Prospecto: information for the user

COLIRCUSÍ GENTADEXA 5 mg/ml + 1 mg/ml + 0,5 mg/ml eye drops in solution

gentamicin sulfate/dexamethasone sodium phosphate/tetrahydrozoline hydrochloride

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

• Keep this prospect, 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 should not give it to others 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 do not appear in this prospect. See section 4.

1. What isCOLIRCUSÍ GENTADEXAand for what it is used

2. What you need to know before starting to useCOLIRCUSÍ GENTADEXA

3. How to useCOLIRCUSÍ GENTADEXA

4. Possible adverse effects

5. Storage ofCOLIRCUSÍ GENTADEXA

6. Contents of the package and additional information

It is an association of treatments for inflammation and infection in the eye and ear. It contains gentamicin, an antibiotic that belongs to a group called aminoglycosides used to treat infections, dexamethasone, a corticosteroid with anti-inflammatory and antiallergic properties, and tetrazoline, with a decongestant action (produces narrowing of the visible blood vessels of the eye); three components that work together to treat the infection and inflammation.

Colircusí Gentadexa is indicated for the treatment of anterior eye infections with inflammatory complications that respond to corticosteroids, caused by gentamicin-sensitive pathogens, such as conjunctivitis (infection of the conjunctiva, a transparent membrane that covers the eye) and blepharoconjunctivitis (infectious and allergic inflammation of the eyelid). It is also used for the treatment of keratitis (inflammation of the cornea or transparent layer that covers the front of the eye, of superficial, deep, hypersensitivity reaction, or flictenular, sclerosing, or rosacea acne type) and for the treatment of inflammation of the eye white, deep (scleritis) and superficial (episcleritis).

Colircusí Gentadexa is also used for the treatment of ear infections (otitis) such as allergic otitis externa and in all conditions where corticosteroid-antibiotic treatment is required.

Do not use COLIRCUSÍ GENTADEXA

If you are allergic to gentamicin, dexamethasone, tetrahydrozoline, or related products, or to any of the other components of this medication (listed in section 6).

Do not use Colircusí Gentadexa in your eyes:

• If you have or think you may have:

• Simple glaucoma.
• Narrow-angle glaucoma or narrow-angle glaucoma in your eyes due to anatomy (with blockage of drainage channels).
• Chickenpox, shingles, or any other viral eye infection.
• Fungal eye infections or untreated eye infections caused by parasites.
• Eye tuberculosis.
• After the removal of a foreign body from the cornea.

Do not use Colircusí Gentadexa in your ears:

• If you have or think you may have:

• Infection in the ear canal caused by fungi or viruses, or untreated infections caused by parasites.
• Damaged or perforated eardrum.

Warnings and precautions

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

• Only use this medication in your eyes or ears.
• Due to the risk of possible systemic effects, be careful in children, if you are elderly, or have a history of severe heart disease, such as hypertension, arteriosclerosis, coronary disease, aneurysm (bulge in the walls of an artery or vein), or other cardiovascular diseases or if you are prone to them, such as if you are diabetic; if you often experience a drop in blood pressure when changing position or have hyperthyroidism, or an adrenal gland tumor (pheochromocytoma).
• Due to the presence of tetrahydrozoline, you may experience pupil dilation, increased eye pressure, and systemic adverse effects by absorption. Cases of effects such as headache, increased blood pressure, arrhythmias, rapid heart rate, dizziness, and cerebrovascular accidents have been reported. Precaution is required if you are receiving certain anesthetics (e.g., halothane).
• If you are taking monoamine oxidase inhibitors (MAOIs) or have taken them in the last 15 days, you may experience a pronounced increase in blood pressure with this medication. Also with other products that raise blood pressure.

• Severe adverse reactions such as neurotoxicity, ototoxicity, and nephrotoxicity have been observed with aminoglycoside antibiotics used systemically (internally, e.g., orally) or when these are applied locally in open wounds or damaged skin.
• If you experience allergic reactions such as itching, swelling, or redness of the eye with this medication, discontinue treatment and consult your doctor. Allergic reactions can vary from localized itching or redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. These allergic reactions can occur with other topical or systemic antibiotics of the same family (aminoglycosides).
• If you are using another antibiotic treatment at the same time, consult your doctor.
• If your symptoms worsen or return, consult your doctor. With the use of this medication over a long period, you may become more sensitive to eye or ear infections, such as fungal infections; in the case of this type of infection, you should discontinue treatment.

