Oftalmolosa Cusi dexamethasone 0.5 mg/g ophthalmic ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OFTALMOLOSA CUSÍ DEXAMETASONA 0.5 mg/g eye ointment

Read this entire leaflet carefully before you start 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Contents of this 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. How to store OFTALMOLOSA CUSÍ DEXAMETASONA
6. Contents of the pack and other information

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

It is an eye ointment containing dexamethasone sodium phosphate as the active substance, a potent corticosteroid with mainly 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 covering the eye), the cornea, or the anterior segment of the eye. Spring and allergic conjunctivitis. Superficial (episcleritis) and deep (scleritis) inflammations of the white of the eye. Inflammations of the iris (iritis), the ciliary body (cyclitis), or combined inflammations (iridocyclitis).

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

Do not use Oftalmolosa Cusí Dexamethasone:

• If you are allergic to dexamethasone or to any of the other ingredients of this medicine (listed in section 6).

• If you have or think you have:

• Untreated bacterial eye infection.

• Corneal inflammation (keratitis) due to herpes simplex or any other eye infection caused by viruses, such as smallpox or varicella.

• Tuberculosis affecting the eye.

• Fungal diseases (fungal infections) of the eye or untreated eye infections caused by parasites.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Oftalmolosa Cusí Dexamethasone.

• Use this medicine only in your eye(s).

• This medicine may increase intraocular pressure, especially if you already have glaucoma or elevated intraocular pressure, or a family history of it; therefore, it should be used under medical supervision.

• If you use this medicine for a long time, you may:

• Develop ocular hypertension and/or glaucoma (with damage to the optic nerve and reduced visual acuity). You should have your eye pressure monitored regularly while using this medicine. Consult your doctor if you have any doubts. The risk of elevated intraocular pressure and/or corticosteroid-induced cataract formation is higher in predisposed patients (e.g., diabetes).

• Develop cataracts. You should visit your doctor frequently.

• Develop Cushing's syndrome and/or suppression of adrenal gland function due to the medicine reaching the bloodstream. 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 discontinuing intensive or long-term treatment with Oftalmolosa Cusí Dexamethasone. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients taking a medicine called ritonavir or cobicistat.

• If your symptoms worsen or return suddenly, please contact your doctor. You may become more susceptible to eye infections while using this medicine. Corticosteroids may also mask signs of 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 appropriate treatment.

• Prolonged use of corticosteroids in the eye may lead to fungal infections of the cornea. If this occurs, treatment should be discontinued. Excessive ocular corticosteroid use may delay healing of eye wounds. Ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are also known to slow or delay healing (see section "Other medicines and Oftalmolosa Cusí Dexamethasone").

• If you have a condition causing thinning of ocular tissue (the outer layers of the eye), using this medicine could lead to corneal perforation.

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

If you wear contact lenses:

• Wearing contact lenses (rigid or soft) is not recommended during treatment for 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 potential increase in intraocular pressure associated with prolonged use of this medicine is particularly important in pediatric patients; the risk of corticosteroid-induced ocular hypertension may be higher in children and may occur earlier than in adults.

Other medicines and Oftalmolosa Cusí Dexamethasone

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor if you are using ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Concomitant use of steroids and ophthalmic NSAIDs may increase corneal healing problems.

Tell your doctor if you are taking ritonavir or cobicistat, as these may cause an increase in the amount of dexamethasone in the blood.

Pregnancy, breastfeeding, and fertility

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

Use of Oftalmolosa Cusí Dexamethasone is not recommended during pregnancy.

If you are breastfeeding, you must decide whether to discontinue breastfeeding or discontinue treatment with this medicine, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using machines

You may notice that your vision becomes blurred for a short time after applying the ointment to your eyes. Do not drive or operate machinery until this effect has passed.

3. How to use OFTALMOLOSA CUSÍ DEXAMETHASONE

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For ophthalmic use (in the eye[s]).

Recommended dose:

Adults:

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

When a satisfactory response is observed within 3-4 days, the frequency of administration may be gradually reduced to once daily.

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

Instructions for use:

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

If you use more Oftalmolosa Cusí Dexamethasone than you should

An overdose in the eyes can be removed by rinsing the eyes with lukewarm water. Do not apply more ointment until your next scheduled dose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount used.

If you forget to use Oftalmolosa Cusí Dexamethasone

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

Apply a single dose as soon as you remember, and then continue with your next scheduled dose. However, if it is almost time for your next dose, do not apply the missed dose and continue with your next dose according to your regular schedule.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are classified by frequency, defined as follows: 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 adverse effects have been reported with this medicine:

Common adverse effects:

• Eye-related effects: eye discomfort.

Uncommon adverse effects:

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

• General effects: disturbance of taste sensation (bad taste).

Frequency not known:

• Eye-related effects: glaucoma (increased intraocular pressure with reduced 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 growth of body hair (particularly in women), muscle weakness and wasting, purple stretch marks on the skin, increased blood pressure, irregular or absent menstruation, changes in body protein and calcium levels, growth delay in children and adolescents, and swelling with weight gain in the body and face (Cushing's syndrome) (see section 2, "Warnings and precautions").

Prolonged use of corticosteroids in the eyes may also cause:

• Increased intraocular pressure with optic nerve damage and reduced visual acuity.
• Cataract formation.
• Delayed corneal healing.
• In diseases causing corneal thinning, there is an increased risk of perforation.

Corticosteroids may reduce resistance to ocular infections, thereby promoting their occurrence.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of OFTALMOLOSA CUSÍ DEXAMETHASONE

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 tube and the carton after EXP. The expiry date refers to the last day of the month indicated.

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

Record the date you opened the tube in the space provided for this purpose on the carton.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oftalmolosa Cusí Dexamethasone

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

Appearance of the product and contents of the pack

Oftalmolosa Cusí Dexamethasone is a white or whitish ophthalmic ointment.

It is presented 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 most recent review of this leaflet: November 2016.

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