Package Leaflet: Information for the User

DEXAFREE 1 mg/ml, eye drops in single-dose solution

Dexamethasone phosphate

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Dexafree is and what it is used for

2. What you need to know before using Dexafree

3. How to use Dexafree

4. Possible side effects

5. Storage of Dexafree

6. Contents of the pack and additional information

Dexafree is a single-dose eye drop solution containing a substance called dexamethasone. This substance is a corticosteroid that inhibits inflammatory symptoms.

Dexafree is indicated for the treatment of inflammation of your eye(s).

The eye should not be infected (red eye, discharge, tearing, etc.); otherwise, this medication should be combined with a specific treatment for your infection (see section 2).

No use Dexafree:

•If you have aneye infectionthat may be bacterial (acute purulent infection), fungal, viral (herpes virus, vaccine virus, varicella-zoster virus), or amebic.

•If you havecorneal damage(perforation, ulcerations, or lesions associated with incomplete healing).

•If you havehigh intraocular pressurecaused by glucocorticosteroids (corticosteroid family).

•If you areallergic(hypersensitive)to sodium phosphate dexamethasoneor to any of the other components of Dexafree.

Warnings and precautions

Consult your doctor or,pharmacist before starting to use Dexafree

DO NOT INJECT, DO NOT INGEST

Avoid contact of the tip of the dispenser container with the eye or eyelids.

• If you use Dexafree, you must follow a strict control by your ophthalmologist in any case and in particular:

• For children and the elderly, a more frequent ophthalmological control is recommended.
• If you have an eye infection, you should only use Dexafree if the infection is controlled by an anti-infective treatment.
• If you have a corneal ulcer, do not use a local treatment with dexamethasone or Dexafree, unless the inflammation is the cause of the delayed healing.
• If you have high intraocular pressure or if you have reacted with an increase in intraocular pressure after a previous treatment with steroids, you are at risk of suffering an increase in intraocular pressure if you are treated with Dexafree.
• If you have glaucoma.

• Children:Avoid prolonged treatment.
• Severe allergic conjunctivitis: If you havesevere allergic conjunctivitisthat does not respond to standard therapy, you should use Dexafree only for short periods of time.

• Diabetes:If you arediabetic, you must inform your ophthalmologist.
• Red eye: Do not use Dexafree in the case of undiagnosed red eye.
• Contact lenses: You should avoid using contact lenses during treatment with Dexafree.

Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal function may occur after interrupting intensive or long-term treatment with Dexafree. Consult your doctor before interrupting treatment on your own. These risks are especially important in childrenand patients treated with a medication called ritonavir or cobicistat.

Contact your doctor if you experience blurred vision or other visual disturbances.

Use of Dexafree with other medications:

In case of treatment with another eye drop solution, space the instillations 15 minutes apart.

Inform your doctor if you are taking ritonavir or cobicistat, as this may cause an increase in the amount of dexamethasone in the blood. Depositions of calcium phosphate in the cornea have been described during the combined use of corticosteroids and topical beta-blockers.

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Pregnancy and lactation

There is insufficient data on the use of Dexafree in pregnant women to evaluate the possible harmful effects.

For this reason, Dexafree is not recommended during pregnancy.

It is not known if this medication is excreted in breast milk. However, the total dose of dexamethasone is low.

Therefore, Dexafree may be used during breastfeeding.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Driving and operating machinery:

As with all eye drops, temporary blurred vision or other visual defects may affect the ability to drive or operate machinery. If blurred vision occurs, the patient should wait until vision is clear before driving and operating machinery.

Athletes

Inform athletes that this medication contains a component that may give a positive analytical result in doping control tests.

Dexafree contains phosphates

This medication contains 80 micrograms of phosphates in each drop.

Dosage

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again

The recommended dose is 1 drop, 4 to 6 times a day in the affected eye. In severe cases, treatment may begin with 1 drop every hour and should be reduced to 1 drop every 4 hours when a favorable response is observed. It is recommended to gradually discontinue treatment in order to avoid relapse.

Use in elderly individuals

No dose adjustment is necessary in elderly individuals.

