Colircusi Gentadexa 5 mg/ml + 1 mg/ml + 0.5 mg/ml solution for ophthalmic and otic use

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

COLIRCUSÍ GENTADEXA 5 mg/ml + 1 mg/ml + 0.5 mg/ml eye/ear drops solution

gentamicin sulfate/dexamethasone sodium phosphate/tetrahydrozoline hydrochloride

Read all of this 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. Do not give it to other people, even if they have the same symptoms as yours, because it may 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 COLIRCUSÍ GENTADEXA is and what it is used for
2. What you need to know before using COLIRCUSÍ GENTADEXA
3. How to use COLIRCUSÍ GENTADEXA
4. Possible side effects
5. How to store COLIRCUSÍ GENTADEXA
6. Contents of the pack and other information

1. What COLIRCUSÍ GENTADEXA is and what it is used for

It is a combination treatment for inflammation and infection in the eye and ear. It contains as active ingredients gentamicin, an antibiotic belonging to a group called aminoglycosides used to treat infections, dexamethasone, a corticosteroid with anti-inflammatory and antiallergic properties, and tetrizoline, a decongestant (causing narrowing of the visible blood vessels in the eye); three components that work together to treat infection and inflammation.

One of the active substances in this medicine is an antibiotic. Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Colircusí Gentadexa is indicated for the treatment of anterior segment eye infections with inflammatory complications responsive to corticosteroids, caused by microorganisms sensitive to gentamicin. These include conjunctivitis, i.e. infection of the conjunctiva (the transparent membrane covering the eye), and infectious and allergic blepharoconjunctivitis (inflammation of the eyelid). It is also indicated for keratitis, i.e. inflammation of the cornea or transparent layer covering the front of the eye (superficial, deep, hypersensitivity-related, or flictenular, sclerosing, associated with acne rosacea), and for the treatment of deep (scleritis) and superficial (episcleritis) inflammation of the white part of the eye.

Colircusí Gentadexa is also used for the treatment of ear infection(s) (otic), such as allergic external otitis, and in all other conditions where corticosteroid-antibiotic treatment is required.

2. What you need to know before using COLIRCUSÍ GENTADEXA

Do not use COLIRCUSÍ GENTADEXA

If you are allergic to gentamicin, dexamethasone, tetrizoline, or related products, or to any of the other components of this medicine (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 in your eyes due to anatomy (with blockage of drainage channels).

• Smallpox, chickenpox, or any other eye infection caused by a virus.

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

• Tuberculosis of the eye.

• After removal of a foreign body from the cornea.

Do not use Colircusí Gentadexa in your ears:

• If you have or think you may have:

• Ear canal infection caused by fungi or viruses, or untreated infections caused by parasites.

• Damaged or even perforated eardrum.

Warnings and precautions

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

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

• Due to the risk of possible systemic effects (affecting other parts of the body), take special care if you are a child, elderly, or have a history of serious heart conditions such as hypertension, arteriosclerosis, coronary artery disease, aneurysm (bulge in the wall of an artery or vein), or other cardiovascular diseases, or if you are prone to these conditions, for example, if you are diabetic; if you frequently experience low blood pressure upon changing posture, or have hyperactive thyroid or an adrenal gland tumor (pheochromocytoma).

• Because of the presence of tetrizoline, you may experience pupil dilation, increased eye pressure, and systemic adverse effects due to absorption. Cases of side effects such as headache, increased blood pressure, heart rhythm disturbances (extrasystoles), rapid heartbeat, dizziness, and stroke have been reported. Caution is required if you are receiving certain anesthetics (e.g., halothane).

• If you are taking monoamine oxidase inhibitors (MAOIs) or have taken them within the last 15 days, this medicine may cause a marked increase in blood pressure. The same applies to other medicines that raise blood pressure.

• Serious adverse reactions such as neurotoxicity (nervous system toxicity), ototoxicity (ear toxicity), and nephrotoxicity (kidney toxicity) have been observed with aminoglycoside antibiotics administered systemically (internally, e.g., orally) or when applied locally to open wounds or damaged skin.

