OFTALMOLOSA CUSI DEXAMETHASONE 0.5 mg/g OPHTHALMIC OINTMENT

Introduction

Package Leaflet: Information for the User

OFTALMOLOSA CUSÍ DEXAMETASONA 0.5 mg/g Ophthalmic Ointment

Read this entire leaflet carefully before starting to use this medicine, as 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

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

Contents of the Package Leaflet

1. What OFTALMOLOSA CUSÍ DEXAMETASONA is and what it is used for
2. What you need to know before using OFTALMOLOSA CUSÍ DEXAMETASONA
3. How to use OFTALMOLOSA CUSÍ DEXAMETASONA
4. Possible side effects
5. Storage of OFTALMOLOSA CUSÍ DEXAMETASONA
   1. Package Contents and Additional Information

1. What OFTALMOLOSA CUSÍ DEXAMETASONA is and what it is used for

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

Oftalmolosa Cusí Dexametasona is 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. Spring and allergic conjunctivitis. Superficial (episcleritis) and deep (scleritis) eye inflammations. Inflammations of the iris (iritis), ciliary body (cyclitis), or combined (iridocyclitis) inflammations.

2. What you need to know before using OFTALMOLOSA CUSÍ DEXAMETASONA

Do not use OFTALMOLOSA CUSÍ DEXAMETASONA:

• If you are allergic to dexamethasone or any other component of this medicine (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 diseases or untreated eye infections caused by parasites.

Warnings and Precautions

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

• Only use this medicine in your eye(s).
• This medicine 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 use this medicine for a long time, you may:

• Develop high eye pressure and/or glaucoma (with optic nerve damage and decreased visual acuity). You should regularly check your eye pressure while using this medicine. Consult your doctor if you have any doubts. The risk of increased intraocular pressure and/or cataract formation induced by corticosteroids is higher in prone patients (e.g., diabetes).
• Develop cataracts. You should visit your doctor frequently.
• Develop Cushing's syndrome and/or suppression of adrenal gland function because the medicine reaches the bloodstream. Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first manifestations of Cushing's syndrome. Adrenal gland function suppression may occur after interrupting intensive or long-term 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 medicine 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 medicine. Corticosteroids can also mask the signs of an infection or worsen it, especially with prolonged use in purulent eye infections.

• If you already have a bacterial eye infection, you should consult your doctor about treatment.
• Prolonged use of corticosteroids in the eye may cause fungal corneal infections. If this occurs, treatment should be discontinued. The use of corticosteroids in the eye in excessive doses can delay the healing of the eye wound. It is also known that ophthalmic NSAIDs can slow down or delay healing (see section "Other medicines and Oftalmolosa Cusí Dexametasona").
• If you have a disorder that causes thinning of the eye tissue (the outermost layers of the eye), the use of this medicine may cause corneal perforation.
• Contact your doctor if you experience blurred vision or other visual disturbances.

If you wear contact lenses:

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

Children

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

The possible increase in intraocular pressure associated with prolonged use of this medicine is especially important in pediatric patients; the risk of corticosteroid-induced ocular hypertension may be higher in children and occur earlier than in adults.

Other medicines and Oftalmolosa Cusí Dexametasona

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

Tell your doctor if you are using ophthalmic NSAIDs. The concomitant use of steroids and ophthalmic NSAIDs can increase corneal healing problems.

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you are breastfeeding, you should decide whether to stop breastfeeding or stop treatment with this medicine, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and Using Machines

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

3. How to use OFTALMOLOSA CUSÍ DEXAMETASONA

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Ophthalmic route (in the eye(s)).

The recommended dose is:

Adults:

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

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

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

Recommendations for Use:

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

If you use more OFTALMOLOSA CUSÍ DEXAMETASONA than you should

An 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to use OFTALMOLOSA CUSÍ DEXAMETASONA

Do not apply a double dose to make up for the forgotten doses.

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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); frequency not known (cannot be estimated from available data).

The following side effects have been reported with this medicine:

Common side effects:

• Eye effects: discomfort in the eye(s).

Uncommon side effects:

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

• General effects: alteration of taste (bad taste).

Frequency not known:

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

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

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

Prolonged use of corticosteroids in the eyes can also cause:

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

Corticosteroids can reduce resistance to eye infections, favoring their occurrence.

Reporting Side Effects

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

5. Storage of OFTALMOLOSA CUSÍ DEXAMETASONA

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiration date shown on the tube and carton after EXP. The expiration date is the last day of the month indicated.

To avoid infections, you should discard the tube 4 weeks after first opening it.

Write the opening date of the tube in the space provided on the carton.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of OFTALMOLOSA CUSÍ DEXAMETASONA

• The active ingredient is dexamethasone sodium phosphate. Each gram of ointment contains 0.5 mg of dexamethasone sodium phosphate (0.05%).
• The other ingredients are cholesterol, liquid paraffin, and white petrolatum.

Appearance of the Product and Package Contents

Oftalmolosa Cusí Dexametasona is a white ophthalmic ointment.

It is available in an aluminum tube with a polyethylene cap containing 3 g of ointment.

Marketing Authorization Holder

Fidia Farmaceutici S.p.A.

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

Manufacturer

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 Revision of this Leaflet:November 2016.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es