Use in children and adolescents

Prolonged use should be avoided in children.

Administration method

Ophthalmic use: This medication is for administration in the eye.

?Wash your hands carefully before using the product.

?Incline your head slightly backward with your gaze directed upward.

Use your free hand to pull the lower eyelid down over the affected eye.

Apply carefullyone drop to the lacrimal sac with the inferior conjunctiva.

?After application, press lightly with your finger on the lacrimal duct for a few minutes (to reduce the risk of systemic reactions and increase the penetration of the active substance in the eye).

?Discardeach single-use container after its use. Do not store it for reuse.

Administration frequency

4 to 6 times a day.

Treatment duration

The treatment duration may vary from several days to a maximum of 14 days.

If you use more Dexafree than you should:

If you have instilled too much product in your eye and you notice persistent irritation, rinse your eye with sterile water.

Contact your doctor or pharmacist immediately.

If you forgot to use Dexafree:

Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with Dexafree:

Do not discontinue treatment abruptly. Always consult your doctor if you decide to stop treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone experiences them.

Endocrine disorders

• Unknown frequency: cannot be estimated from available data.

• Hormonal problems: excessive body hair growth (particularly in women), muscle weakness and wasting, purple skin discoloration on the body, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, and body and facial swelling and weight gain (Cushing's syndrome) (see section 2, "Warnings and precautions").

Ocular disorders:

•Frequent: 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, itching, stinging, and blurred vision after instillation.

These symptoms are usually transient and mild

•Uncommon: may affect up to 1 in 100 people

-Allergic and hypersensitivity reactions to one of the components of the eye drops,

-Delayed wound healing,

-Cataract formation

-Infections,

-Glaucoma

•Rare: may affect up to 1 in 10,000 people.

-Conjunctivitis (inflammation of the eye membranes)

-Pupil dilation (mydriasis)

-Facial edema (swelling)

-Ptosis (drooping eyelid)

-Uveitis (inflammation of the pigmented membrane of the iris)

-Corneal calcification

-Corneal crystalline keratopathy

-Changes in corneal thickness

-Corneal edema

-Corneal ulceration

-Corneal perforation

If you suffer from severe damage to the transparent layer at the front of the eye (cornea), treatment with phosphates, in very rare cases, may cause cloudy patches in the cornea due to calcium.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on each single-dose unit after EXP. The expiration date is the last day of the month indicated.

After the first opening of the blister pack: Use the single-dose container within 15 days of its opening.

After opening the single-dose container: Use immediately and discard the single-dose container after use.

Store single-dose containers in the blister pack to protect them from light.

Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dexafree

The active ingredient is sodium phosphate of dexamethasone.

Each milliliter of solution contains 1 mg of dexamethasone phosphate (as dexamethasone phosphate and sodium).

The other components are disodium edetate, disodium dodecahydrate hydrogen phosphate, sodium chloride, and water for injectable preparations.

Appearance of the product and contents of the packaging

Dexafree is a colorless or slightly brown solution presented in single-dose units.

Each single-dose unit contains 0.4 ml of solution. The box contains 10, 20, 30, 50, or 100 single-dose units packaged in blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder: Laboratoires Théa S.A.

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

(France)

Local representative:

Laboratorios Thea S.A.

C/ Enric Granados, nº 86-88, 2nd floor

, 08008 Barcelona

Responsible for manufacturing:

EXCELVISION

Rue de la Lombardière, 07100 Annonay, (France)

Or

Laboratoires UNITHER

1 rue de l’Arquerie,

50200 Coutances

(France)

This medication is authorized in the member states of the European Economic Area with the following names:

Bulgaria, Cyprus, France, Greece, Ireland, Poland, Portugal, Spain, and United Kingdom………………………………………………………………DEXAFREE

Belgium, Netherlands, and Luxembourg….............MONOFREE DEXAMETHASON

Germany and Austria…………….…………………………………MONODEX

Italy and Slovenia………………………………………................DEXAMONO

Denmark, Finland, Norway, and Sweden…………….……………..MONOPEX

Last review date of this leaflet: August 2018

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)

http://www.aemps.es