• If you experience allergic reactions with this medicine such as eyelid itching, swelling, or redness of the eye, stop treatment and consult your doctor. Allergic reactions may range from localized itching or redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. These allergic reactions may occur with other topical or systemic antibiotics of the same family (aminoglycosides).

• If you are simultaneously using another antibiotic treatment, consult your doctor.

• If your symptoms worsen or recur, consult your doctor. Long-term use of this medicine may increase your susceptibility to eye or ear infections, such as fungal infections; in case of such infections, treatment should be discontinued.

If another infection develops, your doctor will advise you on appropriate treatment.

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

  • Experience increased pressure in the eye(s) and/or glaucoma. You should have your eye pressure monitored regularly while using this medicine. This is especially important in children, as the risk of corticosteroid-induced increased intraocular pressure may be higher in children and may occur earlier than in adults.

• Cataracts may also develop.

Patients predisposed to these conditions (e.g., diabetics and myopes) are at greater risk.

• • You should visit your doctor frequently if you use this medicine for a prolonged period.
  • Develop Cushing's syndrome 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 generally the first signs of Cushing's syndrome. Suppression of adrenal gland function may occur after stopping intensive or long-term treatment with Colircusí Gentadexa. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine called ritonavir or cobicistat.
• Steroids applied to the eye may delay healing of eye injuries. It is also known that ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) slow or delay healing. The combined use of NSAIDs and ophthalmic steroids may increase healing problems.
• If you have a condition causing thinning of eye tissues before using this medicine, consult your doctor, as it could lead to corneal perforation.
• With prolonged use of this medicine, you may experience abnormal dryness in the eyes, which may worsen symptoms of allergic conjunctivitis.
• 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 or infection.

Otic route

If used in the ears (otic route), your doctor must examine the condition of your eardrum.

Children

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

Elderly patients

The safety and efficacy of this medicine have not been established in elderly patients.

Other medicines and Colircusí Gentadexa

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

Inform your doctor if you are using ophthalmic NSAIDs. Concomitant use of corticosteroids and ophthalmic 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 they 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Colircusí Gentadexa is not recommended during pregnancy.

If you are breastfeeding, your doctor 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 use of machines

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

Use in the ears: No effects on driving or use of machines are expected.

Colircusí Gentadexa contains benzalkonium chloride and phosphates

This medicine contains 0.04 mg of benzalkonium chloride per ml.

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

Benzalkonium chloride may cause ocular irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you feel a foreign body sensation, stinging, or pain in the eye after using this medicine.

This medicine contains 1.8 mg of phosphate per ml.

If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, cause blurred vision due to calcium accumulation.

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

3. How to use COLIRCUSÍ GENTADEXA

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

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

How to use in the eye (ophthalmic route)

Recommended dose:

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

Treatment should be gradually tapered by reducing the frequency of administration.

Treatment should not exceed 14 days, unless otherwise directed by your doctor.

Instructions for use

1 2 3

• Wash your hands.
• Take the bottle (dropper container).
• After opening the bottle for the first time, remove the loose plastic seal ring if present.
• Hold the bottle upside down between your fingers.
• Tilt your head backward. Gently pull down the eyelid with one finger to create a pouch between the eyelid and the eye, into which the drop should fall (figure 1).
• Bring the tip of the bottle close to the eye. A mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the drops.
• Gently squeeze the base of the bottle with your index finger to release one drop at a time (figure 2).
• After applying the eye drops, release the eyelid, close your eye, and gently press with your finger on the inner corner of the eye near the nose for at least 2 minutes. This helps prevent the medicine from passing into the rest of the body (figure 3).
• If applying 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 symptoms do not improve within 2 days, consult your doctor.

If you have used more Colircusí Gentadexa than you should, rinse the eyes with lukewarm water. Do not apply further drops until your next scheduled dose.

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

How to use in the ear

Recommended dose:

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

Treatment should not exceed 14 days.