If another infection appears, your doctor will indicate the treatment to treat it.

• If you use this medication for a long period in your eyes, you may:
• • Experience increased eye pressure and/or glaucoma. You should regularly monitor eye pressure while using this medication. This is especially important in children, as the risk of increased ocular pressure caused by corticosteroids may be greater in children and occur before it does in adults.

Patients with a higher risk include, for example, diabetics and myopes.

• • You should visit your doctor frequently if you use this medication for a long period.
  • You may develop Cushing's syndrome due to the medication entering 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. Suppression of adrenal gland function may occur after interrupting intensive or long-term treatment with Colircusí Gentadexa. Consult your doctor before discontinuing treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat.
• Topical steroids can delay the healing of eye wounds. It is also known that non-steroidal anti-inflammatory drugs (NSAIDs) can slow down or delay corneal healing. The use of NSAIDs and topical steroids may increase corneal healing problems.
• If you have a condition causing thinning of the eye tissues before using this medication, consult your doctor, as it may cause corneal perforation.
• With prolonged use of this medication, you may experience abnormal dryness in your eyes, which may worsen the symptoms of allergic conjunctivitis.
• 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 or infection.

Ocular route

In the case of use in the ears (ocular route), the doctor should check the status of your eardrum.

Children

Do not use Colircusí Gentadexa in children under 18 years old, as its safety and efficacy have not been established.

Older adults

The safety and efficacy of this medication have not been established in older adults.

Other medications and Colircusí Gentadexa

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. The concomitant use of corticosteroids and NSAIDs may increase corneal healing problems.

Especially inform your doctor if you are taking or may be exposed to monoamine oxidase inhibitors (MAOIs).

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

Colircusí Gentadexa is not recommended during pregnancy.

If you are breastfeeding, your doctor should decide whether to discontinue breastfeeding or discontinue 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

Use in your eyes:You may experience blurred vision immediately after applying Colircusí Gentadexa for a while. Do not drive or operate machinery until this effect has disappeared.

Use in your ears:No expected effects on driving or operating machinery.

Colircusí Gentadexa contains benzalkonium chloride and phosphates

This medication contains 0.04 mg of benzalkonium chloride in each ml.

Use in your eyes:Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases. Consult your doctor if you experience a strange sensation, stinging, or pain in the eye after using this medication.

This medication contains 1.8 mg of phosphate in each ml.

If you have severe corneal damage, treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Use in your ears:Benzalkonium chloride may cause skin irritation. Do not apply on mucous membranes.

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

Colircusí Gentadexa can be used as eye drops (ophthalmic route) and ear drops (otic route).

How to use in the eye (ophthalmic route)

The recommended dose is:

Adults: 1 or 2 drops in the affected eye(s) every 4 or 5 hours (in severe infections, the instillation frequency may be increased). The frequency may be reduced as directed by your doctor.

The treatment should be gradually reduced, reducing the administration frequency.

The treatment should not exceed 14 days, unless otherwise indicated by your doctor.

Usage recommendations

123

If a drop falls outside the eye, try again.

If symptoms do not improve in 2 days, consult your doctor.

If you use more Colircusí Gentadexa than you should, you can remove it by washing your eyes with warm water. Do not apply more drops until you touch up.

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

How to use in the ear

The recommended dose is:

Adults: 3 or 4 drops in the affected ear(s), 3 times a day.

The treatment should not exceed 14 days.

Usage recommendations

123

If a drop falls outside the ear, try again.

If you use more COLIRCUSÍ GENTADEXA than you should

Do not apply more drops until the next dose.

You can remove an overdose in the eyes by washing your eyes with warm water.

