Package Insert: Information for the User

COLIRCUSÍ DEXAMETASONA 1 mg/ml Eye Drops in Solution

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

This medication has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

It is an eye drop solution 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.

Colircusí Dexametasona is indicated for the treatment of non-infectious eye inflammations that respond to corticosteroids, which may affect the conjunctiva (a 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 white. Inflammation of the iris (iritis), ciliary body (ciclitis), or combined inflammation (iridociclitis).

Do not use Colircusí Dexametasona:

• If you are allergic to dexamethasone or any of the other components of this medication (listed in section 6).
• If you have or think you have:
• • Untreated bacterial eye infection.
  • Corneal inflammation (keratitis) caused by herpes simplex or any other viral eye infection, such as smallpox or chickenpox.
  • Tuberculosis that affects the eye.
  • Fungal eye infections or untreated eye infections caused by parasites.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Colircusí Dexametasona.

• Only use this medication in your eye(s).
• This medication may increase eye pressure, especially if you already have glaucoma or high eye pressure, or a family history, so you should use it under medical supervision.
• If you usethis medication for a long period of time, you may:
• • 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 are unsure. The risk of increased intraocular pressure and/or corticosteroid-induced cataracts is higher in susceptible patients (e.g., diabetes).
  • Develop cataracts. You should visit your doctor frequently.
  • DevelopCushing's syndrome and/or adrenal gland suppression 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. Adrenal gland suppression may occur after interrupting long-term or intensive treatment with Colircusí 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 eye infection, you should consult your doctor about your treatment.
• Thelong-term use of corticosteroids in the eye may produce 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 eye injuries. It is also known that non-steroidal anti-inflammatory drugs (NSAIDs) in eye drops slow down or delay healing (see "Other medications and Colircusí 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 blurry vision or other visual disturbances.

If you use contact lenses:

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 Colircusí 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 (Non-Steroidal Anti-Inflammatory Drugs) eye drops. The concomitant use of steroids and NSAIDs eye drops may increase corneal healing problems.

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 Colircusí Dexametasona during pregnancy is not recommended.

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

Driving and operating machinery

You may notice that your vision becomes blurry for a while after applying the eye drops to your eyes. Do not drive or operate machinery until this effect has disappeared.

Colircusí Dexametasona contains benzalkonium chloride

This medication may cause eye irritation because it contains benzalkonium chloride.

Avoid contact with soft contact lenses.

Remove contact lenses before application and wait at least 15 minutes before reinserting them.

Alter the color of soft contact lenses.

Follow exactly the administration instructions of this medication as 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:

One or two drops in the affected eye(s) three times a day.

When a satisfactory response is observed after 3-4 days, the administration frequency can be gradually reduced to once a day.

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

Usage recommendations:

• Wash your hands.
• Take the bottle (dropper bottle).
• After opening the bottle for the first time, remove the plastic ring from the cap if it is loose.
• Hold the bottle, upside down, between your fingers.
• Incline your head backward. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and eye, where the drop should fall (figure 1).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do not touch your eye or eyelid, nearby areas, or other surfaces with the dropper. The drops could become contaminated.
• Press gently on the base of the bottle with your index finger to allow one drop to fall at a time (figure 2).
• After using the eye drops, press the corner of your eye near your nose with your finger. This helps prevent the medication from passing into the rest of your body (figure 3).
• If you apply drops to both eyes, repeat all the previous steps for the other eye.
• Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between administering this eye drop and the other eye medications. Eye ointments should be administered last.

If you use more Colircusí Dexametasona than you should

An overdose in the eyes can be treated by rinsing the eyes with warm water. Do not apply more drops until the next scheduled dose.

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

If you forgot to use Colircusí 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 questions 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 frequency, which is 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::alteration 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 skin of the body, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, and facial and body 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.
• In diseases that cause corneal thinning, there is a greater 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 the 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 the 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 bottle and on the box after CAD. The expiration date is the last day of the month indicated.

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

Record the date of the bottle's opening in the designated space on the box.

Medications should not be disposed of through drains or 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 white ophthalmic ointment.

It is presented in an aluminum tube with a polyethylene plug 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 medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es