Instructions for use

1 2 3

• Wash your hands.
• Take the bottle (dropper container) and hold it in your hand for a few minutes to warm the contents and prevent the drop from being too cold when entering the ear (figure 1).
• Hold the bottle upside down between your fingers.
• Lie down on your side with the affected ear facing upward.
• Bring the tip of the bottle close to the ear canal (figure 2).
• Do not touch the earlobe, ear canal, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the drops.
• Gently squeeze the base of the bottle with your index finger to release one drop at a time.
• Remain lying down for at least 5 minutes to allow the ear drops to flow into the ear canal (figure 3).
• If applying drops to both ears, repeat the previous steps for the other ear.
• Close the bottle tightly immediately after using the product.

If a drop falls outside the ear, try again.

If you use more COLIRCUSÍ GENTADEXA than you should

Do not apply additional drops until your next scheduled dose.

An overdose in the eyes can be managed by rinsing the eyes with lukewarm water.

Serious reactions may occur (especially in children), such as symptoms of central nervous system depression and severe reactions affecting the heart and circulation; including among others, lowered body temperature, slow heartbeat, sweating, fainting, increased blood pressure followed by a drop.

Other symptoms that may occur if the medicine is accidentally ingested, especially by children, include: palpitations, irregular heartbeat, headache, dizziness, nausea, vomiting, pupil dilation, breathing difficulty, or others.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use COLIRCUSÍ GENTADEXA

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

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 regular dosing 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.

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

Frequency not known (cannot be estimated from the available data ):

• Eye effects: eye irritation, eye pain (including burning), local allergy.
• General adverse effects: allergy (hypersensitivity).
• 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").

Rare cases of corneal calcification have been reported with the use of eye drops containing phosphates in patients with significantly damaged corneas.

Description of selected adverse effects

Use in the eyes:

Prolonged use of ophthalmic corticosteroids may lead to elevated intraocular pressure and/or glaucoma, which may cause optic nerve damage, affecting visual acuity and visual field; cataract may also occur. Delayed corneal healing may appear.

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

In patients with diseases causing thinning of the cornea or sclera, topical use of corticosteroids may lead to corneal perforation, particularly with prolonged treatment.

Secondary infections may develop following combined use of corticosteroid and antimicrobial drugs (such as gentamicin).

Due to the presence of tetrahydrozoline in the formulation, in addition to the other adverse effects mentioned, eyelid inflammation (blepharitis) may occur, as well as systemic adverse effects (in internal parts of the body) resulting from absorption, which appear to be more frequent in children and elderly patients. Systemic toxicity has been reported following local application of sympathomimetic drugs such as tetrahydrozoline, including headache, increased blood pressure, sweating, heart rhythm disturbances (extrasystoles), rapid heartbeat, fainting, and stroke.

Other adverse reactions reported with ophthalmic use include epithelial defects in the conjunctiva and conjunctival redness, and pseudomembranous conjunctivitis.

Use in the ears:

Although uncommon, patients requiring prolonged use of aminoglycoside antibiotics administered via the ear for the treatment of chronic otitis media have experienced hearing loss that may affect both the inner ear and the auditory nerve (sensorineural).

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

Additional adverse effects in children

Excessive use of this medicine in children may cause serious reactions such as decreased body temperature, fainting, 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 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 COLIRCUSÍ GENTADEXA

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

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the bottle and the carton after EXP. The expiry date refers to the last day of the month indicated.

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

Record the date of first opening 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 the SIGRE collection point in your pharmacy. If you are in doubt, please consult your pharmacist on how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Colircusí Gentadexa

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

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

Description of the product and package contents

Colircusí Gentadexa is an eye drop (for ophthalmic use) or ear drop (for otic use) solution; it is a liquid, clear, colourless or slightly yellow solution.

It is presented in a dropper container (plastic bottle with screw cap) containing 10 ml of solution.

Marketing Authorization Holder

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

Manufacturer

SIEGFRIED El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona,

Spain

Or

EXCELVISION S.A.

27, Rue de la Lombardière

07100 Annonay

France

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

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

Date of latest review of this leaflet: January 2019

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