Severe reactions may occur (especially in children), such as symptoms of central nervous system depression and severe reactions affecting the heart and circulation; among other symptoms, low body temperature, slow heart rate, sweating, fainting, high blood pressure followed by low blood pressure.

Other symptoms that may appear if the medication is accidentally ingested, especially by children, are: palpitations, irregular heartbeats, headache, dizziness, nausea, vomiting, dilated pupils, difficulty breathing, or others.

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

If you forgot to use COLIRCUSÍ GENTADEXA

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

Apply a single dose as soon as you remember, and continue with the next dose 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.

The following side effects have been observed when this medicine is used in the eye.

Unknown frequency(cannot be estimated from available data):

Rarely reported cases of corneal calcification have been reported with the use of phosphate-containing eye drops in patients with significantly affected corneas.

Selected adverse effect descriptions

Use in the eyes:

Prolonged use of ocular corticosteroids may cause increased intraocular pressure and/or glaucoma, which can cause optic nerve damage, affecting visual acuity and visual field; it may also produce cataracts. Andmay appear delayed corneal healing.

The corticosteroid (dexamethasone) may cause dizziness, headache, corneal inflammation, conjunctivitis, dry eye, corneal staining, sensitivity to sunlight (photophobia), blurred vision, eye itching, foreign body sensation, increased tear production, crust formation at the eyelid margin, eyelid redness, corneal erosion, and pupil dilation.

In patients with diseases that cause corneal or scleral thinning, topical corticosteroid use causes corneal perforation, more likely with prolonged treatment.

Secondary infections have developed after the combined use of corticosteroid and antimicrobial medications (such as gentamicin).

Due to the presence of tetrahydrozoline in the composition, in addition to other adverse effects mentioned, blepharitis (inflammation of the eyelid) may appear, as well as systemic adverse effects (in internal body parts) resulting from absorption, which appear to be more frequent in children and the elderly. Systemic toxicity has been reported with the local application of sympathomimetic medications, such as tetrahydrozoline, including headache, increased blood pressure, sweating, heart rhythm disturbances (extrasystoles), rapid heartbeats, dizziness, and cerebrovascular accidents.

Other reported adverse reactions via the ocular route are epithelial defects in the conjunctiva and its redness, and pseudomembranous conjunctivitis.

Use in the ears:

Although rare, patients requiring prolonged use of aminoglycoside antibiotics via the otic route for the treatment of chronic otitis media have experienced hearing loss that can affect both the inner ear and the auditory nerve (neurosensorial).

Other otic adverse effects are: acne with prolonged administration, delayed healing, and skin irritation.

Additional adverse effects in children

Excessive use of this medication in children may cause severe reactions such as hypothermia, dizziness, or other symptoms of central nervous system depression.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30 °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 it has been opened for the first time.

Note the date of opening the bottle in the reserved box for this purpose on the box.

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

Composition of Colircusí Gentadexa

• The active principles are gentamicin, dexamethasone sodium phosphate, and tetrahydrozoline hydrochloride. One milliliter of solution contains 5 mg of gentamicin sulfate (0.5%) (corresponding to 3 mg/ml of gentamicin), 1 mg of dexamethasone sodium phosphate (0.1%), and 0.5 mg of tetrahydrozoline hydrochloride (0.05%).

• The other components are: benzalkonium chloride, disodium dodecahydrate hydrogen phosphate, sodium chloride, povidone, and purified water/water for injectable preparations.

Appearance of the product and contents of the packaging

Colircusí Gentadexa is an eye drop (for ophthalmic use) or eye drops (for otic use) in a solution; it is a liquid, transparent, colorless, or slightly yellowish solution.

It is presented in a dropper bottle (plastic bottle with a screw cap), which contains 10 ml of solution.

Holder of the marketing authorization

NTC s.r.l., via Luigi Razza, 3, 20124 Milan, Italy

Responsible for manufacturing

SIEGFRIED El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona,

Spain

O

EXCELVISION S.A.

27, Rue de la Lombardière

07100 Annonay

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

NTC Ophthalmics Iberica S.L., Calle Pinar, 5, 28006 Madrid, Spain

Date of the last review of this prospectus:January 2019

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