyelid margin and conjunctiva of allergic origin);
• Allergic keratoconjunctivitis (inflammations of the cornea and conjunctiva of allergic origin);
• Inflammations of the outer wall of the eye, the sclera (scleritis, episcleritis), or of the uvea (uveitis).

2. What you need to know before using DESADOC

Do not use DESADOC
Do not use DESADOC if you are allergic to dexamethasone or to any of the other ingredients of
this medicine (listed in section 6).
Also do not use DESADOC in the following cases: endocular hypertension, Herpes simplex, viral
corneal infections in the acute ulcerative phase, except when associated with specific chemotherapeutic agents for herpes; ulcerative conjunctivitis with keratitis even in the initial stage (positive fluorescein test), tuberculosis and fungal infections of the eye, acute purulent ophthalmia, purulent conjunctivitis, purulent and herpetic blepharitis, styes, corneal lesions or abrasions.
It is contraindicated in children under three years of age; furthermore, it is generally contraindicated during pregnancy and breastfeeding.
If the aluminum pouch or containers are visibly damaged.

Warnings and precautions
Talk to your doctor or pharmacist before using DESADOC.
Exercise particular caution with DESADOC:
Prolonged use of corticosteroids may lead to increased intraocular pressure.
Ask your doctor to check your intraocular pressure if you are using corticosteroids for more than two weeks. Prolonged use over time (from 1 to 4 years) and high doses of ophthalmic corticosteroids may cause clouding of the lens (posterior subcapsular cataract) (see section 4).
The use of corticosteroids in the presence of viral infections or bacterial, viral, or fungal conjunctivitis may worsen the disease or mask signs of infection progression (see section 2 “Do not use DESADOC”). The use of corticosteroids in herpetic keratitis is permitted only under strict supervision by an ophthalmologist.
The use of corticosteroids in the presence of tissue damage may delay healing and promote the onset and spread of possible infections.
In all these cases, consult your doctor before using DESADOC.

This medicine contains 0.18 mg of phosphate buffer per drop, equivalent to 3.66 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause opaque corneal spots due to calcium accumulation during treatment.
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 DESADOC. 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.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
DESADOC is contraindicated in children under 3 years of age.
In children aged 3 to 12 years, the medicine should be administered only when strictly necessary and under direct medical supervision.

Other medicines and DESADOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other ophthalmic products or other medicines, including medicines without a prescription.
Talk to your doctor if you are taking ritonavir or cobicistat, as they may increase the level of dexamethasone in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use during pregnancy
This medicine should be administered during pregnancy only when clearly necessary and under direct medical supervision.
Use during breastfeeding
DESADOC is generally contraindicated during breastfeeding.

Driving and using machines
DESADOC 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.

3. How to use DESADOC

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop of eye drops in one or both eyes 3 - 4 times a day, or as prescribed by your doctor.
The eye drops come in single-dose containers, contain no preservatives, and must be used immediately after opening. Avoid contact between the tip of the container and the eye or any other surface.
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Use in children and adolescents
Desadoc should be administered in children from 3 to 12 years of age only when strictly necessary and under direct medical supervision.

Instructions for use

1. Make sure the single-dose container is intact.
2. Detach the single-dose container from the strip.
3. Open by twisting the top part without pulling.
4. Instill the eye drops, taking care not to touch the eye, eyelid, or any other surface with the tip of the single-dose container; this helps prevent contamination.

If you use more DESADOC than you should
In case of overdose, temporarily and gradually discontinue use of DESADOC to avoid irritation, injury, or sudden increase in intraocular pressure (acute glaucoma).
Contact your doctor or pharmacist immediately. If the product is accidentally ingested, inform your doctor immediately or go to the nearest hospital, and drink fluids to dilute it.

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

If you stop using DESADOC
Do not stop treatment without consulting your doctor.
If you have any questions about the use of 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 DESADOC:
Systemic effects:

• Allergic reactions (hypersensitivity)

The following side effects have been reported with medicines belonging to the same class as DESADOC (corticosteroids):
Ocular 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 eye pressure
• Eye disease due to elevated intraocular pressure (glaucoma)
• Burning sensation in the eye
• Blurred vision (frequency not known)
• Delayed wound healing

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (cornea) developed opaque corneal spots due to calcium accumulation during treatment.
Occasionally, the product may cause mild itching or burning.

Side effects with frequency not known (frequency cannot be estimated from available data):

1. 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");
2. Blurred vision.

In all these cases, treatment should be discontinued and appropriate therapy initiated.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: 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 DESADOC

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month in the original packaging, provided it has been stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Validity after opening
Discard the opened vial after administration. Store unopened containers inside the opened sachet and within the cardboard carton, and use them within 28 days.

6. Package contents and other information

What DESADOC contains
Each single-dose container contains:
The active substance is dexamethasone sodium phosphate 0.45 mg, equivalent to dexamethasone 0.342 mg.
The other components are: trisodium citrate dihydrate, monosodium phosphate monohydrate, disodium phosphate dibasic dodecahydrate, water for injections.

Description of the appearance of DESADOC and contents of the pack
Carton containing 20 single-dose containers made of low-density polyethylene, 0.3 ml each, divided into 4 strips of 5 units, individually packaged in PET/Al/PE sachets.

Marketing Authorization Holder
DOC Generici Srl
Via Turati
20121 Milan, Italy

Manufacturer
Farmigea SpA
Via G.B. Oliva, 6/8
56121 Pisa (PI)
Italy