Prospecto: information for the user

OFTALMOLOSA CUSÍ DEXAMETASONA 0.5 mg/g ophthalmic ointment

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is OFTALMOLOSA CUSÍ DEXAMETASONA and how it is used

2.What you need to know before starting to use OFTALMOLOSA CUSÍ DEXAMETASONA

3.How to use OFTALMOLOSA CUSÍ DEXAMETASONA

4.Possible adverse effects

5.Storage of OFTALMOLOSA CUSÍ DEXAMETASONA

1. Contents of the package and additional information

It is an eye ointment that contains dexamethasone sodium phosphate as its active ingredient, a potent corticosteroid with anti-inflammatory and antiallergic properties, mainly, which reduces the inflammatory response caused by allergic, mechanical, or chemical agents.

Oftalmolosa Cusí Dexametasonais indicated for the treatment of non-infectious eye inflammations that respond to corticosteroids, which may affect the conjunctiva (the transparent membrane that covers the eye), the cornea, or the anterior pole of the eye. Allergic and seasonal conjunctivitis. Superficial (episcleritis) and deep (escleritis) inflammation of the eye's white. Inflammation of the iris (iritis), the ciliary body (ciclitis), or combined inflammation (iridociclitis).

No use Oftalmolosa Cusí Dexametasona:

• Infection of the eye not treated by a doctor.
• Corneal inflammation (keratitis) caused by herpes simplex or any other eye infection caused by a virus, such as smallpox or chickenpox.

• Tuberculosis that affects the eye.

• Fungal eye infections or untreated eye infections caused by parasites.

Advertencias and precautions

Consult your doctor or pharmacist before starting to use Oftalmolosa Cusí Dexametasona.

• Develop increased eye pressure and/or glaucoma (with optic nerve damage and decreased visual acuity). You should regularly check your eye pressure while using this medication. Consult your doctor if you have any doubts. The risk of increased intraocular pressure and/or corticosteroid-induced cataract is higher in patients prone to it (e.g. diabetes).
• Develop cataracts. You should visit your doctor regularly.
• Develop Cushing's syndrome and/or suppression of adrenal gland function because the medication reaches the blood. Consult 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 occur after interrupting long-term or intensive treatment with Oftalmolosa Cusí Dexametasona. Consult your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat.

• If your symptoms worsen or return suddenly, please contact your doctor. You may become more sensitive to eye infections with the use of this medication. Corticosteroids can also mask the signs of an infection or intensify it, especially with prolonged use in pus-producing eye infections.

• If you already have a bacterial infection in your eyes, you should consult your doctor about your treatment.
• Prolonged use of corticosteroids in the eye may cause fungal infections of the cornea. In case of occurrence, treatment should be suppressed. The use of corticosteroids in the eye in excessive doses may delay the healing of your eye wound. It is also known that NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) eye drops slow down or delay healing (see section "Other medications and Oftalmolosa Cusí Dexametasona").
• If you suffer from a condition causing thinning of the ocular tissue (the outer layers of the eye), the use of this medication may cause corneal perforation.
• Contact your doctor if you experience blurred vision or other visual disturbances.

If you use contact lenses:

• Wearing contact lenses (hard or soft) is not recommended during treatment of an eye inflammation.

Children

The safety and efficacy of this medication have not been established in children. Therefore, its use is not recommended in children.

The possible increase in intraocular pressure associated with the prolonged use of this medication is especially important in pediatric patients; the risk of corticosteroid-induced glaucoma may be higher in children and occur before it does in adults.

Other medications and Oftalmolosa Cusí Dexametasona

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

Inform your doctor if you are using NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) eye drops. Concomitant use of steroids and NSAIDs eye drops may increase the problems of corneal healing.

Inform your doctor if you are using ritonavir or cobicistat, as it may cause an increase in the amount of dexamethasone in the blood.

Pregnancy, breastfeeding, and fertility

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

The use of Oftalmolosa Cusí Dexametasona during pregnancy is not recommended.

If you are breastfeeding, you should decide whether it is necessary to stop breastfeeding or stop treatment with this medication, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machinery

You may notice that your vision becomes blurry for a while after applying the ointment to your eyes. Do not drive or use machines until this effect has disappeared.

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

Ophthalmic route (in the eye/eyes).

The recommended dose is:

Adults:

Generally, apply approximately 1 cm of ointment in the affected eye(s)two or three times a day.

When you observe a satisfactory response in 3-4 days, you can gradually reduce the frequency of administration to once a day.

The maximum recommended treatment duration is 14 days unless your doctor has given you different instructions.

Usage recommendations:

If you are using other ophthalmic medications, wait at least 5 minutes between the administration of this ointment and the other ophthalmic medications. Ophthalmic ointments should be administered last.

If you use more Oftalmolosa Cusí Dexametasona than you should

A possible overdose in the eyes can be eliminated by rinsing the eyes with warm water. Do not apply more ointment until the next dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Oftalmolosa Cusí Dexametasona

Do not apply a double dose to compensate for the missed doses.

Apply a single dose as soon as you remember and continue with the next dose that was scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects are classified by frequencies, which are defined as: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people);unknown frequency (cannot be estimated from available data).

The following side effects have been reported with this medicine:

Common side effects:

• Eye effects: eye discomfort.

Uncommon side effects:

• Eye effects: corneal inflammation (keratitis), conjunctivitis, dry eye, corneal spot, light sensitivity (photophobia), blurred vision, abnormal sensation in the eye, tearing, crusts on the eyelid, itching, irritation, or redness in the eye.

• General effects: altered sense of taste (bad taste).

Unknown frequency:

• Eye effects: glaucoma (increased intraocular pressure with decreased visual acuity), corneal ulcer, increased intraocular pressure, reduced vision, corneal damage, eyelid drooping, eye pain, enlarged pupil.

• General effects: hypersensitivity (allergy), dizziness, headache.

• Endocrine problems: excessive hair growth (particularly in women), muscle weakness and wasting, purple striae on the body skin, increased blood pressure, irregular or absent menstruation, 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").

The prolonged use of eye corticosteroids may also cause:

• Increased intraocular pressure with optic nerve damage and decreased visual acuity.
• Cataract formation.
• Delayed corneal healing.
• En diseases that cause corneal thinning, there is a higher risk of perforation.

Corticosteroids may reduce resistance to eye infections, favoring their appearance.

Reporting of side effects

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

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the tube and on the box after CAD. The expiration date is the last day of the month indicated.

To prevent infections, discard the tube 4 weeks after first opening it.

Record the date of opening the tube in the reserved box for this purpose.

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment..

Composition ofOftalmolosa Cusí Dexametasona

• The active ingredient isdexametasonafosfate sodium. Each gram of ointment contains 0.5 mg of dexametasona fosfate sodium (0.05%).
• The other components arecholesterol, liquid paraffin and white vaseline.

Appearance of the product and contents of the packaging

Oftalmolosa Cusí Dexametasonais a whitish eye ointment.

It is presented in an aluminum tube with a polyethylene stopper containing 3 g of ointment.

Holder of the marketing authorization

Fidia Farmaceutici S.p.A.

Via Ponte della Fabbrica, 3/A - 35031 Abano Terme – Italy

Responsible for manufacturing

Siegfried El Masnou S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

Local representative

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Edificio Torona

Avenida de Europa, 24 - Edificio A - 1 B

Alcobendas 28108 - Madrid

Spain.

Date of the last review of this prospectus:November 2016.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es